INDIA Trends and Developments Contributed by: Pravin Anand, Vaishali Mittal and Gursimran Singh Narula, Anand and Anand
The pre-grant opponent had argued that Formula V had already been disclosed in prior art, and that the application was therefore barred under Section 3 (d) of the Patents Act for being mere use of a known pro ‑ cess. The Court rejected this contention, observing that the cited prior art did not disclose any method for lyophilising the therapeutic peptibody of Formula V. Instead, the prior art only described the composition, not the lyophilisation method itself. The Court further dismissed the objections under Sec ‑ tion 3 (e) and for insufficient disclosure. It noted that the objective of the claimed invention was to enhance the stability of the therapeutic peptibody through lyophilisation, whereas the cited prior art focused on increasing the protein concentration via lyophilisation. Therefore, for establishing synergistic effect, it was sufficient for the applicant to demonstrate interaction between the ingredients, and there was no require ‑ ment to furnish data showing pre-lyophilisation and post-lyophilisation. In Novo Nordisk AS v Dr Reddy’s Laboratories Lim- ited and Another , the Delhi High Court declined the plaintiff’s application to restrain the defendants from the manufacturing of Semaglutide in India. Novo Nor ‑ disk had alleged infringement of its patent concerning GLP-1 analogues used for treatment of Type 2 dia ‑ betes and obesity. The suit patent claimed the com ‑ pound Semaglutide, which is widely marketed under the brand names Ozempic, Wegovy and Rybelsus. The defendants challenged the validity of the suit patent and invoked the Gillette defence on infringe ‑ ment. At the interim stage, the burden rested on the defendants to demonstrate a “credible challenge” to the patent’s validity. The defendants argued that the Semaglutide compound as claimed in the suit pat ‑ ent lacked novelty for being prior claimed/disclosed in the genus patent. Specifically, example 61 of the genus patent referred to an Alanine (Ala) version of the Semaglutide compound and that the only distinc ‑ tion between example 61 and the suit patent was the substitution of “Ala” with “Aib” at the eighth position. The Court observed that independent claim 1 of the genus patent broadly claimed a GLP-1 analogue com ‑ prising an amino acid sequence that could be select ‑
ed from a broader group containing “Ala”, “Gly” “Val”, “Leu”, “11e”, “Lys”, “Aib”, etc. Further, in claim 16 of the genus patent, the patentee specifically identified “Aib” as the preferred amino acid at the eighth posi ‑ tion. In light of this, the Court held that, for a person skilled in the art (in the present case, a “person in the know”, since inventors of the genus patent and the species patent were common), substituting “Ala” with “Aib” at the eighth position would be obvious. The Court also noted contradictions in the plaintiff’s position, noting that, while it claimed that no thera ‑ peutic drug was developed from the genus patent, in its statement of working (ie, Form 27) it nevertheless declared that the genus patent had been commercially worked, and filed common declarations with that of the species patent. It needs to be emphasised that the defendants had already given an undertaking to not sell Semaglutide in India till the expiry of the suit patent. However, the defendants had sought to continue manufacturing for exportation to jurisdictions where the plaintiff held no patent rights over Semaglutide. The Court noted that, though there was a prima facie credible challenge to the patent’s validity, it would not release the defend ‑ ants from their undertaking to not sell in India. This was because the defendants had failed to “clear the way” before commencing manufacture, reflecting pro ‑ cedural mala fides. Patentability of diagnostic methods under Section 3 (i) of the Patents Act In a series of decisions, the Delhi High Court has clari ‑ fied the scope of ineligible subject matter relating to diagnostic methods under Section 3 (i) of the Patents Act. In Natera Inc v Assistant Controller of Patents , the invention related to a non-invasive, in vitro method to detect and monitor genetic mutations associated with lung squamous cell carcinoma, using blood samples. The Court held that the claims were ineligible for grant under Section 3 (i) of the Patents Act. It was held that Section 3 (i) applies where the claimed process con ‑ cerns diagnostic or therapeutic purposes, especially the activities that lie at the core of a medical practi ‑ tioner’s training. At the same time, the Court clarified
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