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Balancing the scales

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Besides the balanced reasoning within the Delhi HC judgement, it is the SC’s intervention which could see this case go down as a major milestone

20151015ep03The Delhi High Court (HC)’s October 7 decision to uphold Merck Sharpe and Dohme (MSD)’s patent on anti-diabetes drug sitagliptin and its salts is being seen as proof that India’s patent authorities are capable of unbiased decisions. Spicy IP’s Shamnad Basheer in fact advises the Modi government to ‘flaunt this decision to our US counterparts who’ve been ranting against the Indian IP system.’ (http://spicyip.com/2015/10/a-madhu-victory-for-merck-busting-the-patent-bias-myth.html)

Will these measures discourage generic manufacturers from challenging patents in the future? Not likely. Glenmark is not the only pharma company to challenge MSD’s patents on sitagliptin phosphate monohydrate and was taking its cues from Teva Pharmaceuticals in this instance. The 133-page Delhi HC judgement details that MSD’s patent for this salt faced opposition from the European Patent Office and the WIPO on the grounds that it lacked novelty and inventive step but the original applicant argued the sitagliptin phosphate monohydrate had remarkable advantages over the hydrochloride salt in terms of chemical stability (which allowed it to manufacture tablets better). MSD (as Merck) was granted a European Patent for sitagliptin phosphate monohydrate which was challenged by Teva Pharma on the same grounds of lack of novelty and inventive step, but its challenge was rejected by the EU authorities.

Which begs the question, what made Glenmark confident that it had a good chance of a win, given Teva’s experience? Was it relying on previous decisions in similar cases, where the impression is that Indian courts tended to rule in favour of the local company? Glenmark’s case initially seemed strong as Merck had voluntarily abandoned its patent application for the phosphate monohydrate salt in India as well as other patents, which earned it a rap on the knuckles from the Delhi HC.

This case dragged on for more than two years and would have continued at the same pace, but for the Supreme Court (SC)’s monitoring and strict diktat dated May 15 this year to expedite matters. (For more details of the Delhi HC judgement, see http://www.expressbpd.com/article/pharma/latest-updates/delhi-hc-upholds-msds-sitagliptin-patent/147743/)

Future patent challengers need to take note of this increased scrunity and be aware that the SC could step in whenever required in future as well. Which means that patent challengers cannot rely on using the interim injunction period to sell stocks already in the market, or as some market analysts point out in Glenmark’s case, launch a replacement product. Besides the balanced reasoning within the Delhi HC judgement, it is the SC’s intervention which could see this case go down as a major milestone in the evolution of the Indian intellectual property disputes, specifically in the pharmaceutical universe.

The judgement came just a few days after the signing of the Trans-Pacific Protocol (TPP), between 12 countries, led by the United States. The grouping includes seven countries in the Asia-Pacific region (Vietnam, Malaysia, Japan, Australia, New Zealand, Singapore and Brunei), with a clear intention to draw these nations away from China. Health activists groups have criticised both the methods used to draft the agreement as well as the contents based on via leaked versions. Doctors Without Borders (MSF) said that even though the final leaked version was better than the initial versions, ‘the TPP will still go down in history as the worst trade agreement for access to medicines in developing countries, which will be forced to change their laws to incorporate abusive intellectual property protections for pharma companies.’

The full text of the TPP is due to be made public in a month’s time and it has yet to be passed by the US Congress, so all legal experts are holding back their analysis but from all accounts, the die has been cast. While India rightly chose not to be part of the TPP, primarily due to these concerns, we have to mitigate the loss of exports to these countries by quickly closing our own trade deals like the India-EU Bilateral Trade and Investment Agreement and the ongoing negotiations under the Regional Comprehensive Economic Partnership. The next few months could be crucial on this front and we hope India remains firm on its stance on IP issues within these agreements.

Viveka Roychowdhury
Editor

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