…The incentives to innovate provided by the patent system depend above all on predictability. Only with the knowledge that patents will provide some period of exclusivity will innovators continue to make the massive investment of time and resources needed to develop innovative diagnostic tests and deliver these life-changing products to patients in need.
Intellectual Property Position Statements
The Coalition for 21st Century Medicine’s Intellectual Property Workgroup is deeply committed to advocacy for protection of intellectual property rights for innovators and accordingly the IP Workgroup has prepared Amicus Briefs in several Federal Court of Appeals and Supreme Court landmark cases. The Coalition has also drafted comments and met directly with the United States Patent and Trademark Office leadership on the issues surrounding patent eligible subject matter.
The collective experience of the Members of the Coalition for 21st Century Medicine in trying to obtain much needed patent protection for their novel, life-saving technologies has led to one inescapable conclusion: It is critical to the future of precision medicine that the Supreme Court review the Federal Circuit’s decision in Ariosa Diagnsotics, Inc. v. Sequenom, Inc.
…The Coalition is concerned about the restrictive interpretation of § 271(a) adopted by the panel majority in this case, Akamai Techs., Inc. v. Limelight Networks, Inc., Nos. 2009-1372, -1380, -1416, -1417, (Fed. Cir. May 13, 2015). This standard permits potential infringers to divide the steps of diagnostic method claims among multiple parties to circumvent patent infringement liability, jeopardizing the ability of innovators to enforce their patents.
We greatly appreciate the USPTO’s outreach to the patent user community in its efforts to revise and improve its March 4, 2014 examination guidance for the determination of subject matter eligibility of claims relating to products and processes derived from natural sources or materials.
…This case concerns whether material derived from human genes — isolated DNA — is patentable subject matter under Section 101 of the Patent Act. Amicus believes that efforts to undermine DNA sequence patents in the United States endanger this future by pushing inventors away from molecular diagnostics technology. Without their continued investment, private industry will no longer be able to subpport the same breadth of expensive and complex research, development, and commercialization of these critical health care products. This will cause serious harm to the well-being of patients who would otherwise benefit from personalized medicine. In view of amicus’s role in the genetic diagnostic field, it has a unique perspective on and keen interest in the question presented.