Life Sciences and Pharma IP 2026

INDIA Trends and Developments Contributed by: Pravin Anand, Vaishali Mittal and Gursimran Singh Narula, Anand and Anand

Sufficient disclosure requirement In The Regents of the University of California v The Controller of Patents , the Court examined the suf ‑ ficiency of disclosure requirement in a patent appli ‑ cation relating to a vaccine composition designed to induce an immune response to salmonella. The claims covered both the genetically modified salmonella strains and the vaccine composition itself. The Court noted that the inventive contribution lay in the deliberate introduction of mutations such as insertions, deletions and substitutions at gene sites to attenuate virulence. However, the complete specifica ‑ tion disclosed only deletion mutations, and provided no sufficient disclosure regarding insertion and sub ‑ station mutations. This omission was held to violate the mandatory requirement of sufficient disclosure under Section 1 (3)(1). The Court further held that, since the recombinant sal ‑ monella claimed in the subject patent application was a modified bacteria which would not be accessible to the public, it was also liable to be deposited in the rec ‑ ognised depository, according to the Budapest Treaty referred to in Section 10 (4)(d)(ii) of the Patents Act. Judgment on admissions In GSP Crop Science Limited v BR Agrotech Limited and Another , the suit concerned a specific formulation of two agrochemical ingredients, namely Pyriproxyfen and Diafehthiuron, which was commercialised by the plaintiffs in their insecticides, named SLR 525. The defendants used an identical formulation and admit ‑ ted that they marketed and sold the product, believ ‑ ing that their regulatory licence protected them. This admission was recorded in their affidavit. The Court decided the suit using its powers under Order XII Rule 6 of the Code of Civil Procedure, based on “admissions of fact” made by the defendant. The Court noted that, in light of admissions, it was impos ‑ sible for the defendant to succeed, and despite suf ‑ ficient opportunity it could not provide any explanation as to why such a decision should not be made. The Court mapped the patent in question to the ingredi ‑ ents of the defendant’s product and held them liable for infringing actions. In light of the sales carried out

that such exclusion does not extend to patent applica ‑ tions concerning medical or surgical devices. In EMD Millipore Corporation v Assistant Control- ler of Patents , the Court rejected the Patent Office’s objection under Section 3 (i). The invention related to an improved method for quantitative analysis of biomolecules using infrared spectroscopy, where pre ‑ viously generated calibration data reused by refining the curve generation methodology through algorith ‑ mic and spectral adjustments is patentable. The Court held that, while the interpretation of a diagnostic curve cannot itself be patented, the present invention con ‑ cerned a novel method of conducting the quantisation of biomolecules in a new form of infrared spectros ‑ copy, which had a bearing on improving the efficiency and reliability of quantitative analysis by reducing cali ‑ bration time. It therefore was not hit by Section 3 (i). On similar lines, in Sequenom Inc v Assistant Control- ler of Patents the Court refused a patent application concerning an in vitro method for determining pres ‑ ence of fetal aneuploidy. The Court noted that Sec ‑ tion 3 (i) does not differentiate between non-invasive prenatal testing and diagnostic testing. It was also held that a positive or negative for both tests would In Astellas Pharma Inc and Another v Everest Pharma- ceuticals Limited and Others , the High Court granted an ex parte injunction against the defendants for ille ‑ gally selling the patented compound Gilternib in India. The modus operendi involved manufacturing the drug in Bangladesh and illegally bringing it into the Indian market, including selling it through e-commerce web ‑ sites. The Court restrained the defendants and their agents from dealing with these products, and issued directions to the e-commerce website to delist and remove the infringing web links. In Astrazeneca Ab and Another v Glarea Healthcare LLP and Others , the High Court granted an ex parte ad interim injunction to the plaintiffs for their patented compound Osimertinib, used for treatment of non- small cell lung cancer (NSCLC). The Court restrained the defendants and their agents involved in unauthor ‑ ised manufacture and sale of the drug in India. be covered under the provision. Ex parte ad interim injunctions

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