SpicyIP Events

1. IP Business Congress 25-27 June 2008, Amsterdam

Presented by iam-magazine and Ocean Tomo. From the conference website:

The IP Business Congress 2008 is an event unlike any other in the IP calendar.

Bringing together IP leaders from around the world, the Congress will demonstrate why more and more people describe intellectual property as the pivotal business asset of the 21st century. No one who has an interest in the management and monetisation of IP rights will want to miss this groundbreaking event.

The Congress comprises a one and a half day CIPO Summit, organised by Intellectual Asset Management (IAM) magazine, aimed at defining the role of the Chief Intellectual Property Officer in business today, and the second European Live IP Auction hosted by Ocean Tomo LLC.

2. Mission Intangibles, 14 December 2007, New York City
Presented by the Intangible Asset Finance Society. A conference on the financial impact of extra financial information.

SpicyIP Tidbits

1. Natco (unsurprisingly) considering challenge to HC ruling on Glivec
Thanks to livemint for this article confirming that Natco is considering a challenge to the High Court ruling that India's Intellectual Property Appeals Board may hear it's appeal without a technical member.
For more on this dispute, click here, here and here.

2. A nice piece on music copyright infringement in India
Thanks to Ben from musiclawupdates for pointing out this Hindustan times article. The article sets out the usual arguments as to why copyright infringement in this sphere damages the industry.

3. Indian centres drive US patent rush
Here's an interesting piece from The Economic Times which states in part:

Notably, the number of patent filings from India R&D centres have been growing over the years. It is the quality and hi-tech bit that’s changing. More and more cutting-edge products are being developed in India. While outsourcing lower-level technical jobs to India has been a practice of multinational technology firms, the increasing reliance on Indian R&D operations is a growing trend.
...
A government report in the US has pointed out that US patent applications from China, India, Singapore, South Korea and Taiwan rose 759% during 1981-2001, while the patent applications from the US grew 116% during the same period.

4. Venus Remedies files patent for Meningitis formula
Mumbai (PTI): Pharmaceutical company Venus Remedies Ltd on Monday said it has filed for patent protection of its fourth research product - a formula for treating Meningitis - in 48 countries. Read more at The Hindu News.


5. Open Source approach could lead to more affordable drugs for the world's poor
This fascinating piece from scidev.net looks at a proposal made last week by Samir Brahmachari, a recently appointed director general of the Council of Scientific and Industrial Research (CSIR), a chain of 38 government laboratories engaged in industry-oriented research. Quoting the article:
Brahmachari, who was previously director of the Institute of Genomics and Integrative Biology, suggested an openly accessible website through which researchers could explore how information about the Mycobacterium tuberculosis genome and other scientific data could be used to design new TB drugs.

6. GSK has doubled the number of clinical trials conducted in India in 2007

Mumbai, Nov. 25 GlaxoSmithKline Pharmaceuticals has witnessed close to a two-fold increase in its clinical trials in India. The multinational drug maker clocked about 31 trials in the country this calendar year, up from 16 in 2006.

The company had undertaken only three trials in the country, in the pre-2005 period, a GSK official told Business Line. What has changed since is the product patent regime came into effect in India from 2005, he indicated.

Interestingly, the the company is looking to bring in Phase II and Phase I trials into India as well.

Read more at The Hindu Business Online.

7. Astra's Iressa patent rejected under new patent laws
Thanks to livemint for this one.

After hearing pre-grant oppositions filed by Indian drug companies for more than a year, the patent office in New Delhi has rejected pharmaceutical giant AstraZeneca’s patent application for its lung cancer drug Iressa.
The patent office rejected the application citing “known prior use” of the drug, which prevents grant of a patent in India under the country’s 2005 amended patent laws.

Astra’s Indian generic rivals, Natco Pharma Ltd and J M Pharmaceuticals Ltd, had opposed the patent application citing that the drug has been in the public domain before the company filed its patent in India. Iressa is a branded formulation of the drug, known in generic terms as Gifitinib.

“We understand that India has different interpretations to patent applications, though Iressa is a patented product for Astra elsewhere in the world,” noted Staffan Ternby, a spokesman for AstraZeneca. He declined to say if the company would challenge the Indian patent office’s decision.

8. WHO funded study reveals 3.1% of drugs sold in India are counterfeit suspects
Pharmabiz reports:
In probably the first-ever survey, involving inspection of more than 10,000 samples of pharmaceutical products sold in India, 3.1 per cent are found to be counterfeit suspects valued at around Rs 1,000 crore, according to a survey funded by the World Health Organisation and conducted by SEARPharm Forum, a leading pharmacy professional organisation in the country.

The survey is based on 10,743 samples collected from 234 retail outlets in metros and district headquarters spread over 38 locations in 15 states in 5 regions. The locations were chosen based on their perceived regulatory status.

9. The subcontinent's wealthiest 40 individuals doubled the value of their fortunes over the past year.
Read all about it at Forbes.com

10. Just in case you haven't seen it yet, we suggest you check out http://www.google.com/patents

11. When faces are not billboards
Thanks to the Hindu for this great piece on celebrity endorsements.
Here's an extract:
Every advertiser in South India would dream to have Rajinikanth or Kamal Hassan endorse any product. But the two have consistently stayed away from product endorsements. This cannot be explained away as a simple personal choice. It has much more to do than warding off the seduction of easy money. It is certainly not the fear of overexposure; at least not for these two.
...
the free circulation of their images ensures and cuts across the class divisions. They appear to believe in the democratisation of their image. This position is politically nuanced and culturally well tuned. Such a decision pays and brings in its own benefits. The frequent and free use of images by the fans makes the point clear, that what matters in such displays is Rajinikanth and not what his image is tagged on to. Rajinikanth is the product and he is the image. So is Kamal Hassan.

12. Educomp - an unusual approach to property development - supply IP + Schools
Thanks to DNAIndia for this one:

While alliances between schools and property developers have been common from the early 1990s, real estate funds and other education providers have spotted an opportunity and are now scurrying to get a piece of the action.

“We want to acquire property and provide intellectual property to the trusts that run schools,” says Shantanu Prakash, chief executive officer of Educomp Solutions. Laws permit only trusts to manage schools.

13. Copyright notices to ISPs on the rise

Business Software Alliance has issued more than 15,000 notices to ISPs (Internet service providers) in India till September this year, on infringing activity.

Sharing this information with Business Line, the BSA’a Vice-President and Regional Director (Asia), Mr Jeff Hardee, said the monthly average notice issuance has risen from 220 in 2006 to 1,682 this year.

14. Another piece on the impressive R&D programs of India's (generic?) pharmaceutical companies
By the Times of India
Leading companies who are developing new molecules include Ranbaxy, Glenmark and Dr Reddy's. Over last couple of years, Indian pharmaceutical companies have stepped up their R&D spends, following a patent product regime. At present, nearly 10-12 companies have molecules under various stages of development.

Neem It Up!

A thumping ovation to the Organizers of the recently concluded Neem Conference held in the balmy city of Coimbatore.

Spearheading the Neem Revolution, the Neem Foundation organized the 5th World Neem Conference (WNC) 2007 to popularize the Neem tree and its vast potential in the bio-sphere. Attended by delegates from 35 countries the conference highlighted the latest breakthroughs in Neem research, organic farming, bio-medicine, socio-economic issues and intellectual property rights.

Having captured popular acclaim as the wonder tree of the humid tropics, the potential benefits form the Neem Tree reads like a medicinal cornucopia derived from Pre-Vedic. times.

