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- Apple v. Squires: USPTO Director Has Unlimited Discretion on IPR Institution
- The Ghost in the Machine: Why GenAI Can Be Both a Brilliant Researcher and a Terrible Advocate
- Bayer Files Suit Against Trio of COVID-19 Vaccine Makers
- Allen v. Cooper (4th Cir. 2026)
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Category: Enablement
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By Andrew Williams — When is it undue experimentation in practicing the full scope of a claim that contains a genus of chemical compounds and a functional limitation of activity, when the specification provides a method to assess the claimed functional activity (and it can be routinely performed by one skilled in the art)? The…
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By Kevin E. Noonan — Whether ANDA litigation has had a positive or negative impact on generic drug availability is an open question, in view of several recent reports looking at the effects such litigation has had on both branded and generic drugs over the past thirty years. Indeed, the current squabble over "reverse payment"…
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By Donald Zuhn — Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories. For 2012, we identified fifteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners…
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By Andrew Williams — In a sequel of sorts to the hugely popular Streck, Inc. v. Research & Diagnostic Systems, Inc. (Fed. Cir. 2011), the Federal Circuit released Streck II (Streck, Inc. v. Research & Diagnostic Systems, Inc. (Fed. Cir. 2012)) earlier this month. Not to be upstaged by the original, this ambitious follow-up leaves…
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By Kevin E. Noonan — On the same day the Federal Circuit rendered its opinion in AMP v. USPTO (the Myriad case), the Court also handed down its opinion in Eli Lilly & Co. v. Activis Elizabeth LLC. In an opinion by Judge Newman, joined by Judge Lourie (Judge Friedman was on the panel, but…
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By Kevin E. Noonan — Today the Federal Circuit reversed a priority determination in an interference over claims to human beta-interferon, in an opinion teeming with irony, déjà vu, anachronism, and the peculiar effects on outcome caused by the form of interference counts. Two interferences, Nos. 105,334 and 105,337 between Junior Party David Goeddel and…
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By Kevin E. Noonan — The old proverb "success has many fathers, while failure is an orphan" comes to mind when considering the Federal Circuit's decision in Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc. In the Court's decision, repeated failures, even by Lilly scientists in developing its osteoporosis drug Evista® (raloxifene hydrochloride), were…
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By Andrew Williams — Last week, in ALZA Corp. v. Andrx Pharms., LLC, the Federal Circuit affirmed the U.S. District Court for the District of Delaware's decision that ALZA's patent related to treating Attention Deficit and Hyperactivity Disorder ("ADHD") was invalid for lack of enablement. ALZA markets the drug Concerta® for the treatment of…
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By Donald Zuhn — Last week, a divided panel of the Federal Circuit affirmed a determination by the District Court for the District of Delaware that the claims of U.S. Patent No. 4,663,318 were invalid for lack of enablement. The '318 patent, which issued on May 5, 1987 from U.S. Application No. 06/819,141, is…
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By Donald Zuhn — Last Friday, the Federal Circuit affirmed the determination by the District Court for the District of Delaware that U.S. Patent No. 5,236,940 does not qualify as an enabling prior art reference, and therefore, does not anticipate claims 1-5 of U.S. Patent No. 5,527,814. The ‘814 patent, which is owned…
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