This afternoon, a Supreme Court bench consisting of Justices Aftab Alam and RM Lodha dismissed the Special Leave Petition (SLP) filed by Bayer in the patent linkage matter.It’s a huge surprise that this matter reached the Supreme Court at all, when the point of law (whether or not Indian law permits patent linkage) seemed as crystal clear as Swarovski’s elegant offerings. Indian law simply does not permit patent linkage i.e. the DCGI does not have the legal or institutional competence to assess whether or not an application for drug approval implicates an existing patent. The DCGI’s job is simply to approve only those drugs that are safe and efficacious.
However, as I’ve argued elsewhere earlier, the DCGI needs to foster more transparency and ensure that its website list out all drug applications, so that patentees can monitor and sue in a court of law, where they apprehend that a drug (corresponding to a filed application), will, if introduced in the market, violate their patent rights.
But the legal dispute is far from over. Bayer also sued Cipla for patent infringement and Justice Bhat strategically ensured that both parties consented to a quick trial rather than wasting their time at the interim phase: a phase that will soon become a thing of the past for complicated patent matters.
ps: image from here
Well, this is a very good news for me on the professional level, as no patent-linkage is one of our main defenses in patent infringement suit. On the personal level, I would not like to see big pharma companies threatening Indian generic manufacturers into submission.
This matter was just a waste of the Supreme Court’s precious time. The High Court learned Single judge did not mince his words while pronouncing his judgment last year.
Patent linkage is known to be against the interests of public health, because it would delay the introduction of cheap generic drugs on the market and keep medicines out of reach of those who need it.