SpicyIP: Roundup of the Convention on Biological Diversity Summit

The Convention of the Biological DiversitySummit was held in Bonn, Germany between the 19th to the 30th of May. Coinciding with the World Biodiversity day on the 22nd of May, the Summit was attended by by the supremo uno's of the CBD world and key government negotiators. The summit could well go down as a watershed event in the annals of CBD history.

Laudable milestones and significant breakthroughs in the IP agenda pertaining to key issues sullying the CBD in the past years were reconciled with a near consensus between the members countries

(i) The negotiating parties reached an agreed to set up an equitable ABS mechanism for biodiversity and its use.

(ii)A near consensus was also reached on laying down a framework for the protection of traditional knowledge and biodiversity

Simultaneously the ninth session of the COP(Conference of the Parties) which is the governing body of the CBD also assembled in Bonn to review and assess the progress of the member states in the achievement and implementation of the convention goals.

While the earlier CBD meet in 2002 had decided to set up the ABS mechanism , progress was slow and stunted. Most notably, after years of ardent negotiation and lobbying by the various interest group the agenda was successfully completed this year with the much awaited ABS architecture in place.

The ABS text lays down the blueprint and the way forward for the next few years. Also it deals with other substantive issues such as linking access to genetic resources with benefit-sharing, access to technology and technology transfer, and mechanisms to promote equality in negotiations. The latest available drafts can be downloaded from the CBD website.

Th most noteworthy provision in the draft is the instruction to "clearly [identify] the components of the international regime that should be addressed through legally binding measures, non-legally binding measures, or a mix of the two.”

The negotiations on CBD Article 8(j) pertaining to biodiversity and indigenous communities, witnessed a display of solidarity and strength. Most issues were reconciled and agreed on save for the one on climate change.

The “conference room paper” on Article 8(j) set out guidelines for defining, documenting, and protecting indigenous knowledge as well as the rights of indigenous people and local communities to participate in the definition and protection of their knowledge, including by sui generis (in kind) means. tems in 8(j) involving intellectual property include: a request for the executive secretary of the CBD to work with the World Intellectual Property Organization as well as the UN Forum on Indigenous Issues and the UN Educational, Scientific and Cultural Organization (UNESCO) to address issues involved in documenting traditional knowledge. Some indigenous groups feel that documentation may prevent biopiracy by proving that they have ‘prior art’ on their traditional knowledge, even without patents, while others feel that databases for documentation are inappropriate means to store indigenous ideas.

For all CBD enthusiasts, there is lot of good read on the CBD site, ip-watch does an in depth covergae of the developments at the Summit... I also recommend reading Susan Finstons(of the American Bioindustry Alliance) notings on the International Regime in the context of the CBD

SpicyIP Jobs

We have a few positions open for legal professionals with relevant IP experience.

For those of you seeking to access 'SpicyIP Jobs' on our blog site to check on current and past listings, please find instructions as below.

Go to the SpicyIP homepage.

On the left hand side of the page, you will find a list of sub headings.

Click on the title 'SpicyIP Jobs'. This will take you to the posts related to the jobs listed on our blogs and provide you with instructions on how to apply.


Current Positions

1. IP Infringement Lawyer

Location : Dubai

Position : Manager Legal – IP

Role : To manage and protect the company’s intellectual property. This would include developing and implementing strategy to deal with infringement of the company’s intellectual property. Instituting and managing litigation and other action relating to infringement of the company’s IP in Asia and Europe.

Experience : 4- 8 years of IP experience in a law firm or company with a specific experience in handling IP infringement.

Salary : Among the best in the industry

To Apply: Interested professionals may send their resumes to iris@rainmaker.co.in with the subject line titled “IP Infringement – Dubai”

2. Junior IP Lawyer

Employer : Global Investment Bank

Location : Bangalore

Position : IP Attorney

Role: Drafting, negotiating and executing trademark license and sponsorship agreements, trademark clearance and internet domain name search and clearance, copyright clearance, IP database management

Qualification

India attorney qualification; at least 2-3 years intellectual property and commercial experience with global branding issues (preferably in the financial sector) or involvement with a in a major law firm or reputable company;

US or English law experience helpful

ability to review detailed documents with an eye for detail and provide prompt responses to clients;

able to work as a member of close team and respond to client demands while adhering to firm policies and practices;

solid basic contract law/intellectual property knowledge;

Word processing skills required.

ability to understand complex commercial issues in dissemination and distribution of information over the internet;

excellent interpersonal and communication skills both oral and written required

To Apply: Interested professionals may send their resumes to iris@rainmaker.co.in with the subject line titled “Junior IP Lawyer – Bangalore”.

We request candidates applying for these positions to mention in their application that 'SpicyIP' is the source of contact and information.

SpicyIP tidbit:Nalsar moves to Number one slot

In a recent survey conducted by the Indian Today publication, the Hyderabad based National National Academy of Legal Studies and Research (NALSAR) University of Law, Hyderabad has emerged as the top law school of the country.

Ranked No. 2 for the last two years, NALSAR has finally toppled the formidable National Law School of India University (NLSIU), Bangalore, from the numero uno position it had been occupying for several years. Their distinction is reflective of the learning ethos at NALSAR, which, as the fifth batch passes out this year, has emerged as the top law school in the country. What has helped NALSAR emerge on top is the consistency in training and the holistic educational experience offered with superior infrastructure.

“We inculcate qualities in students: a commitment to ethics, diversity, public interest, and social justice,” says Vice-Chancellor Professor Ranbir Singh. He argues NALSAR’s reputation “has grown dramatically and it is known for developing lawyers of strong character who become the best of legal professionals”.

Indian Supreme Court on an "IP" Roll: "Scotch" Whisky Denied Protection While Music "Compulsory Licensing" Scope Expanded

As temperatures continue to soar in New Delhi, the Supreme Court of India hands down three IP decisions—and all within a span of a month. Leading one to paradoxically muse in this blisteringly hot month, “When it rains, it really pours!”

All three decisions were penned by Justice Sinha, one of the finer Supreme Court judges on the bench today. Constitutional law scholars will remember his landmark judgment in a sex discrimination case, Anuj Garg v. Hotel Association of India. Commenting on this case, which pushed the frontiers of “equality” jurisprudence in India, a friend of mine who researches constitutional law at the Univ of Oxford, Tarunabh Khatain writes in an article (to be published): “The judgment, if it becomes an established precedent, has the potential to transform constitutional jurisprudence in India on a scale comparable to Kesavananda Bharati, Royappa and Maneka Gandhi”.

My special thanks to V. Venkatesan, a leading legal journalist (Deputy Editor at Frontline) and my co-blogger at "law and other things" for pointing me to these decisions.

These decisions add to the repertoire of Indian trademark and copyright jurisprudence in significant ways. I’m blogging on only one of these decisions….not least because it involves my favourite drink. I deal peripherally with the other two judgments—and will leave detailed anlayses of the same to my more capable team members, Mrinalini Kochupillai and Kruttika Vijay.

1. Khoday Khoday India Limited vs The Scotch Whisky Association and others (Civil Appeal 4179 of 2008: decided on May 27, 2008)
In this case, the issue was whether or not the trademark "Peter Scot" ought to be deleted from the Register of Trademarks (under section 46 of the Trademarks Act, which provides for rectification of the register).

The brief facts, available in this Times of India report are:

“Khoday India Ltd (KIL) started producing 'Peter Scot' whisky in 1968 and got the trademark registered in 1974. After 13 years, the Scotch Whisky Distillers Association (SWDA), an industry body of distillers, blenders and exporters of Scotch whisky, moved the Assistant Registrar Trademarks for cancellation of the registered trademark 'Peter Scot' on the ground of its deceptive similarity to a foreign mark (Scotch whisky).”