The neem tree (Azadirachta indica) originates from the Indian subcontinent and now grows in the dry regions of more than 50 tropical countries around the world. The Neem tree has multiple uses. It is mentioned in Indian texts written over 2000 years ago and has been used for centuries by local communities in agriculture as an insect and pest repellent, in human and veterinary medicine, toiletries and cosmetics. It is also venerated in the culture, religions and literature of the region.

Since the 1980s, many neem related process and products have been patented in Japan, USA and European countries.

The first US patent was obtained by Terumo Corporation in 1983 for its therapeutic preparation from neem bark. In 1985 Robert Larson from (USDA) obtained a patent for his preparation of neem seed extract and the Environmental Protection Agency approved this product for use in US market. In 1988 Robert Larson sold the patent on an extraction process to the US Company W.R. Grace (presently Certis). Having gathered their patents and clearance from the EPA, four years later, Grace commercialized its product by setting up manufacturing plant in collaboration with P.J. Margo Pvt. Ltd in India and continued to file patents from their own research in USA and other parts of world

The Indian Kurushethra against a Neem patent held by W.R. Grace & Co. brought to light the intellectual property related issues controversies and reiterated the menace of Bio-colonialism.

These two cases not only created a global awareness on neem and its properties but also raised issues on biopiracy, need for documentation of traditional knowledge, equitable sharing of gains from traditional knowledge and harmonization of patent rule. Success of revocation of European patent illustrates the requirement of systematic documentation of knowledge whether traditional or scientific. Further these cases demonstrate the potential of IPR in creating awareness, enthusiasm in scientists, entrepreneurs, organizations and society and increased investments in research and development of products which compete in the market place. This is evident from upward trend of patents filed globally on neem from 1994 – 96 onwards – intense patent debate period and commercial product available in markets from neem.

Largest number of patents is in USA (54) followed by Japan (35), Australia (23), India (14). In India additionally more than 53 patent applications are pending for either gazette notification or opposition since 1995. If granted India will have the largest number of patents in neem. This illustrates that IPR does not stifle creativity and innovation but creates challenges and opportunities to over come the existing patents barriers by innovation and invention. (Courtesy: Pramilla Thakkar, Neem Foundation)

No Bitter Sweet Victory this-after all bitter sweet is an acquired taste.

SpicyIP Petition: Indian Patent Database

Thanks to the overwhelming support of many of our readers , our online petition has now garnered close to 100 signatures.

An interesting mix of folks who signed--ranging from students to attorneys/in-house counsels to academics/policymakers to even the founder of a company that first brought Ayurveda to the US.

For those of you who support the cause and still haven't signed, we would please request you to do so now. The petition is available here. We intend submitting this petition in the next couple of days. If possible, please also include your affiliation (and designation) in brackets after your name. Please also forward this message to your friends/colleagues who may be interested in supporting this cause.

Some of you wrote to inform me that the government is already doing this i.e. creating the database. Let me assure you that the government has been attempting to do this since the mid '90's. However, we're worried that this has taken far too long. A little pressure from various stakeholders can only help--so your signature definitely counts!

Secondly, the government may be making some efforts at creating a database for patent applications. However, there is no move as yet to make patent office decisions publicly available. As we stress in the petition, it is critical that these decisions (either accepting or rejecting a patent application) be made public. This is the only way in which we can hope to increase public scrutiny of the Indian patent office. This will also help us in evolving better patent policy for India.

A recent Mint article seems to suggest that even with respect to patent application data, the scope of information to be made publicly available may be limited. The article states in pertinent part as below:

"Complete applications of patents granted after 2006 will be available in the next few months."

Clearly, this is a good step forward. However, merely having post 2006 data is not enough--what about patents issued in all the previous years? With all our IT prowess, why has it taken this long? We need to make our collective voices heard and to request that this task, which began in the mid 90's, be given priority status and fast tracked.

Novartis' Gleevec Patent Challenged in the US?

With characteristic flair, CH Unnikrishnan of Livemint is again the first to unearth this interesting story:

"US drugs regulator food and drug administration (FDA) has accepted a generic challenge by India’s Sun Pharmaceuticals Industries Ltd against Glivec, a controversial mega-earner cancer drug of Novartis AG, potentially weakening the Swiss drug maker’s petition against an Indian ruling denying the drug a patent.

The challenge in the US, if it invalidates Novartis’ patent, will not only significantly stre-ngthen the plea of local drug makers here, but also open up a huge generics market for them in the US for this drug, which, last year, grossed some $2.5 billion (Rs11,605 crore then), equivalent to more than one-10th of Novartis’ revenues. Novartis’ patent on Glivec was challenged by Sun Pharma through what is called a Para IV filing with FDA.

The filing initiates a process with which a generics firm can seek marketing approval for an already patented product either by invalidating the patent, by proving there is fundamentally nothing novel in the product or by proposing to introduce a variant without infringing the patent. The appeal was listed early this month by FDA after a six-month surveillance by the regulator. Under the rules, Novartis is expected to respond to this challenge within 45 days of the date of listing.

At least two drug industry insiders confirmed the Sun Pharma challenge and the FDA listing. The filing is likely aimed at invalidating the existing patent as the Mumbai drug maker has found gaps in Novartis’ patent. An email sent to Novartis’ media relations office at Basel on Wednesday did not elicit any response and an India spokesperson said she was not authorized to comment. In 2006, the Chennai patent office refused Novartis’ claim on the ground that it is not an innovation.

An invalidation of the Glivec patent, if it happens through Sun Pharma’s Para IV filing, will help strengthen local drug makers’ claims against Novartis in India. “This very disclosure in the US will make Novartis’ appeal against the Chennai patent office’s decision to reject its patent application unacceptable,” said Gopakumar Nair, a patent expert in Mumbai.

Shamnad Basheer, an associate at Oxford IP Research Center, UK, echoed this view. “If the US, which is comparatively liberal in granting patents, invalidates the Glivec patent, it will look ridiculous for any (of the) patent court(s) in the world, which are (usually) more cautious, to grant a patent for this drug,” he said in a telephone interview. Novartis has challenged the Indian patent office’s decision to turn down its patent application through an appeal filed early in 2006 in the Madras high court.

The case has since shifted to the Intellectual Property Appellate Board, or IPAB, which hears such disputes in the country. In 2006, the Chennai patent office refused Novartis’ patent claim for Glivec—which is a beta crystal or polymorphic form of the known cancer drug Imatinib Mesylate—on the ground that it is not an innovation and the Indian patent law does not identify this as patentable.

One of the newly amended provisions in the Indian patent law, Section 3D, specifies that no derivatives or modified forms of known drug substances are patentable unless it enhances the therapeutic efficacy substantially. Following the refusal of its patent application in India on this ground, Novartis challenged this provision of the Indian law, saying the rule is not compliant to World Trade Organization’s globally accepted patent law.

This challenge was rejected by the Madras high court early this year. Rajeev Nannapaneni, chief executive of Hyderabad-based Natco Pharma Ltd, which is one of the corporate opponents in Novartis’ patent dispute at IPAB, said: “The US patent challenge gives us a most important message that the Glivec patent has been questioned not only in India, but elsewhere also.”

Meanwhile, Sun Pharma and Natco Pharma have also filed drug master files or DMFs with FDA for off-patent or generic versions of Glivec. Filing a DMF sets off the process for generic drug firms to get their products registered in the US pharmaceuticals market.

