Is Biotech Patentable Subject Matter?
Can You Patent Human Genes? ACLU Says No
Yours, Mine and Ours (not yet!): An Update on the Patentability of Human Genes
The US Court of Appeals for the Federal Circuit affirmed the district court’s grant of a Rule 12(b)(6) motion to dismiss on the basis that, under the two-step Alice analysis, the patent claims—directed to a digital...more
On October 23, 2020, in a remarkable order demonstrating how a “bitterly divided” Federal Circuit views post-Alice patent eligibility jurisprudence, the court denied the motion of American Axle & Manufacturing, Inc. (“AAM”)...more
AMERICAN AXLE & MANUFACTURING v. NEAPCO HOLDINGS LLC - Before Dyk, Moore, and Taranto. Appeal from the District Court for the District of Delaware. Summary: Claims directed to a law of nature, without more, may not be...more
Federal Circuit (Again) Hands Down Revised Opinion in Response to Petition for Rehearing - Recently the Federal Circuit has begun a practice of withdrawing an original opinion and handing down a substitute opinion in...more
Patent eligibility is a bit of a mess these days. Ever since the Supreme Court handed down the Alice v. CLS Bank decision six years ago, the distinction between what might be subject matter that can be patented and what is...more
Is a new method of diagnosing a disease patentable? Can it survive a motion to dismiss? And, irrespective of the current precedent, should a new method of diagnosing a disease be patentable? These are questions the U.S. Court...more
Case Summary- On March 17, 2020, the Federal Circuit found that patents claiming methods of preparing an extracellular fraction of cell-free DNA that is enriched in fetal DNA were patent eligible and not invalid under 35...more
There are (at least) two ways of looking at the course of the Federal Circuit's evolving interpretation of the Supreme Court's subject matter eligibility jurisprudence under Mayo Collaborative Services v. Prometheus Labs.,...more
This month, the U.S. Court of Appeals for the Federal Circuit has handed down a pair of opinions concerning Section 101 in the field of pharmaceuticals and life sciences. In both cases, the district courts held claims of the...more
Mallinckrodt filed a certiorari petition with the Supreme Court last week, over the Federal Circuit panel decision (by Chief Judge Prost joined by Judge Dyk; Judge Newman dissented on the issue before the Court in this...more
The latest Federal Circuit decision on subject matter eligibility in the life sciences came down (by a divided court) in favor of eligibility, in Illumina, Inc. v. Ariosa Diagnostics, Inc. The claims at issue fell into the...more
Ever since the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories was handed down in 2012, diagnostic method claims have been routinely invalidated by the district courts and those decisions...more
The PTAB Cannot Approve or Deny Certificates of Correction - In Honeywell International, Inc. v. Arkema Inc., Arkema France, Appeal Nos. 2018-1151, -1153, the Patent Trial and Appeal Board (“Board”) does not have the...more
AMERICAN AXLE & MANUFACTURING, INC. v. NEAPCO HOLDINGS LLC - Before Dyk, Moore, Taranto. Appeal from the United States District Court for the District of Delaware. Summary: Mechanical method claims involving tuning...more
In a remarkable collection of opinions that have no direct effect on the law, the Federal Circuit has implicitly given its support to efforts in Congress to override the Supreme Court’s decision in Mayo v. Prometheus, which...more
Broad Claim Language and Unpredictability in the Art Lead to Non-Enablement - In Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., Appeal Nos. 2017-2498, -2499, -2545, -2546, broad patent claims were invalid as...more
Just Because Something May Result From a Prior Art Teaching Does Not Make it Inherent in that Teaching - In Personal Web Technologies, LLC v. Apple, Inc., Appeal No. 2018-1599, the Federal Circuit clarified that the mere...more
In Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit distinguished method of treatment claims that involve personalized dosing from the claims invalidated in Mayo v. Prometheus, and found them...more
Before Wallach, Clevenger, and Stoll. Appeal from the United States District Court for the District of Delaware. Summary: Claims directed to a specific method of treatment for specific patients using a specific compound...more
In Athena Diagnostics Inc. v. Mayo Collaborative Services, LLC, the Federal Circuit has once again held that claims directed to a diagnostic method are invalid under 35 U.S.C. § 101 for being directed to ineligible subject...more
Federal Circuit Summary - Before Prost, Reyna, and Taranto. Appeal from the U.S. District Court for the District of Maryland. Summary: An abstract idea cannot be used to supply an inventive concept that renders a claim...more
In Natural Alternatives Internat'l v. Creative Compounds, LLC, the Federal Circuit vacated the district court decision that held the asserted claims invalid under 35 USC § 101 at the pleadings stage. I previously wrote about...more
Federal Circuit Finds Claims Directed to Tabbed Spreadsheets Patent Eligible and Claims Directed to Tracking Changes in Documents Ineligible Under Section 101 - In Data Engine Technologies LLC v. Google LLC, Appeal No....more
Federal Circuit Summary - Before O’Malley, Reyna, and Hughes. Appeal from the District Court for the Northern District of California. Summary: Testing for the presence of a bacterium that causes tuberculosis and the...more
The United States Patent and Trademark Office (USPTO) recently issued a memo providing examination guidance on the subject matter eligibility of the method of treatment claims. The memo discussed the recent Federal Circuit...more