The Supreme Court (Justice Sinha and Justice LS Panta) held in favour of KIL's right to continue being the registered proprietor of the "Peter Scot" mark. One of the factors that influenced the court to hold the way it did was the delay/acquiescence on the part of SWA i.e. although SWA had knowledge about registration of the 'Peter Scot' trademark as early as September 1974, it waited for more than 12 years to move the Registrar for deletion of the said mark. The judge held that “We, therefore, in the peculiar facts and circumstances of this case, are of the opinion that action of the respondents is barred under the principles of acquiescence and/ or waiver. "


I was amused to find this Mint report provocatively titled “Whisky win could be offset by potential losses in rice and tea”. The report then goes on to state:
“India can have its whisky, and drink it too, but it risks losing out in the global rice and tea market. A ruling by the Supreme Court on Tuesday ended the almost two-decades-long challenge by an association of Scotch whisky makers to Khoday India Ltd’s right to have a non-Scotch whisky brand called Peter Scot because of the similarity between the words “Scot” and “Scotch”.

But the ruling could result in global retaliation and affect Indian products such as basmati rice and Assam tea, say analysts. That’s because the Supreme Court ruled in favour of Khoday despite the geographical indication (GI) status enjoyed by Scotch. Unlike a trademark—a unique and distinctive sign to identify a product or service—a GI is a sign used on goods that have a specific place of origin and possess qualities or reputation that are due to that origin.”

I couldn’t stop laughing at this doomsday prediction. Obviously our dear reporter hadn’t read the judgment. Else she would have found out that this case turned more on the traditional law of “passing off”, and much less on the new law of Geographical Indications (the Indian Geographical Indications of Goods Act was passed in 1999, but came into force only in 2003).

In fact, she might have also uncovered that the “Scotch Whisky” wasn't even registered as a geographical indication (GI) in India. In fact, I am given to understand that no application for registration has been filed as yet in India! And yet, she presciently notes that India will face retaliation!

The only possible connection with GI law is the fact that the Indian GI Act specifically preserves the rights of existing trademark owners i.e. Section 26 of the Act protects trade marks which had been acquired through use in good faith prior to the coming into force of the GI Act or the date of filing of the GI application in question.

Luckily, her report goes on to quote one sensible source, Neel Mason, managing partner, Mason and Associates, a firm that specializes in intellectual property rights law who cautions that: “…every case is decided on specific facts. Issues of pricing, delay and nature of the labels or products are different and need to be seen on a case-to-case basis."

As Neel rightly states, one has to look specifically to the facts of this case. And if one did so, one would find that it was “delay” and consequent acquiescence/waiver that caused Justice Sinha to decide the way he did. And not any deep disrespect for this fine whisky from Scotland--a whisky that perhaps his Lordship indulges in occasionally.

In other words, the principle endorsed by Justice Sinha is that if you delay enforcing your rights, you run the risk of an assumption that you have either waived your rights or that you have acquiesced in the infringement. This principle is applied by most other sensible legal systems that I know of. Expecting some sort of foreign “retaliation” for adhering to such a well-established legal principle is amusing, to say the least.

2. M/s Entertainment Network (India) Ltd. Vs M/s Super Cassette Industries Ltd (Civil Appeal NO. 5114 of 2005, May 16, 2008).

This case involved challenging issues pertaining to the “scope” of compulsory licensing (CL) of sound recordings under Indian law. The case had its origins in complaints filed by several radio operators under Section 31 (1) (b) of the Copyright Act, 1957, before the Copyright Board praying for a compulsory license in relation to the “sound recordings” held by Phonographic Performance Ltd (PPL) as they were unable to negotiate a rate with PPL. PPL is one of the two collecting societies in India (the other is IPRS: Indian Performing Rights Society, which is mainly a collecting society for underlying works in sound recordings).

While PPL argued that a compulsory license could issue only if the ”work” had never been made available to the public earlier, the radio stations argued for an almost automatic CL ground i.e. it was to be granted upon request and the only point for consideration was a determination of “reasonable royalty”.

Justice Sinha (again sitting with Justice LS Panta) held in favour of the latter interpretation. A second issue pertained to whether the Act (section 31 (2)) restricted CL applications to only one party or whether multiple parties could apply. Here again, although a literal reading of the section made clear that there could only be one such applicant, Jusice Sinha adopted a “purposive” approach and held in favour of multiple applicants. He noted in particular that:

“Sub-section (2) of Section 31 would lead to an anomalous position if it is read literally. It would defeat the purport and object of the Act. It has, therefore, to be read down. Purposive construction therefore may be resorted to.”

Based on his interpretation of section 31 permitting an almost automatic compulsory license (subject to reasonable royalty) and multiple licensees, he refers the case back to the copyright board for determining "appropriate" royalties.

What is interesting in this case is that Justice Sinha equates an intellectual property right to a “property right” (under Article 300A of the Constitution of India) and even to a human right!
He states that:

“An owner of a copyright indisputably has a right akin to the right of property. It is also a human right. Now, human rights have starte gaining a multifaceted approach. Property rights vis-`-vis individuals are also incorporated within the `multiversity' of human rights.

However, he later goes on to suggest that such rights can be overridden for greater public good:
“…when a right to property creates a monopoly to which public must have access, withholding the same from public may amount to unfairtrade practice. In our constitutional Scheme…, monopoly is not encouraged. Knowledge must be allowed to be disseminated. An artistic work if made public should be made available subject of course to reasonable terms and grant of reasonable compensation to the public at large.”

The judge also makes very interesting statements regarding the applicability of international conventions in interpreting domestic issues (an issue that came up in the famous Novartis patent litigation in India, where it was alleged that section 3(d) contravened TRIPS).

Unfortunately, Justice Sinha falls prey to the verbal diarrhoea syndrome exhibited by many Indian judges (the most flamboyant of whom was Justice Krishna Iyer). In his 178 page judgment, the key part really begins only at page 138 or so.

Kruttika will bring you a full-fledged analysis on this case soon. In the meantime, for a concise view of this ruling from an industry perspective, see here.

3. Kabushiki Kaisha Toshiba vs TOSIBA Appliances Co. & Ors: Civil Appeal No 3639 of 2008 (decided May 16, 2008)

The third Supreme Court decision to be handed down this month is a very complicated trademark case involving the famous mark “Toshiba”. Like the Scotch whisky case mentioned earlier, this one also involved an application (by an Indian entity, Tosiba Appliances Co) to rectify the register of trademarks under section 46. The key ground was that the mark “Toshiba” was never “used” in India (in relation to some goods such as washing machines and spin dryers) and that the proprietor of this mark indulged in “trademark trafficking”.

The court (Justice Sinha sitting with LS Panta) seemed to suggest that a mere use of the mark in relation to servicing centers (which serviced washing machines imported from abroad) could amount to “use”. And that a person such as Tosiba Appliances who never engaged with washing machines and dryers was not a “person aggrieved” under section 46 and did not have “locus standi” to challenge the mark.
As Shwetasree Majumder, one of the counsels in this litigation and a former blogger at SpicyIP quips: the court was attempting to prevent the challenger (Tosiba Appliances) from playing “dog in the manger”. Tosiba Appliances, the Indian company that challenged the mark was neither dealing with washing machines and spin dryers itself. Nor did it want the Japanese Corporation, Kabushiki Kaisha Toshiba, the proprietor of the mark to avail of it in relation to these goods!

In my rather simplistic analysis, I may have missed out on some of the finer points of this case. But have no fear—in a short while, our very own Mrinalini Kochupillai will navigate you dexterously through this complex morass of facts and law.

The first 2 decisions commented upon above appear to be adverse to the rights owner---the first decision does not protect a world famous “Scotch Whisky” mark and the second one carves out very broad compulsory licensing norms in the context of copyright law, even at the cost of explicitly overriding the express terms of statute. The third one however supports the rights of a foreign trademark owner, even when the “use” is not really substantial or direct.

Once we have detailed analyses from Mrinalini and Kruttika, we can begin to engage with the merits of these decisions.

Till then, lets celebrate the fact that there have been 3 IP Decisions in a single month from the Supreme Court. And while these judgments may not be path-breaking in terms of pushing the frontiers of IP jurisprudence (barring perhaps the copyright judgment), they are nonetheless very significant contributions to the area from the apex court. Lets toast to the Supreme Court of India!

Australian Publisher Seeks Writers For "insider" News on Indian Tech Industry

SpicyIP was requested to pass on the following message to the readers of SpicyIP by DJ Varma, an Australia based journalist who publishes Techgoss , a website that reports on the inside stories in the Indian IT, BPO and KPO industry.