A Sun Pharma spokesman confirmed that the company has filed DMFs for six drugs in the US in April-June 2006, and one of them is the polymorph of imatinib, but declined further details on the Para IV filings.

I'm not sure when Sun filed its ANDA and para IV (if indeed it did file a Para IV). Some sources suggest that this was filed as far back as 2006. Though, it is likely that the 2006 filing was only a DMF (drug master file)--a filing that normally predates an ANDA filing.

If the para IV filing was in 2006, then the 45 day window that the patentee has (to sue the ANDA filer) has clearly passed. Under the Hatch Waxman Act, the mere filing of an ANDA under para IV is deemed to constitute a "patent infringement". And the patent owner gets 45 days to sue. If it sues within this window, then the FDA automatically stays the ANDA application (i.e. the application by Sun claiming that it is bio-equivalent and therefore ought to be approved as a generic version of Gleevec) for 30 months.

If this is indeed a Para IV filing and Novartis hasn't filed a law suit within 45 days, then clearly Sun's application to be approved as a generic will proceed and most likely be granted by the FDA. In which case, will Sun be bold enough to introduce its generic version into the market and risk being sued by Novartis (and be held liable for damages)?

In order to avoid this uncertainty, Sun ought to file a declaratory suit, asking the court to hold that the patent is invalid or that it is not infringing. Chances of a declaratory suit being admitted are much stronger after the US Supreme Court decision in Medimmune.

It also needs to be noted that there are several patents protecting Gleevec:

1. The original patent covering the Imatinib free base (filed around 1993)
2. The patent covering the beta crystalline version of Imatinib Mesylate (filed around 1997 or so)

Even assuming Sun has actually challenged these patents, it is not likely to win against the basic patent ('93 one). Which means that Sun cannot enter the market with a product prior to the expiration of this basic patent (till 2013 or the date when the patent term extension expires). Rather, it's likely win will be against the '97 patent. In which case, it can enter the market as soon as the first basic patent expires. It will also obtain a 6 month exclusivity after its first entry into the market.

(Readers will be interested to know that Sun Pharma recently won a shared 180 exclusivity period in relation to Novartis' Trileptal ( a drug for epilepsy).

Another possibility is that Sun is not actually challenging the '97 patent (as being invalid) but is only claiming that it's particular drug does not infringe this patent. As we stated in one of our earlier posts, the '97 patent covers only one polymorphic form i.e the beta crystalline form. Therefore generics can enter with other forms, such as the alpha crystalline form. And published patent data from India show that Hetero has pending patent applications for some other forms (alpha as well as some amorphous forms).

The last possibility of course is what is stated in the news item. i.e. that 45 days haven't passed as yet and Novartis may end up suing Sun Pharma within this time frame!

Without Sun or Novartis issuing a statement, we are all shooting in the dark. And to make matters worse, the FDA keeps such information confidential. SpicyIP is very interested in hearing from readers who know more intricate details about this case (nb: the confidentiality of sources will be maintained at all costs..)

CIPLA Milking Indian Consumers? Charity Does Not Begin at Home!

They say "charity" begins at home. If a recent news item is to believed, then CIPLA is doing exactly the opposite!!

It has donned the mantle of being a charitable messiah in parts of the world like Africa by supplying cheap AIDS medicines--whilst at the same time over-charging its Indian consumers!

The Hindu Reports that:

"Drug-maker Cipla has received a Government notice demanding Rs 24.23 crore, inclusive of interest for alleged overcharging by the company on antibiotic ciprofloxacin during the period April 2006 to March 2007.

In the past, Cipla has received notices from the National Pharmaceutical Pricing Authority demanding an estimated Rs 941.92 crore with interest, also for alleged overcharging by the company till March 2006 in respect of five drugs.

The drugs under the scanner for alleged over-charging are respiratory drugs Salbutamol and Theophylline; antibiotics, Ciprofloxacin and Norfloxacin; and cephalosporin-antibiotic Cefadroxil. The overcharging allegations have dogged Cipla for over five years.

Cipla had legally contested the Centre’s previous orders on overcharging saying, among other things, that the medicines in question were not under price-control."

An earlier news item stated that CIPLA was charging Indians more than 150% of the price that it was charging in Africa.

"Anti-monopoly watchdog MRTPC has directed its investigative arm to probe the alleged overpricing of HIV drug 'Viraday' by Cipla.

Taking suo moto cognizance over advertisements brought out in various newspapers by an American NGO, the Aids Healthcare Foundation, the Commission has directed the Director General of Investigation and Registration (DGIR) to submit a report within 60 days.

The NGO alleged that Cipla is exporting its HIV/AIDS drug Viraday to African countries at just Rs 21,200 per patient a year while the same for Indian patients cost over Rs 54,000. According to sources in MRTPC, the anti-monopoly watchdog felt that the over 150 per cent price difference between Africa and India was unjustifiable and suspected it to be an unfair trade practice"

Over the years, CIPLA has carefully cultivated an image of a new age Robin Hood that steals from the rich to help the poor, by supplying them with affordable medicines. Unfortunately, these news item reveal that the " rich" in this case are not limted to big pharma --but includes poor Indian consumers as well!!

Notwithstanding the "legalities" of the case, this is terribly damaging for the reputation of CIPLA. One has to wait and see if this media exposure and will force CIPLA to price charitably in it's home turf.

This over pricing in India may also be "one" of the reasons why India's HIV population have had such an abysmally low rate of access to ARV's (anti retrovirals). Amongst the 2.5 million HIV patients (the numbers keep changing each year!!), only about 1 lakh (1,00,000) or so have access to HIV treatment!! India had no product patents till 2005. So clearly, we cannot resort to the oft easy and now fashionable patent "bashing" strategy to explain the low "access" numbers in India!

[Thanks to clarifications from Priti Radhakrishnan of IMAK, the following facts emerge:

1. India’s antiretroviral therapy coverage still remains well below 10% (See "Progress on Global Access to HIV Antiretroviral Therapy", a 2006 document by WHO).

2. As of this week, 1.05 lakh people are receiving ART (anti retroviral treatment) from the government.

3. The Indian ARV programme run by NACO (which provides free ARVs) purchases its ARVs at the lowest prices in the world -- even lower than the "global lowest prices" quoted in MSF's "Untangling The Web" document. CIPLA is one of the main suppliers to the government at this low price. CIPLA may therefore be charging the alleged high prices only to other outlets such as pharmacies and private hospitals.]

Patents certainly cause price rises. But the recent allegations against CIPLA may caution us that the mere existence of generics is not a sufficient guarantee of low prices--we need a vigilant price regulator as well. And to this extent, as an earlier SpicyIP post noted, a more active NPPA (National Price Control Authority) is a welcome trend.

