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2021 was a fascinating year in biotech, especially for legal issues. Of course, 2021, as the second year of a global pandemic, must be viewed in context with 2020....more
When it comes to SARS-CoV-2 infection (and resulting COVID-19), it seems our Neanderthal ancestors giveth and taketh away. Genetic material inherited from interbreeding between Neanderthals and early humans has been shown to...more
Our “Innovation Conversations” series continues with our guest Dr. Claire Fraser, President of the American Association for the Advancement of Science (AAAS) and Director of the Institute for Genome Sciences at the University...more
Cancer of the appendix is a very rare form of cancer, having an incidence of 0.12 per 1,000,000 person-years (Siegel et al., 2020, Cancer statistics 2020 70:7-30). Incidence is rising (by 232% from 2000-2016 in the U.S.)...more
Earlier this year, and almost one year to the day (January 17, 2019) that the Opposition Division (OD) of the European Patent Office revoked in its entirety European Patent No. EP 2771468, the Technical Board of Appeal...more
Claims Covering Human Engineering That Exploit a Naturally-Occurring Phenomenon Are Patent Eligible - In Illumina, Inc. V. Ariosa Diagnostics, Inc., Appeal No. 19-1419, the Federal Circuit modified its earlier decision...more
ILLUMINA, INC. v. ARIOSA DIAGNOSTICS, INC. Before Lourie, Moore, and Reyna. Modified opinion following Ariosa rehearing petition. Summary: The Federal Circuit modified its earlier decision and clarified the difference...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
The inherent, ineluctable unpredictability of biology can be the basis for biological patent claims being non-obvious (lacking the requisite "reasonable expectation of success"; see, e.g., OSI Pharmaceuticals v. Apotex) and...more
March 23rd was the deadline for the parties in Interference No. 106,115 between Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad") and Junior Party the...more
ILLUMINA, INC. v. ARIOSA DIAGNOSTICS, INC. Before Lourie, Moore, and Reyna. Appeal from the Northern District of California. Summary: Use of a natural phenomenon in a method of preparation claim found patent eligible...more
The Federal Circuit, in Illumina, Inc., v. Ariosia, reversed the summary judgment decision of a lower trial court and upheld—as patent subject matter eligible—claims in two patents (U.S. 9,580,751; U.S. 9,738,931). The...more
The BRCA2 gene is one member of a pair of genes that changed the patent landscape several years ago, when the Supreme Court ruled that "mere" isolation was insufficient to render genomic embodiments thereof patent eligible,...more
Hyatt v. Pato (No. 2017-1722, 9/24/18) (Reyna, Wallach, Hughes) - Hughes, J. Reversing dismissal for lack of subject matter description stating, “the exclusive jurisdiction of this court and the Eastern Virginia district...more
Until the cloning of Dolly the sheep in 1996 by scientists at the Roslin Institute, the idea of cloning a mammal, let alone a human being, was an idea relegated to science fiction. Dolly was created using a technique known as...more
In vitro gametogenesis (IVG) is a recent development in reproductive technology, and has been used for creating mouse embryos in vitro. IVG includes obtaining cells from a donor (such as skin cells), and differentiating the...more
The Supreme Court of Canada has commented on the issue but no Canadian court has directly answered the difficult question of whether genes are patentable. So the answer appears to be yes, for now. Identifying genetic...more
Clearly the High Court has given an answer to a question, but was that question the one we anticipated? That in itself is an open question!...more
Like the United States Supreme Court, the High Court of Australia has determined that Myriad’s patents directed to purified and isolated DNA molecules encoding the BRCA genes are unpatentable. Indeed, the Australian Court...more
The Full Federal Court of Australia affirmed that isolated nucleic acids, i.e. whether it be DNA or RNA, are patentable subject matter in Australia. While an appeal to the High Court of Australia may be possible, absent an...more
The Full Federal Court of Australia has handed down its long awaited decision in D'Arcy v Myriad Genetics Inc today, affirming that isolated DNA and RNA are patentable subject matter under Australian law....more
In an article in The Cancer Letter entitled "Robert Cook-Deegan's Viewers' Guide To the Super Bowl of Gene Patent Cases," Professor Robert Cook-Deegan (at right) of the Institute for Genome Sciences & Policy and Sanford...more
In a 106-page opinion, U.S. District Court Judge Robert J. Shelby on Monday denied Myriad Genetics motion for preliminary injunction in Myriad Genetics v. Ambry Genetics. Characteristic of its aggressive defense of its...more
The U.S. Court of Appeals for the Federal Circuit, in a decision providing a glimpse into a panel’s post-Alice position with regard to patent-eligibility of computer-implemented inventions (under 35 U.S.C. § 101), determined...more