Kea Enos 2013-12-05 00:16:04
Unstable Ground: The Changing Landscape Of Patentable Subject Matter Recently, the topic of patent eligible subject matter has been a highly argued topic in the United States and several cases have contributed to a shift in what actually is patentable subject matter. 35 U.S.C. §101 establishes that “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” Additionally, §101 of the Patent Act also includes a limitation that patents are not issued on a claim directed to or encompassing a human organism. Patent eligible subject matter has further been limited by courts to exclude abstract ideas, laws of nature and natural phenomena. The field of biotechnology has a long history of being the industry that has significantly shaped the exclusions to patent eligible subject matter of abstract ideas, laws of nature and natural phenomena. It is, therefore, no surprise that it is this same field that is contributing to the current evolution of what is patentable. In Mayo v. Prometheus Laboratories, Inc., 566 U. S. ____ (2012), the Supreme Court limited the exclusion of laws of nature. The Prometheus case deals with patents that cover the use of thiopurine drugs in the treatment of autoimmune diseases, such as Crohn’s disease and ulcerative colitis. Because patients metabolize thiopurine compounds differently the process of the patents help determine whether for a particular patient a given dose is too high, risking harmful side effects, or too low, and so likely ineffective. The court held that the patent claims were invalid and the reasoning for such a holding was summarized by the court by stating, “If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. A patent, for example, could not simply recite a law of nature and then add the instruction ‘apply the law.’” The Supreme Court’s decision in Association for Molecular Pathology, Inc. v. Myriad Genetics, Inc., 133 S.Ct. 2107 (June 13, 2013) has also served to limit what is patent eligible subject matter. Myriad Genetics owns seven patents related to a test for mutations in BRCA1 and BRCA2 genes. It was discovered that mutations in these genes can increase an individual’s risk of developing breast and ovarian cancers. Myriad’s claims related to isolated DNA sequences created by extracting DNA from cells, and synthetically created complementary DNA or cDNA. The patents gave Myriad the exclusive right to isolate an individual’s BRCA genes and the exclusive right to synthetically create BRCA cDNA. In its decision, the court held “that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that [complimentary DNA] is patent eligible because it is not naturally occurring.” The Prometheus and Myriad cases are now added to the likes of Chakrabarty and Bilski in hopes of establishing guidelines as to what is and is not patent eligible subject matter. Particularly, from Prometheus and Myriad, we now know that isolated DNA is not patentable, while synthetic cDNA is patentable and a process reciting a law of nature is not patentable, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. The U.S. Patent and Trademark Office (USPTO) is now taxed with the duty of implementing these newly created guidelines in its examination of patent applications. Additional cases have been heard on the federal circuit level, such as CLS Bank Intern. v. Alice Corp. Pty. Ltd., 717 F. 3d 1269, 106 U.S.P.Q.2d 1696 (Fed. Cir. 2013) (en banc), that will contribute to this changing landscape of patent eligible subject matter. What is readily evident from these cases is that the USPTO and the courts often view patentable subject matter differently. The fact that a particular patent is granted is not determinative that a court will maintain that the same patent is directed to valid patent eligible subject matter. Therefore, the writing of a patent application must consider not only the examination of the patent application by the USPTO and how it will implement any new guidelines, but must also consider how that particular patent application will stand up in a court when the validity is challenged as non-patentable subject matter. It becomes even more critical that inventors utilize patent counsel to assist in navigating through this ever evolving patent eligible subject matter. From the America Invents Act to newly decided Supreme Court cases that provide additional guidelines as to the validity of patents, it can be seen that the patent laws are not static. It becomes increasingly more important for businesses to establish a dynamic plan for handling inventions developed by and for the company. This dynamic plan must have a certain amount of fluidity to allow it to morph and change with any change that the patent laws may undergo. Yet, through all of this change, a constant that remains is if you have a difference that makes a difference, then that difference is patentable. Kea Enos is a partner of Schmeiser, Olsen & Watts LLP and is admitted to practice in Arizona and before the United States Patent and Trademark Office. Schmeiser, Olsen & Watts was recognized in March 2012 by Intellectual Property Today as one of the Top Patent Firms in the United States with 535 patents issued for clients in 2011. Kea provides services in all areas of intellectual property, particularly patents, trademarks and copyrights. For a free initial consultation call 480-655-0073. To learn more about Kea or his firm, go to www.iplawusa.com.
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