Patent clearance for
pharma innovators in
India and the US

Wyeth's patent claimed any covalently-binding EGFR inhibitor at any calculated dose, but only disclosed in-vitro data for three compounds and dosage ranges that would poison patients at the levels the patent's own numbers implied. The Federal Circuit affirmed that this is not enablement, wiping out a $107.5 million jury verdict.

The Delhi High Court set aside the refusal of a sugammadex process patent because India's Patent Office skipped a hearing the Patents Act guarantees separately from a pre-grant opposition, and flagged, without deciding, that the obviousness rejection stacked four prior-art documents without saying why a chemist would combine them.

Actelion sued Mylan over its generic Veletri (epoprostenol), arguing pH should be measured at the solution's cold manufacturing temperature rather than standard lab conditions. The Federal Circuit disagreed, and Actelion lost its equivalents fallback on two separate, independent grounds tracing back to its own patent drafting choices.

The Federal Circuit affirmed that a patent claiming a reaction "at a pH between 7.0 and 9.0" requires that pH be maintained for the entire reaction step, not just touched briefly -- so Vifor's manufacturing process staying in range 90 percent of the time was, under that reading, still zero percent infringement.

The Federal Circuit affirmed that Exelixis's patents on crystalline cabozantinib (L)-malate, the active ingredient in the cancer drug Cabometyx, adequately describe an entire genus of crystalline salt forms even though the specification names only two of them by name. MSN Laboratories built its own, separately patented crystal form to work around the disclosed ones, conceded that its product still infringed, and lost its remaining argument: that the patent never really described what it was claiming.

The Federal Circuit wiped out a 41.8 million dollar verdict against the makers of Enhertu because Seagen's original 2004 patent filing never actually disclosed a working example of the exact linker chemistry it later tried to claim, only the ingredients that could theoretically build it.

A Federal Circuit ruling this year invalidated Enanta's coronavirus protease inhibitor patent because its 2020 provisional application described a substituent as a two-to-twelve-carbon range, while Pfizer's real Paxlovid compound uses a one-carbon version at that exact position.

Weeks after courts kept striking down broad antibody genus patents following the Supreme Court's Amgen v. Sanofi decision, the Federal Circuit went the other way for Teva's headache antibody patents against Eli Lilly's Emgality, and the difference comes down to exactly what was being claimed.

The Indian Patent Office rejected AbbVie's foundational patent application for venetoclax (Venclexta/Venclyxto), the Bcl-2 inhibitor behind a multi-billion-dollar leukemia franchise, after seven pre-grant oppositions spanning 2018 to 2025. The Deputy Controller found that a Markush genus claim covering thousands of sulfonamide compounds was backed by real inhibition data for only a handful of them, a chemistry problem, not a technicality, that also sank the claim under Section 3(d) and for insufficient disclosure.

A May 2026 Delhi High Court ruling on a fungicide crystal polymorph tested whether Section 3(d)'s efficacy standard, the same rule that decided the Glivec case, should apply the same way outside medicine. The court's answer keeps the pharma-specific bar exactly where Novartis left it.

After four pre-grant oppositions and fifteen years of prosecution, the Indian Patent Office granted Novartis and Astex a patent on ribociclib (Kisqali), a breast-cancer drug, and the chemistry arguments on both sides are worth examining honestly, not just the outcome.

The Controller rejected Array BioPharma's triple-drug combination on three separate grounds in one order — obviousness, Section 3(d), and method-of-treatment. The Delhi High Court set aside all three, not because the underlying law was wrong, but because the order never showed its work.

The Delhi High Court upheld the Patent Offices rejection of Intra Cellular Therapies patent application for deuterated variants of its own genus-patented compound family, holding that coverage under a Markush claim can anticipate a later species claim even where the genus patent never specifically discloses that exact compound. The Court separately rejected the applicants Section 3(d) evidence, finding that improved bioavailability in animal data did not by itself establish enhanced therapeutic efficacy over the known non-deuterated compound.