[author: Donald Zuhn]

As part of its efforts to implement the Leahy-Smith America Invents Act, the U.S. Patent and Trademark Office issued a Federal Register notice (77 Fed. Reg. 3748) earlier this year indicating that the Office had begun to collect information on independent second opinion genetic diagnostic testing where patents and exclusive licenses exist that cover primary genetic diagnostic tests (see "USPTO News Briefs," January 26, 2012).  This collection of information was needed in order for the Office to fulfill its obligations under § 27 of the AIA to prepare a report on genetic diagnostic testing for submission to the Committee of the Judiciary for both the Senate and House.

In the first phase of the Office's information gathering process on genetic diagnostic testing, the Office held two public hearings on the matter.  Readers may recall that Patent Docs author Kevin Noonan testified at the first of these hearings in February (see "Patent Docs Author Testifies at Genetic Diagnostic Testing Hearing"; "USPTO Holds First Hearing on 'Second Opinion' Genetic Testing").  In the second phase of this process, the Office asked members of the public to submit written comments on several topics presented in AIA § 27 or any of the additional issues presented in the Office's Federal Register notice.

To provide the public with access to comments that were submitted in response to the Office's request, a webpage on genetic diagnostic testing has been established as part of the Office's AIA implementation site.  The Office has divided the thirty submissions into those from:

• Intellectual property organizations -- includes comments from the American Bar Association (ABA) Section of Science and Technology Law and Section of Intellectual Property Law, American Intellectual Property Law Association (AIPLA), Association of University Technology Managers (AUTM), Intellectual Property Owners Association (IPO), and Pharmaceutical Research and Manufacturers of America (PhRMA).

• Academic and Research Institutions -- includes comments from Duke Institute for Genome Sciences and Policy.

• Companies -- surprisingly includes comments from organizations such as the American Civil Liberties Union (ACLU), American Medical Association (AMA), and Myriad plaintiffs American Society for Clinical Pathology (ASCP), Breast Cancer Action, and College of American Pathologists (CAP), along with those from companies such as Myriad Genetics and Prometheus Laboratories; other commenters include Bio-Reference Laboratories, Cancer Legal Resource Center, Genspace, Knowledge Ecology International, National Society of Genetic Counselors, and joint comments from Roche Molecular Systems and Abbott Laboratories.

• Individuals -- divided into "practitioners" and "others," with the latter including Dr. Wendy Chung, a plaintiff in the Myriad case, and Dr. Luigi Palombi, who spearheaded a campaign against the BRCA gene patents in Australia, which resulted in an Australian Senate Inquiry into gene patents, and six other commenters (James Evans, Sharonmoyee Goswami, Lori Pressman, Pamela Scudder, Rochelle Shoretz, and Brenda Simon), and the former including comments from three practitioners (Christine Gritzmacher, Siu Lo, and Suzannah Sundby).

It would be difficult to adequately cover the full range of comments submitted in response to the Office's notice in a single post, so Patent Docs plans to examine a number of the submissions in subsequent posts.  Today, we look at the comments submitted by the IPO.  In its submission, the IPO focuses on the issues raised in Questions 8 and 9 of the Office's notice, which are as follows:

(8) What effect would providing more widespread access to independent second opinion genetic diagnostic tests have on existing owners and license holders of patents that cover genetic diagnostic tests?  How should policy makers consider the relationship of patents, which may cover purified genetic substances, to proprietary data derived from conducting tests, each of which may be useful in both improving high quality and wide access to testing but may also provide important competitive advantages that can drive investments in research and development?

(9) What effects, if any, do patents and exclusive licenses have on genetic diagnostic testing?
    (a) What effects, if any, do patents and exclusive licenses on genetic diagnostic tests have upon the development of new testing procedures?
    (b) What effects, if any, do patents and exclusive licenses on genetic diagnostic tests have upon how new testing procedures are performed?
    (c) What effects, if any, do patents and exclusive licenses on genetic diagnostic tests have upon the interpretation of testing results?
    (d) What effects, if any, do patents and exclusive licenses on genetic diagnostic tests have upon the further improvement of testing procedures?

With respect to Question 8, the IPO contends that "compelling patent owners to grant licenses for the purpose of permitting third parties to provide second opinion genetic diagnostic tests would have a detrimental effect on the U.S. patent system," by "undermin[ing] the incentive created by the patent system to create new tests, as well as to design around existing patents to provide tests that are comparable to existing tests."  In response to Question 9, the IPO states that "exclusive licenses do not materially reduce the availability of second opinion genetic diagnostic tests, as these tests are usually available from the patent owner or another licensed provider."

The IPO notes that the phrase "confirming genetic diagnostic testing activity" in the AIA encompasses a "very narrow category" of activity, namely providing an individual with independent confirmation of results obtained from another test provider’s prior performance of a test on the individual.  According to the IPO, this is not the type of second opinion that most patients seek.  The IPO suggests instead that "most patients who are seeking second opinions are asking for second medical opinions, not for second diagnostic tests performed by a different testing facility," adding that "[t]he existence of patents and exclusive licenses does not impair in any way patients’ access to second medical opinions" (emphasis added).

In addition, the IPO points out that "while labs [that conduct genetic diagnostic testing and utilize genetic diagnostic products] can be affected by the enforcement of patents, it is diagnostic companies that are most directly affected."  The IPO explains that "[i]f a diagnostic company is excluded from offering a genetic diagnostic test, in most cases, hospitals and reference labs can obtain the desired test from another genetic diagnostic company that is not excluded (either the patentee or the licensee)."

The IPO also notes that "[i]t is rare that a single type of test for a single gene provides independent diagnostic capability," adding that "due to evolving case law in the area of biotechnology, patents for these types of diagnostics are increasingly difficult to obtain and are even more difficult to obtain with a broad claim scope."  However, when confronted with these rare situations, the IPO contends that a diagnostic company has many options:  "It can look for alternative markers (which is typically done), license a number of patents needed to make the complete diagnostic, or choose to license and sell a diagnostic that comprises part of the diagnostic solution sought."  In addition to encouraging diagnostic companies to design around a patented test, "[f]orcing those who have not invented to license provides an economic incentive to invent in the first place and rewards the inventor for doing so."  The IPO argues that if such patents are unavailable or required to be licensed on a compulsory basis, "there will be little incentive for diagnostic companies to conduct or sponsor research in these areas."

The IPO concludes its comments by declaring that it would be "a mistake to weaken the patent system in the area of genetic diagnostic testing."