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Guest Post: Novartis and Myriad: A Surprisingly Similar Tale of Access to Medicine and limits on Patent Eligibility


Smaran Shetty, final year student at NUJS and Editor of NUJS Law Review, has sent us this interesting guest post which explores the similarities between the recent US Supreme Court’s decision in Assn. for Molecular Pathology v. Myriad Genetics and Indian Supreme Court’s Novartis decision. For our previous coverage on both the cases, see here and here.
Novartis and Myriad: A Surprisingly Similar Tale of Access to Medicine and limits on Patent Eligibility 
 
By 
Smaran Shetty
On 1st April, the Supreme Court of India in Novartis A.G. v. Union of India upheld the rejection of a patent application, in relation to Cancer saving drug, as coming within the folds of Section 3(d) of the Patents Act, 1970. Roughly two and a half months later the United States Supreme Court in Association for Molecular Pathology v. Myriad Genetics partly rejected a patent application over a naturally occurring gene sequence that significantly increases the chances of breast and ovarian cancer (Both cases have previously been discussed on this blog and may be accessed here and here). Despite the facial difference between these two cases, certain compelling similarities emerge when viewed closely. These cases provide interesting commonalties with reference to the context of their agitation, the limits they place on patent eligibility standards and the broader social consequences these cases hold for public health and access to medicine issues. This post is an attempt to compare these decisions, albeit in a methodologically imperfect manner, to highlight some fundamental details of patent law, even where doctrinal particulars may operate in a significantly disjunctive manner.
Both Novartis and Myriad are not traditional instances of patent litigation, in that they involve a dispute between a patent holder and a rival competitor in the relevant field. Instead, at all levels of their agitation, crucial intervention has been made by patient groups, civil society organizations and academics. In the context of Novartis, cancer patient groups were represented by Mr. Anand Grover, who made important submissions as to the interpretation of Section 3(d) and the exact scope of “enhanced therapeutic efficacy”. Representing the interests of those whose lives depended on access to cancer medication, he argued that merely ensuring that a new version of a drug is more available in the body or is less toxic, should not be a ground for patent eligibility. This position was characterized as the “rigid position” in contrast to the more “liberal position” taken by Prof Shamnad Basheer, who argued that in certain cases, significantly reduced toxicity should be construed as enhanced therapeutic efficacy (Para 183-186). Although, neither of these arguments were completely accepted (since the scope of Section 3(d) was consciously left open), it nonetheless assisted the court in understanding the manner in which Section 3(d) was intended to operate and which situations it should apply to. In Myriad Genetics too, important amicus briefs were filed by civil and women’s rights organizations highlighting important access to medicine issues at stake in this case (more than a dozen briefs were filed and may be accessed here). In fact, the appeal against the lower courts ruling which granted patent over Myriad’s claims, was preferred by a group of scientist known as the Association for Molecular Pathologists and was also assisted by the American Civil Liberties Union.
Interestingly, the inventors of the claimed drugs, in both cases have come out in support of the decisions to deny patent protection over their discoveries. The statement in relation to Novartis may be accessed here and for Myriad here. These perspectives are instructive, as they help us examine the unfair and predatory use of a patent, if these cases had been decided in the alternative. In the context of Myriad, not only was the petitioner attempting to claim a patent over a naturally occurring gene sequence, but it also sought to prevent other entities from testing for such gene sequences. Considering the fact that the gene sequence under consideration, BRAC1 and BRAC2, were known to significantly increase the chance of breast and ovarian cancer, Myriad Genetics was effectively attempting to monopolize the means for breast cancer testing. Women’s health activist assert that testing for breast and ovarian cancer was already prohibitively expensive, and would only further skyrocket, if a patent was granted (see here and here). In the context of Novartis, a patent was being claimed over a minor modification in Glivec (a cancer saving drug), and in doing so would cost several times more, than drugs that would have been produced by generic manufactures, if the patent were not granted. Although, the pricing of a drug cannot in and of itself, be a ground of patent eligibility, it reminds of us of the sobering reality of the exploitative potential of patents, when the three fold criteria of patent eligibility (novelty, inventive step and industrial application) are not applied in a tailored and cautious manner.
The most compelling similarity between Novartis and Myriad appear in their ability to place cogent limits on patent eligibility. In Myriad, the court had to interpret Section 101 (which places no textual restrictions on patent eligibility) with judicial precedent, such as Diamond v. Chakrabarty, which held that laws of nature, abstract phenomenon and naturally occurring substances were not patent eligible. Relying on Chakrabarty, the court in Myriad correctly pointed out “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry”. In Novartis, the Indian Supreme Court had to decide whether the claimed drug was an invention within Section 2(j) of the Act, and if so, whether it would be excluded from patent protection in view of Section 3(d). The court held that even though the drug may be an invention for the limited purpose of Section 2(j), it could not pass the threshold requirements of Section 3(d), as the Appellants had been unable to clearly prove, how and if at all, the new version was a significant improvement over the known versions of the same drug.
Both Novartis and Myriad, draw attention to an often neglected understanding of patent law. They help to stress the importance of the need to treat the three fold criteria of patent eligibility, as merely the starting point of patent eligibility and not a conclusive determination of the same. This helps individual countries to fashion patent law regimes where exclusionary principles for patent eligibility, may reflect the social and economic needs of the domestic populace, instead of being bound by universally agreed principles that can rarely, if ever, be implemented in a universal manner. This however, it not meant to serve as challenge or even a critique to the TRIPS regime, which itself informs the drafting and implementation of most domestic patent law regimes. But is instead meant to remind courts and patent offices that TRIPS itself, recognizes pursuant to Article 27(2), individual exceptions that countries may use to temper the application of the three fold criteria of patent eligibility.
The foregoing analysis is meant to highlight the ways in which Novartis and Myriad are similar and not to prove that they are identical. In fact there remain strong difference between the two cases. The decision in Myriad is largely a product of the decision in Chakrabarty, and to that extent was an easier outcome to reach, when compared to the Indian Supreme Court’s task of interpreting Section 2(j) and 3(d) without any applicable judicial precedent. More importantly, Novartis and Myriad stand for different degrees of patent ineligibility. Myriad recognizes a milder and more intuitive principle of excluding patent protection for unaltered naturally occurring substances, whereas Novartis reinforces a contested safeguard against predatory use of a patent, known in the pharmaceutical sector as “ever-greening”. The question of the validity of such a practice was not addressed by the Court and the exact scope of Section 3(d) was consciously left open. This will only ensure that the exclusions to patent eligibility under the Patent Act, 1970, and its equivalent in other jurisdictions continue to be the site of further patent litigation.

