INDIA Trends and Developments Contributed by: Pravin Anand, Vaishali Mittal and Gursimran Singh Narula, Anand and Anand
Delay in ministerial act of uploading the order cannot permit wrongful acceptance of a pre-grant opposition against the patentee In Vertex Pharmaceuticals v Controller General of Patents , a single judge of the High Court effectively dismissed a pre-grant opposition that was filed by an opponent on the same date as that of a grant order. The Court held that the patent was granted on 28 November 2023, and before the signing of said order no pre-grant opposition was filed by an opponent. It was held that, after signing of the order, the Con ‑ troller had become functus officio and thus was no longer seized of the patent application. Hence, a pat ‑ ent application filed after the point of signing the order cannot be considered, even if it was filed on the same date and the patent certificate was uploaded at a later date. Quia timet injunctions In Helsinn Healthcare SA v AET Laboratories Private Limited and Another , a single judge of the High Court denied granting a quia timet injunction to the plaintiff. The Court noted that there was absence of credible apprehension against the defendants for launching the alleged drug covered by the patent. The single judge held that mere filing of post-grant opposition by the defendant itself and business discussion for devel ‑ oping the products for the foreign market cannot be said to be apprehension of an imminent threat. It was clarified that, before commercial launch, a party has to conduct clinical trials and testing and obtain regula ‑ tory approval – no such approvals had been obtained by the defendants. Moreover, the defendants’ mar ‑ keting material only showed that the impugned prod ‑ ucts were “under development” drugs. The Court also noted that both defendants were located outside the jurisdiction of the Court and none of them had any offices in Delhi. The Court further noted that mere accessibility of the defendant’s website would not amount to specific targeting of customers in Delhi, and no jurisdiction was made out. Coverage v disclosure For several years, Indian courts have grappled with the question of whether coverage of a compound in a genus patent would ipso facto invalidate the specifi ‑ cally disclosed compound in the species patent. In F Hoffman-La Roche AG and Another v Natco Pharma
Limited , the Division of the Delhi High Court clarified the law surrounding this question. The Court rejected the view that mere coverage of the claimed compound amounts to disclosure of the claim in the species pat ‑ ent, unless the genus contains requisite teaching for a person skilled in the art. Instead, the bench took the view that coverage is relevant for deciding infringe ‑ ment and disclosure is relevant for deciding (ena ‑ bling disclosure) invalidity. Therefore, if the defend ‑ ant’s product falls within the broad coverage of the Markush, said entity would be liable for infringement. “Person in the know” test for determining obviousness A Division Bench in AstraZeneca v Intas Pharmaceu- ticals Ltd (2013) had earlier devised a new test: where the inventors of the genus patent and the species patent were the same, the aspect of obviousness in such case has to be assessed from the perspective of the inventor, who would be the “person in the know”. Therefore, in the case of genus and species patents, if a species was obvious to a person skilled in the art from the genus patent, such species would be more obvious to the person in the know. The Division Bench has upheld the application of this test in F Hoffman-La Roche AG and Another v Natco Pharma Limited . It was held that the inventor cannot be permitted to keep the invention out of the public domain whereby the modification would be obvious to a person in the know. The Court has lent its rea ‑ soning for preventing evergreening of the invention. The decision primarily appears to have been made to ensure that drugs for treating spinal muscular atro ‑ phy are widely accessible to the public at large. The decision leaves more questions than answers, and the Patents Act lacks any support for the new “person in the know” test. Assessment of therapeutic efficacy In Tapas Chatterjee v Assistant Controller of Patents and Another , the Division Bench of the Delhi High Court clarified the scope of the “efficacy requirement” under Section 3 (d) of the Patents Act. It was noted that, for application of Section 3 (d), the first condition is that there must be a “known process” forming the subject matter of the patent. Said provision would also
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