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The HealthCare Vs. Patent Law – A Paradox

The HealthCare Vs. Patent Law – A Paradox

When you give to the poor, do not let your left hand know what your right hand is doing”. A very wise saying, which however appears to create untenable situations in the world of healthcare. This is especially true when the adjudications at the Patent Office, the IPAB and at the Courts put the letter of law (usually Patent Law) in direct conflict with the spirit of equitable justice. The IP issues pertaining to healthcare are left to the vagaries of self serving advocacy in a largely adversorial hearing. Justice PrabhaSridevan former chairperson of IPAB observed that it becomes imperative for Courts to also adopt an inquisitorial approach where grave matters of health are concerned to ensure that facts and the law are tabled.

Adjudications in matters including the Novartis case (Novartis v. UoI), F.Hoffman La Roche v. Cipla, UCB Farchim v. Cipla and the trail-blazing Mohd. Ahmad v. UoI, have created interesting jurisprudence in the healthcare sector that have become center point of patent law debates in international fora. However, there is much more to be done.

At the Consultations on IP & Healthcare organised by Ministry of Health, WHO and Centre for Technology and Policy (CTaP) at IIT Chennai from 7-9 August 2014, it was clear that the trend of granting ex-parte interim injunctions without establishing credible prima facie case and balance of convenience has done more harm than good in matter relating to process patents for drugs. Here the irreparable injury is borne by the Public at large. Further, the Courts’disinclination to hear vacation applications coupled with the Courts’ propensity to disregard alternative remedies such as damages / account of profits in lieu of interim injunctions has contributed to artificial hike in prices of medicines. In many instances the questions of validity of patent claims filed in counter-claim for revocation are placed on the back-burner while the plaintiff enjoys nation-wide injunction till the case is finally adjudicated in 7 to 8 years.

The three day Consultations also deliberated on the rising trend of using compulsory licence (CL) as a business model by competing companies which is incongruous with the legislative intent behind CL. The provision of CL (S. 84) in the Patents Act 1970 provides a safety net for ensuring access to patented inventions in a situation capable of being construed as anti-competitive.

In its zeal to appear as an IP friendly jurisdiction, the Courts, the advocates and the media have failed to appreciate that exparte interim injunctions must be exercised carefully in health related intellectual property matters.

It would be helpful if legal mechanisms like Expert Determination for resolution of complex questions of facts (many of them being pure or applied biochemistry) and appointment of Amicus are used by Courts to overcome this impasse.

Former Justice GS Singhvi has rightly observed that when the issue before the Court concerns the health and life of citizens, the judiciary can neither prevaricate nor procrastinate (on PIL filed by All India Drug Action Network (2011(12)SCALE100)).

About Author

Sunita K Sreedharan

Sunita K. Sreedharan is an Advocate, Patent Agent and CEO, SKS Law Associates. She has recently authored a book on “An Introduction to Intellectual Asset Management”. Sunita is a member of Licensing Executive Society (LES) and Association Internationale pour la Protection de la PropriétéIntellectuelle (AIPPI). Presently, she is the Legal Advisor on the Central Technology Management Committee of the Indian Council for Agricultural Research.