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Full-Text Articles in Law
Eviscerating Patent Scope, Shahrokh Falati
Eviscerating Patent Scope, Shahrokh Falati
Articles & Chapters
The scope of patent claims directed to inventions in the field of pharmaceuticals and biotechnology has been stumped by the Court of Appeals for the Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112. Specifically, the application of a heightened test for enablement of claims to a genus of compounds with functional limitations or a genus of therapeutic antibodies, coupled with an increasingly broader application of the written description doctrine, has resulted in considerable uncertainty in the biopharmaceutical industry. The Federal Circuit’s shift in interpreting 35 U.S.C. § 112 contravenes the statute and Supreme Court precedent by splitting the singular …
Inventive Steps: The Crispr Patent Dispute And Scientific Progress, Jacob S. Sherkow
Inventive Steps: The Crispr Patent Dispute And Scientific Progress, Jacob S. Sherkow
Other Publications
Recent decisions by patent offices in the USA and Europe concerning the revolutionary gene-editing technology, CRISPR/Cas9, have shed light on the importance — and puzzles — of one particular area of patent law: “nonobviousness”, as it known in the USA, or, in Europe, the “inventive step”. Patent law does not always neatly align itself with the realities of biological research. But these competing decisions from the U.S. Patent and Trademark Office and the European Patent Office have put those differences on parade. Unpacking these standards for CRISPR tell us a lot about how advances in biology are actually made — …
Crispr, Surrogate Licensing, And Scientific Discovery, Jorge Contreras, Jacob S. Sherkow
Crispr, Surrogate Licensing, And Scientific Discovery, Jorge Contreras, Jacob S. Sherkow
Other Publications
Several research institutions are embroiled in a legal dispute over the foundational patent rights to CRISPR-Cas9 gene-editing technology, and it may take years for their competing claims to be resolved. But even before ownership of the patents is finalized, the institutions behind CRISPR have wasted no time capitalizing on the huge market for this groundbreaking technology by entering into a series of licensing agreements with commercial enterprises. With respect to the potentially lucrative market for human therapeutics and treatments, each of the key CRISPR patent holders has granted exclusive rights to a spinoff or "surrogate" company formed by the institution …
The Changing Life Science Patent Landscape, Arti K. Rai, Jacob S. Sherkow
The Changing Life Science Patent Landscape, Arti K. Rai, Jacob S. Sherkow
Articles & Chapters
Over the past two decades, patent law in the life sciences has been buffeted by numerous controversies. With courts, legislatures and patent offices all responding, one could be forgiven for believing that the main constant has been change. In the following article, we look back at some of the major events in life science intellectual property (IP) law and business practice over the past 20 years and then suggest where IP practice in the life sciences may be heading in the coming years.
Pursuit Of Profit Poisons Collaboration, Jacob S. Sherkow
Pursuit Of Profit Poisons Collaboration, Jacob S. Sherkow
Other Publications
The CRISPR–Cas9 patent battle demonstrates how overzealous efforts to commercialize technology can damage science.
Who Owns Gene Editing? Patents In The Time Of Crispr, Jacob S. Sherkow
Who Owns Gene Editing? Patents In The Time Of Crispr, Jacob S. Sherkow
Other Publications
New gene-editing technologies, like CRISPR, promise revolutionary advances in biology and medicine. However, several patent disputes in the USA and UK may have complicated who can use CRISPR. What does this mean for the future of gene editing?
Pursuit Of Profit Poisons Collaboration, Jacob S. Sherkow
Pursuit Of Profit Poisons Collaboration, Jacob S. Sherkow
Other Publications
The CRISPR–Cas9 patent battle demonstrates how overzealous efforts to commercialize technology can damage science.
Protecting Products Versus Platforms, Jacob S. Sherkow
Protecting Products Versus Platforms, Jacob S. Sherkow
Articles & Chapters
Patents have long been the most important legal assets of biotech companies. Increasingly, however, biotech firms find themselves on one side of a divide: as either traditional product companies or platform companies. Given the differences between these two types of business models, the merits of intellectual property (IP) protection vary between them. This article explores how those differences relate to biotech startups and entrepreneurs seeking to protect their inventions.
Describing Drugs: A Response To Professors Allison And Ouellette, Jacob S. Sherkow
Describing Drugs: A Response To Professors Allison And Ouellette, Jacob S. Sherkow
Articles & Chapters
Profs. Allison and Ouellette’s Article, How Courts Adjudicate Patent Definiteness and Disclosure, 65 Duke L.J.609 (2015), on courts’ adjudication of certain patent disputes presents some surprising data: pharmaceutical patents litigated to judgment fare substantially worse on written-description analyses if they are not part of traditional pioneer-generic litigation. This Response engages in several hypotheses for this disparity and examines the cases that make up Allison and Ouellette’s dataset. An analysis of these cases finds that the disparity can be best explained by technological and judicial idiosyncrasies in each case, rather than larger differences among pharmaceutical patent cases. This finding contextualizes …
Law, History And Lessons In The Crispr Patent Conflict, Jacob S. Sherkow
Law, History And Lessons In The Crispr Patent Conflict, Jacob S. Sherkow
Articles & Chapters
Predicting the outcome of the ongoing patent disputes surrounding genome-editing technology is equal parts patent analysis and history.
Genome-editing technology based on clustered, regularly interspaced, short palindromic repeats (CRISPR) and CRISPR associated protein 9 (Cas9) has generated great excitement in both academia and industry. But a potential patent dispute between two sets of inventors has left the biotech community pondering its fate. Understanding several facets of patent law and history may provide some lessons about the probable — and best — outcome for the dispute.
Stem Cell Patents After The America Invents Act, Jacob S. Sherkow, Christopher Scott
Stem Cell Patents After The America Invents Act, Jacob S. Sherkow, Christopher Scott
Articles & Chapters
Under the newly passed Leahy-Smith America Invents Act (AIA), the U.S. Patent and Trademark Office may hear new challenges to stem cell patents. Here, we explore how the new law affects challenges to stem cell patents, focusing on two recent cases, and discuss the future of stem cell patent disputes.
Myriad Stands Alone, Jacob S. Sherkow, Christopher T. Scott
Myriad Stands Alone, Jacob S. Sherkow, Christopher T. Scott
Articles & Chapters
Myriad took no prisoners on its way to the top of the molecular diagnostics field. That strategy is unlikely to endure.
Myriad Genetics began in 1991 as a small University of Utah startup interested in the then-novel arena of diagnostic genetic testing. After winning a highly publicized race to sequence the BRCA1 and BRCA2 breast cancer genes, the company obtained patents on the gene sequences and methods of using them to determine cancer risk. The patents were broad and interlocking, covering BRCA genomic DNA, cDNA, methods of diagnosis and systems detecting mutations. Myriad also filed for diagnostic 'toolbox' patents, including …
Federal Trade Commission V. Actavis, Inc. And Reverse-Payment Or Pay-For-Delay Settlements, Jacob S. Sherkow
Federal Trade Commission V. Actavis, Inc. And Reverse-Payment Or Pay-For-Delay Settlements, Jacob S. Sherkow
Articles & Chapters
An imminent US Supreme Court ruling should resolve one of the thorniest legal issues facing pharmaceutical companies today.