Natco vs Pfizer: Today's Hearing at the Patent Office

The Assistant Controller (Delhi Patent Office), Mr Dev Karar heard counsels appearing for Natco and Pfizer today. The hearing was limited to the interlocutory petition filed by Natco challenging the legality of the "hearing" granted to Pfizer. The Asst Controller stated that he would issue a decision on this in about 10 days or so. For our previous posts on this case, see here, here, here and here.

Interestingly, I had interviewed Dev Karar some years back for a paper that I was doing on the Indian patent office, using the backdrop of the Dimminaco decision--a case where the patent office had refused a patent on a biotechnology process, on the grounds that it involved "living" matter--the Kolkatta High Court reversed the decision of the patent office, holding that nothing in the Indian patent regime foreclosed the possibility of patenting "living matter". Mr Karar gave me some very insightful comments then--since then he has risen through the ranks and is now heading the Delhi patent office. I'm sure that we will have a well reasoned decision in India's first Doha CL case.

Anyway, for those interested in the Dimminaco decision (which boosted biotech patenting in India) and the broader aspects of how patent decisions are made in India, see the paper here titled "Policy Style Reasoning at the Indian Patent Office."

Natco vs Roche (Doha License): First Day

I've been given to understand that Natco's counsel presented arguments before the patent office today. However, it appears that most of the arguments were centered around the interlocutory application filed by Natco, opposing the move by the patent office to hear Roche/Pfizer. Tomorrow, the patent office will hear arguments in this regard from counsels representing Pfizer/Roche.

It is only after they decide on this interlocutory application (i.e. that parties cannot be heard under section 92A) that the matter will be heard and decided on the merits. Our earlier blog posting on this contained some discussion on whether or not a "hearing" was permissible under section 92A.

While a strict reading of the section does not permit a hearing, the denial of such opportunity could result in a writ petition from Pfizer/Roche alleging that principles of natural justice (audi alteram partem) had been violated. Particularly since the patent office has to decide on appropriate royalty rates. Without there being a pre-determined fixed formula in India (unlike Canada), it may be difficult to counter Pfizer/Roche's contention that the absence of a hearing/representation (that might have helped establish the "economic value" of patent and the impending CL), seriously prejudices the rights of Pfizer/Roche.

Interestingly the patent office has just released an updated version of their draft manual. We are very happy to note that, consistent with principles of transparency and public participation, they have called for comments. So please do send in your comments by the 25th of March, 2008.

This manual has an entire section on the Doha license. And from this manual, it appears that at the first stage, the patent office has to grant a license, if a "prima facie" case is established by Natco. And that they are to grant a hearing, if they decide against Natco. But such hearing shall only be for Natco and not for Pfizer/Roche. I reproduce sections of this manual below:

"Section 92 A :Compulsory licence for export of patented pharmaceutical product in certain
exceptional circumstances.

18.3.1 The section was introduced by The Patents (Amendment) Ordinance, 2004 which came into force on 1st January 2005, to provide for grant of compulsory licence by the Controller for export of patented pharmaceutical product in certain exceptional circumstances, where compulsory licence has been granted by the country to which the export is intended. This provision was further amended by The Patents (Amendment) Act, 2005, to allow grant of compulsory licence even in cases where the importing country has by notification or otherwise, allowed importation of patented pharmaceutical products from India.

18.3.2 The procedure for obtaining the compulsory licence is laid down in Rules 96 and Rule 97.

18.3.3 This provision is introduced to address the public health concerns of the countries having insufficient or no manufacturing capacity in the pharmaceutical sector to implement the decision of the TRIPS council on Para 6 of the Doha Declaration on TRIPS Agreement and Public Health. This section lays down the conditions that are required to be fulfilled, when the compulsory licences for export purposes will be available. The compulsory licence is
available only for:

(a) The patented pharmaceutical product
(b) Manufacture and export to any country having insufficient or no
manufacturing capacity in the pharmaceutical sector
(c) The product addressing the public health problems in such country.

18.3.4 The explanation under this section technically defines the scope of the pharmaceutical product that comes under the purview of this section. The pharmaceutical product covered under this section is any patented product or product manufacture by a patented process including all such ingredients that are necessary for manufacturing of such products. The diagnostic kits required for the use of the patented product are also covered.

18.3.5 The product on which the applicant has either obtained the compulsory licence from importing country or the importing country has by notification or otherwise, has allowed Importation of patented pharmaceutical products from India.

18.3.6 The application for compulsory licence shall be filed in the office where patent has been granted. This application shall be made on Form 17. The applicant shall give the ground relied on for making the application. He shall also specify the nature of his interest and the terms and conditions of the licence he is willing to accept. This condition is not applicable, where the application is made by the Central Government.


18.3.7 The applicant shall furnish the certified copies of the documents giving details of documentary evidence in support of his interest and the ground on which the application is made. Fee for filing this application Rs. 1500/- for natural person and Rs. 6000/- for other than natural person either alone or jointly with natural person.

18.3.8 The Controller shall ascertain whether a case is made out or not for grant of compulsory licence.

18.4 Where on consideration of the evidence the Controller is satisfied that the prima facie case has been made out he shall proceed to pass an order for grant of compulsory licence with following terms and conditions:

i. Specify the product for which the licence has been granted.
ii. Specify the quantity of product to be exported based on the need of the importing country.
iii. Specify the distinguishing feature of the product and/or packages:-
The distinguishing feature of the product may be colour/shaping of the product or packages provided the Controller shall take into consideration that there is no significant impact on price.
iv. Specify the importing country and the quantity to be supplied to each country.
v. Specify the remuneration to be paid to the patentee: The Controller determines the remuneration taking into account the economic value to the country of the use that has been authorised by the Controller.
vi. The Controller shall direct the licensee to post the information relating to the quantity of the product supplied under licence to each destination with its distinguishing features on the website before the commencement of the shipment.

The Controller then publishes the following information in the official
journal:-
(i) Patent number
(ii) Name and address of the licensee
(iii) Quantity allowed for manufacture and export
(iv) List of the countries and the quantity to be supplied to each country.
(v) Duration of the licence.


18.5 If the prima facie case is not made out

18.5.1 Where on consideration of the evidence the Controller is satisfied that the prima facie case has not been made out he shall proceed as per the provision of rule 97

18.5.2 The procedure for dealing with the cases where the prima facie case is not made out is given in rule 97(1). According to this rule the Controller is required to notify the applicant that a prima facie case has not been made out and if the applicant so desires he may request the Controller for hearing before the Controller within one month from the date of issue of a notification. If the applicant fails to make such a request within the specified time the Controller shall refuse the application.

18.5.3 Where the applicant make a request to the Controller for hearing, the Controller shall proceed as per the provisions of rule 97(2) and hear the applicant and pass an order for grant of licence or refusal of licence depending on the merits of the case.

18.5.4 This provision provide that the grant of compulsory licence under section 92A (1) and section 92 A(2) has no effect on the compulsory licence granted under other provisions of the Patents Act.

18.5.5 In case of compulsory license for export of patented pharmaceutical products to any country having insufficient or not manufacturing capacity to address public health problem, the application will also have to be made on form 17, and the compulsory license will be granted, immediately under Section 92 A of the Act."

SpicyIP Tidbit: Sun challengesJ&J

Sun Pharma has as of February 28th, 2008 decided to file a post grant opposition with the Mumbai patent office against a product patent extension granted to Johnson & Johnson's Risperdal, used to treat psychological disorders and schizophrenia.