"Do you know of or are working on interesting legal/IP cases about the IT, BPO, KPO, search engines, social networking sites and other elements of the booming tech sector? Techgoss reports on the inside stories in the IT/BPO and KPO Sectors and is looking to cover such cases for our readers. Techgoss is fully funded till late, 2009.

We pay Rs. 1,000 for short 200 word snippets.

If this piques your interest do write in to editor@techgoss.com. Please Cc every email to techgoss@hotmail.com

Company Profile: Website reporting on the interesting things happening in the IT, BPO and KPO Services industries in India and abroad. ‘About Us’ in techgoss.com has more details."

DJ Varma has a very interesting background (see 'About Us' column on website) and has archived some of his articles on the website(he has written for Tehelka, Sydney Morning Herald and other media).

All of Techgoss' articles are also syndicated to the print edition of the Indian newspaper in Australia. Techgoss reports on anything that happens in the IT, BPO and KPO sectors as well as anything to do with computing departments/tech sections in India. Its focus also includes the social aspects of people who work in the tech sector: however, it avoids articles like setting up networks, optimizing databases etc. So if you have insights (of the "spicy" kind on the Tech industry in India) and could do with some extra money, please write to DJ Varma.

Roche vs Cipla: Was Roche's Legal Strategy Flawed?

Readers may recollect our earlier post on legal strategy in the context of the famous Novartis (Glivec) patent dispute. I compared the patent strategies of Roche and Novartis and noted:

"Compare and contrast Novartis’ aggressive and weakly thought out patent strategy with that of Roche, which has gone on to acquire four patents already. Its patent covering pegylated interferon (Pegasus) has now been challenged in a post grant opposition, but one hardly hears of this in the press. Roche has been strategic enough to play it quiet, increasing the chances of it’s patent applications being decided in a more objective manner. Novartis has only excacerbated the politicization of this dispute—and given that most adjudicators are not hermetically sealed off from society, it is likely that a steady stream of anti Novartis headlines pouring out of leading newspapers will have their desired impact."

Well, from whatever little we've seen of Roche's performance in their latest bout with CIPLA before the Delhi High Court, it appears that I'd spoken too soon. Folks watching this litigation closely will agree that Roche's loss can be attributed in large part to flawed legal strategy. For our previous posts on this issue, see here.

Let me try and discuss some of them below. I hope our readers appreciate that this post centers around legal strategy (a topic that I am deeply interested in, given that I was an intellectual property practitioner, prior to making the transition to academia). It does not purport to deal with policy arguments or determine which side is right or wrong.

1. Failing to Produce Patent Claims In Court

We had already touched upon this in an earlier post, and I recapitulate:

"Apparently, Roche's application for an ex-parte interim injunction did not even contain the complete specification of the patent! They merely filed a copy of the patent certificate issued--as anyone familiar with patents knows, the certificate merely lists the title of the invention and the inventor's name etc. It does not contain the "claims", "description of invention" or other substantive details of the patent. How did Roche expect to get an ex-parte injunction without submitting this, we wonder? Of course, CIPLA's counsel immediately pointed to this, and on the next day of hearing, this complete specification was submitted. Bad foot to start off on, I think."

2. Failure to Argue "Irreparable Injury"

Any decent law student will know that an injunction is not automatic in India, but can issue only if 3 conditions are satisfied:

1. Prima Facie case in favour of the plaintiff
2. Irreparable injury to the plaintiff, if injunction not granted
3. Balance of convenience is in favour of the plaintiff.

Roche merely set out to satisfy the first criterion above and assumed that once a "prima facie" case was made out, it would win the case. Not so, said the judge and took the counsel to task in his judgment:

"The last and also significant factor that has to be examined is the question of irreparable hardship. Strangely, the plaintiff did not even address the court on this issue - presumably on its assumption that an injunction would follow once a prima facie case was established. As discussed earlier, in the section concerning balance of convenience, irreparable hardship is a separate distinct head which the Court of necessity has to examine and be satisfied about, while considering interlocutory applications for injunction. The crucial aspect here is whether refusal of injunction would cause such irreparable hardship to the plaintiff as cannot be later compensated in mandatory terms. "

3. Misrepresenting the "Price"?

Roche's counsel argued that its drug, Tarceva was priced at Rs 3200 per capsule. CIPLA's counsel countered this by producing packaging belonging to Roche which showed the MRP as Rs 4800 per tablet. As stated in the judgment by Justice Bhat:

"The Defendant contests this and has produced packaging of the plaintiff and copies of bills disclosing the particulars of Tarceva, as costing Rs. 48,000/- per strip of 10 tablets."

It was Roche’s word against what was stated on the packaging. No points for guessing which way the judge went. No doubt, this error must have cost Roche's credibility dearly. Judges are human after all, and do not take too kindly to litigants that are seen to be taking it for a ride.

4. Failure to Publicise "Access" Program

Prashant posted earlier on a Mint report, where Mr Telang went on record to state that: "We have assistance programmes where we support patients, free of cost. I don’t have numbers but, whenever a patient needs assistance and the doctor requests us, we always provide it."

Pray, why wasn't this brought to the attention of the court? An access program would have sufficed to dispel the court's concern that poor patients could not afford Roche's expensive drug, Tarceva. Had this been publicised, the court would have been more likelier to find that the "public interest" was in favour of Roche being granted the injunction.

Roche ought to have carefully studied the Novartis EMR litigation, wherein Novartis publicised its access program (GIPAP) and used it effectively to procure an injunction against generic manufacturers. A little background to enable our readers to appreciate this point:

Novartis had procured an exclusive marketing right (EMR) covering Glivec in November 2003, subsequent to which the price of Glivec shot up around 30 times. Novartis sued generic drug makers such as Ranbaxy and Cipla before the High Courts of Madras and Bombay on the strength of its EMR. The Madras High Court upheld the EMR and injuncted the said drug producers on various grounds, including, inter alia, the fact that Novartis ran a free patient access programme titled “GIPAP” (Glivec International Patients Assistance Program) and undertook to make this programme even more user friendly to patients that could not afford the drug. This, the court held, was sufficient to take care of any “public interest” ground that might have militated against the grant of an injunction. (The Bombay High Court however disagreed with the ruling of the Madras High Court, noting that the validity of Novartis’ EMR had been seriously challenged by the generic manufacturers).

OPPI Nasscom Conference: Responding to Roche's Counsel

I posted some weeks back on an OPPI-Nasscom conference that I had attended in New Delhi. Interestingly, during the course of my presentation, I was confronted by Roche's company secretary, Shivkumar Laud. He was very upset with the fact that I attempted to demonstrate Justice Bhat's decision as a perfectly reasonable one. He alleged that I hadn't read the judgment and that I had my facts wrong.

Since the moderator didn't give me a chance to respond (for reasons best known to him), I was unable to point Mr Laud to specific paragraphs in the judgment that would have made clear what the "facts" were. For the benefit of our readers and to throw more light on whether or not Roche got its strategy wrong, let me try and recount some of his contentions and compare them with the findings in Justice Bhat’s judgment.

1. Pricing

Mr Laud contended that Roche was selling at Rs 3200 per tablet. Also, in a recent interview, Roche's MD in India, Girish Telang insisted that the cost per capsule is Rs 3200.

As I'd mentioned earlier in this post, the judge very categorically dismissed this figure of Roche in favour of figures asserted by Cipla and backed up with hard evidence (i.e Roche's packaging produced in court). Unless CIPLA doctored the packaging produced in court or produced the wrong packaging, Laud's "Rs 3200" version will not fly.

Laud further contended that Roche was hit with an import duty of 32%. His contention was that if we removed this "import duty" from the final price, then the price differential (between Roche's Tarceva and Cipla's Erlocip) is not that significant. Here again, Cipla effectively demonstrated to the court that Roche ought not to claim the benefit of this import duty in computing the price differential, as Cipla was also hit with a significant excise duty. The judge reproduced Cipla’s contention (as below) and appeared to agree with it:

“The Plaintiff justifies the huge price of Tarceva on the ground that it includes huge customs duties by the plaintiff. Counsel [for the Defendant] submits that Defendant also pays huge excise duties on the drugs manufactured by it and thus the price differential is extremely high despite the said duties paid by parties.”

