The Patent Copyright Clause, United States Constitution, Article 1, Section 8: To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.
35 U.S. Code § 101 - Inventions Patentable: 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.
Mark Benedict, Knobbe Martens, provided an introduction to patentable subject matter. The U.S. Constitution and the legislation passed by Congress was the basis for the 1980 Chakrabarty case where by the Supreme Court held that a live human made micro organism is patentable under 35 U.S. Code § 101. This judicial interpretation has been incremental for patents and the growth of the biotechnology industry.
In 2013, the Supreme Court came out with the Myriad decision whereby they held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. However, the Supreme Court did come to the conclusion that synthetic cDNA is patent eligible because it is not naturally occurring.
On March 4, 2014 the United States Patent and Trademark Office (PTO) issued a guidance, Myriad - Mayo Guidance, for determining subject matter eligibility of claims reciting or involving laws of nature, natural phenomena, and natural products. The guidance was designed to implement new procedure for determining subject matter eligibility of claims under 35 U.S.C. § 101 in view of the Supreme Court decision.
Hans Sauer, BIO, has not been hearing the conventional questions but rather whether or not they can even be considered to be patented. When the Supreme Court decision came out a lot of companies were unconcerned. At face value it looked like a narrow decision, however, the opinion is ripe to be extended. Between 8,000-9,000 issued patents have been initially impacted by the decision.There has never been a Supreme Court case whereby this many patents have been affected.
Additionally, effects of the Myriad decision have been seen out the DNA area, including enzymes and purified proteins. The question for these patents is that they are isolated in a fashion similar to DNA as addressed in the Supreme Court decision. The PTO has a long standing rule against placing a patent on naturally occurring things. Further, the language in decision clearly states that you cannot patent things that occur in nature. The PTO arrived that many thing that are not DNA must be interpreted similarly. Similar areas include fermentation products, cell cultures, organic crop protection products, mineral compositions, certain food products, and distillation products.
The way in which the PTO chose to interpret the decision has resulted in significant criticism. The PTO invited written comments. Due to the great concern about innovation and investment, the PTO is revising the guidelines. It is important to note that the patents in question remain patentable in many of our trading partners. Our major trading partners, including Japan, Australia, Canada, and Europe allow for these patents to be approved. Filing overseas and waiting until the revised guidance is issued is the best bet at the moment.
Jason Jardine, Knobbe Martens, explained that the guidelines from the PTO have basically extended the law to the point that the PTO examiners look at the underlying DNA claim. Since the guidelines have been released not many patents have made it through in this area. Clients of Knobbe Martens have been advised to wait to file a patent and see the new the PTO guidelines. Teresa Spehar, Synthetic Genomics, has also found that the examiners are reluctant to approve patents and rather force applicants through the appeal process. Sauer explained that even when you try to tweak a claim for approval, you lose a lot of scope, sometimes to the point where it becomes so narrow that you cannot commercially use it.
It is important that the PTO issues a clear guidance that people can get behind and know what the industry is facing. Certainty is imperative to moving the industry forward.