The patent, granted to Janssen Pharmaceutica, a group company of Johnson & Johnson, on July 20, 2007, with patent number 208191 relates to sustained-release particles of risperidone.

Sun Pharma has been marketing a generic version of this drug for the last few years in India under the brand name Sizodone and has moved against the patent on Risperdal, that is due to expire in the US on June 29, 2008. News reports state that the extension has only been sought in India and not in the US.

SpicyIP Tidbits: Interpol to Step in to Protect IPR

Tightening the noose on counterfeiting of goods for protection of IPR, a Database on International Intellectual property (DIIP) was launched at a Confederation of Indian Industry (CII) forum in Mumbai, as part of a joint initiative by the Interpol and the US Chamber of Commerce. Laying emphasis on the importance of protection of IPR in countries like India and China, Ron Noble, secretary general of Interpol and David Chavern, executive vice president and chief operating officer of the U S Chamber of Commerce felt that:

"With India graduating to a worldclass innovator, protection of IPR has become all the more important"

According to Mr.Chavern, DIIP would prove to be useful in identifying links between criminal groups during investigations and also in production of global strategic reports. An article from the TOI states that one of the key functions of DIIP will be to maintain reliable data on the scale of counterfeiting and piracy to determine the nature of crimes against brand and copyright integrity In fact, trade bodies from 50 countries are already cooperating with Interpol in this endeavour. In the six months of its existence, the database reportedly has details of 5000 entities and 500 cases are already under investigation. May be it is time that India evolved a policy on the lines of the Economic Espionage Act, 1996 of the US.

SpicyIP Tidbits: Pharma MNCs struggle in India

Three years after India's patent law refurbishing exercise, the verdict is out: MNCs are still struggling to carve a sizeable pie of the Indian market share, while domestic pharma majors continue to rule the roost.

A report by Noemie Bisserbe of the ET gives several probable reasons for Pfizer, Novartis and Merck losing market capitalisation over the past three years, including poor pricing strategies and fewer global product launches.

Elsewhere, at an ET summit on the Indian pharma industry, Dr Swati Piramal projects that by 2010, India will have discovered at least five new drugs, and estimates that the cost of innovating a new drug at home was under USD50 million.

And 'Nano' is surely the buzzword of the year in India! Even Kapil Sibal has put his two cents in, of the possibility of replicating the low-cost model in pharma. (The cynic in me refuses to use the word 'success', because the model is yet to be tested in the market, even if only in the automobile sector.)

SpicyIP Tidbits: It’s a Case of Purple Heartburn

Here’s the story so far. AstraZeneca, the Anglo-Swedish manufacturer of prescription drugs had a basic patent on Prilosec (Omeprazole), a drug used to treat gastroesophageal reflux disease (acid reflux) and heartburn. Gastroesophageal reflux disease is the name given to erosions in the oesophagus on account of churning of pepsin in the stomach over a period of time which chips away at the delicate lining of oesophagus. This patent was supposed to expire in April 2001. However, the company came up with a new formulation in the form of Nexium (esomeprazole), also known as the Purple Pill, which protects specific aspects of Prilosec. Apparently,this was done because Prilosec earned the company $5.91 billion in the year 1999 alone.

Nexium too was granted a US patent (US 6369085) which according to the company is scheduled to expire in 2019. However, this patent has been challenged by several companies, notably Ranbaxy and Israel-based Teva Pharmaceutical in separate suits. In fact, Ranbaxy went ahead for a first-to-file status under the Hatch Waxman Act of 1984. This Act is designed to promote generic versions of patented drugs and gives Ranbaxy a 180-day window during which it shall have exclusive marketing rights to the drug on the expiry of the Nexium patent. Also, the USFDA has given a tentative approval to Ranbaxy’s generic version of Nexium. Following the challenge to the Nexium patent, an automatic stay of 30 months was ordered. This stay is lifted automatically at the end of the said period which will be on April 14, 2008 in the case of Ranbaxy and in July 2008 for Teva. It is being speculated that Ranbaxy and Teva Pharma may jointly go for an “at risk” launch.

"At risk" launch occurs when a generic company launches a product after the automatic 30-month stay granted at the beginning of patent litigation between two companies, but before the completion of the case and the expiration of the patent. The danger to the generic company is that if it loses the litigation, it is then liable for triple the damages it would normally incur for patent infringement. But if it wins, the generic company’s drug is on the market faster than a competitor’s. Past experience says that a loss in the Court isn’t sufficiently huge to deter the generic companies which can offset future losses with big gains from early sales. Teva in particular has been using this strategy to its advantage which has emboldened other generic manufacturers.

Rumour mills are working overtime saying that AstraZeneca would probably cut a deal with the challengers, but the company has denied the possibility of any such deal saying that it was confident of winning the case on the merits of the patent. Further, Astra has won seven out of eight patent disputes. However, several industry observers are divided on this issue. According to them, the trend is that companies which lose patent protection on blockbuster drugs protect their markets by introducing single-enantiomer versions of those drugs and most feel that Prilosec and Nexium fit this pattern. Prilosec is a racemic mix of enantiomers, which can be likened to the left-handed and right-handed versions of a molecule. With Nexium, the S-enantiomer has been isolated, which according to AstraZeneca gives it several advantages over the basic patent. Dr. Doug Levine, chief medical officer of the gastrointestinal division at AstraZeneca, opined in 2000 as follows:

“We found that Nexium was metabolized differently than omeprazole. The way the enzymes see the molecule is different. I like to use the analogy of a key in a lock. If you had a mirror image to that key, it wouldn't necessarily fit into the key hole.”

Richard DiCicco, president of Falls Church Technology Catalysts International, too was confident that Nexium is clinically superior to omeprazole at four endpoints: fast healing of reflux esophagitis, fast symptom relief, new approach to long-term management of symptomatic GERD (gastro-esophageal reflux disease) and new approach to helicopylary (the treatment of ulcers caused by bacteria). A few others feel that not every such drug which is an isolated enantiomer receives the same amount of success for it depends on that particular case. For instance, Levabuterol, a single-enantiomer version of Albuterol, an asthma medication marketed by Abbott and Sepracor, came and went without a whimper. Accordingly, without resorting to comparisons, one will have to judge the merits of the drug individually and cannot blindly draw parallels on the basis of success or failure of other drugs.

The complete details are available here.

SpicyIP Tidbits: Basmati 'stirs' up new protests.

Just when India's initiative to protect products was finally beginning to be appreciated by SpicyIP, farmers in Karnataka have begun protesting the recent move to grant the geographical indication to the rice grown in Punjab, Haryana, UP and Uttarakhand alone.

Claiming that this would adversely affect the margin on profits earned by the variety of Basmati grown by them, the farmers have now started protesting, in the hope that they will be included as a part of the GI.

The full article, can be found here.

Free IP Database: The WIPO Magazine!

The World Intellectual Property Organisation's magazine endeavours to inform readers about WIPO-led activities, and to showcase intellectual property, creativity and innovation at work across the world, this issue of the WIPO Magazine covers a wide range of topics like from climate change to a public forum at the WIPO for LDCs.

The WIPO Magazine is currently available free of charge. This can be availed by readers- both online and in print in three languages (English, French, Spanish).

The launch of the magazine is great news for all IP enthusiasts, who are ecstatic about one more database, dedicated to patents, and available easily and inexpensively to readers!

