Brazilian Patent Office Issues Final Refusal for Tenofovir – But Gilead Files Divisional Application

14 Jul 2009

Updating our earlier posts here and here, The Working Group on Intellectual Property (GTPI) of REBRIP and Associação Brasileira Interdisciplinar de AIDS (ABIA) have circulated a press release that on 30 June 2009 the Brazilian Patent Office (INPI) issued a final refusal of Gilead’s patent application no. PI 9801145-4 for tenofovir disoproxil fumarate (TDF).

Gilead’s only recourse to overturn INPI’s decision with respect to application no. PI 9801145-4 now lies with the courts.

However, unsurprisingly Gilead has not left all its eggs in one basket. Under Article 26 of Brazil’s Law No. 9279/96, applicants may divide an application out until the end of examination, provided they give specific reference to the original application and do not claim any additional matter. According to our search of INPI’s patent database, Gilead filed divisional application no. PI9816239-0 on 31 March 2009. If 30 June was the date INPI issued its final refusal during examination, it would appear that Gilead’s divisional application falls within the requirements of Article 26.

Having reviewed the claims of the divisional application (our unofficial translation of which can be downloaded here), it appears that Gilead is still attempting to seek protection on the product related aspects of TDF that could prevent generic competition. For example,despite the preambles to Claims 1 and 2 starting with the words “Use”, it seems clear that Gilead is trying to protect the use of a composition that is TDF. In some jurisdictions i.e. the U.S., applicants can act as their own lexicographer for the purpose of defining patent claims. Therefore, Gilead may attempt to give a common word or phrase like “Use” a meaning that is very specific and different from the normal definition of the term. It is also possible that Gilead could amend these claims further during prosecution, by adding in additional product claims provided the subject matter was disclosed ion the original application.

It will be interesting to see how INPI interprets these claims. Also, as Gilead is required under Article 26 to provide reference to the original application that PI9816239-0 was divided from, one would expect that INPI would refuse the divisional claims also.

This situation only re-confirms the existing problems with the current patent system. It shows how divisional applications will be used by applicants to get a second bite of the cherry, avoid patent oppositions/ observations and to keep uncertainty in the market place. We have already discussed these practices by originator companies in India here and here.

It’s about time that legislators and patent offices around the world changed patent laws to prevent these “never-ending” patent applications that prevent legitimate competition. The European Patent Office, following the recent EC Competition Report on the Pharmaceutical Sector, has made some improvements in this regard by changing its rules on divisional applications (see here). But more can and should be done. If an application is refused during examination, the applicant should either amend the claims to those that the patent office will allow or lose the application completely without recourse to filing a divisional. As it stands, the patent system is stacked highly in favour of applicants and those with deep pockets.

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