Knobbe/Martens: Intellectual Property Law

Biotechnology

Subscribe to Biotechnology Blog

Cleveland Clinic II: Has the Federal Circuit Undermined Patent Office Guidance and Eliminated an Important Tool for Patenting Diagnostics?

On April 1, 2019, the Federal Circuit issued a non-precedential decision in Cleveland Clinic Foundation, Cleveland HeartLab, Inc. v. True Health Diagnostics LLC (“Cleveland Clinic II”), affirming the district court’s holding that claim 1 of U.S. Patent No. 9,575,065 (the “ ’065 patent”) and claims 1 and 2 of U.S. Patent No. 9,581,597 (the “’597 patent”) were invalid under 35 U.S.C. § 101 as being directed to a patent-ineligible law of nature.  In its decision, the Federal Circuit held that the courts are not bound by United States Patent and Trademark Office (USPTO) guidance, and concluded that a portion of the USPTO’s guidance on subject matter eligibility was inconsistent with controlling judicial precedent.

 

Natural Alternatives International, Inc. v. Creative Compounds, LLC.: Dietary Supplement Containing A Natural Product Incorporated into a Dosage Form is Patent Eligible

In Natural Alternatives International, Inc. v. Creative Compounds, LLC., Appeal No. 2018-1295, a divided panel of the Federal Circuit reversed and remanded a decision by the District Court for the Southern District of California that granted a judgment on the pleading holding the asserted claims invalid as not patent eligibile.

 

FDA and USDA Enter into Formal Agreement to Jointly Regulate Cell-Cultured Food Products

On March 7, 2019, the U.S. Food and Drug Administration (FDA) and the U.S. Food Safety and Inspection Service (FSIS) announced a formal agreement, in the form of a memorandum of understanding (MOU), to jointly regulate the production of human food derived from cultured cells of livestock and poultry, including cell-based meat.  [1], [2]  The FDA is an agency of the U.S. Department of Health and Human Services (HHS), and the FSIS is an agency of the U.S. Department of Agriculture (USDA).  The MOU follows a joint public meeting held in October 2018 at which the Agencies discussed the use of cell culture technology for human food production, including potential hazards, oversight, and labeling, with representatives of industry, consumer groups, and other stakeholders.  [3]  The October 2018 meeting resulted in a statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on November 16, 2018, confirming that the Agencies had agreed to joint oversight of this emerging technology.  [4]

 

Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC: Claims Reciting Conventional Method Steps found Patent Ineligible

On February 6, 2019, the Federal Circuit decided Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, affirming a District Court for the District of Massachusetts decision that the claims at issue were patent ineligible for being directed to a natural law.

 

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.

 

Pages

Attorney Finder