Through a bipartisan effort, a draft bill proposes clarifying patent eligibility requirements. Under U.S. patent law, patent eligibility is delineated in Title 35 U.S.C. §101. The scope of patent eligibility is “[w]hoever invents or discovers any new and useful process, the machine, manufacture, or composition of matter, or any new and useful improvement thereof. . . .[1]” The precedent set by the Supreme Court excludes the patent eligibility of naturally occurring isolated human genes from the scope of 35 U.S.C. §101 and safeguards against anyone from having an exclusive claim of right with regards to ‘products of nature.’ Yet, there are limitations on what is considered a ‘product of nature.’ As noted in Mayo v. Prometheus, “[a]ll inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas,” and “too broad an interpretation of this exclusionary principle could eviscerate patent law [2

In Association for Molecular Pathology et al., v. Myriad Genetics, Inc., the petitioner sought to eliminate the exclusive patent rights Myriad Genetics, Inc. had in isolating the BRCA-1 and BRCA-2 genes and sought to eliminate Myriad’s exclusive right to synthetically create BRCA-1 and BRCA-2 genes for research purposes. The issue became whether cDNA BRCA-1 & cDNA BRCA-2 falls within the definition of an invention or discovery as defined by the statutory requirements of 35 U.S.C. §101, thus making it patent-eligible? The Court reasoned, the process of making cDNA BRCA-1 and cDNA BRCA-2 in and of itself is not a discovery, thus not patent-eligible.

The draft legislation proposed by Senator Chris Coons (D-DE) and Senator Tom Tills (R-NC) proposes changing 35 U.S.C

Section 100: 

(k) The term “useful” means any invention or discovery that provides specific and practical utility in any field of technology through human intervention.

Section 101: 

(a) Whoever invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

(b) Eligibility under this section shall be determined only while considering the claimed invention as a whole, without discounting or disregarding any claim limitation.

The provisions of section 101 shall be construed in favor of eligibility.

No implicit or other judicially created exceptions to subject matter eligibility, including “abstract ideas,” “laws of nature,” or “natural phenomena,” shall be used to determine patent eligibility under section 101, and all cases establishing or interpreting those exceptions to eligibility are hereby abrogated.

The eligibility of a claimed invention under section 101 shall be determined without regard to: the manner in which the claimed invention was made; whether individual limitations of a claim are well known, conventional or routine; the state of the art at the time of the invention; or any other considerations relating to sections 102, 103, or 112 of this title.

As a means of drafting a final bill that finds a balance and decides where to draw the line, a three-part series of hearings titled “On the State of Patent Eligibility in America” was convened by the Senate Judiciary Intellectual Property Subcommittee. In his opening statement, Sen. Coons (D-DE) emphasized the proposed draft will not make any changes to the precedent set by the Supreme Court in Myriad that prohibits the patent eligibility of genes as they exist in their natural state.

In Chairman Thom Tillis’s (R-NC) opening statement he noted:

“Our [draft] bill is a good faith attempt to produce consensus and to address the issues raised by both sides.”

Ranking member Sen. Coons (D-DE) stated the main reason for having these hearings is that there is that the gold standard for patent protection is being eroded by  recent decisions by the Supreme Court.  Further stating that:

“I worry that this continuing lack of clarity…in the law, has led to reduced investment…”  “For medical diagnostics this uncertainty has led really to a presumption against eligibility that is nearly impossible to overcome.”

Sen. Coons (D-DE) went on to state the purpose of the hearings is to have stakeholders from diverse backgrounds, many of whom will not agree with some of the proposed legislation, voice their opinions.  And that they did.

Testimony, given by a former federal judge, asserted that the uncertainty of the law concerning the patent system is a fundamental issue. He stated there is difficulty in predicting whether your patent will become patent-eligible based on the law. He further commented that the draft proposal would be an improvement to the current case law and correctly abrogate the entire case law of the Supreme Court.

Another stakeholder, a patent lawyer, posed the question-What happens when the patent system goes too far? He stated patents should spur innovation with the expectation of collaboration. However, before the Mayo decision, when naturally occurring genes were patentable, science was stifled because of continued threats of patent liability. Furthermore, he noted there are concerns about what the proposed legislation would do with drug prices, access to medicines, and whether the American people would still experience the benefits of a competitive market. In a direct response to this testimony, another stakeholder gave her opinion based upon a more personal note. She spoke about how the patent eligibility of a naturally occurring product saved her life. She went on to say that this was before the Myriad decision when a company was granted a patent to a naturally occurring product. Through research and development, the company developed the product into a drug that was later marketed by a pharmaceutical company for her treatment.

The testimony during this hearing reflects the diversity of arguments surrounding patent eligibility. Based upon the testimony, the draft bill would need to strike a balance between developing a concise definition of patent eligibility and guaranteeing more protections for patent holders while still encouraging innovations and continued development through collaboration without fear of litigation. Whether a proposed bill this ambitious could ever become law is yet to be determined. But what is certain is that it should not be drafted with the intent to start anew; this would only lead to more confusion and uncertainty. If this draft bill becomes incorporated with Title 35 U.S.C. it should be taken into consideration with the current precedent set by the Court and used as a tool for clarification on the point of patent eligibility requirements.

[1] Title 35 U.S.C. §101

[2] Mayo v. Prometheus, 566 U.S. (2012).