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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.
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 …
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.
The History Of Patenting Genetic Material, Jacob S. Sherkow, Henry T. Greely
The History Of Patenting Genetic Material, Jacob S. Sherkow, Henry T. Greely
Articles & Chapters
The US Supreme Court’s recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc. declared, for the first time, that isolated human genes cannot be patented. Many have wondered how genes were ever the subjects of patents. The answer lies in a nuanced understanding of both legal and scientific history. Since the early twentieth century, “products of nature” were not eligible to be patented unless they were “isolated and purified” from their surrounding environment. As molecular biology advanced, and the capability to isolate genes both physically and by sequence came to fruition, researchers (and patent offices) began to apply …
The Natural Complexity Of Patent Eligibility, Jacob S. Sherkow
The Natural Complexity Of Patent Eligibility, Jacob S. Sherkow
Articles & Chapters
It has long been assumed that the doctrine of patent eligibility’s prohibition of patents on “laws of nature,” “natural phenomena,” and “products of nature” rests on legalistic interpretations of those terms. But there is good reason to doubt this assumption. Since the doctrine’s inception, the Supreme Court has yet to provide any framework, formula, or factors explaining these “natural” terms. Rather, the Court has increasingly fixated on a list of scientific tropes, such as gravity, the heat of the Sun, and extracted metals, that it believes are true examples of “natural laws,” “phenomena,” and “products.”
An actual examination of scientific …
Preliminary Injunctions Post-Mayo And Myriad, Jacob S. Sherkow
Preliminary Injunctions Post-Mayo And Myriad, Jacob S. Sherkow
Articles & Chapters
The Supreme Court's recent interest in patentable subject matter has had several, unexpected downstream effects on preliminary injunctions in patent disputes.
The Supreme Court has recently expressed increased interest in patent eligibility, or patentable subject matter, the doctrine that limits the types of inventions eligible for patenting. Its two decisions, Mayo Collaborative Services v. Prometheus Laboratories, Inc., in 2012, and Association for Molecular Pathology v. Myriad Genetics, Inc., in 2013, represented the first broad restrictions on patentable subject matter in over thirty years. And later this term, the Court will decide yet another patent eligibility case: Alice Corp. v. CLS …