Unfortunately, neither party nor the judge inform us as to what the excise duty faced by Cipla is. Does Cipla also get hit with a 32% excise duty? Hopefully, more light will be thrown on this during the trial.

2. Injunction Jurisprudence

Laud contended that since the Indian patent act did not speak about "public interest", the judge was wrong to rely on it.

Perhaps Mr Laud needs to go back to law school. The principles governing the grant of injunctions are not found in the “Patents Act”. Rather, they’ve come out of case law, particularly American Cyanamid vs Ethicon Ltd, a case which Indian courts pledge allegiance to even today. The principles evolved through American Cyanamid and recounted in innumerable Indian decisions are again reproduced below:

1. Prima Facie case in favour of the plaintiff
2. Irreparable injury to the plaintiff, if injunction not granted
3. Balance of convenience is in favour of the plaintiff.

As we noted in an earlier post, the judge creatively read in “public interest” into the "irreparable hardship" and the "balance of convenience" factors (the second and third factors) and held as below:

"“ Court is of the opinion that as between the two competing public interests, that is, the public interest in granting an injunction to affirm a patent during the pendency of an infringement action, as opposed to the public interest in access for the people to a life saving drug, the balance has to be tilted in favour of the latter. The damage or injury that would occur to the plaintiff in such case is capable of assessment in monetary terms. However, the injury to the public which would be deprived of the defendant’s product, which may lead to shortening of lives of several unknown persons, who are not parties to the suit, and which damage cannot be restituted in monetary terms, is not only uncompensatable, it is irreparable. Thus, irreparable injury would be caused if the injunction sought for is granted.”

It is also important to point Mr Laud to the fact that "public interest" is not a far fetched idea in injunction jurisprudence. In fact, it is routinely deployed by the worlds most patent friendly nation--the US. What is paradoxical is that even as we speak, Roche is invoking "public interest" to avoid being injuncted by a court in a matter involving Amgen’s patent. In other words, while Roche admits that it infringes Amgen's patent, it is asking the court to not injunct it since it is in the "public " to make a cheaper and allegedly better product to the consumer. As we remarked in an earlier post: surely, what's sauce for the goose is not sauce for the gander!

Laud also fails to appreciate the fact that Justice Bhat’s judgment does actually help patentees to some extent. This judgment categorically dispels the existing myth (reinforced through countless case law) that no injunction would issue if the patent is a recent one (the oft touted 6 year rule). This myth resulted in a scenario where there would be no injunction in a patent case, where the patent was in force for less than 6 years. Justice Bhat held as below:


Thankfully, Bhat dispelled this myth and found against this almost “per se” like rule. He held thus:

"One must confess bafflement at the “six-year” rule preventing courts in India from granting interim injunction. No provision of law or rule was brought to the notice of the court in support of this practice. The six-year rule appears to have crept in Manicka Thevar, and subsequently picked up in other judgments to be developed into a universal rule."

3. Wrong Counsel:

Laud contended that the legal strategy and advise by Roche's counsel were top of the line and that Roche did not suffer on this count.

As we noted earlier, Roche's counsel went to court on the first day praying for an ex parte interim injunction without so much as producing the patent claims before the court. Secondly, Justice Bhat takes Roche to task in his judgment for failing to argue the "irreparable injury" factor.

If a court has to berate counsel for missing out on what are obvious points of law/arguments, this must be some indication of whether or not counsel is competent.

On a related note, it seems paradoxical that in two of the biggest patent litigations till date (Novartis first and now Roche vs Cipla), MNC's with deep pockets picked incompetent counsels who botched up their cases. Whereas the home grown generic companies picked the smartest legal brains, who formulated a far superior legal strategy for them.

Can Roche Win the Case?

Justice Bhat's order is under appeal now. I'd be very surprised, if an appellate bench overturns Justice Bhat's nuanced findings. As I’ve repeatedly argued, given Roche’s flawed legal strategy and the facts on record that he had before him, the judge could not have decided any other way.

However, one has to remember that Justice Bhat's order was in the context of a suit for an “interim injunction”—Roche prayed that till the matter was finally adjudicated upon, Cipla be injuncted. The matter will soon go to trial for a final adjudication--to determine whether or not Roche is entitled to prevent Cipla from manufacturing and selling Erlocip.

At the trial, Roche has two options if it desires to procure a permanent injunction against Cipla.

i) It ought to publicise its access program (if it does really exist) and not be coy about it. In fact, it has to successfully demonstrate to the court that its access program works reasonably well and that there are “objective” and "transparent" criteria for determining patient eligibility etc .

ii) The second option is to lower its prices. Readers will recollect our earlier post, where we have shown that the price of Tarceva in India is almost the same (or higher) than what it costs in the richer developed countries such as the US and UK.

As we noted in an earlier post, Justice Bhat’s finding on “public interest” could be transposed to the final stage as well—in other words, if the price differential between Roche and Cipla continues and if Roche’s price causes a serious access crunch, then "public interest" would weigh in favour of denying Roche the permanent injunction.

Naturally, Roche ought to be concerned about this. If Roche does lower Tarceva prices (or demonstrates effectively that no patient is denied access to the drug despite its high price), a judge is more likely to find in its favour on the “public interest” count. Most judges and policy makers are not likely to be bothered about where the drugs are coming from, so long as they are reasonably priced. In other words, if the drugs are affordable, then there is no reason to prefer Cipla over Roche, in a patent infringement context. That would smack of pure jingoism!

Concluding Remarks: Pricing, Number Crunching and Perception

I hope the above points on strategy offer some food for thought to those of our readers who are interested in legal strategy. I would love to hear from you on what you think.

On a broader note, in view of the prevailing political climate in India, big pharma needs to be concerned about its pricing strategy. The recent BJP victory in Karnataka and the onset of national elections is bound to spur the Congress to pursue more populist policies. It is likely that it will favour measures aimed at lowering drug prices. Therefore, big pharma needs to introspect and carefully rethink pricing strategies.

Granted that its extremely difficult to determine what constitutes an “affordable” price. Or to determine the extent to which pricing impacts access. Till date, I’m not sure how many extra patients have availed of CIPLA’s lower priced version, Erlocip. In other words, how many patients can afford Erlocip (at Rs 1600 a capsule) as opposed to Roche’s Tarceva (Rs 4800 a capsule). More importantly, what is the number of patients that cannot afford either of these drugs? And in such a case, who bears the burden of ensuring access? Interesting issues to mull on—lets hope that some numbers emerge once the matter goes to trial--numbers that will help throw more light on the ever contentious "patents vs public health" debate.

Difficulties in "affordable price" determination notwithstanding, it seems unfair that India pays the same price as the richer and better insured countries such as the US and UK. As a friend of mine quipped once: when a McDonald burger costs less in India than in the US, why should Indians pay the same price for drugs as their richer counterparts in the US or EU? I agreed and replied that it ought to be the other way around—drugs ought to cost less and burgers and junk food ought to cost more!

Abhishek Manu Singhvi, Congress spokesperson, was on television (NDTV) last night attempting to explain the Congress’s defeat in the Karnataka elections. He contended that the Left parties failed to appreciate the value of public “perception” i.e. the public saw the Congress-Left coalition as a terribly divided government that could never work together. Take the nuclear deal for instance. Singhvi’s remarks were in response to a statement by the Left spokesperson (Raja) that all that the Left offered was “constructive criticism” of the Congress’ economic policies.

My point is not to delve deeper into these political spins—but to merely highlight a key word used by Singhvi, who also happens to be counsel for Roche and had argued the case on their behalf before Justice Bhat. Throughout his interview, Singhvi stressed the word, “perception”.

I want our readers to try and imagine what transpires in the mind of an Indian judge, when he/she is informed by a very persuasive counsel that a drug costs the same in India, as it does in richer countries such as the US and UK. “Perception” matters! At least from the point of view of legal strategy and courtrooms.

SpicyIP Tidbit: Orissa follows the G.I trend

The G.I awareness is catching on. The latest to join the fray is the State of Orissa.

Efforts are underway to protect the geographical identity and exclusivity of the Mudhi (puffed rice) of Mayurbhanj ; the ‘Moong’ bean of Nayagarh and the ‘Urad’ bean grown in the plateaus of Malkanagiri and Keonjhar districts, crops native to the Orissa state.