GOOGLE'S MILITANT APPROACH TO COPYRIGHT LAW

SpicyIP had posted a couple of weeks ago, on the first case of copyright infringement against Google’s U-Tube in India. The plaintiffs in this case are T-Series a company which grew in the face of a daunting monopoly (of HMV) because of its daring, pro-active approach to copyright law. Google itself is a veteran of several such battles on the IP front in the Western world. Google News, Google Image Search, Google Book Search Project, Google Search Engine have all been targets of several lawsuits alleging copyright infringement. More often than not Google wins these battles or settles them before judgement.
One of the primary reasons for Google’s phenomenal growth is its militant approach to copyright law. Departing from conventional IP strategies of first negotiating with the copyright owner to secure the licensing rights, Google’s IP strategy is basically to first violate the copyright of certain content and then later negotiate with the owner of the copyright content and share advertising revenues with them. Even as late as last month Google refused to join an online copyright pact with other content providers. What is even more shocking to copyright owners is Google’s audacity in actually offering the copyright owners an opt-out policy an e.g. The Google Book Search Project. The effect of this policy is that Google deems all content as fair until the copyright owner informs Google that he no longer wishes to be a part of Google’s program. This essentially amounts to an implied license. The concept of implied licenses has been upheld in the Google v. Field case where the basic search engine function of Google was held not to violate copyrights because of the fact that there was a prevalent industry practice on the internet whereby the copyright owner could specifically obstruct the Google search engine from indexing his website. The implied license defence obviously cannot be applied to those copyright infringements where copyright owners are not in a position to prevent the potential infringements. In such cases Google falls back on the classic copyright defences of ‘fair use’, as in the case of the Google Book Search Project, which by the way, is also being sued by the Author’s Guild of America.
The usual defences that Google employs in U-Tube cases, in America, including the $1 Billion suit filed by Viacom against it, is the ‘safe harbour’ provision of the Digital Millennium Copyright Act - 17 U.S.C.§512(c)(1)(B). As per this provision all internet content providers are exempted from secondary liability for potential offences if they have complied with the conditions of the ‘safe harbour provision’ i.e. 1.) The content has been stored and uploaded by a user 2.) Google must have a policy to bar repeat infringers 3.) Google must designate an agent in the Copyright Office to issue ‘takedown’ notices regarding copyright infringed material. As SpicyIP already reported India doesn’t yet have such a ‘safe harbour’ provision, and the policy makers are still in the middle of a heated debate on this issue. So then on what line is the current T-Series case going to proceed?
The facts in the present case are – a U-Tube user posted T-Series copyrighted content on U-Tube. One obvious step is for T-Series to proceed against the use who posted the content in the first place. Under Section 51 of the Indian Copyright Act, 1957, this would be deemed to be an act infringing the copyright of T-Series by the User. Under Section 63 the user would be fined and imprisoned. Obviously T-Series is not going to be interested in pursing such small fry especially when the wording of Section 63 includes the word ‘abets in infringement’. They would be more interested in suing Google which has much deeper pockets. In this regard it is worthy to note that T-Series was actually in talks with Google on arriving at a revenue sharing agreement and just as Viacom slapped a suit on Google as a part of its negotiating strategy it is very likely that even T-Series is using this lawsuit as a negotiating tactic.
Presuming however that T-Series does intend to follow up the lawsuit; the important question is whether it is possible for T-Series to establish the secondary liability of U-Tube? There are two theories of secondary liability in the context of copyright infringement – contributory liability & vicarious liability. The important elements of contributory liability are 1.) the presence of a primary infringer 2.) knowledge on part of the contributory infringer of the underlying primary infringement & 3.) a material contribution on the part of the contributory infringer to facilitate the secondary infringement. An example of this is the various bulletin board services online which were extensively sued for contributory infringement.
Vicarious liability on the other hand occurs only when an online content provider has the right and ability to control the user and obtains a financial benefit from the infringing action of the user. The difference between the two is the degree of ‘control’ over the primary infringer.
The American Supreme Court has had an opportunity to adjudicate several cases on this issue the most famous being the Betamax case where Sony was being sued by Universal Studios for a selling a technology, the VCR, which could be used to making copies of movies thereby violating the copyright of Universal Studios. The other important American cases in the context of the internet are Napster and Grokster both of which relate to online peer to peer file sharing.
To the best of my knowledge there is no Indian case on the issue and it would be really interesting to see how an Indian court decides the issue. Hopefully this current case will speed up a policy decision on the issue of exemption of liability for content service providers over the internet.

SpicyIP Tidbits

1. "Geographical Indication" (GI) Application for "Darjeeling" in Europe:

The Eco Times reports that:

"The Tea Board of India filed an application here Monday to register Darjeeling as a Geographical Indication (GI) in the European Union (EU). GI is a sign used on products, which have a specific geographical origin. The use of a GI often acts as a certification that the product possesses certain qualities, or enjoys a certain reputation, due to its geographical origin. Darjeeling was the first GI to be registered in India and is the first application for registration of a tea in Europe.

The distinctive characteristics of Darjeeling tea are due to both its geographic origin and the way in which the tea is processed in Darjeeling. A major portion of the annual production of Darjeeling tea is exported, the key markets being Japan, Russia, the US and the EU countries."

2. Government issues Circular on border enforcement of IPRs

Thanks to Nihas Basheer of Wadia Gandhy Associates for referring me to this recent news on IP rules in relation to customs:

"In its Circular dated October 29, 2007 (“Circular”), the Central Board of Excise & Customs under the Ministry of Finance, India, has issued instructions to the relevant customs and excise authorities, for implementation of the Intellectual Property Rights (Imported Goods) Enforcement Rules, 2007 (“IPR Rules”) dated May 8, 2007.

The IPR Rules emanate from Section 11 of the Customs Act, 1952 which empowers the Central Government to prohibit import or export of goods infringing intellectual property rights. Before the notification of the IPR Rules, the notification of January 18, 1964, prohibited import of goods infringing trademarks and design.

These new IPR Rules prohibit import of goods infringing patent, copyright and geographical indications as well. The implementation of IPR Rules was preceded by a series of representations by industry players to the Government.

Another reason behind this change cited by the Government of India is its obligations under Articles 51 to 60 of TRIPs. While the mandatory obligations under Articles 51 to 60 of TRIPS dealing with border measures are restricted to Copyright and trade Marks infringement only, the Indian Government has taken a proactive step to include other IPRs."


3. Makali Ber, a promising "herbal" drug

Pharmabiz reports that CFTRI researchers have identified extracts of 'Makali ber' having promising stomach ulcer control properties.

Central Food and Technological Institute (CFTRI) has identified extracts of 'Makali Ber' (swallow root), a widely available root in Karnataka and used in the making of pickles, as having property to block the stomach ulcer-related complications and provide relief.

....The team of researchers found that 'Makali ber' prevented the bacterial growth of Helicobacter pylori, which causes severe acidity leading to ulcers in the stomach in lab conditions This confirmed its ability to inhibit various steps of gastric ulceration directly.

Another feature of 'Makali Ber' is that it is known to be non-toxic. The root has also emerged as an ideal anti ulcerant alternative over the existing allopathic drugs, which have known to cause serious side-effects. Further, 'Makali Ber' is also known to lower the drug burden on patients.

The extract was also found to protect against alcohol stress induced ulcers in experimental animal models. The study also provided details about normalizing damage to stomach tissue by preventing the entry of an ulcero-genic such as Helicobacter pylori."

What is the government doing to incentivise more research into herbal drugs? We've been focusing too much on our traditional generic strength.

There needs to be more of a focus on herbal medicines. This could be an excellent way to not only decrease our health care cost, but also to lead to more innovation around our ancient medicinal systems. The Chinese are leading here, having already devised a 15 year plan to boost more innovation in Chinese traditional medicine.


4. Indian Government Seeks to Spur More Creativity and Innovation

A. Creativity Institute for India

The Hindu Reports on the establishment of the Rajiv Gandhi Institute of Creativity in Hyderbad.

"The institute will foster creativity by imparting education, nurturing cutting edge research driven by industry and societal requirements. To be set up by the Ministry of Science & Technology, it will render professional services to demonstrate the creativity application potential by developing relationship with prominent institutions and organisations across the world. The institute will be a global leader focused on enhancing the creative quotient in children, entrepreneurs and professionals while enabling the application of creative ideas for the industry, thus making India a hotbed for innovative solutions."

