SpicyIP Weekly Review- ( February Week 3)

SpicyIP posts:

The week started with some good news brought to our notice by Sai Vinod, indicative of the government’s inclination to seriously consider the compulsory licensing route for cancer treatment drugs. The Patent Office issued a public notice on February 12, 2013 directing all patentees and license holders to submit Form 27 applications for each calendar year by end of March for the previous year, failure of which would make the patentee liable to a fine of up to 10 lakh rupees. For the uninitiated, Form 27 seeks the information, which enables the controller to grant a compulsory license vide s. 84 of the Patents Act. Sai also stressed on the need to re-examine the "efficacy" of the current format of the Form 27 statement.

Madhulika Vishwanathan wrote an insightful post on how India stands to gain in terms of increased domestic patent filings by becoming a part of the Patent Prosecution Highway Program. The patent prosecution highway (PPH) is a kind of bidirectional work sharing agreement between two patent offices which allows examiners of one patent office to reuse search and examination results already conducted by another patent office. She mentioned several advantages of initiating a PPH program - accelerated examination and higher allowance rate (more than 90 percent of cases are allowed; only 50% of non-PPH cases are allowed) among several others. PPH participation also offers applicants the advantage of decreased prosecution costs owing to the substantial reduction in the number of office actions. She also briefly discussed the USPTO PPH model and also drew our attention to certain drawbacks which need to be addressed if India embarks on the Patent Prosecution Highway. 

Shamnad Basheer spotlighted the invalidation of a pharmaceutical patent covering Baraclude (Entecavir), a leading anti-viral drug for Hepatitis B patients in the US. The drug brought in more than a billion dollars a year to its patentee- BMS . The invalidation may have some serious repercussions on the ongoing Indian case ( BMS v. Ranbaxy in the Delhi HC), which deals with a patent on the same drug (the the US patent covers the basic Entecavir compound, the Indian patent only covers an alleged dosage "improvement"). He discussed the interesting aspects of the US decision. Broadly speaking, the drug was invalidated because even though the drug was based on a new compound, the said compound was not patentable, since it was obtained by modifying a known natural substance in a "stock in trade" manner. He also noted that the fate of the patent in India remains highly vulnerable owing to its ‘improved dosage’ claim in the light of the ‘therapeutic efficacy’ test.


We then had L.Gopika discussing a recent decision on copyright licensing- Dorling Kindersly v. Sanguine Technical Publishers. Sanguine breached a licensing agreement with Pearson Education (DK is a part of Pearson PLC), which required them to co-brand books for a certain period. After some time Sanguine backed out of the agreement, and it was also discovered by Pearson that titles listed under their agreement with Sanguine was being published by another publishing house, namely, Reed Elsevier India Private Limited. Books already published by Pearson were also being published subsequently by Elsevier. Pearson promptly filed a petition before the Delhi HC to restrain from breach and had the common books published by Elsevier sealed. Elsevier filed a review petition to overturn the sealing order. The Delhi HC rejected the review petition. For an analysis of the contentions and the ruling, click here.

Further, Prashant reported that the public records pertaining to the G.I. Registry have now been made available on the website of the G.I. Registry – a very welcome development in the GI arena. Until the website was launched, finding information regarding GIs used to be a troublesome exercise without any guarantee as to the veracity of that information, as noted by Prashant in his post.
Now all information seekers can rejoice! The website is rather well designed and functional. Check it out!

Madhulika reported that the Patent Office revoked Pfizer’s patent on Sunitib- an exorbitantly priced drug. The patent grant has been challenged several times, and has a chequered history, which has been briefly covered in the post. The Controller opined that “I observe that when as the instant claims are clearly obvious to a skilled artisan, so, the commercial success of the instant product (Sunitinib) as submitted by the patentee cannot be considered as an evidence of a patentable invention.” This is delightful news for cancer patients in India! 

Next, Aprajita Lath brought to our notice a development that has put plans to eradicate diseases such as malaria, TB and AIDS in slight jeopardy. The post relates to Global Fund's multi-billion plan to eradicate these diseases.  In a 2011 letter to Hillary Clinton, United States Senator Orrin Hatch opposed the Fund’s pro generic drugs procurement policy. This was a rather contradictory stand taken by him, as he was also a co-sponsor to the United States Hatch-Waxman Act of 1984 which encouraged generic drugs. Another significant development is the Ambassador Mark Dybul, a former US Global AIDS Coordinator, becoming the new head of the organization. Dybul was known for his role in creating the US-based President’s Emergency Program for AIDS Relief (PEPFAR). Also, Christopher Game was appointed as the new Procurement Officer in 2011. This change has come amid speculations that Mr. Hatch and a drug maker Abbot [ Both are against procurement of generic drugs] had lobbied for his appointment. In a time when ‘totally drug restraint’ tuberculosis is spreading in South Africa and USA’s dominant role in the Global Fund, it remains to be seen as to how the Fund will respond to the TB crisis in South Africa and to its procurement and IPR policy.

