Swiss giant Novartis has dragged Biocon to Delhi High Court for allegedly infringing patent rights of its diabetes drug “Galvus” and now Biocon cannot manufacture, sell or export vildagliptin until the next hearing. The multinational is seeking an injunction against the Indian opponent, trying to block the launch of a generic version of Galvus.
Biocon, on the other hand, has elucidated that it stands for all valid patents and had neither been issued any injunction on Vildagliptin nor had it launched the product in India. This issue has come into light a year after a prominent patent case involving Novartis’ blood cancer drug Glivec ended. Its next hearing is due on April 28th, 2014.
Galvus is the trade name for Vildagliptin which is an oral anti-diabetic agent used to lower blood sugar levels in patients with Type 2 diabetes mellitus. It belongs to class of drugs, known as gliptins or DPP4 inhibitors and works well in combination with certain other medicines like metformin or insulin injections and when diet & exercise do not provide adequate blood sugar level control.
The patented drug was launched in India in 2008 by Novartis and its patent term is set to expire in 2019. It has been selling well in India considering India’s dubious distinction as the diabetes capital of the world.
WO 2007035665 entitled “Use of a DPP-IV inhibitor to reduce hypoglycemic events”
Also published as CA2622579C, EP1928499B1, US20080300171, US20120149639
What Benefits Novartis Is Seeking With an Injunction?
An injunction is an equitable remedy in the form of a court order that requires a party to do or refrain from doing specific acts. Party that fails to meet the terms of the injunction faces penalty and may have to pay damages or accept sanctions. Injunction can play an important role in safeguarding one’s IP. Some of its advantages are:
A. It can be used when urgent action is required (they can be obtained within 48 hours). Even for less serious cases, applications for an injunction can usually be heard within two weeks.
B. There is no statutory requirement for consultation with other organizations.
C. In exceptional circumstances, injunctions can be granted without giving any prior notice of the legal proceedings to the perpetrator.
Novartis Wockhardt Patent Fight For Galvus
In February 2014, Novartis had also obtained an injunction from the Delhi High Court against another local drug-maker, Wockhardt, over the alleged infringement of its compound after it had challenged Novartis’ patent on the drug. The Delhi high court will hear the dispute between Wockhardt and Novartis on May 20.
Biocon Roche Patent Fight
It is not for the first time that Biocon has been locked in a high-profile battle with a multinational. In the past, Biocon and Roche locked horns for Roche’s breast cancer drug trastuzumab, sold under the brand name Herceptin. Roche obtained an injunction from the Delhi High Court preventing Biocon (and even Mylan) from comparing their products to Roche’s drug. The injunction came just as the two companies were poised to launch their generically-similar versions in India, at a price 25% lower than the innovator’s drug.