To Beat China at Drug Innovation, Big Pharma and Generics Need the Supreme Court to End This Patent Absurdity

What’s really holding America back in the biopharma race against China isn’t just Beijing’s subsidies or cheaper labor. It’s the U.S. Court of Appeals for the Federal Circuit’s self-inflicted wound: a court so panel-dependent that no one—brand or generic—knows which rule will apply until the panel is drawn. The Supreme Court can fix this in one stroke by granting certiorari in MSN Pharmaceuticals v. Novartis (No. 25-225) and killing the bizarre “after-arising technology” exception that lets old, vague patents swallow future inventions.

While U.S. companies bleed billions litigating 20-year-old genus claims, Chinese innovators are sprinting ahead in antibody-drug conjugates, bispecific antibodies, cell therapies, and next-generation obesity drugs. They file narrower, better-disclosed patents, face far less evergreening litigation, move faster, and increasingly license their breakthroughs to Western giants desperate to fill patent-cliff holes.

According to the Financial Times, “[t]he data reflects that shift. China’s share of global innovative drug candidates in clinical trials has risen from 8 per cent in 2018 to 30 per cent this year, according to McKinsey. Over the same period, the US share has fallen from 47 per cent to 36 per cent.”

The center of gravity for blockbuster drugs is shifting east, and America’s patent-law roulette is pouring fuel on the fire.

Even Novartis’s own head of IP policy, Corey Salsberg—now president of the Federal Circuit Bar Association—told the Senate in October that the court’s jurisprudence has become “panel-dependent” and “deeply uncertain,” leaving even judges “at a loss.” Yet his company is currently defending the poster-child example of that uncertainty before the Supreme Court.

The Entresto Story: Old Patents Swallowing New Inventions

The Entresto story is almost comic if the stakes weren’t so high. In 2002, Novartis filed a patent on the simple combination of two known molecules, valsartan and sacubitril. Four years and over 1,000 experiments later—experiments its own scientists called a “loooong shot”—Novartis finally made the revolutionary single-molecule complex LCZ696 that became Entresto, an $8-billion-a-year heart-failure drug.

Novartis is now using that 2002 patent, which never taught anyone how to make the complex, to block MSN’s generic. The Federal Circuit let them do it in In re Entresto by labeling the complex “after-arising technology” and declaring it off-limits for testing whether the 2002 claims were actually enabled or adequately described under Section 112. Result: Novartis gets the later invention as a sword for infringement but keeps it shielded when validity is on the line.

Two Incompatible Rules, One Court

The Federal Circuit now openly runs two incompatible doctrines. The Petition and Reply filed by Amit Vora of the Kasowitz law firm for MSN, and the amicus brief filed by Unified Patents detail this important circuit split. Put simply, one line of Federal Circuit cases—typified by Idenix—allows courts to rely on after-arising species to show that a broad genus claim was never properly supported. Another line—built on In re Hogan and capped by the Entresto decision—says after-arising technology cannot be used that way at all.

Same statute, same question, opposite answers depending on which three judges you draw.

And the panel-dependency problem itself is not theoretical.

On December 2, 2025—literally days ago—the very same court handed down Seagen v. Daiichi Sankyo and reversed a $42 million jury verdict that Seagen had won over the breast-cancer drug Enhertu. The court invalidated Seagen’s claims because a 2004 application describing millions of possible peptide linkers did not provide written description or enablement for the specific Gly/Phe-only tetrapeptide subgenus that Daiichi later discovered and used in Enhertu.

The parallels to MSN are striking. Seagen’s inventors admitted at trial that they first observed the claimed tetrapeptides in Enhertu—meaning they didn’t possess the specific invention when they filed in 2004. The Federal Circuit applied the Idenix approach: broad genus disclosure plus later-arising species equals invalid patent. The panel didn’t even mention Hogan or Entresto, the very cases controlling Novartis’s identical situation.

Same legal issue. Completely different rule. Pure roulette.

