Senate HELP Committee Markup of FDA Bills on Wednesday, April 25, 2012
On Wednesday, April 25, 2012 at 10:00 AM, the Senate Health, Education, Labor and Pensions (HELP) Committee will have an executive session to do a markup of FDA bills.
Author: Krista Cox
Senator Harkin (D-IA) sends letter to President Obama supporting a WIPO treaty for the visually impaired
On Friday, March 30, 2012, Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee sent a letter to President Obama supporting an international treaty for persons who are visually impaired or have other disabilities. The letter urges the Obama administration to achieve several goals in such a treaty, including robust minimum standards that do not diminish the rights provided for under U.S. Continue Reading
KEI Comments to USPTO on Genetic Diagnostic Testing
In response to a Federal Register notice seeking comments on genetic diagnostic testing, KEI submitted comments detailing several proposals with respect to patents on diagnostic technologies and also included notes regarding our position in the American Molecular Pathology v. Myriad Genetics litigation. In addition to the questions listed in Federal Register notice, we recommended that the USPTO address two additional questions:
Unanimous Supreme Court decision invalidates Prometheus diagnostic test patents and reverses Federal Circuit decision
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.
Wyden files legislative amendments to require transparency in TPPA and Congressional approval for ACTA
On March 20, 2012, Senator Wyden (D-OR) filed two amendments to H.R. 3606, a bill known in its short form as “Jumpstart Our Business Startups” or JOBS Act, related to the Anti-Counterfeiting Trade Agreement (ACTA) and the Trans-Pacific Partnership Agreement (TPPA).
KEI Notes From the Eleventh Round of TPPA negotiations in Melbourne, Australia
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The eleventh round of negotiations for the Trans-Pacific Partnership Agreement (TPPA) took place in Melbourne, Australia from 1-9 March 2012. Stakeholders were given the opportunity to present at the stakeholder platform on 4 March, attend a reception on 6 March and the stakeholder briefing on 7 March.
CCIA proposes alternative text for TPPA, but proposals do not address many problems in the text
The Computer & Communications Industry Association (CCIA) recently made proposals for what it considers to be necessary “to make the Internet work” in the Trans-Pacific Partnership Agreement. The proposals put forth either as additions or alternatives to some of what the US has tabled are, in general, a step in the right direction as they seek to improve copyright exceptions and limit liability. Continue Reading
USPTO Holds Public Hearing on Genetic Diagnostic Testing
On February 16, 2012, the USPTO held a public hearing on genetic diagnostic testing, permitting stakeholders to present their views relating to DNA patents, exclusive licensing, patient health and genetic testing, particularly as they relate to secondary or confirmatory genetic diagnostic testing. Notes from the hearing and speaker statements are included below. KEI’s oral statement can be found here.
KEI Statement at USPTO Public Hearing on Genetic Diagnostic Testing
On February 16, 2012, the USPTO held a public hearing on genetic diagnostic testing, pursuant to a Congressional mandate that was part of the America Invents Act. This mandate directed the USPTO to evaluate several questions related to genetic diagnostic testing, particularly with regard to second opinion or confirmatory genetic testing. USPTO will deliver its final report to Congress in June. Notes from the public hearing are available in a separate blog post.
2012: KEI asks Senator Leahy (D-VT) to demand greater transparency in the TPPA
On January 26, 2012, KEI sent a letter to Senator Patrick Leahy (D-VT), Chairman of the Judiciary Committee, calling for greater transparency in the Trans-Pacific Partnership Agreement (TPPA). The letter highlights the fact that the general public is kept in the dark regarding negotiating positions and the actual text while “cleared advisers” and corporate lobbyists have unequal access to information. It calls for Senator Leahy to urge the Obama Administration to release the negotiating text in order to allow full and effective public participation in our democratic society.