Spicy Tidbit: Injunction granted in HCV TRI-DOT case

J Mitra's company dealing with HCV-TRIDOT( a device for the detection of the Hepatitis C within 10-15 days) has been granted an injunction in its favour preventing Span Diagnostics from making or selling any diagnostic test which might infringe their patent.

"The defendant (Span Diagnostics) and its agents are restrained from manufacturing, selling, offering for sale or in any manner dealing with the impugned product Signal HCV or any other product violative of the plaintiff's (J Mitra's) patent," Justice Sanjay Kishan Kaul said.

The Assistant Controller of Patents and Designs upheld Mitra's patent when it was opposed by Span Diagostics in September 2006. Span Diagnostics manufactures a similar product called Signal HCV.

The High Court has passed the judgement on a lawsuit filed by J Mitra against Surat-based Span Diagnostic seeking injunction against the manufacture of Signal HCV which, J Mitra alleged is a copied device its HCV TRI-DOT. J Mitra through its counsel Pratibha M Singh had submitted that the patent over HCV TRI-DOT, a device for detection of antibodies to Hepatitis C Virus, has been infringed by Span Diagnostic which copied its product.
It was submitted that all components of the plaintiff's (J Mitra) test device HCV TRI-DOT form an integral part of defendant's (Span Diagnostic) product Signal HCV, the suit said.

The full article can be found here. For a little more background check out an earlier post on Spicy IP here. Also for more perspective do check out Sandeep Rathod's opinions here.

The Tale of the Two Patents: SpicyIP in the news.

Our readers are most likely to remember the recent patent blooper with the issue of the same patent to different inventors. This was preceded by SpicyIP's appeal to the Prime Minister to create a database of sorts to prevent exactly these sort of incidents. As a followup to the previous post by Mr. Basheer, CH Unnikrishnan from Livemint not only reports this patent issue, but acknowledging SpicyIP's role in the same- has closely followed the recent developments in the story--

"Adding fresh ammunition to the fight against a lack of transparency and inadequate data searching systems at Indian patent offices, a recent case at the Delhi high court suggests that the Mumbai and Chennai patent offices have granted exclusive rights to identical technologies claimed by two leading consumer durable companies.

The patents under dispute are those granted to Hindustan Unilever Ltd, or HUL (previously Hindustan Lever Ltd), and Eureka Forbes Ltd for gravity-fed water purifiers.

While Eureka Forbes was granted a patent for the product in September 2005 by the Chennai patent office without hearing an opposition filed by HUL, the Mumbai office granted a patent to HUL in 2006 after examining an application filed four years earlier.

HUL has now challenged the decision to grant the patent to Eureka Forbes despite its application for the technology pending with the Mumbai office since 2002, almost two years before Eureka Forbes made its approach.

Indian patent law follows the “first-to-file” criterion for considering grant of patent.

As reported by Mint in a series of articles related to malfunctions at the Indian patent offices, critics hold an incompetent data search facility and poor cross-verification systems responsible for this duplication. An intellectual property blog, SpicyIP, had in December 2007 petitioned Prime Minister Manmohan Singh to take steps to mandate the creation of a database that would eliminate such anomalies.

HUL, one of the top patent holders in India, had petitioned the court that Eureka Forbes had infringed its patent by introducing Forbes AcquaSure in the market. HUL markets a similar product under the brand name Pureit. The four-year delay in granting the patent to HUL was mainly due to the office’s much delayed publication and examination process. HUL’s patent application was published in the patent journal only in May 2005.

Meanwhile, in September 2005, the Chennai office granted Eureka Forbes the patent on its application dated 29 March 2004 and published it in February 2005 in the patent journal without giving HUL a hearing on its pre-grant opposition filed in August that year. HUL also filed a post-grant opposition in November 2005.

Patent applications are published in a journal to ensure there is no opposition or counter-claims.
The post-grant opposition too proved unsuccessful, despite the failure of Eureka Forbes to reply to it within two months. As per Indian patent law, a patent holder should reply to a post-grant opposition within two months or risks losing the patent. Instead, the Chennai patent office granted an extension of two months to Eureka Forbes to make its reply, contrary to provisions.

An HUL writ petition challenging this is pending with the Madras high court.

An official at the Mumbai patent office turned down Mint’s queries on why it took nearly three years to publish HUL’s application and whether the delay was caused by the applicant or by its own offices.

SpicyIP, run by a team of patent experts worldwide, in a recent blog had highlighted that “HUL’s allegations, if proven true, will put the patent office in a spot, as the facts suggest a high level of collusion between the office and Eureka Forbes.”

Spokespersons of both companies declined to comment, saying the issue was sub judice.

Shamnad Basheer, a patent lawyer and an associate at the Oxford Centre for Intellectual Properties, who led SpicyIP’s campaign to petition the Prime Minister, said: “This case is likely to pose some complex jurisprudential problems. If HUL can sue Eureka Forbes on its patent, then the reverse is also possible, i.e. Eureka Forbes can sue HUL on the strength of its own patent. We understand that it has not done so as yet, owing to a restraining order from the Madras high court (which is currently deciding the petition)."

Meanwhile, Eureka Forbes has filed a post-grant opposition challenging HUL’s patent.

Earlier, Mint reported a similar case of Chennai patent office granting a patent to Swiss drug company F. Hoffman-La Roche Ltd for its anti-infection drug, Valcyte, ignoring a pre-grant opposition by two non-governmental organizations— the Indian Network for People Living with HIV/AIDS and the Tamil Nadu Networking People with HIV/AIDS. Ranbaxy Laboratories Ltd, has legally challenged the Chennai patent office’s decision to grant a patent for the drug."

One can only hope that with such a long list of litigation caused solely due to the lack of communication between the patent offices, the PMO will sit up and take notice of the SpicyIP initiative for a database.

India's First Doha Case: Has Nepal Issued a Notitication?

Pursuant to our posts on the Natco's application for a Doha Style Compulsory license to export two anti-cancer drugs patented by Roche/Pfizer, there have been some articles on this theme in the mainstream media. We bring you two of them in this post. For our earlier posts, see here (in particular see the exchange with Tahir Amin in the "comments" section of the blog post), and here.

Tatum Anderson wrote a piece in IP Watch and Jonathan Allen reports on this in Reuters.

The Reuters piece has an interesting quote from a Roche spokesperson:

"Natco has offered 5 percent royalties on sales it makes to Roche and Pfizer, in keeping with TRIPS guidelines.

Asked to comment on Natco's offer, a Roche spokesman said: "Tarceva is already available in India through Roche and therefore patients in Nepal have access to Tarceva."

I've been trying to make sense of this statement. If Roche has made Tarceva available in India, how is it necessarily available to patients in Nepal?? The last I checked, these were two separate countries.

On a more serious note, this brings us to an important issue. Is Tarceva available to patients in Nepal, and if so, how is it priced? Unless we know this, it is very difficult to comment on whether Nepal has a "public health" problem. After all, section 92A cannot be invoked unless there is a public health problem.

Aren't there any Nepalese reporters covering this issue who can give us more facts? Many missing links here, including: does Natco have drug regulatory approval to sell in Nepal; do Roche/Pfizer have regulatory approval and are they selling in Nepal etc etc.

Secondly, it appears that the Nepal notification is a mere authorisation from Nepal's drug controller to a Nepalese distributor permitting imports of Natco's generic drug--this authorisation does not speak of a public health problem in Nepal.

As far as Nepal is concerned, they can permit anyone to import these drugs, as there are no patents. But Natco cannot export, without complying with the terms of the Doha regime and section 92A--as otherwise, it would amount to patent infringement in India (since it manufactures in India).