At SpicyIP, we’ve always actively written and championed for rights of the disabled. L.Gopika reported here, that 20 disability rights groups wrote to the Ministers of Culture, HRD and Social Welfare requesting the Government to take action in removing the barriers People with Disabilities face in accessing public library facilities and collections. This was in furtherance of the 2012 amendment to the Copyright Act which enables libraries to convert their collections into formats accessible to PWDs free of cost. A long list of suggestions for improvement has also been provided by the 20 disability rights groups. She also linked to the comprehensive checklist prepared by International Federation of Library Associations and Institutions, for additional information to our readers. 

The publication of unfavourable pieces on review of IIPM as an institution received considerable attention when it filed a suit against Penguin( the publisher of an essay which criticises IIPM), and Google India.

In this post, Shouvik brings to our attention the latest development on this dispute. In a sweeping order by the DoT in compliance with a directive issued by a Court in Gwalior, the DoT ordered blocking of 78 URLs. The URLs include plain spoof publishing websites such as FakingNews and Unreal Times and reputed journalistic publications such as TOI, Indian Express, Careers 360, The Caravan, etc. These even include the UGC website, which had earlier published a notice confirming the unrecognized status of IIPM. While Arindam Chaudhuri told Firstpost in an interview that while he’s no objection to satiric comments made in the democratic spirit, he’s still glad that “defamatory links with malicious interests have been ordered to be removed.” This is the first time a judicial order has censored the internet in such a blanket manner! Several questions have been raised such as whether the Court has the legal authority to censor official government websites to whether the order is flawed from lack of fair hearing opportunities given to parties affected.

Interviews in the IP arena:

Apothecurry, a leading Indian blog on the Indian Pharmaceutical industry presented an interview [in three parts] with Yusuf Hamied. Yusuf Hamied is the Chairman of Cipla and, is also known as the Grand Old Man of the Indian Pharmaceuticals Industry. While Cipla was the first company to provide HIV drugs to developing countries at affordable prices in 2000, since then several companies have joined the competition in generic drugs market. He expressed his dissatisfaction on the global tendering process of generic drugs, and how it is extremely dangerous to for companies. He also discussed how voluntary licensing is more preferable to compulsory licensing. His organisation has grown exponentially in terms of revenue and manpower; he spoke about the challenges faced and also on Cipla's overhaul of its export strategy.

International Developments:

The BMS-Teva patent invalidation was reported widely in the international media (here), with Shamnad's prompt coverage on the same at SpicyIP. The invalidation is significant, because apart from the loss of a billion dollars caused to BMS, it is also the first time when a US court has invalidated a patent obtained on a drug developed via lead optimisation, in other words a modification of an older molecule. BMS plans to appeal.

On 15th February, President Obama in a Google+ hangout lashed out at patent trolls. He said that patent litigation in America still had a long way to go. American IP is still grappling with problems like patent trolling, piracy and a constant pressing need to keep up with advancements in technology. You can watch the hangout here.

Meanwhile, Apple lost a trademark dispute over 'iPhone' in Brazil. The Brazil's Institute of Industrial Property ruled that a company Gradiente, who had registered the mark in Brazil in 2000 way before Apple had launched iPhone on 2007, also enjoys the right to the mark, and Apple cannot claim exclusive rights to the mark.

We know how Facebook's like button has become the ultimate gauge of a company's presence on social media. Now, the like button has become embroiled in a patent infringement suit.  Van Der Meer, a Dutch programmer had developed a social webpage diary called Surfbook and patented the same in 1998. He passed away in 2004 and now the patent holder[Rembrandt Social Media] has claimed that the diary had a function to log third party content into the diary- very similar to the like button, thereby infringing their patent.

Event Alert 

Pharma IPR 2013: We are pleased to announce the 2nd Annual Pharma IPR 2013 conference taking place from 10th - 12th April, 2013 in Mumbai, India.

You may register here.