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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

Amgen Inc. v. Sanofi: U.S. Supreme Court Addresses Enablement for Biotechnology Inventions

I’m a bit behind and therefore am not part of the slew of commentary that flowed from the Supreme Court’s decision in Amgen Inc. v. Sanofi, 143 S. Ct. 1243, 1248 (2023), addressing Amgen’s claims to “antibodies that (1) bind...more

U.S. Supreme Court to Decide on Enablement Standard for Biotech Antibody Patents in Amgen v. Sanofi

In 2021, the Federal Circuit determined that Amgen’s biotech antibody patents lack enablement, i.e., the specification did not teach one of ordinary skill in the art how to make and use the invention without undue...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 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

IBSA v. Teva: Indefinite Scope of Key Term in Patent Description Rendered a Thyroid Medication Patent Invalid Under Section 112

In a recent decision, the Federal Circuit affirmed Delaware District Court’s finding of invalidity based on failure to define the scope of the invention and to meet the written description requirements of 35 USC § 112. IBSA...more

Verdict in T-Cell Immunotherapy IP Case Tests 'Reasonable Royalty' Concept for Large Damage Awards [Audio]

One of the most interesting and promising areas of medical research today involves the use of T-Cell therapies, which offer hope and promise as a new approach to cancer treatment. It has also made for a robust climate for...more

Federal Circuit Ruling in Patent Case Expands 'Obviousness' Doctrine

The Federal Circuit held that a prima facie case of obviousness can be established by prior art ranges for solutions of structurally and functionally similar compounds that overlap with a claimed range in Valeant...more

Patent Office Issues New Guidance for Antibody Written Description Requirements

Since 1999, the United States Patent and Trademark Office (“Patent Office”) has permitted the claiming of antibodies by disclosing the targeted antigen. In 2002, the Federal Circuit adopted Patent Office guidelines and...more

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