The first is the appeal by Novartis (Appeal No. 20539 – 549 of 2009) against the decision of the Intellectual Property Appellate Board, upholding the decision of the patent office to reject the Novartis's patent application for the beta-crystalline form of imatinib mesylate. NATCO has filed a cross-appeal (Appeal No. 32706 of 2009) in this case. Both appeals are are scheduled to be heard by the Supreme Court on the 6th of July, 2010 i.e. tomorrow. (Please do feel free to send in tidbits if you happen to be in the Supreme Court tomorrow).
The second is the appeal by Bayer (Appeal No. 6540 of 2010) against the decision of the Delhi High Court in regards the linking of drug regulatory approvals to the patent status of the drug. Bayer had lost before the Single Judge and the Division Bench, both of whom imposed heavy costs on Bayer for 'frivilous litigation'. The Bayer appeal is coming up for hearing on the 3rd of August, 2010 for final arguments and disposal. We've blogged about the case here.
Both Novartis and Bayer are being lef by Senior Advocate Shanti Bhushan who is being briefed by Remfry and Sagar, one of the biggest IP law firms in India. The Respondents in both appeals are being led by, amongst others, Senior Advocate Dr. A.M. Singhvi who is being briefed by Ms. Prathibha M. Singh & renowned patent attorney – Mr. S. Majumdar (only the Novartis case). The Attorney General's office will also be involved in this case since the Patent Office is one of the respondents. Mr. Anand Grover of Lawyer's Collective will most probably be representing cancer patient associations in both cases.
The morality and constitutionality of high priced drugs: The key aspects of this appeal is bound to be the interpretation of Section 3(d) of the Patent Act. Novartis will be arguing for a wider interpretation of 'efficacy' which not limited to mere 'therapeutic efficacy' as interpreted by the Madras High Court and the IPAB which considered itself to be bound by the Madras High Court decision. The Supreme Court is also expected to settle several other points of Indian patent law.
However the more controversial question before the Supreme Court is the IPAB's interpretation of Section 3(b) of the Patent Act i.e. the high price of the pharmaceutical product covered by Novartis's patent is so high that it is likely to cause dis-order amongst the general public and hence constitutes non-patentable subject matter as per the Patents Act, 1970. In pertinent part the IPAB held the following:
We are fully conscious of the Appellant’s benevolent GIPAP program for free distribution of GLEEVEC to certain cancer patients. But as per information furnished in its written counter–argument by R 3 that when the Appellant was holding the right as EMR on GLEEVEC it used to charge Rs. 1,20,000/- per month for a required dose of the drug from a cancer patient, not disputed by the Appellant, which in our view is too unaffordable to the poor cancer patients in India. Thus, we also observe that a grant of product patent on this application can create a havoc to the lives of poor people and their families affected with the cancer for which this drug is effective. This will have disastrous effect on the society as well. Considering all the circumstances of the appeals before us, we observe that the Appellant’s alleged invention won’t be worthy of a reward of any product patent on the basis of its impugned application for not only for not satisfying the requirement of section 3(d)of the Act, but also for its possible disastrous consequences on such grant as stated above, which also is being attracted by the provisions of section 3(b) of the Act which prohibits grant of patent on inventions, exploitation of which could create public disorder among other things
We've carried a more detailed post on this decision over here.
This argument of 'high prices being against 'public order' was put forth by Mr. Anand Grover of the Cancer Patients Aid Association (CPAA). It is highly unlikely that the Supreme Court is going to agree with such an interpretation of Section 3(b). However if the CPAA were to complement this issue with arguments based on the fundamental rights enshrined in Article 21 of the Constitution then in that case the issue will remain wide open for the Supreme Court to rule either way. The Indian Judiciary has already attempted to link up fundamental rights to pharmaceutical patents. Justice Bhat in the Roche v. Cipla judgment denied an injunction on similar grounds as the IPAB except it did so in a much more articulate manner. In pertinent manner Justice Bhat stated the following:
Undoubtedly, India entered into the TRIPS regime, and amended her laws to fulfilll her international obligations, yet the court has to proceed and apply the laws of this country, which oblige it to weigh all relevant factors. In this background the Court cannot be unmindful of the right of the general public to access life saving drugs which are available and for which such access would be denied if the injunction were granted. The degree of harm in such eventuality is absolute; the chances of improvement of life expectancy; even chances of recovery in some cases would be snuffed out altogether, if injunction were granted. Such injuries to third parties are un-compensatable. Another way of viewing it is that if the injunction in the case of a life saving drug were to be granted, the Court would in effect be stifling Article 21 so far as those would have or could have access to Erloticip are concerned.
Although the above precedent was in the context of temporary injunctions, the nature of fundamental rights and 'public interest' is so fluid that, it can be extended to other cases depending on the ideological disposition of the judge in question. The Division Bench hearing the appeal against Justice Bhat's order does not seem to have picked up on this argument since the respondents most probably failed to make such an argument. Justice Bhat is not alone in his interpretation of Article 21. The influential but retired Supreme Court Justice Krishna Iyer has written this piece in the Frontline arguing precisely on these lines i.e. pharmaceutical patents are invalid in light of Article 21 of the Indian Constitution which assures every citizen with a fundamental right to life. In pertinent part he stated the following:
To manufacture cheap outside, import and sell at any price in our market preventing by law indigenous producers is almost a definition of colonisation by a foreign power entering India, forbid Indians making the goods but offer a monopoly market. Why concede this dog-in-the-manger strategy? This is a textbook case of the violation of Article 19 (1) g and 19 (6) of the Constitution. This stratagem, if legislatively approved, is a shock and shame and proof of conquest by patent. Articles 14 (equal protection of the law), 19 (right to any trade or business) and 21 (right to life in good health) stand stultified if such glaring inequality between Indian products (denied patent) and foreign import of any commodity granted exclusive selling rig hts with no special benefit to the Indian consumer. This is gross inequality writ large, arbitrary, with no rational nexus to the wellbeing of "We, the People of India... (Article 14). Similarly, Article 19 is unreasonably transgressed. To refuse the non-patentee the right to manufacture the same product, the restriction must be justified constitutionally by reasonable grounds relatable to public interest. For the surrender of a non-pa tentee's Article 19 rights, what is the substantial public interest for Indians? No other ground save that MNC Might is Right. And "the most unkindest cut of all" is that by the grant of patents on even agriculture, pharmaceuticals and essential items ne cessary for the life of the community, Article 21 - the right to life, health, shelter - is frustrated.
Therefore the nature of the challenge before Novartis and Big Pharma is much graver than was ever anticipated before. The Supreme Court of India is known to be blatantly activist on occassions. Given that Justice Bhat is scheduled to hear the Bayer patent infringement suit on the 13th of July, 2010 I am willing to bet that he would reiterate his Article 21 jurisprudence in much firmer terms regardless of whether or not Cipla's counsel raises such an argument.