Patent

The Fate of the Rosiglitazone Patents: Far From Rosy?


Recently, a colleague of mine asserted that till date, GSK had obtained only one pharmaceutical product patent in India! Given that GSK has the largest sales in India (of all the MNC’s operating within India) and have introduced most of their global products in India as well, this figure seems a tad too difficult to believe. Anyone in the know from amongst our readers?

And with this puzzling statistic, which if true, could raise some very interesting questions about the Indian patent regime, let us move on to GSK’s famous Rosiglitazone patent applications, one of which made it to the Supreme Court of India and featured in earlier blog posts. The fate of these applications and what they mean for GSK and its generic competitors is examined in the below note by Lakshmikant Goenka of Dolcera, a leading patent intelligence firm.

Case background

Avandia is the popular drug name marketed by GSK had strong sales of 2.3 billion USD in 2007 till reports of its cardiovascular risks came out in the market place (forcing lots of physicians to change prescriptions to their patients, though the data was proclaimed as inconclusive by FDA).

Avandia finds strong applications for glycemic control or in others words for diabetes type II treatment. Its active ingredient is a compound called Rosiglitazone, and a variant of this chemical compound was patented by GSK with expiry in 2005 (US5741803).

GSK Indian strategy

Per change in the Indian patent act in 2005, GSK filed a patent for the same active ingredient as disclosed in US 5002953 as an Indian patent 00295/DELNP/2003 trying to claim the ethanesulfonate salt of the active ingredient. This patent was subsequently rejected by the India Patent office citing no evidence of the complex showing substantially different clinical efficacy than the available pharmaceutical version of Rosiglitazone.

However, it is interesting to note that GSK has not given up. It has at least three more pending application before the IPO for the same compound Rosiglitazone and we will have to see how the IPO deals with that. These applications are:-

a) IN3546/DELNP/2004 in which GSK has tried to patent a cyclodextrin complex of rosiglitazone and

b) IN4030/DELNP/2005 in which GSK has tried to patent the process for manufacture of a rosiglitazone polymorph (the maleic ester form as patented in US7358366)

c) IN6569/DELNP/2007 in which GSK has tried to patent a novel method of delivering rosiglitazone (enmeshed in nanofibres)

To counter this threat, Cadila and Dr. Reddys have also filed process patents for manufacture of amorphous Rosiglitazone maleate.

Only time will tell, who will win the Rosiglitazone turf war in India.

Sources:

FDA Orange book
Indian Patent office
US Patent Office
Economic times

Note: More such analysis and IP analytics information can be found in the Dolcera Blogs

Shamnad Basheer

Shamnad Basheer

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

3 comments.

  1. AvatarShamnad Basheer

    I’m in the process of looking through the IPO database now. And it appears that there are several product patents in favour of GSK (from the titles and abstracts etc). I will confirm this soon.

    Reply
  2. AvatarTahir

    Hi Shamnad,

    Based on searches to date against the applicant names “Glaxo” and “Smithkline”, and reviewing the titles of the patents – at a glance there are some 100 product related patents, plus around 8-10 vaccine related product patents and their adjuvants.

    If you were to run applicant name searches of all the possible variants of the Glaxo Smithkline (of which there are several) the number increases.

    Of course we don’t know until we see the actual granted claims, but based on experience to date the titles of the granted product patents usually contain product related claims.

    cheers

    Tahir

    Reply

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