Intellectually Property Right (IPR) Cell of Orissa University of Agriculture Technology (OUAT) has now decided to to seek Geographical Indications (GI) registration of these three products.

They have also launched an awareness campaign to disseminate information to the farmers and regulatory authorities on the importance of securing a G.I registration for the indigenous products originating from the State.


Link to the article in The Hindu on this

The DCGI is preparing a document to implement the patent-registration linkage system

Readers may remember that SpicyIP had recently carried an extensive post in regards the ‘Patent-Registration’ linkage system that was proposed by the DGCI. Pharmabiz.com reported a couple of days ago that the DCGI is preparing a document outlining a system to implement the linkage system. Once the document is ready the DCGI has promised to make it available to the industry for debate and discussion to ensure that everybody’s interests are protected. The pharmabiz.com report also informs us that the Central Drugs Standard Control Organization (CDSCO) has embarked on an ambitious e-governance project to digitize all their records in a bid to ensure better co-ordination amongst their various offices. Their stated aim is to ensure better accountability and transparency.

At this stage SpicyIP must once again reiterate what it has previously stated: this proposal will only delay the entry of drugs into the market since the DCGI is going to increase the workload of the already severely burdened Patent Office.

We have one further observation to make as to why this proposal is not keeping with the policy behind the Indian Patent Act: This proposal destroys the very raison d’etre of the Indian Bolar provision (S.107A of the Patent Act). The Bolar provision allows generic drug manufacturers to manufacture, use & sell a patented drug for the purposes of submission of information required under any law for the time being in force. Basically this means that Cipla can manufacture and test Roche’s patented drug for the purpose of gaining regulatory approval from the DCGI. Section 107A was introduced for ONLY this purpose of facilitating faster regulatory approval. The Parliamentary intent behind this provision of law was clear – it was to ensure that the generic drugs could enter the market as fast as possible by gaining regulatory approval from the DCGI even before the patent expired. Therefore once the patent expired instead of waiting for the DCGI to grant approval the generic manufacturer could introduce his drug directly into the market since he would have already got the necessary approvals.

For our previous post on this topic please click here. Below is the relevant portion of the Pharmabiz.com report:

DCGI preparing document to bring in system for patent linkage

May 24, 2008, 0800 IST

The Drugs Controller General of India's (DCGI's) office is preparing a document in a bid to lay down a system to follow while granting marketing approvals. The step is to address the issue of patent linkage between the drug regulatory authority and the Indian patent office.

Once prepared, the document will be made available for the industry for discussion and the authority will ensure protection of interests of the pharmaceutical industry, according to Dr Surinder Singh, DCGI. The document is expected to address the hot issues related to the non linkage between the DCGI's office and the patent office, which has much concerned the foreign innovator companies and the Indian generic companies.

Delivering key note address in a seminar, 'How Quality Pays', conducted by Indian Drug Manufacturers' Association (IDMA), the DCGI said that the Indian pharmaceutical industry is going through a changing scenario and has to meet various challenges. The linkage between patent office and drug regulatory office is one among them which does not have a system to solve mutually at present.

"We should consider that the Indian pharma industry has come a long way ahead over the past few years and the companies were using the patent advantage for generic growth. The document we are preparing, will address the issue with patent office without compromising the interest of the Indian companies and the public," he averred.

The Central Drugs Standard Control Organization (CDSCO) is currently, developing a system for its operations and the primary focus is to bring in Standard Operation Procedures (SOPs), guidance documents and specific time frame for clearance of files. In order to modernise the operations of the organisation, an e-governance project has been designed. With this, the records in the drug regulatory system will be digitalised and an interactive portal will be launched for better communication between the organisation and the industry players from various parts of the country, said Dr Singh."The e-governance method will ensure transparency and accountability in the regulatory system. With our stronghold in IT, the people will be trained to get their needs done from CDSCO using the e-governance," he maintained. He also added that the industry should come forward to communicate its complaints, suggestions and ideas with the drug control mechanism in future.

SpicyIP Tidbits: Sobhraj enforcing his IP rights.

Talking about people who are aware of their IP rights, here is (in)famous Charles Sobhraj is all set to sue filmmaker, Prawaal Raman, who is currently filming a movie titled 'Charles and I' based on the convict's life. He has already sent the filmmaker a notice in this regard.

After evading police for several years, Sobhraj is currently serving a sentence of life imprisonment in Nepal for the murder of an American tourist. IBN reports that earlier this week Sobhraj through his lawyer sent a legal notice to the Mumbai-based People Pictures company claiming that no movie based on his character, his life or any resemblance thereof could be made without his permission and personal authorisation. Sobhraj has also for the same reasons protested any press releases in this regard. Reasons cited for this notice are that a false portrayal of Sobhraj in the movie (including showing him committing any crimes he has not been convicted for in India) could in all likelihood harm him and his reputation.

The notice however, also added that Sobhraj was willing to allow the filming of the movie on "mutually satisfactory terms". SpicyIP will definitely be keeping a watch on this story, especially since Sobhraj claims he has faith in the Indian Judiciary, since he has got "justice" here previously.

Cannes Controversy

Indian controversies at Cannes seem to be stretching beyond what our celebrities are wearing with Reliance Big Entertainment embroiled in a copyright tussle with Mr. Avinaash Jumani, who handles international sales for the Mumbai-based family film distribution company, WEG India Pictures Pvt Ltd. The Telegraph reports that Mr. Jumaani is threatening to take legal action against Anil Ambani's group on the grounds that the movie "Waiting for Clinton" (a project he says he has purchased) is on the list of 69 movies Reliance hopes to make or market. ]

According to The Times of India: Reliance Big Entertainment, the media and entertainment arm of the Anil Dhirubhai Ambani Group has finalised 69 films in nine languages for production and distribution over the next two years.

The Telegraph adds that there has also been an undisclosed amount invested in making movies in collaboration with Hollywood stars like George Clooney and Brad Pitt. The problem lies in the list of 69 movies which Reliance released in which the name "Waiting for Clinton" also figures. Mr. Jumaani claims that he has already put in money into acquiring the story for the film and initiating the project.

Mr. Jumaani was willing to concede that Reliance might have purchased rights to a story that was not for sale however "on behalf of Reliance, Amit Khanna, chairman of Reliance Big Entertainment, denied the company had breached copyright. “We are one of the producers,” he said. “He (Jumani) may have some specific rights. There is no conflict in this."

Jumani said he was left upset and angry after a meeting today in Cannes with Reliance representatives. “I had a discussion with them today but they are simply not bothered by what I have to say. They are saying, ‘it’s your problem.’ Being such a big corporate company and having an attitude is something to be thought about.”

If Mr. Jumaani follows up on his threats to take Big Entertainment to the Courts Reliance may have to consider making this issue their problem as well. We may have to wait for the outcome of this dispute but till then we may take comfort in the fact that some of Bollywood actually seems to be worring about film making and not fashion alone in Cannes.

SpicyIp Tidbits: The Big Bazar Battle

There's a giant tussle on show in India over a small trademark.

Mint gives us the lowdown on what looks like it might be a prolonged battle between Kishore Biyani of Pantaloon Retail and Anil Ambani of Reliance ADAG : and all this over the mark 'Big Bazar.'

An overview: Reliance ADAG applied for the trademark in November 2006, and claims no exclusive right to 'Big Bazar', but has registered for 'Reliance Big Bazar' as its preferred tag. Ambani's conglomerate uses 'Big' across its media and entertainment wing, probably best known through its Big FM, which also happens to be India's largest radio network.

The application opened up for opposition late in 2007, to which Biyani and co. have responded, and set things aflutter. Kishore Biyani's retail stores or 'hypermarkets', of which there are close to a hundred in India, are called 'Big Bazaar' (with two a's), and have been around for a some years. Biyani claims that the application is trying to misappropriate a name that was created by them.

There's an added angle to the story: Anil Ambani's proposed entry into retail, with or without this trademark, might encroach on elder brother Mukesh's territory, and potentially violate a non-compete agreement between the two.

