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Congress needs to amend the law on patent eligibility to counter recent Supreme Court decisions that have made it harder for life sciences companies to protect their intellectual property, attorneys told a conference.
The panelists discussed an Intellectual Property Owners Association (IPO) proposal that Congress amend 35 U.S.C. §101 in response to high court decisions that found certain claims for biological materials like DNA and for diagnostic methods are patent ineligible as products or laws of nature, one of three court-developed exceptions to patent eligibility.
“Something needs to be done because the entire situation concerning Section 101 is a mess,” said David Boundy, a partner at Cambridge Technology Law and a panelist at the BIO IP Counsels Committee Conference in Newport Beach, Calif., on March 27.
Amending Section 101 has been a concern in the life sciences patent community over the past few years. Speakers at the 2015 Biotechnology Innovation Organization (BIO) international convention also called for amending the section ( 09 LSLR, 6/26/15 ), and these calls continued at the 2016 conference, along with recognition of the challenges of getting an amendment through Congress ( 10 LSLR, 6/24/16 ).
The IPO‘s proposal is designed to:
“At this point in time, with all that is going on, I would say the answer is no. But the approach has to include addressing the Supreme Court’s concerns that led to its decisions, that the practice of medicine and innovation are being adversely affected. We can consider giving exceptions for physicians who are worrying about being sued for infringing a diagnostic method patent in the course of their practice and to medical researchers who are also afraid of infringement suits as they try to find new drugs,” Noonan, a Bloomberg BNA advisory board member, said.
Noonan continued, “Such action could eliminate some or all of the reasons behind the court’s decisions.”
Robert Sachs, another panelist and a partner at Fenwick & West, told Bloomberg BNA his work on the IPO task force on the proposed amendment focused on the language, but he knows others who are having discussions with policymakers about the IPO’s proposal. “We developed the language of the proposal, and the language is the underpinning, the architecture of future discussions. Things can be added, clarified and simplified further.”
Sachs noted at the session, Congress revised the Patent Act in 1952 to clarify problems of interpretation of the patent law. Before then, the U.S. patent law relied on an arbitrary and subjective “invention” standard of patentability. In part as a reaction to this, Congress passed the Patent Act of 1952 with the intent that the scope of patent-eligible subject matter be broad and that patentability would be determined on objective basis, Sachs said. Section 101 defined eligibility simply; and whether the invention was patentable was determined by analysis of the other sections of the patent law.
In 1982, Congress created the U.S. Court of Appeals for the Federal Circuit to bring consistency in patent law interpretation and solve conflicts from earlier Supreme Court decisions as a result of technology and circumstances changing over time, Noonan said. “The Supreme Court let the Federal Circuit have its legs for a long stretch, but in this last decade it has come back with a vengeance. Most of these decisions were the court overturning the Federal Circuit’s bright line rules, feeling the Federal Circuit had gone too far, strayed from precedent and that patent law is not special after all.”
“But the Supreme Court isn’t the last word on this, and, in fact, the court has said that it is interpreting what Congress has written and that Congress can amend it,” he added.
Sachs said the IPO proposes the creation of three parts of Section 101. Section 101(a) would read: “Whoever invents or discovers and claims as an invention any useful process machine, manufacture, composition of matter, or any useful improvement thereto, shall be entitled to a patent for a claimed invention thereof, subject only to the exceptions, conditions and requirements set forth in this Title.”
The main changes, Sachs said, are: the deletion of “new” from the current wording, which is “new and useful;” the insertion of “claims as an invention;” and acknowledging the existence of exceptions to patent eligibility, which were basically developed in court decisions.
There are currently three court-created exceptions to patent eligibility: law or product of nature, abstract idea and natural phenomenon. “We wanted to clarify and simplify the exception issue and basically close the door on any more exceptions,” Sachs said.
According to Sachs, Section 101(b) would describe the sole exception to eligibility: a claimed invention is ineligible only if it, as a whole and as understood by a person having ordinary skill in the art to which the claimed invention pertains, exists in nature independently of and prior to any human activity, or exists solely in the human mind.
Section 101(c) would state that determination of patent eligibility under Sections 101(a) and (b) shall be determined without regard to the requirements of Sections 102, 103 and 112.
To contact the reporter on this story: John T. Aquino in Washington at email@example.com
To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com
The IPO's Section 101 proposal is at http://src.bna.com/npE.
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