B. Rs 75-cr fund to promote tech start-ups

The Hindu Business Line reports:

"A Rs 75-crore fund to promote start-ups involved in product development in the areas of information and communication technology's (ICT), will be launched soon by the Centre. The Department of Scientific and Industrial Research (DSIR) will operate the fund with the active involvement of the Indian School of Business (ISB), TiE (The Indus Entrepreneurs) and the Indian Institute of Science (IISc).

According to Mr A.S. Rao, Advisor, DSIR, the fund will focus on helping start-ups to convert intellectual property into product developments. As there are not many funds for technology start-up, the idea of the Government is to promote core product development, he told newspersons on the sidelines of the TiE-ISB meet, here. Mr Rao said the Government will take the help of the ISB and TiE in examining the viability of the business models proposed by the start-ups, while the IISc, Bangalore would validate the technological competencies.

5. Indian companies hiving off their R&D Units

The Economic Times Reports:

"Risk and reward don't come unstuck. That's what top Indian pharma companies are realising as they step out to leverage the expertise gained in reverse engineering of patented molecules, and build capabilities in original research targeting new chemical entities (NCE) and novel drug delivery systems (NDDS).

In fact, understanding this mix of opportunities and threats, many pharma majors are now de-merging their NCE operations into separate companies to scale-up their R&D activities, achieve better focus and hedge against risks.

The trend is catching up fast and already deep-pocket pharma majors such as Dr Reddy's Laboratories, Ranbaxy Laboratories, Nicholas Piramal India, Sun Pharmaceutical Industries have hived off their NCE activities into separate companies.

Experts feel it's the logical extension for the R&D activities ever since India recognised the product patent regime since 2005. "The R&D operations of Indian pharma companies have reached an inflexion point that could catapult them into the big league globally.

Their expertise in early discovery phase I & II clinical trials is most useful, especially when combined with the late discovery competencies of international pharma majors. R&D for drug discovery is a capital-intensive activity."

Readers will recollect an earlier post asking the question: now that Indian companies have increased R&D spending and more collaborations with MNC's, what role will the Indian patent regime pay in incentivising such R&D? In other words, since most of our big R&D spenders (Ranbaxy and Dr Reddy's) focus more on the Western markets, will the Indian patent regime really make a difference to their R&D incentives.

6. Fewer Drug Approvals

Pharmalot, the leading pharma blog reports:

"New drug approvals by the FDA have fallen further behind last year’s levels, with just 59 NDA approvals through October, down 29 percent year-over-year from last year’s 83, and 13 percent below the 10-year average of 68 NDAs, writes Jim Kumpel, an analyst at Friedman Billings Ramsey, in an investor note this morning.

More importantly, the 14 new molecular entity (NME) approvals through October represent an 18 percent drop year-over-year and is 22 percent below the 10-year average of 18 NMEs. That said, the four NME approvals in October represent the high water mark for NMEs in 2007, although that’s still down 20 percent from the prior October, he notes. Biologics approvals have fallen off a cliff in 2007, he adds, with just one so far this year, compared with four at this time in 2006.

The “NDA approval ratio appears to be on track for the lowest level since 1994,” Kumpel writes. “We have reviewed 40 years worth of NDA submission and approval data to put 2007 into perspective. While some pundits have argued that the pipeline of NDAs submitted to the FDA by the pharmaceutical industry has been weak in recent years, the facts dispute such claims.

“Since 1986, only three years have featured NDA submissions above 126, while the rest of the period has stayed remarkably steady in the range of 98 to 125. The number of NDAs approved each year has been much less predictable, resulting in the ratio of NDAs approved to NDAs submitted ranging from 49 percent in 1987 to 109 percent in 1996. The approval ratio has only dropped below 60 percent in two years since 1989. However, with NDA approvals down nearly 30 percent year to date in 2007, the NDA approval ratio could come down from the 76 percent level of 2006 to something less than 60 percent, would represent the lowest level since 1994.”

Intererstingly, FDA deputy commish Janet Woodcock recently blamed the slow rate of approvals on pharma, which insists the problem is because the FDA is more cautious. “I know the CEOs think we have become extremely conservative, but the standard for getting a drug approved has not changed,” she said. “The number of new drug approvals is directly proportional to the number of applications we receive. It’s because we’re getting fewer submissions.”

SpicyIP Events

1. India R&D 2007: December 5-6, 2007 at FICCI, Auditorium, New Delhi.

See here for more details of this FICCI conference.

Abstract below:

After the success of the last two global conferences organized in Delhi on India R&D 2005 and India R&D 2006.FICCI in partnership with the Department of Science and Technology (DST) and Council of Scientific and Industrial Research (CSIR) is organizing the Third Global Conference on "India R&D 2007- Innovation, Advantage India" on

The objective of the conference is to espouse the diverse Indian approach to innovation, invention and creativity, as they tend to opt for cost effective innovation and also to convince the world on the benefits that would be generated by collaborating and investing in R&D. India in the last few decades has added a number of 'most preferred' tags to itself- from being a favored IT hub, to becoming the back office of the world and now, the knowledge center of the world. India is quickly moving up the value chain by becoming a global R&D hub providing cutting-edge research and development. India is also moving ahead in the R&D value chain, with the country increasingly attracting investments in high-end R&D.


2. Challenges to IPR Awareness and Enforcement’: 4th December 2007, FICCI Federation House, New Delhi, India

Another FICCI conference. See FICCI website for more details.


3. "Pharmaceutical and Biotech Patent Law: Recent Developments" : December 13, 2007 from 1:00-2:00 PM (EST).

More details on Donald Zuhn's excellent blog. Extract below:

"Practising Law Institute (PLI) will be offering a audio-only webcast entitled: The presentation is part of PLI's One-Hour Patent Hot Topic Briefing series. Speakers David K. Barr and Daniel L. Reisner of Kaye Scholer LLP, co-editors of the PLI treatise "Pharmaceutical and Biotech Patent Law," will provide an overview of the patent law issues that arise in the drug approval process, from research and development through FDA approval, and will then discuss recent case law decisions that particularly affect the pharmaceutical and biotech industries.

In addition, the speakers will cover the following topics and issues: The drug development process and the types of patents that result from that process. The patent issues that arise during the various phases of the development of a drug product, including early-stage research in drug discovery, preclinical development, clinical trials, and the FDA approval process.

Recent case law developments, including: KSR v. Teleflex -- the Supreme Court's reevaluation of the law of obviousness, Takeda v. Alapharm -- the Federal Circuits first pharmaceutical case following KSR, Significant decisions governing the patentability of active pharmaceutical ingredients, including: Sanofi-aventis v. Apotex, Pfizer v. Apotex, and Aventis v. Lupin, In re Seagate Technology -- which redefined the standard for establishing willful infringement in patent infringement cases The registration fee for this webcast is $299, and registrants will be entitled to a 40% discount off the price of the PLI treatise "Pharmaceutical and Biotech Patent Law."


4. IP and Gender: Mapping the Connections: April 4, 2008 | 09:30AM - 04:00PM

For details, see here. Here is the extract from the website:

"In the Spring of 2004, the WCL Program on Information Justice and Intellectual Property, Women and the Law Program, and Journal of Gender, Social Policy, and the Law, sponsored an initial effort to bring scholars together to focus interdisciplinary attention on the interplay between intellectual property and gender.

