Tag Archives: patents

Detailed Report Examines the Crucial Role of Patents in Genetic Testing

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In The Critical Role of Patents in the Development, Commercialization, and Utilization of Innovative Genetic Diagnostic Tests, Professor Holman argues that advocates for weakening patent protection have fundamental misconceptions on the role of patents in genetic testing. Opponents assume that patents negatively impact patient access to genetic diagnostic testing. They believe that patents inhibit research that could lead to new or improved versions of genetic tests, and that patent holders charge higher prices as exclusive Read More >

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Protecting your IP Overseas

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According to the World Intellectual Property Organization (WIPO), nearly 100,000 biotechnology and pharmaceutical patent applications are filed worldwide each year, and the trend appears to be rising. As you’ve likely experienced, filing patent applications can be very complex, with different laws, deadlines and languages requiring highly technical translators for most countries in which you’re seeking protection. As a result, companies seeking IP protection often outsource their domestic and foreign patent filings to service providers to Read More >

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Patent Parameters

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Supreme Court Finds Naturally Occurring DNA to Be Patent Ineligible Last summer, the Supreme Court issued its decision in Association for Molecular Pathology v. Myriad Genetics, Inc., which concerned the patent eligibility of the BRCA1 and BRCA2 genes. In Myriad, a unanimous Supreme Court held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. The Court also determined, albeit with one caveat, that Read More >

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Supreme Court Enunciates New Indefiniteness Standard

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The Supreme Court has once again reversed a decision by the Federal Circuit, in this case involving the proper standard for finding claims indefinite. The case, Nautilus, Inc. v. Biosig Instruments, Inc., overturned the Federal Circuit’s “insolubly ambiguous” test and substituted its own “reasonable certainty” test.  The Court left intentionally unclear the precise ways in which their new test will differ from the Federal Circuit’s abrogated test, leaving it to the lower court to decide Read More >

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What OxyContin Tells Us About the Value of “Evergreening” and Patents

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A few weeks ago, the  FDA announced that they would not allow generic versions of older versions of OxyContin. The original formulation of OxyContin goes off patent today. The original formulation did not have “tamper-resistant qualities” that prevent people from “crushing, breaking, and dissolution using a variety of tools and solvents.”  The article reports that the decision will keep Teva Pharmaceuticals and Impax Laboratories from making the older version which the FDA has determined is too dangerous Read More >

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