1. Pre Grant Oppostion to Gilead’s AIDS Drug, “Viread”
Bhuma Srivastava of the Mint reports that:
“Signalling mounting global resistance to patenting of drugs in India, a Brazilian public health group has filed an opposition in India against US drug maker Gilead Sciences Inc.’s patent filing for their anti-AIDS drug, Viread. This is the first pre-grant opposition filed by an overseas body against a patent grant in India and reflects a growing concern about ensuring that the supply of cheaper, non-patented drugs from India is not blocked.”
Interestingly, Gilead has a number of voluntary licensing arrangements with Indian generic manufacturers in relation to this very same drug. However, these licenses have been attacked by civil society activists as causing significant price hikes in jurisdictions where there are no patents, and causing artificial decrease in supplies of API’s, thereby increasing their costs. KEI sent a letter to the FTC in early 2007 asking them to investigate potential antitrust implications of these licenses. Kruttika will blog in detail on this soon.
Bhuma Srivastava mentions these licensing arrangements and the concerns they spur in her report:
“In 2006, Gilead had signed a spate of voluntary licensing agreements with 11 Indian non-patented, or generic drug makers, allowing them to make copies of the anti-HIV drug and selling it in 95 low-income countries including India, in a bid to take the sting out of the patent oppositions.
The public health activists refuse to believe such licence—called “patent settlements and not pure licensing agreements” by one of them— would solve the problem.
“The voluntary licences come with several restrictions on geographies, exports and back-end supplies for the generic companies. There is a lack of transparency on these deals,” said Menghaney, adding that all voluntary licensing agreements should be put out in the public domain and scrutinized for anti-competitive clauses.
The statement explains that the deals forged with Indian companies “are restrictive and do not permit export of the drug or raw material (active pharmaceutical ingredient) to certain middle-income countries, including Brazil”, allowing the innovator Gilead to charge exorbitantly for the drug.”
2. Post Grant Opposition to Roche’s Valcyte
The Economic Times reports that:
“Delhi Network of Positive People (DNP+)—has filed a post-grant opposition against Swiss major Roche’s patent for its HIV drug Valganciclovir at the Chennai Patent office.
The Chennai patent office granted the patent to Roche last year without hearing the arguments of the two NGOs which had filed pre-grant opposition against the drug, a DNP+ release said.
The NGO has opposed the patent on the grounds that Valganciclovir is a known compound, and at most, a ‘new form’ of an already known substance with no improvement in efficacy. DNP+ has also alleged that many patents granted by the Chennai patent office were rejected in the US, which is considered to be far more liberal than Indian patent laws. “
We had blogged on certain “non transparent” aspects of the patent office’s dealing with this case during the pre-grant stage here.
3. Indian Patent Office Rejects BI Patent over Nevirapine
By far, the most interesting and widely reported news was the rejection of the patent office of a patent application by Boehringer Ingelheim (BI) covering the anti retroviral (ARV), Nevirapine. This was in response to a pre grant opposition filed by AIDS patients groups in India. The main grounds of rejection were lack of inventive step, section 3(d) and section 3(e).
Reports on this decision can be found at here and here.
The decision itself can be found at the website of Lawyer’s Collective here. As for commentaries on this judgment, I would recommend Tahir’s post here.
The interesting part about this decision is that the patent office appears to suggest that in the context of life saving drugs (HIV and anti cancer), they will insist on a very “strict” patentability standard.
Concluding Thoughts
Almost all patents covering critical ARV (anti retroviral) and anti cancer drugs are being challenged now in India. Not just by generic manufacturers, but also by patient groups and civil society activists. And lately, even by NGO’s from abroad. From the Nevirapine patent rejection, it appears that the patent office will demand a fairly high threshold for patentability in future life saving drug cases. My own guess is that a number of these patents will be follow on inventions based on pre ’95 basic molecules and may therefore fail the strict patentability threshold.
On a related note, if this strict/conservative approach to patentability in BI’s case involving Nevirapine is followed in other cases as well, perhaps our fears of an access crunch in relation to life saving drugs may be slightly exaggerated? In an article published in the Intellectual Property Quarterly (IPQ) in 2005, I had noted:
“Although the (2005) Act makes wide ranging changes to India’s patent regime, the most controversial provision is the one introducing product patents in the area of pharmaceuticals. Quite naturally, it is feared that this would spur a steep rise in drug prices and an adverse impact on ‘‘access’’ to important drugs. Civil society proponents argue that the TRIPS flexibilities available were not exploited appropriately and that adequate safeguards were not built in to ensure an affordable supply of medicines.
While this concern by civil society has some merit, what it misses is the flexibility that already inheres in the Patent Office to tailor patent protection to suit policy needs. The Indian Patent Office has had an interesting history of taking itself to be a policy guardian of sorts and demonstrating a rather conservative approach to the issue of patentability. Indeed this trend was discernible as late as 2001, when the Office refused an application by Dimminaco AG (a Swiss biotechnology company), claiming a method of producing a live vaccine, on the ground that the term ‘‘manufacture’’ did not include a process that had as its end product a ‘‘living substance’’.
This policy-style reasoning can be traced back to the Ayyangar Committee report, a document that formed the very basis for the current Indian patent regime. Underlying this report was the clear message that fewer patents resulted in a stronger indigenous industry, particularly in the area of pharmaceuticals and chemicals. It will be the endeavour of this article to demonstrate the influence of this policy document on the decisions of the Patent Office even today. Consequently, this article will posit that rooted in a system that stressed the virtues of a weak patent system, it is likely that the Patent Office would continue with a conservative approach to the issue of patentability, even with regard to pharmaceutical inventions (that are patentable under the 2005 Act).
Needless to say, such interpretation would assuage some of the concerns of civil society, in terms of curbing the scope of pharmaceutical patent monopolies and consequently improving access to medicines.”
What do our readers think? In particular, have you seen any critical ARV or anti cancer patents that you think are definitely “meritorious” and are likely to make it past the patentability threshold in India? (of course, ignore the ones that have already been in the news, such as Tarceva etc, which though granted, could not be enforced)
