Patent

"Prioritising" Pharmaceutical Patents in India?


Many pharma patent cases (including the Novartis Gleevec case and the Roche Valcyte case) raise the issue of “relevant” priority dates.

Tahir Amin dealt with this issue at length in this wonderful post here. I extract his introduction as under:

“Ask the question whether pre-95 drug inventions are patentable in India under the 2005 Patents Act – and the answer you are likely to get is ‘no they are not’. The reason? India became a member of TRIPS on 1 January 1995 and so any invention for a drug, and its related patent, before that date does not have to be granted protection in India.

However, in a recent report by Livemint.com , it appears that the Chennai Patent Office disagrees with that reasoning by granting patent Application No. 959/MAS/1995, for the drug Valganciclovir, (otherwise known as the L-monovaline ester pro-drug of the compound Ganciclovir), which is used for treating cytomegalovirus retinitis in patients with AIDS.

The patent was granted despite a pre-grant opposition by HIV/AIDS patient groups arguing that the drug is a pre-95 invention, because although the application was filed in India on 27 July 1995, it claims a convention priority from an earlier U.S Application No. 281 893 filed on 28 July 1994. So has the Chennai Patent Office got it wrong by granting a patent application claiming priority from a 1994 application?”

Subsequent to his post, I had an interesting conversation with him on this issue, and a recent query posed by Pradip Kumar Roy forced both of us to revisit this issue. We agree that there is a definite TRIPS obligation to not only institute a “mailbox facility” for pharma applications (in the period between 1995 and 2005), but also that the application can avail of any relevant priority dates, when such application is finally examined post 2005.

Let me explain as under:

TRIPS mandated countries to expand “patentable subject matter” categories. Illustratively, in the case of India, TRIPS stipulated that product patents for pharmaceutical inventions were to be granted from 2005. However, such pharma applications had to be stowed away in a mailbox and taken up for examination in 2005 (the mailbox facility was introduced in India only around the year 2000 or so, but was made retrospectively applicable from 1995).

Assume that Pfizer files an application for compound X in the US in 1994. It then publishes details of the invention on its website at the end of 1994. It files a similar application in India in 1995. India is obligated to treat this as a mailbox application and keep it pending for examination till 2005. When India opens this application in 2005, would it judge the application for novelty as of 1995? Or of 1994 when it was first filed in the US? If it judges priority as on 1995, Pfizer’s application is not “new”, since it has already been published on Pfizer’s website.

Article 70.8 clearly stipulates that mailbox pharma applications can avail of any applicable priority date. In pertinent part, it mandates WTO member states such as India to apply to mailbox applications, “the criteria for patentability as laid down in this Agreement as if those criteria were being applied on the date of filing in that Member or, where priority is available and claimed, the priority date of the application.”

The question now is whether or not India ought to grant such priority in the first place at all. Article 2 of TRIPS incorporates certain portions of the Paris Convention into TRIPS. Therefore Article 4 of Paris dealing with convention countries (and the availability of priority for a period of one year from the date of filing in the home country) kicks in and India has to grant priority to all applications emanating from any WTO member state (as all of them are signatories to TRIPS). Further, India has to grant such priority to all WTO member states and cannot chose between them, as it will otherwise violate the provisions relating to “most favoured nation”.

Owing to the above framework, it does not really matter that India did not sign up to the Paris Convention till December 1998. Rather some provisions of Paris (such as Article 4) are automatically incorporated into TRIPS and become applicable to India on the day when TRIPS itself becomes applicable to India i.e. 1.1.1995!

Under the above framework, India would have grant priority to the Pfizer application and consider novelty as on 1994. However, another issue crops up. India is a dualist country and no international obligation can kick in domestically unless specifically legislated by Parliament and brought in (barring certain exceptions such as the Vishaka case). We deal with some of these issues with India’s dualist approach in this piece here.

Therefore, unless the patents act were amended (from 1995) to provide priority status to applications from WTO member states, the said “priority” advantage cannot be conferred on such applications. Section 133 dealing with convention countries and priority was brought in only in 2005….and prior to this date, it was upto the Central Government to notify convention countries. Assume that the US had not been notified or at least had not been notified from 1995.

Can Indian courts and the Indian patent office refuse to grant priority to the Pfizer application, since the Patents Act did not mandate such priority as on 1995? I personally think they can…at least on a strict technical interpretation of the law.

This would of course amount to a TRIPS violation. But then Pfizer’s remedy would lie in convincing the US to take India to the WTO? It has no remedy before the IPO or courts,…rather than to grin and bear it.

However, given that courts are not always “technical” but would look at a more harmonious interpretation, it is likely that they will come to a different result. i.e in order to avoid a TRIPS contravention, an Indian court may interpret the existing patents act to read in priority obligations dating back to 1995. We’ll just have to wait and watch for a court decision on this count.

Shamnad Basheer

Shamnad Basheer

Prof. (Dr.) Shamnad Basheer founded SpicyIP in 2005. He's 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 Prof. Basheer joined Anand 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. Later, he was the Honorary Research Chair of IP Law at Nirma University and also a visiting professor of law at the National Law School (NLS), Bangalore. Prof. Basheer has published widely and his articles have won awards, including those instituted by ATRIP, the Stanford Technology Law Review and CREATe. He was consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also served on several government committees.

2 comments.

  1. AvatarNilanjana

    I would have thought that the priority has to in a convention country after 1.1.1995 to put in a mailbox application in India (for the 10 years interim period)

    Reply

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