Category Archives: Written Description

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Federal Circuit Questions Written Description For Antibody Claims

The October 5, 2017 Federal Circuit decision in Amgen Inc. v. Sanofi is getting a lot of attention for its commercial impact, because the court vacated the permanent injunction that prevented Sanofi and Regeneron from marketing their cholesterol-lowering Praluent® (alirocumab) product, which will compete with Amgen’s Repatha® (evolocumab) product. But the decision also addresses several … Continue reading this entry

Inherent Disclosure Supports Priority Claim

In Yeda Research and Development Co. v. Abbott GmbH and Co., the Federal Circuit invoked the doctrine of inherent disclosure to uphold a priority claim to a German priority application that only partly described the claimed protein. Although the patent owner prevailed in this case, the fact pattern underscores the importance of including a robust disclosure in … Continue reading this entry

PTAB Institutes Post Grant Review Against Chemical Process Patent

The USPTO Patent Trial and Appeal Board has instituted Post Grant Review (PGR) proceedings against a patent directed to a process for treating contaminated media. The petition for PGR challenged that patent on written description, enablement, prior art and eligibility grounds, but the PTAB instituted proceedings only as to written description. This case provides an interesting glimpse into … Continue reading this entry

Federal Circuit Holds That Even Functional Claims Require Structural Fence Posts

In AbbVie Deutschland Gmbh v. Janssen Biotech, Inc., the Federal Circuit affirmed the district court decision that found AbbVie’s patents directed to anti-IL-12 antibodies invalid for lack of adequate written description. As between the parties, this decision leaves Centocor free to market its Stelara® product for the treatment of psoriasis. More generally, this decision emphasizes the … Continue reading this entry

Federal Circuit Finds Easy Solution To Avodart Solvate Written Description Question

Are claims that recite a “solvate” of a chemical compound invalid for lack of written description if the patent does not describe any specific solvates? In GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., the Federal Circuit said No, and upheld the district court’s determination that the defendants had not proven that the claims were invalid.… Continue reading this entry

Takeda Prevacid SoluTab Patent Valid, But Not Infringed

In Takeda Pharmaceutical Company Ltd. v. Zydus Pharmaceuticals USA, Inc., the Federal Circuit reversed the district court’s finding that Zydus’s proposed generic product infringed Takeda’s Prevacid® SoluTab™ patent, but agreed with the district court that Zydus had failed to prove that the patent is invalid. However, the Federal Circuit also explained that it would have … Continue reading this entry

Federal Circuit Upholds Lyrica Patents

In a non-precedential decision issued February 6, 2014, the Federal Circuit affirmed a district court decision that upheld the four Orange Book listed patents for Pfizer’s Lyrica® product. According to the court’s rules, the non-precedential designation of Pfizer Inc. v. Teva Pharmaceuticals USA, Inc. means that the panel determined that it did not add significantly to … Continue reading this entry

Federal Circuit Affirms Board Finding That Exclusion Of Genus Does Not Provide Written Description For Exclusion Of Species

In In Re Bimeda Research & Development Ltd., the Federal Circuit upheld the decision of the USPTO Patent Trial and Appeal Board (PTAB) that found that a claim that excluded the presence of a specific compound was not supported by a description that excluded a genus of compounds. This case illustrates the challenges of establishing written … Continue reading this entry

Federal Circuit Finds No Written Description Support For Novozymes Amylase Patent

In Novozymes A/S v. DuPont Nutrition Biosciences APS, the Federal Circuit determined that the Novozymes amylase patent at issue did not satisfy the written description requirement of 35 USC § 112, because the disclosure did not demonstrate possession of the claimed subject matter as a whole. While the opinion states that the decision is consistent … Continue reading this entry

A Tale of Two Antibodies (Centocor Part II)

As I wrote last week, the Federal Circuit held in Centocor Ortho Biotech, Inc. v. Abbott Laboratories, that the human antibody claims that Centocor had asserted against Abbott’s Humira® product are invalid for failing to satisfy the written description requirement of 35 USC § 112. The holding is getting lots of attention because it will negate a … Continue reading this entry

The Written Description Requirement for Antibodies (Centocor Part I)

Yesterday, in Centocor Ortho Biotech, Inc. v. Abbott Laboratories, the Federal Circuit held that the human antibody claims that Centocor had asserted against Abbott’s Humira® product (claims 2, 3, 14 and 15 of U.S. 7,070,775) are invalid for failing to satisfy the written description requirement of 35 USC § 112. (This decision will negate a $1.67 billion damages … Continue reading this entry

Written Description: When Too Much Is Not Enough

In Goeddel v. Sugano, the Federal Circuit determined that a priority application that disclosed the gene encoding a full-length “precursor” protein did not constitute constructive reduction to practice of interference counts that focused on the “mature” protein. This decision is an important reminder that a disclosure that might be effective to render a claim obvious … Continue reading this entry