Skip Page Banner  
Skip Navigation

Myriad Criticized for Lack of Guidance, Putting Too Much Focus on Section 101

Thursday, June 20, 2013
By Natasha Dhillon

The Supreme Court's recent Myriad decision is just the latest in a long string of “failure[s] in judicial lawmaking” when it comes to patent eligibility, former Chief Judge of the U.S. Court of Appeals for the Federal Circuit Paul R. Michel said June 17.

Michel, speaking at a Bloomberg Law sponsored webinar, titled “Interpreting Myriad: Gene Patenting and Other Inventions at Risk,” criticized the high court for failing to provide guidance and suggested that Congress, and not the courts, should be leading the charge on issues of patent reform.

Another speaker, Erika H. Arner, a partner at Finnegan, Henderson, Farabow, Garrett, & Dunner, Reston, VA, argued that if Myriad provides little guidance it is because the Supreme Court placed too much focus on defining Section 101 of the Patent Act, 35 U.S.C. § 101, and failed to consider the entire patent statutory scheme and settled Patent and Trademark Office practice.

The final speaker, Thomas G. Saunders, a partner at Wilmer Cutler Pickering Hale and Dorr, Washington D.C., also criticized Myriad for offering little reassurance that its impact will be limited to human DNA or composition matter claims.


Distinguishing Naturally Occurring Genetics
Arner began the discussion by noting that Association for Molecular Pathology v. Myriad Genetics Inc., No. 12-398 (U.S. June 13, 2013) (115 PTD, 6/14/13)had created a distinction focusing on whether the gene at issue is naturally occurring or required some form of human manipulation.

The panelists seemed to agree that this brings up the question of how to define “naturally occurring,” but were also concerned that the court was creating different eligibility rules depending on the type of technology without considering future technology.

Arner also thought the court was asking Section 101 “to do too much.” She noted that Section 101 is short and broad and is supposed to be read in conjunction with the other subsections, such as Sections 102, 103, and 112, on novelty, obviousness, and written description respectively. However, she stated that the court has become fixated on interpreting and defining Section 101 without considering the other subsections, which has resulted in moving boundaries that are difficult to follow.

Michel, commenting on the court's focus on Section 101, was concerned that a Section 101 discussion would now have to be a part of every patent eligibility claim, an idea he found to be “totally backwards.” With this ruling, he said the court “risks inconsistent judgment making” where “no one can know what is patent eligible.”


Issues Should Be Left to Congress
Michel also thought that Myriad brought up a question other than whether human genes are patentable, and that was who should be answering these type of questions: Congress or the judges?

Focusing on Myriad as the sixth in a line of patent cases starting in the 1970's, he thought these six cases represented a “failure in judicial lawmaking.”

He found Myriad to be another example of the Supreme Court failing to provide adequate guidance, and he said it was an example of “broad judicial activism.”

He criticized the court's reasoning for being based on policy arguments and assumptions rather than the statutory language and a detailed factual record. Pointing to Europe as a good example of how to deal with patent issues, he indicated that these questions should be answered by the legislature, and said he was ready to turn over patent issues to Congress.


Excluding Method Claims Not a Comfort
With method claims left untouched by Myriad, the panel was asked, by the panel's moderator Tony Dutra--who serves as a legal editor for this journal--if the Supreme Court's efforts to limit the ruling to composition matter claims gave them much comfort.

While Arner said it was “nice to see that the court understood the potential consequences,” she noted that “it's hard to think about method claims without thinking about Mayo [Collaborative Services v. Prometheus Laboratories Inc., 132 S. Ct. 1289, 101 U.S.P.Q.2d 1961, (2012) (55 PTD, 3/22/12)].”

Saunders agreed saying, the “carve-out does not give much comfort in light of Mayo.” While the court tried to leave a void, the panelists did not seem optimistic that it exists. Rather they thought the void maybe filled with dicta from Mayo.


Impact on Human DNA and Other Industries
Saunders also discussed Myriad's impact and noted that the most obvious and immediate impact will be seen with claims that look like Myriad. However, he noted that a lot of those claims are due to expire, and therefore, much of the impact will be seen beyond human DNA.

For instance, biotech industries which have a key enzyme in the fuelling process may respond with a delay in seeking patent protection that we haven't seen before, he said. Saunders said these companies will be taking a second look at trade secret protections and pursuing method claims, since this ruling indicates that it will be harder going forward to achieve a composition of matter claim.

To view additional stories from Bloomberg Law® request a demo now