AMP’s argument is that granting patents on these genes to one company would restrict cancer research as well as hamper diagnosis of cancer in patients as it would restrict genetic testing for these genes to one company.
Patents on genetic material have been controversial in the past as well. In March last year, the US Supreme Court had ruled in the Mayo vs Prometheus case, that the latter could not patent a diagnostic test based on the discovery that there was a correlation between blood levels of particular chemicals to drug dosage. (See editorial on the case at this link: http://pharma.financialexpress.com/20120415/editorial01.shtml) Though the Prometheus case is not directly linked to the Myriad Genetics case, it revealed the fine tuning of legal doctrine and a certain line of reasoning being pursued in such cases.
Blogging on SpicyIP, on the AMP vs Myriad case, Samantak Ghosh narrates how one judge observed that “patent law is filled with uneasy compromises.” The blog post goes on to highlight how the Justices were concerned about the “substantial arguments” that patents may be necessary to incentivise private investment in the discovery of DNA sequences and tried to figure out whether alternative forms of incentives such as recognition, process patents on uses of DNA, and patents on primers and probes, could sufficiently inspire potential investors.The final judgment on the patent-eligibility of the BRCA1 and BRCA2 genes, expected in June, will be closely watched as it will have huge implications for the patenting of biological material and its applications.
As legal minds bend their considerable intellect to understand the technicalities of the subject under debate, they are fully conscious of the weight of their decisions, on future policies as well as research and industry.
The burden is double as they may have to deviate from, and even reverse, previous judgments of their peers. For instance, patents on around 2000 isolated human genes had already been granted in the US before the AMP vs Myriad Genetics case came up but on April 15, the Justices heard and debated all the oral arguments afresh. In India, three patents were revoked last year: Sutent, Pfizer’s cancer drug; Pegasus, Roche’s hepatitis C treatment and the patent on the aerosol formulation of Merck’s anti-asthma drug; these are still under appeal.
One of the US Justices at the April 15 hearing sportingly joked about the lack of his scientific expertise, and it is true that most judges face this handicap, especially when it comes to chemical structures and complex genetics. External experts can be called in to support or argue the technical merits of a case but what happens when the legal infrastructure itself is perceived to be weak ?
For instance, the Intellectual Property Appellate Board’s (IPAB) recently released annual report for 2012-13 shows that while it has disposed off a record number of cases this year, it is still facing a shortage of legal personnel, insufficient funds and infrastructure as well as a lack of clarity on certain procedures to be followed.
The IPAB is concerned that these constraints will impact ‘the quality of justice’, with the annual report pointing out that “the orders of the IPAB, especially in pharmaceutical patents, attract notice the world over and the quality of the justice delivery system in the IPAB will depend on the strength of the infrastructure.”
There is no doubt that the legal system in India is not the only one wrestling with the burden of balancing profits with public good. But all their efforts may be in vain if the judgments are perceived to be compromised due to these handicaps and cannot stand up to global scrutiny.
Post the April 1 SC judgment on Glivec decision, Ranjit Shahani, Vice Chairman and Managing Director, Novartis India had commented that in India it was ever-greening, but ever-delaying of patents, alluding to the long drawn out legal process. It is high time the legal infrastructure in the country is shored up so that there is no slur on the quality of the judgments or the delivery system.
Viveka Roychowdhury
Editor