This is not about subtle distinctions in technology or claim construction. It’s about a specialized court creating contradictory mini-doctrines that make U.S. patent law unpredictable and litigation outcomes dependent on panel assignment rather than legal principles. Constitutionally, the Federal Circuit violates the mandate to promote the progress of science.

Why Brand Pharma Should Actually Support MSN’s Petition

Brand pharma hates generics, but they hate unpredictability more. Empirical studies show patent owners fully prevail in fewer than 20% of Federal Circuit appeals and lose outright in roughly 70%. But the Supreme Court has not granted certiorari in a single patent case for over 2.5 years. That’s the longest gap in decades.

Brands need to know their own breakthrough won’t be taxed by some ancient, poorly disclosed genus claim, and they need to know their own genus claims will actually be respected when properly disclosed. The current regime delivers neither. Instead, it creates a litigation lottery where billions in R&D investment can evaporate based on which three judges hear your appeal.

Generics, for their part, increasingly own valuable formulation and device patents too. If the Federal Circuit is willing to carve out policy-driven exceptions to Section 112 whenever it dislikes drug prices, those exceptions will eventually be used against generic patents as well.

The smart move for both sides is to demand coherent, predictable rules. That means backing MSN’s petition on the legal question and forcing the Supreme Court to choose between the Idenix line and the Hogan-Entresto line once and for all.

Alignment with the ‘Born Strong’ Patent Agenda

USPTO Director John Squires has made “born strong” patents his organizing principle: patents should leave the Office presumptively valid because they’ve been rigorously examined under Sections 102, 103, and 112. In his October 2025 remarks at the AIPLA Annual Meeting, Squires praised two patents he’d just signed because “they conferred not only something more to be eligible, but also were tested by the fires of sections 102, 103, and 112—and passed.”

His agenda backs those words with policy: AI-assisted prior-art pilots, streamlined examination, and Patent Trial and Appeal Board (PTAB) guidance disfavoring Section 101 grounds when traditional provisions can resolve issues. But that entire project is undermined when the Federal Circuit later lets old, weakly examined genus claims expand indefinitely simply by calling later inventions “after-arising.”

If patents are to be born strong because they’re properly cabined by Section 112 at examination, courts cannot simultaneously allow an after-arising technology carve-out that lets under-disclosed claims dominate new embodiments after issuance. The two approaches are incompatible.

The Supreme Court Has Resolved This Before

The Supreme Court has rejected exactly this kind of overreach for over a century. In The Incandescent Lamp Patent (1895), the Court invalidated a claim to all “carbonized fibrous material” for light-bulb filaments because the patentees had only tried inadequate examples and Edison’s later bamboo filament proved the claim was far too broad. In Amgen v. Sanofi (2023), the Court reaffirmed the principle: if you claim an entire genus, you must enable the full scope—and later-arising species are the best evidence of whether you actually did.

The Federal Circuit’s Hogan-Entresto line contradicts both precedents by immunizing old patents from the very scrutiny the Supreme Court has repeatedly mandated.

A Clean Vehicle for Urgent Action

MSN v. Novartis is the cleanest vehicle imaginable. The question is crisp: May courts consider after-arising technology when assessing Section 112 validity? The split is acknowledged by virtually every stakeholder except Novartis. The economic stakes are massive—$8 billion in annual sales, millions of heart-failure patients, and the competitiveness of the entire U.S. biopharma sector against China.

The Supreme Court usually reverses the Federal Circuit because the specialized court has created patent-specific exceptions that conflict with century-old precedent and undermine predictability. MSN fits that pattern perfectly.

Grant the petition, reverse the Federal Circuit, and restore the timeless rule: patent rights cannot outrun what the inventor actually taught the world. Do it quickly—before the next blockbuster really does come from China because American patent law made it too risky, too slow, and too expensive to develop it here.

Image Source: Deposit Photos
Author: maxkabakov
Image ID: 22591901