The following year, we built on the discussions from that first workshop by holding a second program highlighting the work of two scholars writing in this emerging area, Ann Bartow and Sonia Katyal. Following the symposium, these two scholars published their work in the Journal of Gender, Social Policy, and the Law.

In 2006, we held a full day Symposium on intellectual property and gender, leading to a number of works published in the Journal of Gender, Social Policy, and the Law and other publications. Topics we have discussed in our past meetings have ranged from: the impact on intellectual property law and policy on gender-related imbalances in wealth, cultural access, political power, and social control; creative production and gender; the effects of stereotyping and of actual and rhetorical feminization and masculinization of participant roles upon intellectual property stakeholders; the gendered development of IP doctrines and doctrinal categories; related issues in the teaching and practicing of intellectual property; and feminist jurisprudential insights about intellectual property law."



5. International Generic Pharmaceutical Alliance

For more details, see here: . Abstract below:

"Attendees include the industry’s top executives, many of whom participate in panel discussions, answer questions from conference participants and hear vital information from such organizations as the World Bank, IMS Health, World Trade Organization, World Health Organization, and regulatory agencies, along with Wall Street analysts and legal experts involved in international patent and regulatory litigation.

The annual International Generic Pharmaceutical Alliance conference is the most important gathering of generic industry leaders and policy makers worldwide. This four-day event, organized by the world’s leading generic industry associations, conveys the latest market and regulatory intelligence regarding opportunities emerging in the generic medicines sector. Each year, international experts address the most pressing and relevant business and regulatory issues impacting the international manufacturing, distribution and sale of generic medicines, drawing more than 400 CEOs, senior executives and industry stakeholders in 2006."

Moving towards the Nano Age

Heralding the arrival of the fist wave of Nano therapeutics, India begins its tryst with the ‘Science of Minuscule’.

Indian innovation as large in its prowess in the field of Biomed is all set to usher in the Nano Medical era-one that is likely to be as promising and challenging.

In January this year, Dabur Pharma launched a novel nanotechnology-based drug delivery system, Nanoxel, for the anti-cancer drug Paclitaxel. This nanoscale drug delivery system is India's first indigenously developed nanotechnology based chemotherapy agent.

A number of nanobiotechnology companies have emerged recently, that are also looking at therapeutic benefits of nanomaterials.

Nano medicine and therapeutics are essentially multi disciplinary in their configuration. Encompassing diverse fields such as Biotechnology, energy, chemistry throw up a gamut of IP issues and a complicated legal landscape. Posing as a classic case of ‘sum of the parts larger than the whole’, policy makers are likely to grapple with issues both old and new.

This would entail an examination of existing patent provisions and available ‘policy levers’ that account for the multi and the interdisciplinary nature of this innovation. Is there a holistic solution within the existing legal framework to address the IP issues ? Else, do we consider a stand alone technology specific legislation that is in consonance with larger policy practicums’?

To examine this techno-legal dilemma perhaps calls for ‘peeling of the onion layers’ approach, where the IP issues specific to each discipline are examined independently and thereafter feasibility of an integrated Nano legislation is explored.

Choosing one over the other seems fraught with practical concerns. The answer seems to lie somewhere between the two!

A suggested way around the Nano path, would be to find solutions within the existing patent framework and provide for innovations current and yet to come, within the proposed Innovation Law.

Again, most Nano innovations are based on basic science discoveries. The implications of ‘Building block’ patents on further upstream Nano R&D , the granting of patents to Nano advances, and in a manner that ensures that the basic and advanced Nano tech synergise in an inter operable manner are vital IP issues in the Nano light. I definitely do see room for a Bayh Dole tweaked to the Indian context.

Not in the least, Nano medicine yet again throws up the gauntlet of ethical considerations that go with medical access and innovation as well as the incessant developing-developed divide.What is the Indian stance is anyones guess!

With a clear cut thrust on capacity building measures to bolster the Nano Age, India needs to engage in an exigent legislative exercise.An ‘Innovation Act’ that embraces within its mandate, a vision that accounts for current dynamics and provides flexible levers for future innovations points to the way ahead.

In postscript, a nano dose for the dyed in the wool desi…..Hail Charaka!

One of the areas that have caught the attention of the scientists and technologists working in the area of nanotechnology across the world is the use of bhasma in Ayurveda.

It has been found by several researchers that some of these formulations have nanoparticles in them. For many, it is still a great surprise that the 5000-year-old Indian system of medicine, had some knowledge of Nanoscience and technology, which modern medicine has started exploring in the 21^st century.

A brownie point for ‘Advantage India’ alright!

.

SpicyIP Jobs and Fellowships

1. Leading UK law firm seeks Patent Attorney in Singapore

The successful candidate will be involved in a wide range of work and will also be involved in the strategic direction of the patent practice. This role requires drafting of patent specifications, advise on filing and protection strategies, patent audits and supervising the drafting work of a team of patent engineers. The ideal candidate should have a degree in the field of Electrical / Electronics Engineering with patent prosecution experience in major jurisdictions such as India,US, Europe and Japan. An attractive remuneration package will be offered to the successful candidate.

Those interested may reply with resume to nandini@legallabs.com

2. Health Care Company Seeks Counsel in India

Advert extract below. If interested, please contact Ms.Lyanne DeCosta (lyanne@gnvrightselect.com: Ph--022-26461936 / 022-26042637).


"We are looking to recruit high caliber LLB in a Leadership role for one of the top 10 Fortune 100 companies of the world. They are amongst the top 10 most attractive employers with a global turnover in access of US$ 100 + billion. He should have worked for 3 to 4 years in corporate legal matters in well known law firms. The candidate will be a part of the business teams and advise business leaders on matter relating to advertising, company law, anti-trust, drug laws, IPR laws, counterfeits. He should thus have strong legal interpretation skills and capacity to advise senior management on corporate legal matters.

This role offers an excellent career growth and the opportunity to network with all legal counsels in Asia Region and give very good overview of legal issues in Asia.

The role includes India, Bangladesh and Sri Lanka The current opportunity is Mumbai based. It is for the world's most comprehensive and broadly-based manufacturer of health care products as well as a provider of related services for the consumer.

Position: Senior Manager – Legal & Company Secretary (Corporate) Designation: Senior / DGM / GM

Location: Mumbai Qualifications: Qualified Company Secretary and Lawyer, from top law firm / Top law practice.

Experience: 6 to 8 years+ post qualification experience of working with public listed Company.

Job Profile:

i) Compliance functions applicable to Public listed companies under Companies Act, SEBI Regulations and Listing requirements of Stock exchange.
ii) Corporate governance and functions relating to Board and Shareholders meetings.
iii) Corporate lawyer with exposure of working with Pharmaceutical manufacturing and Marketing Company.
iv) Familiarity with the legislation applicable to Drugs & Pharmaceutical Industry.
v) Primary business lawyer for Newco
vi) Responsible for the implementation of process, policies and training related to FCPA compliance and tendering.
vii) Responsible for ensuring compliance with company's policies such as Policy on Business Conduct and Credo.
viii) Provide legal input and guidance on HCC related matters.
ix) Responsible for providing legal support to brand protection initiatives and management of outside counsel in the provision of the same.
x) Responsible for negotiating and executing various strategic commercial agreements including supply, distribution, co-marketing, sales product licensing, employment and non- disclosure.
xi) Support all the enabling functions such as HR, IM, Operations, QTA, R&D, Supply chain, Marketing, Sales & distribution Management, Finance on various legal issues relating to Newco."



