On November 30th, 2012, the U.S. Supreme Court will conference and consider whether to review the patent-eligibility of isolated DNA sequences. Our prior post of September 25, 2012 addressed Petitioners’ brief and request for review of the Federal Circuit’s decision that upheld the patent-eligibility of isolated DNA. On October 31st, 2012, Myriad Genetics, Inc. et al. responded and filed its brief in opposition to Supreme Court review (see our post of November 14, 2012). Seven “friend of the court” briefs were filed in support of Petitioners’ request for review and reversal of the Federal Circuit’s decision.

Review and Reverse, Please

The amici curiae parties supporting Petitioner are:

The “Women” urged reversal because the Federal Circuit failed to properly apply the Supreme Court’s analysis set forth in Mayo v. Prometheus, 132 S.Ct. 1289 (2012) (“Mayo”). (Recall, the Mayo decision addressed diagnostic methods, not isolated DNA under consideration in this case.) If the court had applied the Mayo analysis, the Women argued, the claims would lack an inventive concept because the claims add nothing to the law/product of nature to render it patent-eligible. The Women also argued that Myriad’s patents preempt the use of the laws of nature regarding the human genome, e.g., the inability to obtain a second opinion.

The “Academics” similar to the “Women” opined that certiorari is required to redress the “Federal Circuit’s disregard” for the Supreme Court’s Mayo precedent. The Federal Circuit’s legal errors have “introduced confusion into the determination of patent eligibility under § 101” in three respects: (1) it introduced a bright line test of covalent bond-breaking for patent eligibility; (2) it set out two conflicting tests of “markedly different” for determining patent-eligibility; and (3) it wrongly reviewed the claims from the point of view of a chemist, not a geneticist. Brief at pages 4-5. The Academics want guidance on the patent-eligibility of DNA molecules in particular, and compositions of matter in general.   

  • AARP – brief filed October 30th, 2012 [AARP Brief].

AARP argued that patents such as those in the present case significantly elevate the cost of genetic testing, prohibit diagnosis and treatment based a second medical opinions. Limitations on Medicaid and Medicare spending for genetic testing were used as examples of restrictive access.

“Australia” noted that the Australian patent system shares common roots with the U.S.patent system and while the Australian patent system is at liberty to come to its own decisions regarding patent-eligibility, the High Court of Australia is looking to the U.S.for guidance on related patent issues. After a informative review of the relevant U.S.case law regarding the patent-eligibility compositions of matter, Australia came out on the side of Petitioners and argued for narrow application of Diamond v. Chakrabarty, 447 U.S. 303 (1980) to the exclusion of patenting isolated DNA.

Law professors Murray and George urged review and reversal because the Federal Circuit erred by ignoring the Supreme Court’s clear and direct guidance in Medlmmune v. Genentech, 549 U.S. 118 (2007), that a claim of patent invalidity must be examined under “all the circumstances” test that is relevant to determining whether a live controversy exists under the Declaratory Judgment Act. The Federal Circuit also erred by failing to recognize the significant threshold injuries suffered by the individual and organizational plaintiffs engaged in scientific, medical and public health pursuits when the ability to communicate crucial information and engage in inquiry is compromised. These “specific injuries” arose because of Respondents’ patents.

The Canavan Foundation is self-described as a non-profit organization with the mission to provide funding for research efforts for the treatment of Canavan disease through carrier screening and prenatal testing. Other patient groups joined Canavan in filing this brief which argued that, similar to the “Women” and the “Academics”, the Federal Circuit erred in failing to apply Mayo to the claims as issue.

  • American Medical Foundation et al. – brief filed October 31st, 2012 [AMA Brief].

This brief was filed by various medical associations, such as the American Medical Association, the American Society of Human Genetics and the American College of Obstetricians and Gynecologists. Similar to the “Women,” the “AMA” argued that the Federal Circuit should have applied the Supreme Court’s Mayo analysis to the composition of matter claims. As a result, they opined, patient care and medical research will continue to be impeded to the detriment of patients and society.

Nothing New Under the Sun

The amici did not present any new arguments or facts that were not considered by the Federal Circuit and addressed by Respondents’ brief. Many of the amici assumed that without the return on investment that patents provide, the technology will be developed by others to a point where it will be patient-ready. None of the amici addressed who would pay for the validation of new biomarkers and assays without patent protection.