The Advanced Medical Technology Association (AdvaMed) has sent a letter to Senate Majority Leader Harry Reid (D-NV) and Minority Leader Mitch McConnell (R-KY) and other senators, expressing support on the recent Managers' Amendment to S.515, the Patent Reform Act of 2009. AdvaMed is the largest association of medical device manufacturers.

The bipartisan agreement on the Managers' Amendment to S. 515 was announced in early March. A Managers' Amendment adds changes agreed to by both parties in advance. Senator Patrick Leahy (D-VT) stated after the amendment was released that changes would make important reforms to the "outdated patent system;" specifically, changes to first-window post-grant review (requests to cancel as unpatentable one or more claims of a patent must be filed within nine months of the granting of the patent), inter partes review (a petition should be filed after nine months after the grant of a patent or issuance of a reissue of a patent), willfulness, interlocutory appeals, Patent and Trademark Office funding, and supplemental examinations. The agreement retains a transition to a first-inventor-to-file system (as opposed to the current "who invented first" determination), the gatekeeper compromise on damages (acknowledging the court's function to identify the methodologies and factors that are relevant to the determination of damages), and the new district court pilot program.

AdvaMed stated in its letter that it was grateful for the changes in the reviews "as these measures decrease the potential for abusive challenges while increasing certainty and improving patent quality" and in retaining the "gatekeeper" compromise and first-inventor-to-file system "because it will promote international harmonization and generate efficiencies."

"We are hopeful for early action and commit to working with the Congress, the administration, and other stakeholders to advance the proposed legislation," the letter concluded.

Senator Leahy's explanation of the Managers' Amendment can be found at: http://leahy.senate.gov/press/press_releases/release/?id=8b0f5bb3-121b-484a-b0b7-092d7bdee1ac

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