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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

Unitary Patent System Launching in Europe – Patent Holders May Need to Take Action

Businesses throughout the world holding or planning patents in Europe should familiarize themselves with the new Unitary Patent and Unified Patent Court and – depending on patent protection strategy -- may want to take action...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

Intellectual Property Law: Year in Review 2021

Specification and Prosecution History Narrow the Plain Meaning of “0.001%.” The claim at issue included a concentration of 0.001% of PVP. The term’s plain meaning is 0.001% within one significant figure (i.e., 0.0005% to...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

Federal Circuit Construes the Terms “Antibody” and “Antibody Fragment”

The Federal Circuit issued a decision in Baxalta Inc. v. Genentech, Inc., ___ F.3d __, 2020 WL 5048435 (Fed. Cir. Aug. 27, 2020) construing the terms “antibody” and “antibody fragment.” According to the decision: Antibody:...more

Federal Circuit Issues Two Decisions Clarifying Patent-Eligible Subject Matter

One of the murkier areas of patent law is subject matter eligibility—when are patent claims directed to laws of nature, natural phenomenon or abstract ideas and when are they directed to patentable applications of those laws,...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

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

USPTO Extends Certain Patent-Related Deadlines due to COVID-19 Crisis

The United States Patent and Trademark Office (“USPTO”) has further extended the time to file certain patent-related documents or pay fees due to the COVID-19 outbreak. This extension supersedes prior USPTO waivers of...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 Infringement: Successful Litigation Stays the "Course" [Audio]

What happens when your competitors infringe your patent for golf equipment – then declare bankruptcy to avoid paying up? In this episode, Harris Beach intellectual property (IP) attorneys share the story behind the $12...more

Recent District Court Decisions Provide Guidance on Written Description Requirement for Antibodies

One of the most difficult aspects of patenting antibodies and other biologics is obtaining sufficiently broad patent protection. In order to claim a genus of antibodies, rather than specific sequences, the applicant must...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

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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