Section 92A uses the term "notification" without stressing what the notification should contain. Can Natco argue that a mere import authorisation as above mentioned would therefore suffice? And that there need be no notification spelling out a clear "public health" problem in Nepal. Under a strict reading of section 92A, they might be able to do this--but the Doha regime clearly requires Nepal to notify the public health problem on the WTO website, spelling out the quantities of drugs it needs etc.

Also, importantly, section 92A uses the term "public health problem". It would seem therefore that the notification would have to stipulate that there is a public health problem --or perhaps the section could be interpreted to mean that the existence of a "public health" problem could be established through other means--for eg. demonstrating that Tarceva is not available at all to patients in Nepal.

It is also important to note, that, till date, Nepal still hasn't made any notification on the WTO website--and I am guessing that both parties must be lobbying the Nepalese government pretty hard now. The interesting legal issue here would be: can the Controller of Patents stay this compulsory licensing application till such time as such WTO notification in accordance with the 2003 Implementation Decision is made by Nepal? (section 92A itself does not specifically refer to Doha or any of it's conditions).

Thankfully we'll have some answers in the next couple of days: the hearing for the Tarceva case (Natco vs Roche) is tomorrow and the hearing for the Sutent case (Natco vs Pfizer) is the day after.

I was quoted in the IPWatch and Reuters articles referred above--and for the benefit of readers, I'm listing below some of the responses that I offered to the authors of the pieces above:

Q 1. What are the kind of opportunities presented by the Doha style licenses for India?

Ans: It’s interesting to note that when I interviewed some of the generic companies in the year 2005, none of them were really interested in using section 92 A, as they didn’t think it made economic sense to export to countries with low paying consumers. They didn’t think the margins would have been great. And most of them wished to focus on the regulated markets of the developed countries.

Of course, now it presents a huge business opportunity for them, as they must have recalculated potential business gains from these markets. More NGO’s operate in these markets and engage with drug procurement here, which means the chances of selling in larger quantities and making money is far better. A noteable example is the Clinton Foundation, which guarantees large orders to Indian generic companies that wish to supply to Africa etc—this helps with economies of scale and production costs etc.

Even apart from the economics of it all, this presents an excellent opportunity for them to work with newer drugs and hone up their technical skills. But for this window, they would have had to wait for the 3 year compulsory licensing window in India to elapse. Even assuming they waited 3 years, there is still no guarantee that a compulsory license would have issued, as they would had to satisfy one of the grounds under the Act (excessive pricing, lack of “working” in India etc).

However, Natco has only just applied for a license and one is not certain on the kind of administrative roadblocks that they would face. As you can appreciate, if this turns out to be a legally and administratively costly affair, it may deter more companies from applying. However, if the process is fairly easy and a good revenue model is established via this CL mechanism, then big pharma has much to fear....

Q.2 How are MNC's likely to react?

Ans. Earlier on, big pharma must have sat easy, as they saw that despite 3-4 years going by since the 2003 Doha implementation decision, not a single license had been applied for or operationalised. This could have been due to several reasons, one of which no doubt was the potential administrative bottlenecks in operating this mechanism.

However, if a precedent is established in India by Natco and the adminsitrative process proves easy, then a number of Indian companies will follow suit. Big pharma will really have to rethink its model of pricing worldwide and may have to drop down prices to reasonable level in the LDC’s where they operate. More importantly, they will also be forced to introduce drugs in the LDC markets quickly--for if these drugs are not sold in these markets (which is sometimes the case), then the case for a Doha Style CL is really strong.

Some of them are already taking some laudable steps in this direction, but they have to do much more. If they manage to drop down the prices, then they not only make it more difficult to invoke Doha style licensing (as the drugs are affordable), they also make it economically difficult for the generics to sell in that market. Of course, the threat of parallel imports and the fear of their home consumers wanting lower prices may disincentivise them from doing so on a large scale—and one will have to wait and see what strategies they adopt. Perhaps they might voluntarily license generics to manufacture and sell at low prices in these markets.

This way, they control the markets and also the threat of parallel imports etc more effectively, than if they had a “compulsorily licensed” player operating in that market. As more Indian companies engage with R&D and discovery of new molecules, we are seeing a greater R&D collaboration between Indian generics and MNC’s. Will these relationships begin affecting the incentives to apply for such licenses? Only time will tell.

A Patently Preposterous Patent?

“…be careful what you say in your blogs—blogs can work for you by denying property rights to others, they can work against you by exposing your ideas prematurely or narrowing your time window to apply for a patent, and they can establish a trail of evidence that a litigant can use against you to show a judge that your invention is an obvious extension of prior art.”

So goes the blog entry which has now set the stage for the perfect patent storm. And what diabolical precision! Accenture sure knows a thing or two about recruiting far-sighted people (no wonder Tiger Woods endorses them), for this particular blog entry is that of Dr.Kishore Swaminathan, Accenture’s Chief Scientist, and now it might come back to him. This particular post concludes thus:

“I have an idea that could revolutionize an important area of information technology—but I cannot tell you because I might compromise Accenture's patent rights.”

The idea which he has referred to, has taken concrete shape as US 7321886 entitled “Rapid Knowledge Transfer among Workers”, and is being dissected and vivisected by techies on blogs the world over. After going through the patent, one gets a feeling that the system, as claimed, sounds pretty huge and elaborate, given the global scale of application for which it is envisaged. The object of the patent is to cater to one specific and, obviously what the patentee considers to be the most important, aspect in the whole gamut of processes which combine to make up the process of outsourcing and here I quote from paragraph 6 of the written description- “knowledge transfer between expert employees of the client and the apprentice employees of the outsourcing agency who will eventually take over the outsourced job function”.

Accordingly, the patent talks of a system and method to enable “rapid knowledge transfer, for example between a plurality of experts and a plurality of apprentices located remotely from the experts”- as quoted from the abstract. There must have been an underlying reason which triggered the search for such a solution. From the written description, it is inferred that the offset in the profits of a client company gained through outsourcing, on account of administrative and opportunity costs incurred by the company in training apprentices from the outsourcing agency, led to the creation of such a system.

Moving to what the system is made up of, a memory system, a host of servers, networks such LAN, World Wide Web and the rest form the physical architecture and soft tools. The method which this physical architecture is sought to be integrated with is based on what is called Knowledge Transfer Plan (KTP) which is basically a template with user-specific portals for communication of all kinds between the client and the agency in addition to provisions for storage, transfer and the works. Now, before I move on to comment further, heeding to Dr.Swaminathan's words of wisdom, here’s a disclaimer. Being a Mechanical engineer, one doesn’t claim to be an authority on computers. However, the subject-matter of this patent doesn’t require one to be a distinguished member of the Mensa club with 200+ IQ, notwithstanding the technical mumbo-jumbo of the patent which gives it an aura of esotericism.

Returning to the patent, simply broken down, it has two broad features, so to say- the means of communication with assorted functions and a method or a template which integrates all kinds of necessary information and functions in order to ensure that the offshore apprentice doesn’t need to travel half way around the world at the client company’s tabs to learn the job-specific skills. On the face of it, this certainly seems to have a lot of economic value. But the issue here is not about its money-spinning prospects; rather it is about its ability to withstand a patentability scrutiny.

