By Donald Zuhn --
Yesterday, we reported on a session of the Biotechnology Industry Organization (BIO) Intellectual Property Counsel's Committee fall conference, which took place earlier this week in Nashville, TN, in which the U.S. Patent and Trademark Office provided a status update regarding forthcoming revisions to the Myriad-Mayo Guidance. Also participating in the session on "Protecting Products of Nature," were Dr. Fangli Chen of Choate Hall & Stewart LLP (who moderated the session); Henry Gu, Director, Intellectual Counsel for Cubist Pharmaceuticals; Dr. Steve Bossone, Vice-President of Intellectual Property for Alnylam Pharmaceuticals; and Hugh Goodfellow of Carpmaels & Ransford LLP.
Following a presentation by June Cohan, Legal Advisor with the USPTO's Office of Patent Legal Administration (see "USPTO Provides Update on Status of Revised Myriad-Mayo Guidance"), the other panelists discussed the biotech industry's reaction to the Guidance, the impact of the Guidance on industry, and the view on the Guidance from abroad. Mr. Gu kicked things off by addressing the industry reaction to the Guidance, which he succinctly described as "uniformly negative." Noting that natural products are an invaluable source of drug development, Mr. Gu stated that "[d]rug compositions derived from natural products are disproportionately used to treat high-need diseases," and in particular, infectious diseases. He provided examples of two such drugs marketed by Cubist Pharmaceuticals: Cubicin®, which is used to treat Staphylococcus aureus (MRSA), and DIFICID®, which is used to treat Clostridium difficile-associated diarrhea (CDAD). Pointing to the global healthcare crisis stemming from antibiotic resistance, Mr. Gu argued that "[u]ndue restrictions on patentable subject matter would hinder drug development" in this area as a result of the Guidance's "chilling effect on innovation."
With respect to the Guidance, Mr. Gu took issue with its "significantly different" test, which he argued went beyond the Supreme Court's patentable subject matter decisions and "extends further than necessary in restricting patentable subject matter." In particular, he contended that in decisions such as Myriad, Mayo, and Funk Brothers, the Court's holdings were narrow and did not address whether claimed subject matter derived from natural products was patent eligible. Mr. Gu noted that Justice Frankfurter, in a concurring opinion in Funk Brothers, had cautioned against an expansive reading of the decision. He also took issue with the Guidance's focus on structural differences as a means of satisfying the significantly different standard, arguing that the Office should permit applicants to demonstrate patent eligibility by using functional differences, new utility, and other characteristics. Mr. Gu concluded his portion of the presentation by providing a list of other issues with the Guidance, including that it conflates a § 101 analysis with §§ 102 or 103 analyses, promotes an analysis in which the claim is not examined as a whole, is at odds with the Constitutional mandate to promote the progress, raises international concerns by violating international trade agreements, undermines global patent harmonization efforts, and was implemented despite a "complete absence of a policy justification."
Following Dr. Gu's presentation, Dr. Bossone tried to put a human face on the issue as well as provide examples of real-world § 101 rejections that Alnylam Pharmaceuticals had received. He stated that it was important to put a human face on the Guidance's impact, noting that the patents at issue in Myriad had allowed the company to develop a test that has saved numerous lives. As for Alnylam, he noted that the company had received approval in 2009 to test its drug in cancer patients who had not responded to any other treatment and that one individual had responded to the drug and was alive today as a result. Turning back to the specific examples, Dr. Bossone pointed out that under the Guidance issued in March, Alnylam had had some success in overcoming rejections, but that this success had required a showing of structural differences, and not functional differences.
Mr. Goodfellow closed the panel discussion by discussing the view on the Guidance from abroad. The European patent attorney began by declaring that "I hate to be smug," and then explaining that patent eligibility was one issue on which Europe had been out front. In particular, he pointed to EU directives 98/44/EC, which "looks prescient" in view of the developments in the U.S. In arriving at the EU directives, Europe recognized that innovation in the biotech industry is high risk, while also recognizing the dignity of the human person. More importantly, the directives explicitly recognized that the patent system should allow the patenting of things isolated from an organism that are identical to natural products in order to encourage applicants to develop new drugs. He noted that in Europe, identity is not a barrier to patentability as long as an application describes the industrial applicability of the claimed subject matter. Mr. Goodfellow then turned to a discussion of Myriad's and Prometheus' European patents, which he noted had not experienced the same problems as in the U.S. As for the impact of the Guidance on European applicants, Mr. Goodfellow remarked that "the UK is confident that [the U.S. is] going to sort out this mess." U.S. applicants and practitioners hope he is right.