5 comments.

  1. AvatarAnonymous

    I find one of the assertion by the author rather ludicrous. THe authors has stated that – ….help us examine the unfair and predatory use of a patent… In the context of Myriad not only… but it also sought to prevent other entities from testing for such gene sequences. Considering the fact that the gene sequence under consideration, BRAC1 and BRAC2, were known to significantly increase the chance of breast and ovarian cancer, Myriad Genetics was effectively attempting to monopolize the means for breast cancer testing…” The patent IS meant to prevent other entities from working one’s invention and it is the right of patent holder to “try to monopolise” which in our language means “asserts one’s patent rights”. If these two things are not available, please throw the patent system out of the window. Who needs years of prosecution is different countries to just publish scientific achievement, when it can be done in one go, in an open access or paid journal?

    After this statement of the author, I did not find rest of the essay worth a glance.

    Thanks

    Reply
  2. AvatarAnonymous

    Anon is true.
    Why to attempt such a fake encounter to put Myriad & Novartis under same lens? Why people still suffering an obsession with “ever greening” & Novartis? Please consider 1) had the original Zimmermann patent been granted in India neither Novaris nor the half- learned media or even we would have get a chance to spent so much time on Novartis case; ii) what would have happened had the specification was drafted with little care to include efficacy data with required comparison (to known-imatinib mesylate.
    West wants us to keep the Novartis & 3d issues alive so that they can come and press us to show how big was the decision that goes foul to TRIPS

    After all this, we still in search for a take away precedence for what can/ can not get love & affection from 3d. Do we?

    Regards.

    TS

    Reply
  3. AvatarAnonymous

    Dear Anon Reader,

    I have no problems with Patent holders exerting their rights against unlawful use by third parties. But I do take issue when people in the guise of using patents, also block others forms of use/innovation in that field. In the case of Myriad, the company was not only attempting to patent the gene, but also the means for testing for such a gene. This creates a monopoly of service in the hands of one company, thereby increasing costs, and decreasing access to testing for women, who already cannot afford such expensive testing. For this very reason, I argue that the intended use of the patent by Myriad was predatory, and I was not making a general assessment that all patent holders use patents in an unreasonable manner. The early parts of the judgement in Myriad in fact recount some of the concerns I have just raised.

    Regards
    Smaran Shetty

    Reply
  4. AvatarAnonymous

    Samaran @7:57
    when you say
    “…….also the means for testing for such a gene”
    shows that either you have not fully read the judgement or not understood what the court said.

    Reply
  5. AvatarAnonymous

    Smaran

    This is first anon. Let me paraphrase and reply you accordingly.

    “I have no problems with Patent holders exerting their rights against unlawful use by third parties.” — Thanks for clarifying.

    But I do take issue when people in the guise of using patents, also block others forms of use/innovation in that field. Where is the proof that Myriad stopped other forms of innovation? When they have a patent on a gene (As per older consensus in the US) they had every right to stop others from using the knowledge gene sequence location, gene sequence, its phenotype etc. in any which area. That is what patent laws do and specifically product patent do.

    In the case of Myriad, the company was not only attempting to patent the gene, but also the means for testing for such a gene. I really doubt whether you have studied the facts of this case and I also am not sure how you interpret patent laws. Myriad had patent on genes -as per established consensus in the US – any means of testing such genes would infringe these patents. What is wrong in asserting patent rights?

    This creates a monopoly of service in the hands of one company, thereby increasing costs, and decreasing access to testing for women, who already cannot afford such expensive testing. I prefer not to reply to this argument for the debate may take a very different path after this.

    For this very reason, I argue that the intended use of the patent by Myriad was predatory… The early parts of the judgement in Myriad in fact recount some of the concerns I have just raised. The use of patent is always predatory, and its predatory use is always legal – if by predatory you mean preventing others.And I really doubt if you went through the opinion. The SCOTUS has not even for once chided/or criticised Myriad for “predatory” use of patent. And they didn’t have to. Because they only accepted one question to be heard – Are genes patentable? And also, Myriad still can prevent other people from testing BRCA1/2 for diagnosis of cancer. Since, the SCOTUS has maintained that use of such genes may be patentable and they have method claims, use claims over these uses of BRCA1/2.

    I do not see any similarity between Novartis and Myriad – because they really were different. Novartis decision was on incremental innovation not giving any additional effect. In Novartis, the Indian Supreme Court has categorically told that the “Draftsmanship” of patent will not decide patentability. A grave error, in my opinion. SC should have been criticised for giving out such a statement – Lawyers/Legal experts have their bread and butter on draftsmanship skills – same “type” of suits may result in different opinion if questions are raised differently. In the SCOTUS opinion, one can see how SCOTUS is not happy with the way claims are drafted. They may be lamenting the lack of draftsmanship skills. Indian SC may have lots of thing to learn from US SC.

    Cheers

    Reply

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