1. On Natco’s principal challenge to the validity of the IN’161: The Division Bench noted that the present dispute centers around the tension between a ‘genus patent’ and a ‘species patent’, terms not explicitly defined in statutes. ‘Genus patent’ typically refers to broad patents covering multiple compounds with a shared core and inventive concept, commonly seen in pharmaceuticals where it includes molecules with therapeutic value used in formulations. On the other hand, ‘species patent’ refers to specific compounds falling within the broad claims of a ‘genus patent.’
Referring to the ruling in Novartis AG ν. Union of India & Ors., Merck Sharpe & Dohme ν. Glenmark Pharmaceuticals and Astrazeneca AB & Anr. v. Intas Pharmaceuticals Ltd. , the Division Bench noted that when both a genus patent and a species patent are claimed by the patentee, the question arises whether the monopoly granted for the substance can be extended because it’s covered by a patent that expires later.
2. Section 3(d) of the Act: The Division Bench observed that Novartis did not assert any increased therapeutic effectiveness in its patent application. The only additional advantage claimed for ELT-O was “improved solubility and bioavailability.” The Bench reconsidered the interpretation of Section 3(d) based on the Supreme Court’s ruling in Novartis AG ν. Union of India & Ors. It concluded that improved bioavailability doesn’t equate to greater therapeutic efficacy. The Division Bench observed that:
“The assumption that enhanced bioavailability necessarily leads to higher therapeutic efficacy is too broad an assumption. It is desirable to have optimal pharmacokinetic parameters. In cases where a formulation has side effects, a lower bioavailability may be more beneficial.”
Additionally, the Division Bench, citing the decision in Merck Sharpe & Dohme ν. Glenmark Pharmaceuticals, stated that the determination that “Natco didn’t present a credible challenge to the validity of IN’ 176” is incorrect. According to the Division Bench, the question of whether ELT-O was disclosed in IN’ 176 is a disputed issue. Nonetheless, considering that ELT-O wasn’t disclosed in IN’ 176 would be essential to assess its enhanced efficacy compared to compounds disclosed in IN’ 176.
3. Coverage νs. Disclosure: The Division Bench relying on Merck Sharpe & Dohme ν. Glenmark Pharmaceuticals, and Astrazeneca AB & Anr. v. Intas Pharmaceuticals Ltd., stated that it’s important to clarify that a broad claim, known as a Markush claim, covering numerous compounds with a common inventive concept, is acceptable as long as it’s not excessively broad or vague. The disclosure must be interpreted in the context of the invention being patented. Therefore, when an active therapeutic ingredient with therapeutic value is claimed and disclosed, it may be patentable. Protection for such a claim would extend to disclosed substances, as well as those not specifically disclosed but obvious to and/ or anticipated by a person skilled in the art. The gap between coverage and disclosure should only include substances anticipated or obvious to a person skilled in the art, not extending to substances or products neither disclosed nor obvious or anticipated by a person skilled in the art.
Additionally, the Division Bench concurred with Natco’s assertions that the rulings in Merck Sharpe & Dohme ν. Glenmark Pharmaceuticals, and Astrazeneca AB & Anr. v. Intas Pharmaceuticals Ltd. are two sides of the same coin. Natco specifically contended that ELT-O, which was being sold under the brand name “PROMACTATM”, was covered under Claim 1 of US patent 7160870 (US’870). Undisputedly, Claim No.1 of US’870 is Claim No.6 of IN’176. It was contended on behalf of Natco – and not controverted by Novartis – that the predecessor-in-interest of Novartis had applied for a Patent Term Extension (PTE) for US’870 to compensate for the time spent in obtaining regulatory approvals.
In alignment with Natco’s stance, the US Food and Drug Administration (USFDA) had also sent a communication dated February 22, 2011 to the US Patent Office confirming that US’870 (which is the counterpart of IN’176) claims PROMACTATM (Eltromopobag Olamine). Additionally, Novartis provided a “statement regarding the working of patented invention on commercial scale in India” in Form 27 regarding IN’176 and IN’161, indicating that Novartis had implemented the patented inventions commercially in India based on ELT-O.
The Division Bench emphasized that if the complete specifications adhere to Section 10 of the Act and the claim is valid, any compound covered within the claim would be included in the complete specifications. Consequently, a second patent for such a fully covered compound would be susceptible to challenge on grounds of prior claiming [under Section 64(1)(a) of the Act] and lack of novelty [Section 64(1)(e) of the Act] and lack of inventive steps [Section 64(1)(f) of the Act].
In view of the above, the Division Bench held that Natco had indeed met the threshold for presenting a credible challenge to the validity of IN’161. The Court overturned the permanent injunction order issued by the learned Single Judge. Furthermore, the Division bench concluded that delving into other issues was unnecessary, given that the term of IN’161 has expired on May 21, 2023, and there was no need for further judicial orders.
Source: Barandbench