The first question would be if the idea and the concept are novel. Without commenting on it, I would like to point out a few other systems which work on more or less similar lines. Collabnet is a platform for globally distributed teams to work in a centralized manner. Then we have IBM’s internal virtual world called Metaverse (we shall come back to IBM in a short while). In a slightly different yet interesting context, is Secondlife. Secondlife is in fact used in a scenario where multiple players in online gaming can interact, share and play. That apart, most design engineers would know of Computer Aided Engineering (CAE) softwares which work on break-the-wall approach where every department of a company aids in the development of a product design. So strictly speaking, the idea of a collaborative virtual environment is not novel.

The next question would be if the system is novel in parts and if the parts together combine to give a unique product? The template as given in the drawings of the patent certainly seems exhaustive, but the written description itself mentions that this template may be customised to suit multifarious contexts thereby indicating that it does not qualify to be a domain-specific or context-specific invention. I dont say that merely because it is capable of being adapted to other contexts, it loses its inventiveness, but the prevalence of such templates in other environments would certainly restrict the extension of this particular Knowledge Transfer Plan to other situations, thereby raising questions about its ingenuity. Had this plan been designed to meet one particular environment, then it may have been non-obvious which again would have had to pass muster in the eyes of those ordinarily skilled in the art (s.103 of 35 U.S.C). Such templates are available even in softwares meant for inventory management. As far as the soft tools and physical architecture are concerned, the written description itself mentions that it makes use of available tools of networking, may be a plurality of them depending on the scale of the proposed activity. Such being the case, even this aspect of the “invention” is neither novel nor non-obvious. As is evident from the examples cited above, the synthesis doesn’t seem to qualify to become a patentable synergy. Now, it is up to the interested members to judge if this “invention” qualifies for a patent grant. This should also be seen with the IBM application (US 20070162321) in mind, which was subsequently withdrawn after opposition from various quarters. Interestingly, the abstract of the application for "Outsourcing of Services" read thus:

“A method for identifying human-resource work content to outsource offshore of an organization. The method is provided on a computer readable medium and includes the steps of identifying at least one task being performed by an organization; associating each identified task with a functional group within a plurality of functional groups related to the organization; determining information about individual human resources spent on each task; determining task information about human resources spent on the plurality of tasks, the task information based on the determined information about individual human resources spent on each task; using the determined task information to determine a value of each task; and outsourcing tasks having a value lower than a predefined limit to at least one of offshore and to a low cost supplier.”

Atleast as far as I understand, the subject-matter of the aforementioned application is not vastly different from that of Accenture’s patent. This was withdrawn with Bob Sutor of IBM citing the following reasons on his blog:

“My IBM colleagues in intellectual property asked me to post the following statement in order to get it out to as many people as quickly as possible:

IBM has put into the public domain and withdrawn its application for patent number US2007/0162321 - Outsourcing of Services. This patent application covers analyzing work flows, skills, economic costs, etc. Here’s why we are withdrawing it — IBM adopted a new policy a year ago to sharply reduce business method patent filings and instead stress significant technical content in its patents. Even though the patent application in question was filed eight months before the policy took effect in September, 2006, had the policy been in place at the time, IBM would not have filed the application. We’re glad the community pointed this application out so IBM could take swift action.”

Note that it is not expressly stated that this application is not “significant in technical content”; rather according to IBM’s policy, the stress would be on patents with significant technical content possibly alluding to the quantum and quality of content (or lack of it) in the application. This application was withdrawn on account of an outburst of a post by a techie on Slashdot. Interestingly, the Accenture patent was granted after IBM’s withdrawal. These two applications/patents are not isolated instances of patents on outsourcing. A host of other patents and applications exist such as US 20070043603, 20060072727 among others.

So was the USPTO paying attention to the content of Accenture’s application? And we thought the Indian Patent Office was not doing a good job. The comments on various blogs on the two “inventions” make for very interesting reading though my sense of propriety prevents me from reproducing them here. Further, some of the comments spew such anti-immigrant (read anti-Indian) venom that the issue has taken a different dimension altogether. Hopefully, the on-going competition among the Democrats to outdo each other in villifying outsourcing doesn’t give this issue a “spicy” political twist, which is all it needs to flare up passions.

SpicyIP Tidbits: Geographical Indications- Just a cup of tea!

The Indian tea industry is now making use of GIs to help globally promote sale of the product. While Darjeeling has long been registered as a logo and has secured GIs in several countries (including the USA, UK, and a collective mark in the EU), the Tea Board plans to protect teas from Assam and the Nilgiris this year.

The Chairman of the Tea Board, Mr.Basudeb Banerjee, said at the 2nd Global Dubai Tea Forum 2008 that this was a long term goal to further bolster the marketing and sale of the teas, especially since India is such a big player in the World Tea Market.

The full article can be found here.

A taxing situation for pharma companies

In extension of an earlier post the Hindu Business Line has reported on the matter in greater detail.

Examining why Indian pharma companies are pushing so hard for tax incentives we see that:

greater regulation of drug prices in the domestic market, a depreciating dollar and pressure on pricing in large markets such as the US, has left the Indian pharmaceutical industry at the crossroads.
In the last nine months, only players with wider geographical presence (with a multiple currency exposure) and with a formulations-based business have managed to clock reasonable financial performance. Thus, the pharmaceutical industry has pinned its hopes on a host of R&D and tax incentives, which if approved in the Budget, would help the players to free up cash flows through tax savings to fund research activities that do not generate immediate earnings.

The proposal to extend income-tax benefits to profits of scientific R&D companies (which not only do innovation, but also focus on other forms of research) may help a larger universe of pharma companies to reap tax exemptions. Players are looking for an extension of this provision by another five years till 2012. Typically, stakeholders in R&D focussed companies do not enjoy meaningful earnings or dividends, till a successful deal is stitched together. With companies exploring options in areas such as oncology which require larger investments compared to other therapeutic areas, the exemption on income-tax will act as compensation. With Indian companies increasingly developing early stage molecules that could be used for further leads, the payments are usually in the form of minor upfront fees as well as larger royalties and milestone compensations, in case of successful commercialisation. This is where exemption of future income from intellectual property (new chemical entities) from taxes, will help.

Its a well written article which looks into a lot of different aspects of pharma companies and their current growth environment. Find it here.

India's First "Doha" Case: Natco, Pfizer and Roche will be Heard Soon...

Sarah Hiddleston from the Hindu reports on a hearing to decide whether or not India should issue its first compulsory license for the export of Pfizer's Sunitnib and Roches' Erlotinib to Nepal.

We had blogged on this application earlier here, setting out the text of section 92A and the various legal issues involved with this compulsory licensing application.

"The government is to consider whether or not it should allow its drugs companies to manufacture patented medicines for export to poor countries at a hearing scheduled in the Delhi Patent Office late next week.

Hyderabad-based Natco Pharma has requested compulsory licences overriding patents owned by the Swiss company Roche on erlotinib and the U.S. company Pfizer on sunitinib — both are anti-cancer drugs. If the government agrees, it will be the second time an export licence has been granted for public health reasons since WTO members agreed on the trade provision in August 2003. The first was issued by Canada for the production of an HIV/AIDS drug for export to Rwanda.

“The Nepal government issued us an import licence and based on that we applied,” M. Adinarayana told The Hindu on Saturday. Natco, which intends to produce 30,000 tablets of erlotinib and 15,000 of sunitinib, has offered the patent holders a 5 per cent royalty, in line with the WTO requirement to provide remuneration."

In order to appreciate the various legal niceties involved in this dispute, we reproduce the text of section 92A:

“(1) Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided compulsory licence has been granted by such country or such country has, by notification or otherwise, allowed importation of the patented pharmaceutical products from India."

