As the mint reports; in response to a quia timet suit filed by Novartis, the Delhi high court issued an order Restraining Ranbaxy from manufacturing and selling a generic version of Vildagliptin (Galvus). Interestingly the court observed the fact that Ranbaxy had applied for revocation of Novartis’ patent shows that the defendant (Ranbaxy) wants to launch the compound patented.
Novartis was represented by senior advocate and former Solicitor General Gopal Subramanium and Ranbaxy was represented by senior advocate and former finance minister P.Chidambaram.
Novartis has been jealously guarding its blockbuster antidiabetic from generic competition. In the recent past Novartis had filed a flurry of quia timet suits against 6 generics Wockhardt,Biocon, Glenmark, Alembic pharmaceuticals, Bajaj healthcare, Cadila healthcare. We had blogged about these suits in detail here and here.This post aims to explore standards of proof for allowing quia timet injunctions in various jurisdictions.
Standard of proof for quia timet injunctions:
As we all know, quia timet Injunction is an injunction to restrain wrongful acts which are imminent but have not yet commenced. The standard of proof for quia timet injunctions and what constitutes genuine threat for infringement is still ambiguous in India. Aparajita has written an incisive post on Delhi HC and Madras HC decisions on quia timet patent injunctions. These cases did not explore the standard of proof for quia timet injunctions but were decided on jurisdiction.As readers may recall Shamnad has discussed quia timet actions in detail over here.
I couldn’t find the order yet, but the Mint article appears to suggest that the court granted the quia timet injunction against Ranbaxy based on the fact that Ranbaxy had applied for revocation of Novartis patent in Intellectual Property appellate board (IPAB). Novartis also produced a study it had commissioned that quotes a manager at Ranbaxy saying that “vildagliptin is at the developmental stage and is being actively pursued for development”.
For the previous cases (Bajaj and Alembic) the standard of proof adopted by the courts for allowing quia timet injunctions was: marketing approvals/ regulatory licenses obtained by generics much ahead of patent expiry.
There is no definite way of ascertaining whether a particular act constitutes proof of imminent threat. For example in the current Ranbaxy case; the court opted for a liberal interpretation, allowed a quia timet injunction and observed that applying for patent revocation is indicative of imminent intent to launch of generic version. However one could argue either way. Applying for patent revocation may also be construed as an act of good faith by the generic company; to have the validity of the patent adjudicated before launching the generic version.
Viewing Quia timet suits through the lens of European doctrines
Merck, Sharp & Dohme Corp. and Bristol-Myers Squibb Pharmaceuticals Ltd vs. Teva Pharma in the UK is an interesting quia timet suit.
Efavirenz, a drug used to control HIV infections patented by Merck was set to expire on 3 August 2013. Teva received marketing authorization for generic efavirenz in EU in early 2012.When BMS questioned Teva about its intentions to launch a generic version ahead of patent expiry, Teva remained silent and maintained that its policy was not to divulge commercial information to competitors.
BMS filed a quia timet suit in UK alleging that Teva’s actions of obtaining marketing approval much ahead of patent expiry, refusing to divulge intentions about launch indicate an intention to launch and infringe BMS’s patent.
The judge granted BMS an interim injunction and opined that the fact that Teva had taken the trouble to obtain marketing approval much ahead of time (22 months) supports an inference that Teva intended to launch generic efavirenz before patent expiry. Also Teva’s past at risk launches also worked against them.
Standard of proof for allowing quia timet injunctions are subjective. I believe that obtaining regulatory approvals/marketing authorizations much ahead of patent expiry may be indicative of imminent intent to launch, but a patent revocation petition alone is insufficient to establish whether threat to launch is imminent. In any case Section 106 of the patent act along with Section 105 provides adequate relief to persons who have been subjected to groundless threats of infringement.
The next hearing for this case is on 28th October. Watch this space for more!