Pre-95 drugs are not patentable in India – or are they?

3 Oct 2007

The latest battle to interpret the law may impact whether several drug product patent applications in India are patentable. 

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 , 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?  

The key Article in TRIPS that is relevant to this question is Article 70.8. The WTO Appellate Body in the India – Mailbox Case , in particular paragraphs 56 and 57, help shed some light on how Article 70.8 should be interpreted. The Appellate Body states:

We believe the Panel was correct in finding that the "means" that the Member concerned is obliged to provide under Article 70.8(a) must allow for "the entitlement to file mailbox applications and the allocation of filing and priority dates to them".  Furthermore, the Panel was correct in finding that the "means" established under Article 70.8(a) must also provide "a sound legal basis to preserve novelty and priority as of those dates.”

One interpretation from the above passages of the Appellate Body’s Report is this: the WTO interprets Article 70.8 as a mechanism for preserving the novelty of patent applications filed after 1 January 1995, including the entitlement for applicant’s to claim priority from earlier convention filings. This seems to be confirmed by the Appellate Body endorsing the Dispute Panel’s view that ‘Without legally sound filing and priority dates, the mechanism to be established on the basis of Article 70.8 will be rendered inoperational. [Panel Report, para 7.28]’. So on this interpretation, it might  incorrect to state that pre-95 drugs are not patentable in India. It could be that an application filed on 1 January 1995, may be able to claim priority from an earlier application filed on 1 January 1994.

However, the wording in Article 70.8 is not the clearest and could be open to alternative interpretations.  The obvious point is because TRIPS came into force on 1 January 1995, Members like India did not have any obligations to TRIPS before that date.

It is also worth noting that the concept of priority originates from Article 4 of the Paris Convention, which was installed into Article 2.1 of TRIPS. Article 65 clearly states that other than Articles 3, 4 and 5 of TRIPS, developing countries can delay the application of the provisions of TRIPS until 1 January 2000 (and an additional five years before granting protection to pharmaceutical product patents). So by this interpretation, does India have to recognise the right to priority claims under the Paris Convention before 1 January 2000? (In fact, India only became a member of the Paris Convention on 7 December 1998).  However, the problem with this interpretation is that Article 70.8 clearly states that it applies ‘notwithstanding the provisions of Part VI’ i.e Article 65. This very phrase means that Article 70.8 applies irrespective of the transistional provisions.

Also, the now defunct s24B of the Patents(Amendment ) Act 1999 only provided exclusive marketing rights (EMRs) for patent applications under s5(2) relating to inventions made in India or in a country other than India for the same invention claiming an identical article or substance in a convention country on or after 1 January 1995. But is it possible to apply the EMR standard to priority claims for applications?

The interpretation of priority dates for inventions dating before 1 January 1995 is likely be another drawn out battle which could affect whether a number of pharmaceutical patent applications are granted in India.

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