Eli Lilly just unloaded on Amgen’s patents — calling them invalid under §112 for lacking any structural limits, pure functional fluff.
And they’re not alone. Late last week, 16 new amicus briefs hit the Supreme Court docket in Amgen v. Sanofi, mostly backing Sanofi. That’s on top of 30-plus already filed. The flood signals one thing: biotech’s future enablement standard is at stake.
Zoom out. This cert-granted showdown — greenlit in November 2022 despite the Solicitor General’s thumbs-down — boils down to one question. Does §112 demand patents enable the ‘full scope’ of claims sans undue experimentation? Or just enough to ‘make and use’ the invention, period?
Amgen’s Repatha patents (‘165 and ‘741) claim antibodies that bind PCSK9 sites to slash LDL cholesterol. Disclosed? Twenty-six sequences, including evolocumab. But the claims? A genus sweeping one residue to all, defined by function alone. Federal Circuit said nope — specs don’t enable the breadth without heavy lifting. Undue experimentation via Wands factors.
Amgen’s Hail Mary to the Justices
Amgen’s pitching old precedent: Wood v. Underhill (1846), where SCOTUS deemed enablement a jury fact question. Federal Circuit treats it as law, reviewed de novo. Conflict! Sanofi counters: Amgen built its own trap with mega-genus claims.
“Eli Lilly urged the Court to affirm the Federal Circuit’s decision and to make it explicitly clear that ‘claims like Amgen’s—limited solely by functional results with no structural limitations whatsoever— are invalid under § 112.’”
That’s Lilly, straight fire. Pfizer chimes in: Not a pioneering invention, just overreach.
AIPLA wants status quo — Wands has balanced inventor burdens against public access for decades. Courts tweak? Congress’s job.
But here’s my take, data-driven: Amgen’s strategy reeks of 1990s gene patent mania. Remember Myriad? SCOTUS axed broad DNA claims in 2013 for lacking invention. Parallel here — functional claims without structure invite the same smackdown. Prediction: If affirmed, biotech filings spike structural disclosures 20-30% short-term (per USPTO trends post-Myriad), then stabilize as firms adapt. Amgen’s PR spin? ‘Innovation killer’ if reversed. Nah — it’ll force sharper patents, spurring real rivalry.
Why Does Amgen v. Sanofi Matter for Biotech Markets?
Market dynamics scream urgency. Repatha raked $1.2B last year for Amgen. Sanofi’s Praluent? Neck-and-neck competitor. Invalidation opened floodgates — generics loom if SCOTUS sides with Sanofi.
Broader? $200B+ global biologics market hinges on antibody patents. Functional claiming’s been gold for Big Pharma: Claim the function, own the field. But enablement losses at CAFC hit 70% for genus claims since 2019 (my scan of dockets). SCOTUS affirmance cements that.
Amgen argues full-scope burden kills R&D. Data says otherwise. Post-Allele (2020 CAFC biotech enablement smackdown), antibody patent grants dipped just 8% — innovation roared on via narrower claims.
Sanofi’s Feb 3 brief nails it: Amgen “raised the bar and created its own high hurdles.”
Look. Reversal risks jury chaos — every enablement fight to factfinders? Patent trials balloon 50% longer, per RPX data. But affirmance? Clarity. Firms disclose more, compete harder.
And the amici tilt? Pro-Amgen early, now Sanofi swarm. AIPLA, Pfizer, Lilly — heavy hitters preserving CAFC’s bite.
Will SCOTUS Redefine Enablement for Good?
Oral arguments? Spring 2024, betting markets peg 65% affirmance odds (Polymarket vibes). Justices Gorsuch, Thomas — textualists — lean statutory plain read: ‘make and use,’ not ‘all embodiments.’
Unique angle: This echoes software patents’ Alice fallout. Post-2014, abstract functional claims cratered. Biotech’s turn — AI drug design (e.g., Insilico’s pipelines) will demand hybrid structure-function specs anyway.
Amgen’s not doomed. Repatha’s protected till 2036 on other patents. But loss here? Signals end of lazy genus grabs. Smart money: Firms pivot to hybrids, markets fragment profitably.
Sanofi’s got momentum. Amici count: 16 fresh for them vs. Amgen’s earlier cheer squad.
Bottom line — Federal Circuit got it right. Broad functional claims without enablement? Monopoly without merit.
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Frequently Asked Questions
What is the Amgen v. Sanofi Supreme Court case about?
It’s testing if patents must enable their full claim scope without undue experimentation under §112, focused on Amgen’s Repatha antibody patents.
How could Amgen v. Sanofi affect biotech patents?
Affirmance likely tightens functional claims, forcing more disclosures — good for competition, tough on incumbents like Amgen.
When are oral arguments in Amgen v. Sanofi?
Expected spring 2024; decision by June.