Read all the juice here. Neither of the two parties - Biyani or Ambani - are going to edge away easily, and both of them have enough clout to keep the battle raging. It looks like some mark-tainment is on the cards for those in the ringside. We shall keep you posted on developments.

KS Jayaraman on Biotech Patents and the Future of Compulsory Licensing

KS Jayaraman, one of India's most well known science journalists (now with "Nature"), has written a very interesting piece on biotech patents and the prospects of compulsory licensing in developing countries such as India, Brazil and Thailand. Apart from two minor mistakes (he assumes that Tarceva is a biotech drug; and that "non emergency" compulsory licensing grounds in India came about only after 2005), the piece is a very good read.

"Patent Threat in Emerging Economies Shifts to Biotech"
"Recently revamped rules for compulsory licenses—which allow national governments to revoke patents for use in urgent or emergency situations—have triggered a spate of challenges to pharma’s intellectual property (IP) in emerging economies like those of India, Thailand and Brazil. Now those challenges are starting to extend to biotech patents.

The Indian Patent (Amendment) Act 2005 broadened the scope for compulsory licenses to include situations other than medical emergencies. Indian authorities can invoke compulsory licenses if a patented drug is unaffordable, unavailable in sufficient amounts, not manufactured in India by the patent holder or manufactured before 2005 by a generic company. Compulsory licenses can also be invoked to export drugs to countries with insufficient manufacturing capacity to address public health needs.

In India, Natco Pharma, of Hyderabad, India, recently pleaded for two compulsory licenses to produce cheap versions of drugs for export to Nepal. One of them is for a biotech drug: Tarceva (erlotinib), originally developed by Genentech, of S. San Francisco, California, and OSI Pharmaceuticals, of Melville, New York, and marketed in India by Roche; the other is for Sutent (sunitinib), the anti-cancer drug produced by New York-based Pfizer.

In March, Thailand’s new government also issued compulsory licenses for a clutch of innovative medications, including three for cancer. And in South America, last May, the Brazilian government stated a national emergency to issue a compulsory license for patent-protected antiretroviral Sustiva (efavirenz) (Box 1).

The question is whether these instances will be taken as precedents spelling trouble for IP- reliant drug makers, particularly biotech firms, which are often valued on the basis of the strength of their patent portfolio.

In the Tarceva case, in which compulsory licenses were filed, the court has given only an ‘interim’ order and not the final ruling, meaning that so far there is “nothing yet for our generic firms to celebrate,” says Gopinathan Nair, Mumbai-based patents consultant. And Dilip Shah, secretary-general of the Indian Pharmaceutical Alliance, does not believe Natco’s precedent-setting filing for a compulsory license will create a chain reaction, either. “India refrained from giving CL [a compulsory license], even when bird flu created a potential emergency in 2006,” he says. “Instead it placed an order for Tamiflu with Roche.”

Prasanna Kumar Ghosh, former adviser to government on biotech, feels the attitude to compulsory licenses ought to remain that way. “CLs will turn the multinationals away,” he cautions.

In fact the Mumbai-based Organization of Pharmaceutical Producers of India (OPPI) that represents multinational (and some large Indian) companies views the compulsory license threat as a tempest in a teapot. “CLs in no way can be considered as an emerging trend for both pharmaceutical and biotech products,” says OPPI director general, Tapan Ray.

Although it does consider national emergency reasonable grounds for a compulsory license, OPPI is opposed to granting them to extend commercial benefit to companies that manufacture copies of brand drugs. In the Natco case, Nepal has not given the generic version a nod, as it has not officially issued a notification to allow the generic drug version to be imported from India—a requirement under the Indian Patents Act for seeking compulsory licenses. “This has never happened in any country in the world and OPPI strongly believes that the situation will not be any different in India,” says Ray.

This remains to be seen. “Although there hasn’t been a biologics CL case as yet in India, it is certainly going to become prominent,” says Shamnad Basheer, an associate at Oxford IP Research Center, UK. One driver for this is the Indian government’s new ‘biotechnology strat- egy’, which is expected to facilitate the growth of biopharmaceutical companies that copy brand biologic drugs in a big way. Last May, Dr. Reddy’s Laboratory in Hyderabad launched its second biosimilar drug Reditux, a copy of Roche’s blockbuster Rituxan (rituximab), a monoclonal antibody used in the treatment of non-Hodgkin’s lymphoma. Reddy’s, which already sells Grafeel, a copy of Amgen’s Neupogen (granulocyte-macrophage colony stimulating factor, which is used to boost white blood-cell production), announced in February it has eight more biologic copycats in its pipeline. “Assuming some of these are patented, Reddy’s could try and avail itself of the Cipla ruling—whereby if the price is too high and it is not manufactured in India, this would be subjected to a CL,” says Basheer.

Basheer warns, however, that growth of the sector will be unsustainable unless the Indian government moves to create a regulatory path- way for biogenerics; at the moment, there is a distinct lack of stringent regulations to address equivalence issues.

OPPI voices similar concerns. Because biologic drugs are difficult to replicate, the OPPI has suggested the authorities consider biosimi- lar drugs as new products and request all the necessary supportive data for their registration.

The issue of biogenerics approval needs to be “urgently addressed,” says Ray, a move expected to delay if not preempt compulsory licenses on biogenerics.

But Basheer argues that because drug prices are the key driver for compulsory licenses, the best way for big pharma and biotech to address this issue is by rethinking their model of pricing worldwide. He believes the increasing R&D collaboration between Indian generics and multinational companies may also reduce the incentives to apply for such licenses.

Another Catch-22 is that even if they do not like compulsory licenses, Western drug firms can’t afford to stop marketing their products in India, says Mrinalini Kochupillai, a patents expert at Boston Law School. This is because “nonavailability in the local market is also one of the grounds for grant of CL,” he says One biologics sector, vaccines, has so faravoided compulsory licenses. There are several reasons they are not on the list of potential compulsory licenses, says Yennappu Madhavi, an expert on vaccine policy. Patents for the old vaccines in the immunization programs in most countries have expired, and, in fact, large pharma is not keen on producing them, she says.

But if a bird flu vaccine is produced, it ought to be available through compulsory licenses, says Cipla’s chairman Yusuf Hamied. “In diseases like AIDS, tuberculosis, malaria or bird flu you cannot afford a monopoly.” Hamied argues in such cases of communicable diseases, generic makers should be allowed to produce copies of patented drugs and vaccines on payment of a royalty. If India did not grant compulsory licenses, Hamied says, Cipla would set up factories in the least developedcountries where product patents will not apply until 2016. “We have already set up a factory in Uganda and we are starting one in Morocco,” he says.

Industry watchers say Cipla’s model is bold, but doubt whether opening up markets for generic drugs in the least developed nations makes economic sense. “The total pharmaceutical market of Africa is less than $2 billion,” says Chandra Mohan Gulalthi, editor of Monthly Index of Medical Specialties. Although it may be easy to set up a bicycle factory in the least developed countries, he notes, pharmaceutical manufacturing requires trained scientists. “Where will Cipla get the trained manpower for its facilities in the least developed countries?”

More cooks for the patent office broth

The USPTO seems willing to consider innovative means of reducing administrative problems - they have decided to review suggestions from students of the George Washington University School of Business. In what promises to be an interesting as well as productive endeavour the "winners of the George Washington University (GWU) School of Business 2008 International Business Case Competition met recently with USPTO senior management to present their proposed solutions to the pressing issues of patent pendency and backlog at the USPTO."


The competition brought together 18 teams of MBA students from around the world to provide recommendations on how to solve the challenges of pendency and backlog at the USPTO, the first federal agency to serve as a case study for the competition.

“Serving as a case study for the competition has given us the opportunity to gain the insights of MBA students and outside judges with fresh perspectives on our agency’s challenges. We found these students were able to see concepts, relationships and potential solutions from non-traditional angles.” said USPTO Deputy Director Margaret J.A. Peterlin. “We appreciated the recommendations of these business students as they applied their business operations coursework to our actual challenges.”



