<div><strong>US companies and trade bodies have been brutally critical of India’s comparatively tight intellectual property right law and the judiciary rulings, points out C H Unnikrishnan</strong></div><div> </div><div> </div><div>Delhi High Court’s Wednesday (7 October) order asking Indian generic drug maker Glenmark Pharmaceuticals to stop manufacturing and sales of anti-diabetes drug sitagliptin is a classic testimony of India’s balanced judiciary on intellectual property rights (IPR) and yet another case in hand for India to defend its strong stand against the contentious “anti-IPR nation” campaign promoted by some of its foreign counterparts including US.</div><div> </div><div>The IPR infringement case, filed by US drug multinational Merck Sharp and Dohme Corporation or Merck and Co., against Glenmark after the latter launched generic versions of this anti-diabetic drug, was pending with the court since 2013. In the interim, a division bench of the court had also issued a similar order restraining Glenmark from selling its generic versions. </div><div> </div><div><table align="right" border="1" cellpadding="2" cellspacing="2" style="width: 200px"><tbody><tr><td><img alt="" src="http://bw-image.s3.amazonaws.com/unni-small.jpg" style="width: 200px; height: 200px; margin: 1px;"></td></tr><tr><td><strong>C H Unnikrishnan</strong></td></tr></tbody></table>Sitagliptin, a comparatively new drug molecule to treat type-2 diabetes invented and patented by Merck, has been granted patent protection in India since 2007. Merck’s local subsidiary MSD Pharmaceuticals has been selling two formulation brands--Januvia and Janumet-- of this drug in the local market. While the brand Januvia is a formulation of sitagliptin alone, Janumet is a combination of sitagliptin and another age-old anti-diabetes drug metformin. Glenmark had launched similar versions using a salt of sitagliptin—sitagliptin phosphate monohydrate and metformin in India with a price tag that is slightly lower than MSD Pharma’s Rs 43 a tablet. </div><div> </div><div>Although the Indian company argued that its drug is different from the original molecule, the court has now ruled that Glenmark’s generic version is infringing Merck’s main patent on sitagliptin as it covers all its derivatives and salts too.</div><div> </div><div>The court has also observed that the Merck’s drug, which was launched in India at a much lower price as compared to it prices abroad, also doesn't have an issue on accessibility to Indian patients. </div><div> </div><div>This ruling, in a way, also supports India’s IPR law that doesn’t allow patent protection for derivatives and any other forms of a previously known molecule, which doesn’t qualify for a patent in India due to various reasons including the 1995 prior art criteria among others. The court’s order has also stressed the point that that Merck’s patent application faced no opposition in India despite multiple options such as pre-grant and post grant oppositions allowed by Indian patent law. </div><div> </div><div>India’s comparatively tight intellectual property right law and the judiciary rulings have been subject to brutal criticism by several economically developed countries, especially from the US companies and trade bodies, for reasons such as not recognising incremental innovations, multiple options for oppositions and for allegedly favouring local industry. There have been also severe pressure on India by the US administration through trade and diplomatic routes to ‘comply’ with international practices, which by and large recognises incremental claims for market exclusivity for products including essential drugs.</div><div> </div><div>The court ruling in this case to restrain the local company by a decree of permanent injunction from making, using, selling, distributing, advertising, exporting, offering for sale or dealing in sitagliptin phosphate monohydrate or any other salt of sitagliptin in any form, alone or in combination with one or more other drugs thereby infringing the suit patent no. 209816 of Merck, thereby clearly shows India by no chance suffer a patent bias and government of India should now display this case ostentatiously to its foreign counterparts who have been attacking the country’s IPR law with baseless charges.</div><div> </div>
