US Supreme Court Agrees to Review Patent Enablement Case

By Julie L. Spieker

Last Friday, the Supreme Court accepted Amgen’s request to review Section 112 of the Patent Act and consider how much a patent specification must disclose to meet enablement requirements. Specifically, the Court will review whether a patent must disclose enough information for the skilled artisan to “reach the full scope” of the claims, or whether […]

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 […]

Deposit of biological material and the differing national laws

By Brian D. Keppler, Ph.D.

For patent applications in the biotechnology area, a biological material is sometimes essential for carrying out the invention. The biological material can be any material capable of reproducing itself or being reproduced in a biological system, including bacteria, fungi, algae, eukaryotic cells, cell lines, hybridomas, plasmids, viruses, and plant seeds. If the biological material cannot […]

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 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 […]

Court of Appeals Gets Specific with Enablement

In Storer v. Clark, the Court of Appeals explored whether a provisional application had sufficiently enabled interference subject matter.  In order to prove enablement it must be shown that “one skilled in the art, having read the specification, could practice the invention without ‘undue experimentation.’” ALZA Corp. v. Andrx Pharm., LLC, 603 F.3d 935, 940 […]

Post-Grant Reviews under the America Invents Act

The America Invents Act implemented the Post-grant Review (PGR) process as a new means of challenging existing patents. PGR differs from Inter Partes Review (IPR) in that PGR allows for a wider array of invalidity challenges. One example of a new challenge allowed under PGR is the ability to challenge the claims as being indefinite. […]

Federal Circuit-Statements in Application Properly Used to Enable Prior Art

One of the basic requirements for the grant of a patent by the USPTO is the invention must be shown to be “new.”In practice, this means that the invention must be sufficiently different from the existing prior art, including patents, publications, and existing products. However, in order for a piece of prior art to preclude […]

2014 Supreme Court Cases Relating to Intellectual Property

On January 10, 2014 the Supreme Court agreed to review a variety of intellectual property cases in the upcoming session, including two patent cases, a copyright case, and a trademark case (including Lanham Act claim). A brief overview of these cases is provided and more detail will be available once decisions are entered by the […]

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 […]