By CRG Staff

Among almost 100 pages of amendments to HR 1240, the America Invents Act (also known as the Patent Reform Act) recently introduced in the House of Representatives, a provision was included to establish a safe harbor for second opinion genetic diagnostic testing providers. Introduced by Congresswoman Debra Wasserman Schultz (D-Fla.), the language appeared to be a response to last year's report by the now defunct Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) entitled Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests. In that report, SACGHS found that:

... trends in patent law appear to pose serious obstacles to the promise of these developments [ in genetic research and clinical practice]. Patenting has moved upstream; instead of covering only commercial products, patents can now control foundational research discoveries, claiming the purified form of genes. Fragmented ownership of these patents on genes by multiple competing entities substantially threatens clinical and research use.

 SACGHS recommended several statutory changes, including:

... the creation of an exemption from liability for infringement of patent claims on genes for anyone making, using, ordering, offering for sale, or selling a test developed under the patent for patient-care purposes.

While seemingly simple and certainly well intentioned, the amendment set off a firestorm of protest from plaintiffs and their supporters in the ongoing Myriad gene patent litigation (including the American Medical Association and the Council for Responsible Genetics). In a letter to ranking members in the House Rules and Judiciary Committees, the ACLU argued that:

The proposed language would fail to block all patent holder objections to such testing, fails to address the many other limitations on scientific research arising out of the issuance of such patents, and risks allowing gene patent holders to argue that Congress implicitly endorses the validity of such patents.

As a result of the outcry, the Congresswoman quickly backtracked, replacing the original language of her amendment with language that would "conduct a study on effective ways to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist." While a significant improvement and a victory for those opposing gene patents, the change of language failed to satisfy many of the opponents who did not see the need for a seemingly duplicative study and remained concerned that any mention of gene patents by the Congress might influence ongoing litigation.

Nevertheless, the new language remains in the now House passed version of the bill.

The future of this provision is still in some doubt, however, as opportunities to eliminate it remain viable. A previous Senate passed version of the Patent Reform Act failed to include similar language, and so it remains to be seen whether such language will survive any formal or informal conference between the two Chambers to reconcile the bills. Any compromise would then have to be passed by both the House and Senate.

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