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.

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.