Since Nepal is an LDC with time till 2106 to implement product patents in pharmaceuticals, Natco need not worry about procuring a compulsory license from the Nepal government. Indeed, in the light of the fact that there is no patent covering either Erlotinib or Sunitinib in Nepal, one may wonder why Natco needs a license at all. Can it not freely export these drugs to Nepal?

Not so, since the Indian patents act provides a patentee with many exclusive rights, including the right to manfuacture, sell, import etc. In order for Natco to export to Nepal, it has to first manufacture the product--an act that violates one of the exclusive rights of a patentee. Hence, Natco has to make their case fall within the exceptional circumstances carved out by section 92A.

Under section 92A, although Natco does not need a compulsory license issued in Nepal, it still requires issue a notification permitting the importation of patented products from India. From the Hindu article above, it appears that the Nepal government has done so. But one is not certain of the terms of this "import" license. Is this clearance sufficient to comply with the requirements of the 2003 Decision (para 2 (a)), which provides that:

"the eligible importing Member has made a notification to the Council for TRIPS specifying "the names and expected quantities of the product(s) needed".

We've checked the TRIPS website again and there is no notification from Nepal to this effect. The only notification till date is that of Rwanda, which states:

"Based on Rwanda's present evaluation of its public health needs, we expect to import during the next two years 260,000 packs of TriAvir, a fixed-dose combination product of Zidovudine, Lamivudine and Nevirapine (hereinafter referred to as the "Product") manufactured in Canada by Apotex, Inc. However, because it is not possible to predict with certainty the extent of the country's public health needs, we reserve the right to modify the foregoing estimate as necessary or appropriate."

Natco should take steps to ensure that the Nepalese government puts up such a notificaiton soon.

The Hindu article states that the patent office will hear the patentee before taking a decision on whether to grant a license, a step which the article notes is "unusual"! It cites Adi Narayana, a representative of Natco in this regard:

"The Patent office has done something unusual, Adi Narayana explains. For compulsory licenses, the government is empowered to take decisions based on the strength of the application alone.

“I intend to ask the patent office why it is allowing representation from the patent holder,” he said.

Contrary to what Mr Narayana suggests, most compulsory licenses are decided after hearing the patentee-so really, there is nothing "unusual" about this. However, from a strict reading of the patents act, the government is not obliged to offer the patentee a hearing. For regular compulsory licenses under the patents act, section 87 mandates such a hearing of both the parties. However, there is no similar section offering such a possibility in the case of a section 92A "Doha style" application. From this, one might argue that the patentee ought not to be heard under section 92A.

However, this omission appears more an oversight than a deliberate intent to exclude the views of a patentee in deciding a section 92A application. Readers will recollect our earlier comment in relation to whether or not the patentee ought to be remunerated under section 92A. We reproduce this portion from our previous post below:

"Interestingly, the above section does not speak of royalties, but leaves it upto the Controller to fix "terms and conditions". Can the Controller issue such a license without any royalties to Roche? Clearly not, since Clause 3 of the 2003 Decision states that "adequate" remuneration (pursuant to Art 31 [h] of TRIPS) has to be paid to the patentee."

It seems reasonable that a patentee should be offered a hearing, before the government determines what royalty is reasonable under the circumstances.

Readers will recollect that SpicyIP decried the grant of a patent without hearing the parties in the Valcyte case. The same sort of considerations ought to prevail here too i.e. in the interests of transparency and having a government authority make the right decision, we have to ensure that both parties are heard--particularly since this is the first case under section 92A.

SpicyIP Tidbit: Is the Sheen Wearing off?

If reports from the industry are any indication, the signs are that the appreciation of the Rupee combined with an acute shortage of trained professionals for basic research are taking its toll on India’s image as a Research and Development outsourcing hub. According to Mr.Pari Natarajan, Chief Executive of Zinnov, an R&D consultancy firm:

“Some companies witnessed a 20 percent rise last year in the cost of running their R&D operations in India. If this trend continues, the cost advantage of doing R&D in India compared with the US will go away”

He cites the example of Cisco to support his observation. Apparently, Cisco has benefited from its R&D facility in India that has generated 110 US patents, with another 400 pending with the USPTO. To overcome the talent crunch, it has opened 170 academies across the country to train 8600 students. The article from the Business Report further states that India churns out more than half a million engineers every year, but they are not adequately equipped for basic research, limiting the available talent pool to no more than 1,00,000 people. Other bigwigs such as Microsoft, IBM, Intel, AMD, Google, Motorola, Yahoo and Siemens too are not completely shielded from this scarcity. This observation read along with Mr. Basheer’s post on Indian software firms does not bode well for Indian industry.

Not only is this shortage pronounced in R&D, there is a huge gulf in the demand for and supply of quality engineers in the core sector for non-R&D jobs as well. Being an engineer, I can personally vouch for this fact that most engineers in top ranking institutions aim for a career in the services sector and in top-of-the-line consultancies like the Mckinsey group, Boston Consultancy group, Jones Lang LaSalle to name a few leaving very few good options for companies in the core sector. 

In addition to this, the pay packages from even the best names in the core sector on any given day cannot match those from the software and services sector for jobs of a similar grade nor are they considered glamorous. If companies with a global reputation have a human resource deficit, what about lesser-known outfits which form the backbone of the industry?

Down South (its Southern India, not South India), especially in cities like Coimbatore, Tirupur and Erode which boast of a Rs.10,000-Crore spare parts industry, attracting talented professionals has become a huge issue. It is a little known fact that every car which rolls out of the assembly lines of BMW, Volkswagen and other such auto giants in Europe, has spares made in the Coimbatore region. In addition, there are companies like Lakshmi Machine Works (LMW), ELGI Equipments Ltd, Pricol Industries which supply textile and auto components. 

These companies are left with limited talent pool to choose from during the placement seasons with not many students turning up even for the pre-placement talk. It should be pointed out that these companies have excellent reputations with their customer profiles boasting of the who's-who of the manufacturing sector, domestic and global. In fact, ELGI Equipments is a market leader in compressed-air technologies investing a whopping 4% of its turnover in its Technology Development Division, which has a tie-up with the Center for positive Displacement of Compressors of City University, London. Ironically, the Coimbatore zone is among the best for engineering education not only in Tamil Nadu, but also in the country with some top-notch institutions that are older than the IITs. Particularly, the core engineering departments of some of the colleges in this region are counted among the finest in Asia. 

Yet, the cream of these students get absorbed in the IT and ITES sector and naturally, the companies have to make do with what they get. Fortunately for this region, their entrepreneurial spirit is comparable to that of the Gujaratis and the Hassidic Jews. To ensure that they do not miss out on proper talent, entrepeneurs in this region have jointly set up training institutes through their forum Coimbatore District Small Scale Industries Association (CODISSIA). Some of them run engineering institutions through trusts and the students finally get absorbed in these companies.

Such endeavours are the need of the hour for only if there is adequate talent to create intellectual property which is worth protecting; it makes sense to wax eloquent on protection of intellectual property. Sporadic efforts in certain pockets to give quick-fix solutions will not go a long way if we are looking at a sustained development for the next 15-20 yrs. Chinese efforts in this direction are worth learning from and much has been said and written on this. What is left is the most important part-comprehensive planning and clinical execution.

Hopefully, we shall have a post in a few days on the number of patents from small scale industries.

