Patent

SECTION 3(d) AND "EFFICACY": MORE CASES


1. Novartis abandons patent application in India:

The business standard thinks that this could be prompted by fears of a Glivec type rejection and reports that:

“Swiss pharma major Novartis has chosen not to pursue the patent application for its AIDS drug Atazanavir in India after the patent was declared “abandoned” even as it continues to fight for the licence rights of its cancer drug Glivec in the Indian patent office.”

2. Eli Lilly loses patent over osteoporosis drug:

CH Unnikrishnan reports at the Livemint (a paper that is coming to be very reputed for it’s excellent reporting):

“After hearings on a pre-grant opposition filed by the domestic drug maker USV Ltd that lasted a year, the Kolkata patent office has rejected US drug giant Eli Lilly & Co.’s patent application for Forteo, its osteoporosis drug. Forteo is a biotechnology-based drug that generates $600 million in annual sales for Lilly. The company had already launched this product in India anticipating a patent protection.

Forteo is the only biotechnology drug available in India for osteoporosis. It is a synthetic form of parathyroid hormone (PTH), which is naturally found in the body. This hormone is to be given by injection for the treatment of osteoporosis in men and post-menopausal women who are at high risk for a fracture.

The decision, which was delivered on Monday, noted that the application has been rejected on grounds of prior knowledge…. and failure to establish enhancement of known efficacy.

Indian patent law does not permit patent protection for drugs if it is patented elsewhere before 1995…. The drug also cannot be patented if its efficacy is not significantly superior to the already known molecule under Section 3(d) of the law.”

I’m trying to lay my hands on the decision to get more details on how section 3(d) was interpreted here. If any of you have a copy, please pass it on.

Interestingly, I wasn’t aware of USV Ltd till I read this news item. It has achieved some success challenging patents in the US as well. A web profile of a patent lawyer states:

“His most recent win was for USV Limited, based in Bombay. The pharmaceutical company wanted to launch a new time-controlled diabetes drug but found a similar patented product in the market. The company hired Pohl in January 2005 to file a reexamination request at the patent office and try to invalidate the patent, which was owned and licensed by the University of Oregon. In July 2006 Pohl, after a vigorous fight with the university’s attorneys, succeeded in persuading the patent office to invalidate the patent. “The university really fought like the dickens,” Pohl says. The decision is considered final as of the first week of June, when the university missed a deadline for filing an appeal, according to Pohl.

3. Abbot’s patent application challenged in India by I-MAK

I-MAK, an NGO that is doing some excellent work in challenging frivolous pharma patents, has recently opposed Abbot’s application for Aluvia in both India and the EU.

“Aluvia” is a “heat stable” form of an anti-retroviral drug, consisting of Lopinavir and Ritonavir and the alleged advantages of this new combination include increased solubility in water and better bio-availability and stability – translating to a lower pill burden and the ability to store without refrigeration.

For more information, see I-MAK’s website. IMAK is run by two friends of mine, Tahir Amin and Priti Radhakrishnan. Along with their college, Viswas Deviah, they’ve been doing some exceptionally good work—and Abbot will be in for a very difficult fight here.

This case will test whether “efficacy” under section 3(d) can include heat stability. As SpicyIP has been reiterating in earlier posts, the need of the hour is to have broad guidelines to spell out what “efficacy” means. Does it connote only “therapeutic efficacy”, as the Madras High Court seems to suggest? Or will it also include bioavailability? And importantly, what will constitute a “significant enhancement in efficacy” under the Explanation to section 3(d)? Will a 30% increase in bio-availability suffice (as was claimed in the Novartis application)?

Let’s hope that some of the above cases throw more light on this perplexing term and make section 3(d) a more “efficacious” section to operate.

Shamnad Basheer

Shamnad Basheer

Prof (Dr) Shamnad Basheer founded SpicyIP in 2005. He is currently the Honorary Research Chair of IP Law at Nirma University and a visiting professor of law at the National Law School (NLS), Bangalore. He is also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof Amartya Sen. Professional History: After graduating from the NLS, Bangalore Professor Basheer joinedAnand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Prof Basheer has published widely and his articles have won awards, including those instituted by ATRIP and the Stanford Technology Law Review. He is consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also serves on several government committees.

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