There is a valuable lesson here for the Indian Patent Office which is handicapped by problems of backlogs, high attrition rates and lack of adequately trained and qualified man power. I'd like to quote Sai Deepak's post here:

The patent office is struggling to cope as applications rise. Despite the increased workload, the four offices that handle examinations — Kolkata, Delhi, Mumbai and Chennai — have under 200 examiners in total. Recruitment has proved difficult and the attrition rate is high: the Mumbai Mirror reported in August 2007 that one-fifth of staff had left their posts in the previous two years.

Other opportunities for reform and suggestion lie in issues regularly covered by SpicyIP like the need for more transparency on which Prashant had posted earlier.

Apart from helping to find solutions for existing problems the input of business students may also be an aid to the implementation of the numerous reforms planned for the Indian Patent Office. Fresh perspectives on the operation and feasibility of the Indian Patent Database, or inputs on recruitment, management and functioning from the perspective of a business student may be what is needed to bring increased professionalism and efficiency to the Indian Patent Office.

Indian Patent Database: Relevant Links

Pursuant to our earlier post (covering the government response to our petition for an electronic patent database), here are the links to the relevant portions of the Indian patent office website.

1. For copies of granted patents, see here (as was mentioned in the last post, as per the government response, you should be able to access the complete specifications of about 100,000 patents)

2. For copies of Controllers Decisions, see here. However, when last checked, this was not working well.

3. For published patent applications, see here.

As requested in our earlier post, if you have any comments on the efficacy or otherwise of these databases, please let us know in the comments section to the post or by emailing me at shamnad@gmail.com

Pricing on the other side of the globe: Drug Manufaturers speak up in Canada.

If developing countries, thought that the problem with strict regulations, generic drugs and pricing only affected one side of the globe, latest developments in Canada definitely prove them wrong.

Canadian generic drug manufacturers are urging their Parliament (and even considering going to Court) to forfeit the idea of new regulations that if implemented, would delay their ability to reproduce drugs, including Viagra and Lipitor. Previously, a manufacturer could (through a Court order) block Health Canada's approval of the generic competitor for two years. However, the new regulations in effect overturn the intention of several judicial pronouncements. The regulations may also cost Canadian citizens much more as per the statements by the Canadian Generic Pharmaceutical Association.

Under the new rules, patents that have been removed from drugs that were on the market prior to June 17, 2006, could be reinstated which essentially could allow brand names to extend their monopoly on drugs that are priced on the higher end of the market and/or on those that are in demand (such as Liptor). Regular SpicyIP readers will remember that we have blogged extensively on the pricing debate across several countries. With manufcturers even in developed countries facing the brunt of drug monopoly, it is time to for Government's to understand the consequences of patent reforms encouraging monopoly. While on one hand, there is a strong lobby for building a strong R&D base and long term investment in a country with extensive capital from drug manufacturers, on the other hand, as a State responsible for making decisions that affect several groups of people (not just the poor, or the rich), extending monopoly of drug manufacturers especially on generic drugs especially those priced on the higher end of the market increase expenditure, and in several cases (if extremely essential in the health care system of the country) are out of reach of the common man.

This post like the one on the ban on varities of rice with GI protection is sure to generate debate of similar nature. But these are just some ideas that must be considered and if necessary, thrashed about to understand them in their entirety.

Read the full report here.

Choking the Patients???

SpicyIP, has in several posts, discussed the issue of generic drug companies taking patients for a ride. The Hindu now reports another instance involving two drugs, theophylline and doxofylline, both of which are prescribed to treat wheezing, shortness of breath, and difficulty in breathing caused by asthma, chronic bronchitis, emphysema, and other lung diseases. Both relax and open air passages in the lungs, making it easier to breathe. In short, they are bronchodilators.

Theophylline, a scheduled drug, and all its derivates such as etofylline, theobromine, oxtriphylline, dyphylline, enprofylline, etamiphylline, proxyphylline and pyridofylline are subject to price control under the NPPA regime. In May 2006, The Hindu reported the launch of doxofylline, popularly known as “Doxobid”, a hitherto unknown derivative of theophylline by Dr.Reddy’s Laboratories under licence agreement from Kent Union Ltd, Hong Kong, and marketing co-operation with Netherlands-based Eurodrug Laboratories BV.

According to The Hindu, since doxofylline is not covered under the NPPA, generic manufacturers are making a killing by aggressively promoting it over its cheaper version theophylline. Quoting Dr.C.M.Gulati, Editor of the medical journal, Monthly Index of Medical Specialities, The Hindu explains the reason for doxofylline’s entry into the country:

“The answer lies in the way drug prices are determined and controlled in the country. Doxofylline is being offered as a more profitable alternative to theophylline, prescribed to prevent and treat wheezing, shortness of breath, and difficulty breathing caused by asthma, chronic bronchitis, emphysema, and other lung diseases. It relaxes and opens air passages in the lungs, making it easier to breathe.”

“Theophylline and etofylline – molecules approved for sale in over 200 countries after having undergone rigorous post-marketing trials -- are scheduled drugs and subject to price control by the Government. By successive orders in 2006, all loopholes to sell theophylline products at high profit margins have been closed by the National Pharmaceutical Pricing Authority (NPPA), the body that monitors medicine prices in India. Therefore, nearly all companies selling theophylline formulations have been scouting for similar molecules outside the price control system irrespective of whether they are similar, better or even worse than their current brands”

This means that where on one hand theophylline is sold at Rs.6.40 a strip; doxofylline costs patients a cool Rs.80 per strip. Dr. Gulati further adds:

“The core issue is profits, not patients. The strategy is to stop selling less profitable, price-controlled products and replace them with hugely profitable alternatives of the same class. Doxofylline fits into this tactic. A molecule which is not even considered fit for mention in standard textbooks is being paraded as if it is major advancement in the treatment of asthma,”

The Hindu also reports that:
Doxofylline bulk drug is not a patented medicine and can be purchased in tons in China at a very low cost without any licence. Yet to give it an international foreign flavour, some drug companies in India have proudly announced that their brands are being produced “under licence” from overseas entities.

The article concludes thus:
Doxofylline is just another derivative of theophylline in this chain and resembles the parent compound in its mode of action, efficacy and safety profile.

The available open literature on the last observation seems to indicate otherwise. An article in PubMed compares the safety of doxofylline and theophylline in treating chronic reversible asthma and on the basis of the results concludes that doxofylline is endowed with a remarkable bronchodilator activity with less extra-respiratory effects than theophylline. It further states that:

“This study provides evidence that doxofylline 400 mg t.i.d. is an effective treatment for relieving airway obstruction and displays a better safety profile with respect to theophylline 250 mg t.i.d. with a favorable risk-to-benefit ratio.”

Another journal paper concludes that doxofylline, unlike theophylline, does not affect gastric acid secretion. Where theophylline can cause upset stomach, stomach pain, diarrhea, headache, restlessness, insomnia and irritability, a paper by a research group from AIIMS reveals that doxofylline has significantly lesser side effects. (Of course, one can always question if the reduction in side effects justifies the price of the drug). If a person casts aspersions on the integrity of these results, it would be a weak line of defense unless he has enough material to substantiate his claims.

In addition to this, doxofylline is not an Over-The-Counter (OTC) drug; it is a prescription drug. This means that the drug can be administered only if a physician has prescribed it and this he does despite knowing fully well that a less-expensive alternative in the form of theophylline exists. Ergo, either he believes that doxofylline is better for his patient notwithstanding the higher price, or he wrongfully furthers the cause of generic companies. If he resorts to the latter, he would be guilty of unethical conduct under Chapter 1 and Chapter 6 of the Code of Medical Ethics laid down by the Medical Council of India. Thus far, we do not seem to have come across instances of such conduct involving doxofylline.

That apart, there exist several instances where derivatives of a drug have been sold at different prices on account of either increased efficacy or reduced side-effects, penicillin being a prominent example has 12 or more derivatives. Such being the case, to say that the company has invested a fortune in "developing" something which already exists solely in the belief that it can take the public for a ride sounds too far fetched a proposition, and in these days of increased consumer awareness, insults the intelligence of the public. In the light of these observations, it may not be easy to point accusatorial fingers at generic manufacturers. I do not deny that there have been instances in the past where even Judas would have been put to shame by the conduct of generic manufacturers, but one cannot base that as a premise in every case, however tempting it may be. "He is bad and so he is bad" kind of argument may not hold water.

