2012: NIH case: exclusive rights in regulatory test data are absolute, even where there are drug shortages

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.

Continue Reading

Uncategorized

AIDS 2012: Former President Clinton and House Minority Leader Nancy Pelosi Speak at Closing Ceremony

The XIX International AIDS Conference, which saw over 24,000 participants, came to a close on Friday, July 27, 2012. A number of people living with HIV/AIDS, activists, the immediate past president and current president of the International AIDS Society (and 2008 Nobel Prize Winner in Medicine), House Minority Leader Nancy Pelosi (D-CA), and former President Bill Clinton were among the speakers.

Continue Reading

AIDS 2012: US Congress and the Global AIDS Epidemic

At the International AIDS Conference 2012, on July 25, 2012, former Senator Frist (R-TN) moderated a panel of four members of Congress on “The U.S. Congress and the Global AIDS Epidemic.” The four members of Congress included Congresswoman Barbara Lee (D-CA), Senator Marco Rubio (R-FL), Senator Chris Coons (D-DE) and Senator Mike Enzi (R-WY).

Congress_Panel_AIDS2012.jpg
From left to right: Congresswoman Lee, Senator Rubio, former Senator Frist, Senator Coons and Senator Enzi

Continue Reading

Uncategorized

BRCA gene case: James D. Watson, co-founder of double helix structure, rejects patentability of DNA and other amici filings

Background
On Friday, July 20, 2012, the Court of Appeals for the Federal Circuit will re-hear the case Association for Molecular Pathology, et. al. v. United States Patent and Trademark Office, et. al. This case, involving the patent eligibility of DNA–specifically claims directed at two human genes, BRCA1 and BRCA2, associated with an individual’s susceptibility to breast cancer–has been litigated for three years now and has resulted in fractured rulings and widely varying reasoning.

Continue Reading

Uncategorized
2

KEI and UAEM file brief as amici curiae in BRCA gene patent case

On Friday, June 15, 2012, Knowledge Ecology International (KEI) and Universities Allied for Essential Medicines (UAEM) filed as amici curiae in the case Association for Molecular Pathology, et. al. v. United States Patent and Trademark Office, et. al which is currently being heard before the Court of Appeals for the Federal Circuit. The full brief is available for download here.

Continue Reading

Uncategorized