Search Results for: drug patents

On Thursday, 16 August 2012, the Court of Appeals for the Federal Circuit issued its opinion in the case Association for Molecular Pathology v. US Patent and Trademark Office, again rejecting the plaintiffs’ contentions that isolated DNA is not eligible for patent protection. This case surrounds the patent eligibility of isolated DNA, particularly the BRCA1 and BRCA2 genes known to be associated with an individual’s susceptibility to breast and ovarian cancer.

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In August 2, 2010, the National Institutes of Health (NIH) was asked to grant an open license to permit manufacture of Fabrazyme, a drug used to treat Fabry disease (more on the march-in case here: https://www.keionline.org/fabrazyme). On December 1, 2010, Francis S. Collins, Director of the NIH issued a determination in the case, rejecting the petition for the NIH to exercise its march-in rights, citing as support for the denial that granting march-in rights would not overcome other barriers, including the exclusive rights in test data.

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This is a rough list of the recent ICE press releases mentioning counterfeit and pharmaceutical. It is quite clear that the overwhelming majority of counterfeit busts involve Viagra and other erectile dysfunction drugs, a problem that will probably resolve itself once the Pfizer patents on Viagra expire.

In my quick read of the ICE press releases, I found just 12 pharmaceutical counterfeiting cases in the ICE press releases from 2009 to May 2012, with 14 defendants.

• 13 of the 14 defendants were men.

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Donald McNeil has an article in the New York Times that appeared in print on May 22, 2012 (page D6 of the New York edition) with the headline: “Malaria: Fake and Substandard Drugs Grow as Threat to Fight Disease.” A web version is available here: http://www.nytimes.com/2012/05/22/health/policy/fake-and-substandard-drugs-grow-as-threat-to-fight-malaria.html

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In a major patent ruling today, the Supreme Court of the United States issued a unanimous decision in Mayo v. Prometheus Laboratories. The case, heard twice before the Federal Circuit (once before the Supreme Court’s ruling in Bilski and once after), has been closely followed because of its impacts on personalized medicine and potential implications for the Myriad Genetics case on the BRCA genes. The Supreme Court reversed the Court of Appeals for the Federal Circuit and held that Prometheus’ patents-at-issue were not eligible for patent protection.

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KEI submission to the WIPO Standing Committee on the Law of Patents (SCP) on Patents and Health

28 February 2012

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On Wednesday, 7 December 2011, the United States of America tabled a proposal on patents and health which was distributed at 6 PM by the WIPO Secretariat after much of the substantive dicussions

Standing Committee on the Law of Patents

Seventeenth Session
Geneva, December 5 to 9, 2011

PATENTS AND HEALTH: PROPOSAL BY THE DELEGATION OF THE UNITED STATES OF AMERICA

Document prepared by the Secretariat

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On November 13, 2011, the Los Angeles Times published a story by David Willman on a no-bid contract with the Department of Health and Human Services (DHHS) to supply the government with a drug for smallpox. The LA Times story begins with this:

Over the last year, the Obama administration has aggressively pushed a $433-million plan to buy an experimental smallpox drug, despite uncertainty over whether it is needed or will work.

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