3. Google Policy Scholarship

Not exactly a job posting, but for those of us who rely on Fellowships for our bread and butter. Excerpts from the website:

"As lawmakers around the world become more engaged on Internet policy, ensuring a robust and intelligent public debate around these issues becomes increasingly important. That's why we're launching the Google Policy Fellowship Program-to support students and organizations working on policy issues fundamental to the future of the Internet and its users.

Think of it as the public policy version of Google's Summer of Code. The Google Policy Fellowship program offers undergraduate, graduate, and law students interested in Internet and technology policy the opportunity to spend the summer contributing to the public dialogue on these issues, and exploring future academic and professional interests.

Program Overview Fellows will have the opportunity to work at public interest organizations at the forefront of debates on broadband and access policy, content regulation, copyright and trademark reform, consumer privacy, open government, and more. Participating organizations are based in either Washington, DC or San Francisco, CA, and include: American Library Association, Cato Institute, Center for Democracy and Technology, Competitive Enterprise Institute, Electronic Frontier Foundation, Internet Education Foundation, Media Access Project, New America Foundation, and Public Knowledge. More information about the host organizations and the areas of focus for the fellows are outlined here.

Fellows will be assigned a lead mentor at their host organizations, but will have the opportunity to work with several senior staff members over the course of the summer. Fellows will be expected to make substantive contributions to the work of their organization, including conducting policy research and analysis; drafting reports and analyses; attending government and industry meetings and conferences; and participating in other advocacy activities."

4. New IBA Scholarship – Corporate Counsel Forum Scholarship 2008

"The IBA Corporate Counsel Forum is for the first time awarding a scholarship for in-house lawyers on the occasion of the upcoming 7th Annual International Corporate Counsel Conference, which will be held in Frankfurt on 17-19 February 2008.

The scholarship will provide an invaluable opportunity for young in-house lawyers to participate by submitting a short paper, of at least 2,500 words, answering the following question: ‘An in-house counsel plays an important role in developing and implementing legal and business procedures to strengthen the backbone of the enterprise and anticipate risk. What essential issues must be kept in mind by the in-house counsel for assuring an overall compliance with policies and legal requirements for safeguarding and successful growth of the company?’ For more information, click here."

Geographical Indications and Certification Trademarks – same difference?

The TRIPs agreement deals with Geographical Indications under Articles 22-24 and requires that each member country put in place a system to protect Geographical Indications. As per the TRIPs agreement, Geographical indications are, …, indications which identify a good as originating in the territory of a Member, or a region or locality in that territory, where a given quality, reputation or other characteristic of the good is essentially attributable to its geographical origin.

The TRIPs Agreement requires that each member country provide legal means of protecting Geographical Indications. The WTO recognizes that a variety of means may be employed to protect GIs – for example, India enacted the Geographical Indications Act in 1999, other countries protect GIs under their certification trademark regimes.

A certification trademark (CTM), as the name indicates, is a mark that certifies the nature or origin of the goods or services to which it has been applied. If the question that just popped into your head is “Why have a GI Act if a CTM serves the same purpose?,” you are in great company. SPICY IP decided to devote a post to this issue in the hope that our rich mix of readers will contribute to increasing general awareness about whether, and if so why, separate systems of protection are necessary.

One obvious difference between a CTM and a GI is that the former has a broader scope. WIPO explains: A CTM application can include, for example, region or location or origin, materials of construction, method or mode of manufacture or provision, quality assurance, accuracy of the goods or services or any definable characteristic of the goods or services. It can also certify manufacture or provision of services by members of a union or other organization to certain standards. A GI, on the other hand, is only an indication (or certification) of the geographic origin of goods (not services mind you! CTMs cover services) and quality or characteristics of the goods that are directly attributable to the geographic origin.

Now the question that arose in my mind was: Given that India already has a certification trademark regime, why did the legislature consider it prudent to enact a whole new act to protect GIs?

Consider the US system: the US has a certification mark system and strongly believes that it is adequate to protect GIs. However, because of its obligations under TRIPs and NAFTA, the United States amended its laws and now a “primarily geographically misdescriptive” mark cannot be registered unless the mark acquired distinctiveness before the date of the NAFTA Implementation Act (1993). Post TRIPs (by virtue of its obligations under Article 23) the US also amended its laws to prevent the registration of "GIs which, when used in relation to wines and spirits, identifies a place other than the origin of the goods...."

The amendments in the US clearly protect GIs that are geographic names. But does the US system protect marks like Basmati, that are not names of Geographic areas/regions? The answer of the US government would probably be a resounding YES – just register Basmati as a CTM!

Whether the protection granted by CTMs, or for that matter the GI Act in India is adequate protection for marks like Basmati and Darjeeling, is a different question. This is where the international fun begins. TRIPs grants separate degrees of protection to GIs relating to Wines and Spirits and a lower degree of protection to other GIs. The WHO Website explains situation in simple terms thus:

…Protection required under the TRIPS Agreement is defined in two articles.

All products are covered by Article 22, which defines a standard level of protection. This says geographical indications have to be protected in order to avoid misleading the public and to prevent unfair competition.

Article 23 provides a higher or enhanced level of protection for geographical indications for wines and spirits: subject to a number of exceptions, they have to be protected even if misuse would not cause the public to be misled.

Exceptions (Article 24). In some cases, geographical indications do not have to be protected or the protection can be limited. Among the exceptions that the agreement allows are: when a name has become the common (or “generic”) term (for example, “cheddar” now refers to a particular type of cheese not necessarily made in Cheddar, in the UK), and when a term has already been registered as a trademark.

Some countries argue that the protection under Article 23 must not be limited to Wines and Spirits. It is not surprising that this argument is supported by countries such as India, that have a larger base of GIs, and is opposed by countries such as the US that do not. Not to say that the US does not have its on GIs – Florida Oranges, Idaho potatoes etc. being common examples. But the US seems satisfied with the Article 22 standard for these GIs. So why are other countries including India insisting that their GIs be grated protection similar to those granted to Wines and Spirits under Article 23?

Answering this question requires answering a number of other questions including what exactly is the scope of Article 23? Is it similar to the standard of protection granted to famous marks? In other words, does it prevent the use of marks such as “Champagne” on any goods/services in order to avoid dilution and tarnishment? (Arguably, at least the marks that are not names of geographic areas, and are “famous,” such as Basmati, ought to get protection similar to the protection granted to famous marks.) Is the enhanced level of protection under Article 23 limited to the use of GIs on goods in the same class? Further, does Article 23 prevent a sparkling wine manufacturer from stating on his product “Tastes like Champagne?” Detailed discussions on these questions are reserved for a later post… In the mean time, we invite comments from our readers!

It does seem sensible to allow the “likelihood of confusion” standard to continue for the marks that are primarily merely geographic marks; unless they have acquired an incredibly strong secondary meaning such “Champagne” of “Chablis” or maybe… “Darjeeling?!?” I am as always, happy to be opposed – all comments, agreements and disagreements are welcome!

PS: For a better idea of why “Scotch” Whisky is such a big deal and the recent debates surrounding the manner of exporting “Scotch,” See here and here.


Second Thoughts: Is there a glitch in the CTM system in India?

Section 70 of the Trademarks Act provides that a person who carries on trade in certain goods/services, may not register as a certification trademark, a mark that seeks to certify these goods/services.

