Antibody Claim Strategies After the Amgen v. Sanofi Decisions

By Charles P. Romano, Ph.D.

Monoclonal antibodies (“mAb”) which specifically bind therapeutic targets dominate the biopharmaceutical market with global sales revenues estimated at nearly US$163 billion in 2019. Prior to the 2017, mAb were often protected in the US by broad claims which described the therapeutic target (i.e., the “antigen”) that the mAb could bind since such mAb could be […]

Has the Federal Circuit Made It Nearly Impossible to Maintain Genus Claims?

By Blog Staff

A recent denial by the Supreme Court of the United States (SCOTUS) to hear an appeal by Merck’s Idenix Pharmaceuticals LLC (Idenix), leaves unanswered questions regarding the overall validity of genus claims, particularly within the biopharma field. The SCOTUS denied a petition for writ of certiorari to clarify certain Section 112 requirements with respect to […]

USPTO Updates 112 Guidance: Presumption Shift of Functional Limitations

Recently, the United States Patent & Trademark Office (USPTO) has announced plans to update their guidance on functional claim language under 112 and will after a period of public input. This update will likely require a more detailed specification for functional claims or result in narrower claims. Under the proposed 112 guidelines, which are aimed […]

USPTO Director Andrei Lancu Takes a Look at Early Prosecution

This week, the USPTO Director, Andrei Iancu, testified before the House Judiciary Committee. In his written statement Director Iancu wrote on topics related to early prosecution that would result in lower costs to clients and would speed up the process of obtaining a patent. A new pilot program that will allow for a pre-search Examiner […]

The Most Difficult Definition: Considerations for Defining “Genetically Modified Organism”

A patent applicant is free to act as their own lexicographer in drafting an application and may define terms as they see fit. Should a word not be defined explicitly in the application, the Patent Office will then give the term “the broadest reasonable interpretation according to a person having ordinary skill in the art” […]

Patenting Ideas Previously Disclosed in an Earlier-Filed Provisional Application but Later-Filed Non-Provisional Application

Can an idea that has already been conceived (and published) still be patented? The scenario appears possible based on a recent holding from the United States Court of Appeals for the Federal Circuit. Many know that nearly all publicly available information with a publication date prior to the filing date of a patent application can […]

Critical Versus Optional, but Desireable Claim Elements

On August 6, 2014, the Federal Circuit Court of Appeals issued its opinion in ScriptPro, LLC v. Innovation Associates, Inc. In 2006, the Petitioner ScriptPro, LLC sued Innovation Associates, Inc. for infringement of claims 1, 2, 4, and 8 of U.S. Patent No. 6,910,601 ("the '601 patent"). The '601 patent describes a "collating unit" that […]

Means-Plus-Function Claims and Written Description for Priority

InEnOcean GMBH v. Face International Corp., the Federal Circuit vacated and remanded a final order of the U.S. Patent and Trademark Office (“PTO”) and the Board of Patent Appeals and Interferences (“Board”) with respect to EnOcean’s U.S. Patent Application No. 10/304,121. The Federal Circuit held (1) the term “receiver” was recited with sufficient structure as […]

Bring on the New Year – What is in Store for IP in 2014?

Happy New Year to all of our FilewrapperÒ followers! We hope 2013 was a productive year and wish you the best in 2014. As the New Year quickly approaches we would like to share with you a few predictions for 2014 for you to look forward to and for which to prepare! · Increased opportunities […]

Federal Circuit Confirms Invalidity for Overbroad Written Description

Novozymes v. DuPont Nutrition Biosciences involved patent 7,713,723 directed toward recombinant Bacillus alpha-amylase enzymes engineered to have enhanced acid tolerance and heat tolerance. The patent owner, Plaintiffs-Appellants Novozymes, sued DuPont for infringement. DuPont defended on grounds of non-infringement and invalidity and countersued for a declaratory judgment that the '723 patent was invalid for failing to […]