Indian Patent Database: Government Response to SpicyIP Petition

The government finally responded to our online petition requesting a comprehensive electronic patent database. We thank our readers for their wholehearted support for this petition which garnered around 170 signatures and can be found here.

I reproduce the government response below:

"No. 8/33/20007-IPR-III
Government of India
Ministry of Commerce & Industry
Department of Industrial Policy & Promotion

Udyog Bhawan, New Delhi,
Dated 17th April, 2008

To,
Shri Shamnad Basheer,

Sub : Making Indian Patent Information Public.

Sir,

Kindly refer to your letter dated 3rd December, 2007 regarding making Indian patent information public.

I am happy to inform you that as mandated by the Patents Act, 1970, patent applications, in the form of bibliography and abstract, are published in the Journal of the Patent Office. It is also published on the web site of the Controller General of Patents, Designs and Trade Marks (CGPDTM), viz, www.ipindia.nic.in. Inspection and supply of full specification and drawings are available against payment of prescribed fee under Patents Rules 2003.

Grants of patents are notified in the Journal of Patent Office and inspection or copies of which can be obtained from the concerned patent office against payment of prescribed fee.

As provided in Section 144 of the Patents Act, 1970, the reports of the Examiners to the Controller are not open to public inspections. They are also not liable to production or inspection in any legal proceeding unless the court certifies that the production or inspection is desirable in the interests of justice and ought to be allowed.

As may be seen from the preceding paras, most of the information is available to public against payment of prescribed fee. In order to make the information related to patents more easily accessible to public, establishment of digital database of patent records has been contemplated as part of the Eleventh Five Year Plan project for Modernization and Strengthening of Intellectual Property Offices. It may be appropriate to mention that out of 214,103 records of granted patents 45,000 are already available to public in searchable format on the website of CGPDTM namely www.ipindia.nic.in. The other records are under either digitization or verification. The same is expected to be completed by end of this year.

The processes of establishment of database of all granted patents and making of other records and documents easily accessible to public are being closely monitored by the Ministry.

Yours faithfully,

T.C.James

Director"

After receipt of this letter, I spoke with Mr James and also exchanged some emails with him on the efficacy and user friendliness of the current database. Mr James indicated that the 45,000 figure (number of granted patents that had been digitized as per the letter above) had now increased to over a lakh (1,00,000).

More importantly, he mentioned that is very open to receiving suggestions from users on their experiences with the current database. In particular, he noted that: "The effort to put on website the patent records is an ongoing process. As and when some records are ready they are being uploaded. Suggestions on improving the search criteria are welcome."

Given that many of our readers are "users" of the patent system and some are experts in the art of "patent searching", could we please request you to come back with your thoughts on this database and its various features (including suggestions for improvements), in the "comments" section of this post? Or you could even email me at shamnad@gmail.com. Please be as elaborate as possible in your feedback. We will then collate this user feedback and send this to Mr James.

The Mint carried a story on this government response to our online petition, which I reproduce below:

"The Planning Commission has proposed a project to digitize all of the country’s patent data in the 11th Plan (2007-2012) as part of the patent office modernization programme.Industry lobbies, patent lawyers and patient groups have for long been appealing for transparency in the Indian patent system.“...this project is expected to be completed by end of 2008,” the department of industrial policy and promotion, or DIPP, an arm of the Union commerce ministry, said in a letter to one of these groups

Once completed, records of all the 214,103 patents granted in India till date will be available with details on the website of the Controller General of Patents, Designs and Trade Marks. About 45,000 records are already available online, and the rest will be incorporated soon, T.C. James, director, DIPP, said in the letter.As reported by on 24 December, a group of industry representatives, patent experts, lawyers and patient groups had urged for Prime Minister Manmohan Singh intervention in creating a system to make information on patents, their filings and grants public.

The plea, signed by about 150 people, had requested Singh to increase transparency and accountability at Indian patent offices by creating an online database, complete with the official decisions and examination details. Currently, grants are notified in the journal of patent offices only in the form of bibliography and abstracts. Patent experts say these abstracts are not of much help as they do not contain details of the patents, which is essential for filing opposition or raising objections. “Another key demand was to provide access to information on how patent grant or rejection decisions are made,” said Shamnad Basheer, a leading patent lawyer and research associate at the Oxford Intellectual Property Research Centre.

Basheer, who had initiated one of the campaigns for transparency in the Indian patent system, said examination reports, file notings and comments by patent officials should be made public to reduce the scope forcorruption. However, DIPP has not made any headway on this demand. The department has clarified in its letter that as per law, “the reports of the examiners to the controller are not open to public inspections. They are also not liable to production or inspection in any legal proceeding unless the court certifies that the production or inspection is desirable in the interests of justice and ought to be allowed.”

But it has mentioned that “the processes of establishment of database of all granted patents and making of other records and documents easily accessible to public are being closely monitored by the ministry now”. In January, India’s National Knowledge Commission—an advisory body to the Prime Minister—had recommended that all patent applications should be released with complete details to give sufficient opportunity for any pre-grant objections.
The commission had also suggested providing electronic access in real time to all steps of a patent application—from detailed patent descriptions, examination reports at each stage to amendments introduced at various points—to maintain complete transparency in the system."

SpicyIP:As you sow ,so you reap!

IP, Climate Crisis and Food Security.

'We have arrived at an 'Era of Consequences'-the take home message from Al Gores' documentary 'An Inconvenient Truth.'

With Global Warming and climate crisis as the central theme of the film, it succinctly weaves in narrative and event the ensuing planetary emergency and the ominous consequences these issues portend for mankind.

'Humanity is sitting on a ticking time bomb. If the vast majority of the world's scientists are right, we have just ten years to avert a major catastrophe that could send our entire planet into a tail-spin of epic destruction involving extreme weather, floods, droughts, epidemics and killer heat waves beyond anything we have ever experienced.'

Undoubtedly the most serious implication of global warming would be its repercussion on global food security. Reports released by FAO indicate that global warming is likely to diminish food production in many countries and increase the number of hungry people...the worst impacted would be the developing countries and LDCs

In that is also witnessed is a shift in technological adavnaces in the field of food and modern biotech-from consumer driven agriculture to an agronomy driven one, methods that aid sustainable crop cultivation resistant to climatic exigencies.

Illustratively, a new breed of gene altered crops has been designed by a handful of Bio-agro companies; crops that will withstand vagaries brought about by climate change and environmental stresses.


Commendable in their R&D initiatives, they have also been nimble in seeking patent rights thus sparking of a outcry of cartelisation and monopoly of critical agro technologies that is likely to have a serious socio-economic impact.

Washington post reports that

Three companies -- BASF of Germany, Syngenta of Switzerland and Monsanto of St. Louis -- have filed applications to control nearly two-thirds ofthe climate-related gene families submitted to patent offices worldwide,according to the report by the Ottawa-based ETC Group, an activist organization that advocates for subsistence farmers.

Activists allege that this tantamounts to 'patent profiteering' and is not really intended to solve the food crisis agenda.Neither is this being viewed positively by farmers who feel that this would result in a departure from traditional crop rotation methods and hence may not add up to favorable agriculture economics. 'Misguided philanthropy' they allege.

In turn the companies are projecting themselves as climate 'crusaders' claiming that such technologies would not gain popular reach unless they go out as proprietary technology , thus justifying their scramble for IPR rights.

With growing skepticism amidst the stakeholders, experts feel that both sides are oversimplifying the issue as ramifications are likely to be more widespread and deeper than projected.

An analysis of the situation throws up three dilemmas, the reconciliation of which could possibly pave an amicable way a forward.

Key question would be that of responsibility-should we deny the benefits of such a major techno development in the face of the crisis that the ecosystem is facing. Would an effective and transparent system of communication help bridge the gap and promote progressive policy formulation.

Also would be the question of establishing legitimacy and how best all the stakeholders are involved in disseminating this technology.

As with most other issues of a similar nature, it is the distribution of benefits that is likely to determine acceptability and success of the technologies.A strategy that will diffuse the effect of a corporate grab,stabilize costs, promote upstream independent research and secure the farmers rights can induce a conducive environment for similar such scientific advances.

A PPP(private public partnership) could again provide the answers.!!!