Association For Molecular Pathology et al v. United States Patent and Trademark Office et al

Filing 184

DECLARATION of Jennifer C. Tempesta in Support re: 181 MOTION to File Amicus Brief.. Document filed by Biotechnology Industry Organization. (Attachments: # 1 Exhibit 1, # 2 Exhibits 2-8, # 3 Exhibits 9-12, # 4 Exhibits 13-16, # 5 Exhibits 17-21, # 6 Exhibits 22-24, # 7 Exhibit 25, # 8 Exhibits 26-28)(Tempesta, Jennifer)

Association For Molecular Pathology et al v. United States Patent and Trademark Office et al

Doc. 184 Att. 8

Exhibit 26

Dockets.Justia.com

Secretary's Advisory Committee on Genetics, Health, and Society Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests

For Public Comment from March 9 to May 15, 2009

SACGHS Public Consultation Draft Report for Public Comment from March 9 to May 15, 2009
1915 1916 1917 1918 1919 1920 1921 1922 1923 1924 1925 1926 1927 1928 1929 1930 1931 1932 1933 1934 1935 1936 1937 1938 1939 Myriad's patent enforcement activities have been a source of the majority of the criticism against the company's BRCA1 and BRCA2 patents. A 2003 survey of laboratory directors found nine instances of enforcement of the BRCA patents by Myriad. This same group reported two instances of FAP patent enforcements and no cases of HNPCC patent enforcement. 248 Of 31 collected gene patent litigation cases, 5 of which were related to Myriad disagrees with this characterization and notes that it launched testing for the five most common rearrangements, accounting for approximately one-third of all rearrangements, in 2002. Myriad also asserts that the rearrangement testing it was conducting at the time would have detected roughly one-third of the "missing" cases reported in the JAMA article. The company incorporated more extensive testing for rearrangements in 2006, the same year the JAMA article was published. The general trend for all diagnostic genetic testing has been to move toward more comprehensive analyses that detect deletions and rearrangements, and Myriad's actions have been consistent with the general trend. Indeed, in areas where there is no sole provider, there has been a similar lag in detecting deletions and rearrangements. Part of the delay in developing such analyses could reflect increased technical difficulty in testing for deletions and rearrangements. It was only after considerable pressure from the scientific community that the company added methods to detect these deletions, insertions, and re-arrangements in 2006, over 10 years after they first introduced clinical genetic testing, and barred anyone else from performing the tests. In a competitive marketplace, this delay never would have occurred. 247

Dr. Chung's testimony appeared as an appendix to the written testimony of Dr. Marc Grodman presented to the House Judiciary Subcommittee on Courts, the Internet and Intellectual Property during a hearing held on October 30, 2007. Testimony is available at http://judiciary.house.gov/hearings/pdf/Grodman071030.pdf. 248 Cho, M., et al. (2003). Effect of patents and licenses on the provision of clinical genetic testing services. Journal of Molecular Diagnostics 5(1):3-8. NB: FAP and HNPCC "patent enforcements" are more unlikely, given nonexclusive licensing and multiple rights holders.

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SACGHS Public Consultation Draft Report for Public Comment from March 9 to May 15, 2009
2664 2665 2666 2667 2668 2669 2670 2671 2672 2673 2674 2675 2676 2677 2678 2679 2680 2681 2682 2683 2684 2685 2686 2687 2688 2689 2690 2691 2692 2693 2694 Thus, there is at least the risk that a patent-protected genetic test will have an inflated price; this inflated price, in turn, may reduce how many patients use the test. Licensing many providers may mitigate price inflation. However, various factors other than patenting and licensing affect the price of genetic tests, including ordinary market forces, such as demand and market size (where there is a large market and high demand, the company stands to make considerable revenue even at a lower price). Many of these factors exert a downward pressure on price. For instance, health insurance providers often will not cover a test that is priced too high, so companies choose to keep the price low so that the test will be covered, which in turn makes the test more affordable to patients. Similarly, a company also has an incentive to set its price in the price range of other genetic tests covered by Medicare, Medicaid, and other private payers (by a formula for 102 The case studies attempted to evaluate how patents and licensing practices affected the price of genetic tests, but could not always reach definite conclusions because of difficulties in obtaining relevant data and challenges in determining the relative contribution of various factors, including overhead costs, to price. For two of the case studies (Alzheimer's disease and LQTS), some findings suggest that the price of the patent-protected test was higher than it would have been had the test been unpatented, with the potential that this price is reducing patient utilization of the test. In addition, it appears that the test developers of the Canavan disease genetic test used their patent monopoly to establish restrictive license conditions and sought fees that exceeded what laboratories offering similar tests for Tay-Sachs disease were willing to pay. Angered by these terms, a consortium organized against the patent holder, initiated a lawsuit roughly a year after the license terms were first proposed, and negotiated a settlement that altered the license terms in a way that the plaintiffs apparently considered acceptable. One surprising finding from the case studies was that the per-unit price of the full-sequence BRCA test, which often is cited as being priced very high, was actually quite comparable to the price of other full-sequence tests done by polymerase chain reaction (PCR), at both nonprofit and for-profit testing laboratories. How did patents and licensing practices affect price?

Exhibit 27

Exhibit 28