Novartis’s Gleevec: Supreme Court Brings Patent Law To New Heights.

The least popular branch of intellectual property (IP) law–patents–got the most coverage in media world over, thanks to the Supreme Court’s verdict today in Novartis patent litigation for Gleevec application.

The judgement of Supreme Court can be accessed here: Gleevec (pdf) (HTML)

Brief facts:

Novartis applied for a patent in India for a anti cancer drug by the name of Gleevec. Even before the application was taken up for consideration, it attracted 5 pre-grant opposition proceedings from Cancer Patients Aid, Natco, Ranbaxy, Cipla & Hetro Drugs. On December 15, 2005, Assistant Controller of Patents heard all 5 proceedings together and rejected patent application by Novartis.

Controller held that the invention claimed by the appellant was anticipated by prior publication, i.e., the Zimmermann patent; that the invention claimed by the appellant was obvious to a person skilled in the art in view of the disclosure provided in the Zimmermann patent specifications; and further that the patentability of the alleged invention was disallowed by section 3(d) of the Act

Novartis challenged the Controller’s order before the Madras High Court in 5 writ petition and filed 2 separate writ petitions challenging constitutionality of Section 3(d) of the Patents Act. Once the High Court dismissed the writ petitions challenging 3(d), Novartis did not prefer any appeal to the Supreme Court. The other bunch of 5 petitions were transferred to Intellectual Property Appellate Board (IPAB) for adjudication.

IPAB reversed Controller’s decisions in all 5 petitions to the extent that Novartis invention satisfied the tests of novelty and non-obviousness. The IPAB, however, held that the patentability of the subject product was hit by section 3(d) of the Act. In an unprecedented manner, and with the Consent of the parties to save considerable time, Their Honours in the Supreme Court decided to hear the appales against the IPAB order though the Appellate Court was Madras High Court.

The 5 Objectors stated before the SC that the TRIPS agreement has sufficient flexibility for Member States to control Patent rights to guard against adverse impact on public health.

The SC also noted that amended portion of section 3(d) clearly sets up a second tier of qualifying standards for chemical substances / pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds.

Furthermore, the Bench also noted that the Zimmermann patent, Novartis applied for, and in several cases obtained, patent in the US not only for the beta and alpha crystalline forms of Imatinib Mesylate, but also for Imatinib in a number of different forms. Novartis, however, never asked for any patent for Imatinib Mesylate in non-crystalline form, for the simple reason that it had always maintained that Imatinib Mesylate is fully a part of the Zimmermann patent and does not call for any separate patent.

This factor also played a crucial role before the Bench since Novartis maintained in the Indian application that Gleevec was a new substance as applied took a contrary position to earlier patent applications and even while sending a cease and desist letter to Natco.

When Novartis cited foreign rulings in support of the arguments, the Bench held as following:

“In this country the law of patent, after the introduction of product patent for all kinds of substances in the patent regime, is in its infancy. We certainly do not wish the law of patent in this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skillful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent.”

Finally, in paragraph 164 of the judgement, SC has stated that while going through the Zimmermann patent one cannot but feel that it relates to some very serious, important and valuable researches. The subject patent application (Gleevec), on the other hand, appears to be a loosely assembled, cut-and-paste job, drawing heavily upon the Zimmermann patent.

Charity programme by Novartis:

Though a lot has been written & spoken about the charity programme by Novartis, few points are very important to note. IPAB in its order notes that : –

“We are fully conscious of the Appellant’s (Novartis’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 Exclusive Marketing Rights 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 un-affordable 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.

Furthermore, Supreme Court in the order also notes that when asking Novartis about the massive pricing of the drugs, it stated to run a huge charity programme for free distribution of drugs as well to the needy. However, when the Supreme Court questioned if Novartis can abolish the charity programme and rework on the pricing, Novartis could not reply satisfactorily.

Point being, the Court were aware of the Charity argument of Novartis but the price difference between a monthly dosage of 120 thousands and 8 thousands was astonishing.

TRIPS agreement versus local laws:

The most crucial aspect which weighed in before Their Honours at the Bench was the contribution which the manufacturers of Indian generic industry had made world over to supply life saving drugs to poor countries. Two letters which the Bench quoted are relevant as well. One was dated 17 December, 2004, from Director, Dept of AIDS at WHO writing to Union Health Minister stating that WHO is aware that TRIPS compliance was important but also is most important that India continues to export cheaper medicines to not only Member States but also countries which are poor. Some countries which WHO mentioned where India is a massive supplier of cheap anti cancer life saving generic drugs were Ghana, Lesotho, Malawi, Namibia, Bangladesh, etc.

Another letter was from UNAIDS asking India to make sure that the Patent regime after complying with TRIPS does not restrict / undermine India’s position as a leader in supplying affordable life saving drugs to countries that do not have manufacturing capacity to manufacture such drugs.

It is, therefore, a fallacy to say that Indian Patent Act is not in consonance with the requirements under TRIPS or that Courts were not mindful of the R&D and charities done by Novartis. However, at the end of the day, courts will have to interpret provisions of Patent Act keeping India as a jurisdiction because Patent provisions, unlike trademarks and copyright, are not enforceable internationally.

In Gleevec ruling, SC has displayed as excellent and pragmatic approach in dealing with one of the most complicated branches of law. The judgement, apart from being excellently sound in law, is written in such an elaborate manner that any person with even basic knowledge about patent law can understand and appreciate it.

After a long time, an excellent IP ruling from  the Supreme Court.

3 Comments

Filed under In Accordance With Law, IP reviews

3 responses to “Novartis’s Gleevec: Supreme Court Brings Patent Law To New Heights.

  1. Reblogged this on AishMGhrana and commented:
    This post provide a very good insight of Novartis patent case. All readers must read the order of Supreme Court because what media is reporting may be its misinformation about law and fact.

  2. Nice article. Well articulated.Novartis’s patent application was a “copy paste” from Zimmermann Patent. Indian patent law contains provisions against “evergreening” of patents-section 3(d). Evergreening in patents field is what tax avoidance is in tax law field. Evergreening is used to extent patent life ad infinitum by making frivolous “improvements” to existing product. Full credit to our Parliamentarians for incorporating section 3(d) requiring higher threshold for patenting improvements to drugs.

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