Section 75 of the Act provides:
“75. Infringement of certification Trade Marks
The right conferred by section 78 is infringed by any person who, not being the registered proprietor of the certification Trade Mark or a person authorised by him in that behalf under the regulations filed under section 74, using it in accordance therewith, uses in the course of trade, a mark, which is identical with, or deceptively similar to the certification Trade Mark in relation to any goods or services in respect of which it is registered, and in such manner as to render the use of the mark likely to be taken as being a use as a Trade Mark.

From the wording of the section, it appears as though the Act grants blanket immunity to the proprietor of the CTM. One might of course argue that as soon as the owner starts “infringing” the mark, she will be caught by section 70 and section 77 that provide that any use of the mark (other that legitimate uses detailed under section 78 – which is by no means clear!) by the proprietor will lead to cancellation of the mark itself. But the question that arises is – will the cancellation of the mark be adequate to prevent a (former) proprietor from using the mark after cancellation? If not, does section 75 need immediate amendment?

NOTE: This post was jointly written by Mrinalini Kochupillai and R.Sathish Kumar. Sathish is a practicing advocate in the Madras High Court. He specializes in IP matters and was also involved in Novartis case in the Madras High Court.

Spicy Tidbits

Prof. Samir K Brahmachari appointed new CSIR Director General

Professor Samir K. Brahmachari took charge as the new director-general of the Council of Scientific and Industrial Research (CSIR) on Monday. Prior to this appointment, Prof. Brahmachari was the director of the Institute of Genomics and Integrative Biology (IGIB). See Full Report Here.


Novartis, Glivec and the IPAB: Who cares about Statutory law?

This Tuesday, the Madras High Court accepted a formula proposed by the government, under which the patent appeal will be heard by a two-member bench comprising the chairman and vice-chairman. In short, a bench sans a technical member will hear the matter!

This is a rather interesting development! Readers might be aware that under section 84(2) of the Trademarks Act, 1999 read with section 116 of the Patents Act, 1970, there is a statutory requirement that “a bench shall consist of one Judicial Member and one Technical Member….” I guess the Madras High Court, in its wisdom, considers itself to not be bound by this provision of statutory law.

Spicy IP has discussed this issue at great length and has opined quiet the opposite. See here.


Piracy: Still a hot topic!

The Hindu reports: “The Central Crime Branch has, over the last one year, arrested 172 persons and registered 159 cases of copying and selling pirated compact discs (CD) and Digital Versatile Discs (DVD) of new films in the city.

Of those arrested, five habitual offenders from Burma Bazaar were detained under the Goondas Act, according to a release. The value of the equipment seized during the period is estimated to be Rs.10.34 crore, as against Rs.1 crore equipment seized last year. This year, Rs.8.36 crore worth VCDs/DVDs, Rs.1.58 crore worth printing machines, besides wrappers, DVD writers, computer equipment, photostat machines and two-wheelers and four-wheelers used for transport have been seized.

On Monday, three persons were arrested and 4,375 CDs of films released during Deepavali were seized by the CCB Police and cases were registered against them under the Copy Right Act. The total value of the items seized on Monday was estimated to be Rs.26 lakh.”

Spicy IP is still welcoming readers’ comments and suggestions on the issue of piracy – pros and cons – for a master compilation of ideas planned for the end of the year!


Hollywood in Mysore? Not exactly, but…

Law takes time to catch up with social change, (or so we were told in law school). However, lawyers by training are quick on the uptake. Following the outsourcing of IT, SPICY IP foresees legal outsourcing to be the next hot topic of discussion for professionals from the real and reel life.

The Times of India reports: “Production houses like 20th Century Fox, Sony Pictures and Universal Studios have roped in Mysore-headquartered SDD Global Solutions to support the legal requirements of their movie releases.”


Darjeeling Tea: The Pride of India

The Econmic Times Reports: "The Tea Board of India filed an application here Monday to register Darjeeling as a Geographical Indication (GI) in the European Union (EU).

….Darjeeling was the first GI to be registered in India and is the first application for registration of a tea in Europe.
The distinctive characteristics of Darjeeling tea are due to both its geographic origin and the way in which the tea is processed in Darjeeling. " Look out for more on GIs from Spicy IP.


Intellectual Ventures LLC: Nurturing University R &D or just another Patent Troll?

Indian Universities engaged in serious R&D may have something new to look forward to. According to the Wall Street Journal, Intellectual Ventures LLC, a low-profile investment firm run by former Microsoft Corp. executive Nathan Myhrvold, is laying plans to go global: It hopes to raise as much as $1 billion to help develop and patent inventions, many of them from universities in Asia.

There are a number of views on the business model of the venture. Some hail it as a fund focused on nurturing "prepatent" ideas, particularly those coming from Asian universities. and state that “The firm would work with inventors there to develop ideas and then help to patent and license them, much as big U.S. universities do through their technology-transfer offices. Intellectual Ventures would own the patents, or have exclusive rights to them, but the original inventors would get a cut of any revenue generated from them”.
According to Mr. Myhrvold, his company is pursuing a new business strategy of helping outside inventors develop ideas before they are patented. He also said Intellectual Ventures wants to work more with inventors overseas and hopes to soon open offices in China, India, Japan, South Korea and Singapore.

Others are not so certain and ventures similar to these are often labeled as patent trolls: Intellectual Venture's business model has stirred debate. Officials from some U.S. universities -- including Stanford University and Massachusetts Institute of Technology -- say they aren't working with the firm because they worry it could use its patents for litigation or other purposes that don't promote innovation.
Read the full report here.


Dr. Reddy’s Lab (DRL): Eyeing the US Market

In keeping with the common accusation that Indian Generic companies focus more on foreign markets and less on Indian requirements, the Economic Times reports that Pharma major Dr Reddy’s Labs is planning to storm the US generics market by launching around 200 products over the next five years. All the elements are in place with the company having entered into a number of in-licensing arrangements and intellectual property sharing agreements to take its business plan ahead.

“The licence and IP sharing arrangements are primarily meant for injectibles, inhalers, liquid orals and topicals,” Dr Reddy’s Laboratories president (North American Generics) Mark T Hartman told ET.

DRL’s focus is not only on the now (in)famous para IV filings (applications that challenge existing drug patents), but also on non-infringing formulations and Para II products.

Non-infringing formulations are those drugs where the company filing for approval to the USFDA has the ability to prove that the drug has been developed through a separate process vis-à-vis the development process of the innovator. Para II products of the Orange Book of the USFDA are drugs that have already gone off-patent.
….
“To keep its sales growing in this area, Dr Reddy’s seems to be looking at launching more than 20-25 products every year. Having a high number of launches every year is becoming more and more essential as the top line from a drug older than two years starts eroding because competition drives down prices,” the analyst said.

DRL has already made 32 para IV filings so far challenging drug patents for a number of therapeutic areas. Of these, 21 para IV filings with the USFDA are first-to-files (FTFs), which if approved could give the company a huge opportunity in terms of exclusive marketing rights.

Read the full report here.


International Tidbit: Michael Robertson and the EMI Group

Techwhack reports that the EMI Group has filed copyright infringement law suits against Michael Robertson and his company MP3tunes LLC. Mr. Robertson, well known founder and former CEO of MP3.com, is also associated with Linspire (originally Lindows), SIPphone, Ajax 13 and a number of other cool technologies. His former company, MP3.com was involved with similar litigation and paid a hefty sum to settle.

According to Techwhack, Robertson had this to say on this new lawsuit: “These guys rush off to court and tell the court that I am terrible and then they end up buying my company. It is really a shame because instead of using these technologies to improve their business they make an enemy of every technology company out there.”