The .Asia domain launched under a ‘sunrise policy’

The DotAsia Organization, an umbrella organization of various national top-level domain registries around Asia (including .IN in India), has launched the global “.Asia” Internet domain for the Asia region under a sunrise policy which gives a preference to trademark owners and celebrities. (Press release available here)

Most domain name launches are a nightmare for trademark owners and celebrities since it means protecting their trademark and identity in yet another jurisdiction. More troubling for them however is the fact that most of the domain names registration occur on a first come first serve basis. This usually means that cyber-squatters grab up domain names of famous trademark and later attempt to sell it to the very same trademark owners for an obscene price. This menace has been effectively countered by the various Domain Name Dispute Resolution Bodies set up ICANN and national registries. However this still does come at quite a price with just the administration fees coming up to about $1500 plus lawyer fees. This when buying a domain name costs lest than $10.

The DotAsia organization however announced a ‘sunrise policy’ for the .Asia launch. This policy gives a first preference to trademark owners and businesses. The organization has also launched a Celebrity Pioneers Program whereby it gives preference to celebrities to register their domain names before the process is opened to the general public. This was undoubtedly a smart publicity move since Kapil Dev who has lost all his other domain names was one of the celebrities to grace this event because he definitely did not want to lose out on yet another domain name.

While I’m sure that trademark owners are breathing a huge sigh of relief at this new policy there is always the other side of the argument – the right to free speech. The internet is crucial to our trade and commerce but there is also the point that the internet is also a platform for people to share ideas and thoughts and criticisms. What if I want to start a website which is a parody of a famous trademark or a celebrity? Parodies are a valid exception to trademark and copyright rights. Under the first come first serve policy all parties have an equal right to grab the domain name of their choice but under the ‘sunrise policy’ the general public is automatically relegated to second class citizens.

However at the end of the day most people would consider the 'sunrise policy' a reasonable policy since it will save millions in litigation expenses.

SpicyIP Tidbit: Natco’s ‘compulsory licensing’ request to come up for hearing next week

IP Watch reports that Natco’s request for a compulsory license to export anti-cancer drugs to Nepal, is going to come up for hearing by the end of February. (Full story is available here) As most of our readers must know SpicyIP had covered this case extensively a couple of weeks ago. The request for compulsory licensing was made under S. 92A of the Patent Act, which allows for ‘compulsory licensing for export of patented pharmaceutical products in certain exceptional circumstances’. This case is especially significant because it is the first time that India is testing this provision. The only other time such a provision has been used in the world has been when Canada used a similar provision to license anti-AIDS drugs to Rwanda. So far compulsory licensing provisions, worldwide, have been used mostly only when ‘AIDS’ had been deemed to have caused a public health issue. This maybe the first time that somebody is alleging that ‘cancer’ is causing a public health issue. Given the inherent flexibilities of the 'public health' provision as a result of the Doha Declaration, it is very likely that even ‘cancer’ will be deemed to be a public health issue. It will therefore be interesting to see how the Controller interprets the ‘public health problem’ in Section 92A.
Another issue which Shamnad had pointed out in one of his posts was that it was not yet clear as to whether the Nepal Government had issued a notification as required by Section 92A. Even the present IP Watch report has not clarified this point. This issue may turn out to be a contentious issue given the fact that Nepal is making a slow transition to a democracy and is still in the process of drafting a new constitution and therefore the question crops up as to which authority in Nepal may issue a notification?
We’ll bring you more on this case next week.

SpicyIP Tidbit: Search for Traditional Remedies for Bird Flu

In a major institutional boost towards applying traditional Indian medicine to modern day afflictions, the National Institute of Siddha (NIS), Chennai has announced that it would jointly work with six other institutions namely, University of Madras, Anna University, Dr. M.G.R.Medical University, King Institute, Madras Medical College and Tamil Nadu Veterinary and Animal Sciences University, in the fight against bird flu. In this connection, a day-long session was held at NIS on Microbiology, Virology and Clinical Parameters in Avian Flu (Siddha perspective).

The details are available here.

SpicyIP Tidbit: Bloopers Galore

Mysteriously, another form of Intellectual Property has cropped out of nowhere. Introducing the “Geographical Indicator Patent” also referred to as GIP. Atleast that is what The Telegraph says:

“Pakistan opposes Jammu and Kashmir’s efforts to get a geographical indicator patent (GIP) on its centuries-old Sozni shawls, saying this embroidery craft is in vogue in its part of Kashmir, too. The neighbouring country’s traders want Sozni shawls made in Pakistan-occupied Kashmir included under the patent Kashmiri Sozni.

Jammu and Kashmir’s Craft Development Institute (CDI) had applied for patents on three handicraft products — Pashmina, Sozni and Kani shawls — with the Chennai-based Registry GIP in 2005-06. The Registry, as required, invited objections from within and outside the country.”

Demons of self-doubt were about to conquer me for a brief while for I thought my knowledge of the rudiments of IPR had gone for a six and I frantically rummaged the net for information on GIP. Luckily, it turned out that the demons were a product of a presumed Tamas (meaning darkness, alluding to all-conquering ignorance). It is disappointing to know that a mainstream popular publication from the land of the silver-tongued Vivekananda is prone to such errors of conception. Probably, we need to conduct a few workshops and seminars on IP awareness for the media before we move on to so-called rural and uninformed sections of the country.

SpicyIP Tidbit: “RIN”

Rural India, it appears, is telling its urban counterpart that it is time the latter caught up with it in terms of innovation. After NIF, we have another NGO helping rural innovators get their due. Rural Innovations Network (RIN), founded by a Mechanical engineer (cant help feeling proud of one of my brethren) Paul Basil, has lent itself to the cause of making commercially viable products out of rural innovations. The primary areas of RIN’s focus are innovations related to water, agriculture, dairy and energy. In addition, RIN has a tie-up with IIT Madras and Servals Automation, an SME. Details on several such grassroots innovations are available here.

SpicyIP Tidbits: Patent Cause List

Here’s a case involving the “Loins of Punjab”. New Delhi-based Enkay Rubber Co. which manufactures bladder shells for inflatable balls including soccer balls has alleged infringement of its US Patents 6,544,608 B1 and 6,949,276 B2 by Score American Soccer Co., Uniroyal Goodrich and Michelin N.A. According to the former, the defendants imported certain soccer balls, including the Jupiter soccer ball, from Sports Syndicate and Hans Raj Mahajan & Sons from Punjab, which infringe claims of the patents. The case has been assigned to U.S. District Judge in Texas T. John Ward.

SpicyIP Tidbit: Ranbaxy’s Dutch Challenge “Pfizzes” Out

Taking a cue from the late Saddam Hussain’s (or is it Hossein to faithfully toe CNN's line?) (in)famous phrase, “the mother of all wars”, it appears that the Lipitor patent challenge is being touted as “the mother of all patent challenges”. Pfizer’s Lipitor is a cholesterol-lowering drug and Ranbaxy’s bid to challenge Pfizer’s Dutch patent on basic lipitor (EP 247633) received a setback with the High Court in the Netherlands, affirming the District Court judgment of 2006, by upholding the validity of the patent. Further, the judgment prevents Ranbaxy from launching its generic version before the Lipitor patent expires in November 2011.

The Lipitor patent which was granted on January 30, 1991, expired in 2007. However, Pfizer had obtained Supplementary Protection Certificates (SPCs) which extended the term of the patent to November 5, 2011. This judgment must be seen in the context of the bitter struggle involving the companies over the Lipitor patent in 17 countries. Ranbaxy though unsuccessful in US in 2005, tasted success in Norway in 2007. 

