Knobbe/Martens: Intellectual Property Law

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Modern Meadow: Patenting Lab-Grown Leather

November 27, 2018 Bryan J. Johnson, Loni Morrow and Peter Law

In 2017, New Jersey based biotech startup Modern Meadow launched Zoa™, which is inspired by leather and is the company’s first brand of biofabricated materials.  Zoa™, a name derived from the Greek term for life, zoi, will feature products created with Modern Meadow’s proprietary technology.  According to the Zoa website, Modern Meadow’s first generation of materials have “the ability to be any density, hold to any mold, create any shape, take on any texture, combine with any other material and be any size.” 

 

Updates to the Law on Cloning

November 8, 2018 Scott R. Seeley and Jason J. Jardine

It was recently reported that China had successfully cloned a 12-year old schnauzer — the most recent of over 20 dog breeds successfully cloned by the nation so far. [1].  "Doudou" the schnauzer was cloned through somatic cell transfer, a technique in which the genetic material of a donor egg is replaced with the genetic material from the animal to be cloned.  The modified egg is stimulated to initiate cell division, and the egg is implanted in a surrogate mother.  Despite the number of breeds successfully cloned, China has only recently applied this technology to the cloning of  dogs.  In May of 2017, China first implemented the technique to produce a cloned beagle that had been genetically engineered to develop atherosclerosis in order to study possible treatments for the disease.  [2].   

 

PTAB Adopts Phillips Standard for Claim Construction in AIA Proceedings

October 31, 2018 Jane Xia and Jane Dai, Ph.D.

On October 11, 2018, the USPTO published a Final Rule in the Federal Register, adopting a new standard for interpreting claims in trial proceedings before the patent trial and appeal board (PTAB).

In particular, the USPTO is replacing the “broadest reasonable interpretation” standard (the BRI standard) with the claim construction standard used in federal courts as articulated in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) and its progeny (the Phillips standard). The new rule applies to inter partes review (IPR), post-grant review (PGR), and the transitional program for covered business method (CBM) patents proceedings. Additionally, under the final rule, when construing a claim term in an IPR, PGR, or CBM, the PTAB will take into consideration any prior claim construction determination that has been made in a civil action, or a proceeding before the International Trade Commission (ITC), if that prior claim construction is timely made of record in that IPR, PGR, or CBM. The final rule will be effective for IPR, PGR, and CBM petitions filed on or after November 13, 2018.

 

Protecting Your Claimed Ranges

Assertions of obviousness based on prior art references in combination with “routine optimization” by one skilled in the art are common in the chemical and biological fields.  The Federal Circuit recently addressed this issue in E.I. DuPont De Nemours & Co. v. Synvina C.V., reversing the Patent Trial and Appeal Board’s (PTAB’s) finding that Synvina’s patent was non-obvious, in view of close prior art references and little to no additional evidence of non-obviousness. 

 

FDA Statement Regarding Quality Assurance Efforts for Foreign Drug Manufacturing Facilities

September 19, 2018 Raj D. Pai, PhD. and Jason J. Jardine

            On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that pharmaceuticals meet high-quality standards[1]. Currently, there are over 5,000 pharmaceutical sites worldwide. Of these sites, over 3000 are based outside of the United States. This large number of ex-U.S. sites requires a regulatory scheme that ensures both Current Good Manufacturing Practice (CGMP) and transparency regarding drug manufacturing.

 

 

UC v. Broad Institute: No Interference-In-Fact in CRISPR Genome Editing Applications

On September 10, 2018, the Federal Circuit decided Regents of the University of California v. Broad Institute, Inc., affirming the Patent Trial and Appeal Board (PTAB)’s determination of no interference-in-fact between the University of California (UC)’s application and the claims of twelve patents and one application owned by the Broad Institute.

 

Recent Update on Patent Trial Practice Guide

August 28, 2018 Jane Xia and Eric Furman, Ph.D.

The United States Patent and Trademark Office (USPTO) published an update to the AIA Trial Practice Guide (‘‘Trial Practice Guide’’) in August 2018 to revise guidance on practices before the Patent Trial and Appeal Board (‘‘Board’’). The original Trial Practice Guide was published in 2012 at the same time as the promulgation of AIA Trial Rules. The Trial Practice Guide contains informative material of standard practices in front of the Board, and outlines procedures during AIA trials.  The recent update incorporates the Board’s current practices and changes in applicable regulations.

 

Microbiome Regulation Emerges From the Shadows: FDA to Co-Host Workshop on Live Cell Therapeutics

Research supporting the role of the microbiome in human, animal, and plant health continues to grow at a staggering rate.  While the wave of new health technologies emerging from this research rises, companies working in the microbiome space have had to confront a number of unique, interlinked technical, intellectual property, and regulatory issues that threaten to derail this extraordinarily promising area of development.  

Jazz v. Amneal: When your FDA Submissions are Prior Art

August 13, 2018 Caleb A. Bates, Ph.D.

On July 13, 2018, the Federal Circuit decided Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, affirming the Patent Trial and Appeal Board (PTAB)’s finding of invalidity of certain claims of seven Orange Book-listed patents for Xyrem®

 

FDA to Hold Public Hearing on Biosimilar Action Plan

July 31, 2018 Daniel A. Kamkar and Jane Dai, Ph.D.

On July 18, 2018, the FDA released a Biosimilar Action Plan[1] that is aimed at promoting competition and affordability across the market for biologics and biosimilar products. The Plan uses four key strategies to accomplish these goals:[2]

 

 

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