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Claims Specifying a “Therapeutically Effective” Dose Have No Additional Efficacy or Safety Limitations

In United Therapeutics Corporation v. Liquidia Technologies, Inc., the U.S. Court of Appeals for the Federal Circuit held that a claim to a method of treatment for pulmonary hypertension was not invalid for lack of enablement...more

Federal Circuit Imposes Heightened Standard for Written Description Support of Negative Claim Limitations

In Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc., the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) held patent claims invalid for lack of written description where a negative limitation was...more

Examples in Specification Did Not Provide Written Description Support for Bounded or Closed Ranges

Examples in Specification Did Not Provide Written Description Support for Bounded or Closed Ranges - The Federal Circuit Court of Appeals affirmed the Patent Trial and Appeal Board's determination that a patent...more

Patent Trial and Appeal Board Determination of "Reasonable Expectation of Success" Must Be Supported by Substantial Evidence

The Federal Circuit Court of Appeals reversed a decision of the U.S. Patent Trial and Appeal Board (“Board”), finding a patent on a method of disinfection obvious. The reversal was based in part on a finding that the Board’s...more

Federal Circuit Court of Appeals Reverses $1.2 Billion Verdict in Juno v. Kite Pharma, Invalidating Genus Claims to a Three-Part...

Functional claims took another hit at the Federal Circuit Court of Appeals. The patent at issue broadly claimed a three-part chimeric antigen receptor including all scFvs that bind to any target. The Court found written...more

Federal Appeals Court Hears Arguments on CAR T-Cell Therapy Patent Dispute [Audio]

T-Cell Therapies offer enormous promise in the development of novel approaches to treating cancer. A federal appeals court recently heard arguments in a patent dispute between two companies that have emerged as leaders in...more

Federal Circuit Denial of En Banc Rehearing in Amgen v. Sanofi Prompts New Considerations in Genus Claims

Based on the denial of rehearing and the Amgen v. Sanofi decision itself, inventors should: Claim as many separate species as possible. Attempt to fashion genus claims that have a limited number of members supported...more

Important 2020 Patent Law Decisions from the Court of Appeals for the Federal Circuit

Whether you are pursuing patents on your new technology, thinking about bringing patent infringement litigation or defending patent infringement claims in court, knowing the important developments in patent law will help you...more

Claiming a New Manufacturing Method Cannot Impart Novelty to Composition or Method of Treatment Claims

In Biogen MA, Inc. v. EMD Serono, Inc., the Court of Appeals for the Federal Circuit has reconfirmed, and to an extent clarified, that an existing product and known method of treatment using that product are not patentable...more

Specification References to Publicly Available Databases or Deposits Can Satisfy the Written Description Requirement for a...

In Immunex Corp. v. Sandoz, Inc. No. 20-1037 (July 1, 2020), the Federal Circuit Court of Appeals addressed whether references to publicly available databases or deposits could provide adequate written description support for...more

Prevent Your Licensee From Instituting Inter Partes Review with a Forum Selection Clause

Courts have a general policy prohibiting licensees from challenging patent validity (even though the licensee may have voluntarily agreed to forego challenges as a part of the negotiation). In Lear, Inc. v. Atkins, the...more

Patent Infringement Claims Simply Require Alleging Facts Stating a Plausible Claim

The United States Court of Appeals for the Federal Circuit (“Federal Circuit”) addressed the pleading standards for direct infringement, doctrine of equivalents infringement, indirect infringement and willful infringement in...more

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