In 2007, a Spanish Court upheld Pfizer's basic patent covering the calcium salt of atorvastatin, the active ingredient in Lipitor but invalidated a patent on a stabilized formulation that includes atorvastatin. This “mother of all patent challenges” is certainly worth observing for it could have several ramifications for Indian manufacturers.

The complete article is available here.

Patent-ly problematic

India's IP regime is being hauled up for not being industry friendly enough by the biotechnology Industry Association (BIA).

Business Standard reports -

The association raised the following concerns:

1. Indian laws lack clarity with regard to the patentability of biomolecules like nucleic acids.
2. The provisions dealing with disallowing patents for known products which do not result in significant enhancement of efficacy.
3. India's capacity to include data protection clauses for medicines.
4. The "onerous" obligations relating to the disclosure of source and geographical origin of biological materials used for inventions which are the subject matter of patent application which subject "valuable patent rights to uncertainty.
5. Indian patent laws do not favour large scale patent monopoly for incremental innovations on known substances.

The BIA has also pointed out similar deficiencies in the IP regimes of other developing nations like China, Thailan, Brazil, Chile, Egypt etc.

In a representation to the office of the US Trade Representative (USTR) on February 11, the association has demanded that India be kept under the priority watch list of USTR due to inadequate intellectual property (IP) compliance.

BIA represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centres and related organizations in the US and 31 other countries. In addition to healthcare, BIA members cover sectors like agriculture, industrial and environmental biotechnology products and services.

Spicy Tidbits: Compulsory Licensing Dilemma

Bangkok is continuing preparations to import the generic drug to treat breast and lung cancer patients to fulfill its obligations under the universal health care scheme. This is despite the uncertainty over compulsory licensing in the country.

The Government Pharmaceutical Organisation board has chosen to sign a deal with Dabur Pharma to distribute Docetaxel.

The GPO chose the Indian drug maker over two other companies, including patent owner Sanofi Aventis, after it offered to distribute the drug for 1,245 baht per 80mg compared to the original version which costs 25,000 baht.

The government has approved compulsory licensing for Docetaxel, lung cancer drug Erlotinib, breast cancer drug Letrozole and Imatinib, a drug used in the treatment of leukaemia and gastro-intestinal stromal tumours.

When asked about the status of compulsory licensing the authorities replied as follows:

Public Health Minister Chaiya Sasomsab said the ministry would take no further action on the licences announced for these cancer drugs. The final decision would be made by Prime Minister Samak Sundaravej.
On Jan 4, then public health minister Mongkol na Songkhla approved ministerial announcements to import generic versions of four cancer drugs for treating patients under the universal health care scheme. He later struck a deal with Novartis after the patent holder agreed to supply its medicine free to more than 900 patients.
Mr Chaiya wanted to review the CL policy introduced by Dr Mongkol, but he found out on Tuesday that it cannot be revoked.

The full article can be found here.

SpicyIP Tidbit: Patent Progress Report

No matter how much we try to extol the virtues of a qualitative analysis, none can deny the relevance and significance of a quantitative evaluation, for numbers speak for themselves or atleast the common man presumes them to do so. The editor of Intellectual Asset Magazine (IAM), Joff Wild, has come up with a “Patent Focus Report for 2008” for Thomson’s Knowledge Newsletter. According to this report:

“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. This is one of the reasons why applicants wait an average of two years before the examination process begins. However, there does seem to have been a surge in the number of patents being granted, if recent reports are correct. During the Indian patent office's current fiscal year, which finishes at the end of March 2008, over 10,000 awards have so far been made. This figure is significantly higher than the 7,500 granted for the whole of 2006/07 and the 4,320 granted during 2004/05. Of course, it also begs the question of just how much scrutiny these patents have received given the low numbers of examiners currently employed.”

The last observation could not have been more apt considering the quality of applications filed and the procedure of examination they are subjected to. For instance, there was one peculiar application which I came across during my search for patents on diamonds. This application was titled “Artificial Sun” and the abstract read thus:

“Artificial sun is the reflector satellite prepared or covered by mirror will be sent to the gravitation of the earth as like as moon. Then the night will be change to the complete day in all over the world or throughout the world and the light is the most source of solar energy of solar electricity.”

Now after reading this application, I was instantly reminded of the movie “Die Another Day’ (2002) where Toby Stephens, who plays the bad guy, builds a satellite similar to the one crudely described above. Since this application was filed in 2006, all my hopes were dashed to the ground for I was naively expecting that for a change here was a case of a Hollywood movie, a slick Bond-flick at that, ripping off from an Indian patent application! Alas, that was not to be.

On a much more serious note, I could not help contemplating if all the efforts at sensitising the public about the importance of IP are of any use at all. I felt so, for if the establishment itself is not able to get its act together, how on earth are we going to convey the message to a population of one billion and still counting? For a moment let us turn a blind eye to the inefficiencies of the establishment which is consistent considering its track record; but what about the mainstream media, print and electronic?

Arguably, a near-accurate indicator of the level of consciousness in any aspect of a nation’s public life can be gauged from the manner in which the media reports. The more informed the media is on subtler aspects of so crucial a branch of social engineering as law, the better it is for the nation’s progress and social evolution. This does not seem to be the case in India. 

The other day a few reputed publications screamed from the rooftops, with the headlines reporting in breathless tones, that Bajaj had won the patent infringement case, when prudence and responsibility required them to refine their language. Were the merits of the case as regards the issue of the validity of the patent ever discussed in detail? No. The 56-page order of Justice Jothimani clearly states that the complexities of the case were not required to be dealt with at this juncture, for a prima facie case had been established on the basis of balance of convenience in favour of Bajaj. Does it not beggar logic to extrapolate this carefully worded piece of judicial pronouncement to illogical extremes thereby demonstrating a classic instance of Reducto Absurdo? One fervently hopes that atleast respected sections of the Fourth Estate retain the dignity of that beautiful profession and hold aloft the flame of truth.

That apart, the patent focus report reels out statistics on the current rate of patent filing in China, Europe, USA and Japan which may be accessed here.

SpicyIP Events: NLSIU to hold a National Symposium on Challenges to India's Patent Regime on the 12th and 13th of April

The National Law School of India University (NLSIU), Bangalore is going to hold a National Symposium on Challenges to India's Patent Regime on the 12^th and 13^th of April, 2008. The symposium is being organized by the Editorial Board of the National Law School of India Review (NLSIR) – NLS's flagship journal formerly known as the Student Bar Review. The website can be accessed here. The concept note for the Symposium is available here. As per the website of the Symposium

The Symposium has been structured to discuss the cutting edge issues relating to the patent regime in India. Over four sessions, it looks to cover the theoretical justifications for patents, India's role as a country which is a signatory to TRIPS, the contentious issue of pharmaceutical patents and finally an analysis of possible judicial attitudes towards patent law and legislation in India. The Symposium hopes to bring together an assembly of judges of the Supreme Court and High Courts, patent attorneys from the USA, senior advocates, technical experts, ideologues as well as activists to facilitate constructive discussion of the issues set out and the best way forward for India's patent law.

For more details you can contact Arghya Sengupta (Pronounced as Orgo Sengupta!), the Chief Editor of NLSIR at arghya.sengupta@gmail.com or call him at 919886023232/919871668286. Incidentally Arghya has been awarded the Rhodes Scholarship for further studies at Oxford University.

Also, you can access the free archives of NLSIR over here. This journal carries some of the finest legal writing ever published in India and I strongly recommend it for anybody interested in Indian law.