Sherry Knowles Responds to ACLU’s Urgent Phone Briefing and Letter Opposing Reform to Section 101

Sherry Knowles

This morning, the American Civil Liberties Union (ACLU), which will be represented in Wednesday’s hearing on Section 101 reform by Senior Legislative Counsel Kate Ruane, announced an urgent phone briefing for members of Congress and staff to address the contention that the “Proposed Patent Bill Would Jeopardize Health Care and Harm Medical Research.”

The phone briefing, which all interested stakeholders should join, takes place today at 2:30 pm EST and will be jointly held by representatives from the ACLU, the Association for Molecular Pathology, a breast cancer survivor and patient, My Gene Counsel, and Invitae. Anyone who would like to listen should dial in to the number provided here.

Below, Sherry Knowles, a well-known patent attorney, policy expert and also a breast cancer survivor, rebuts the arguments made in both the ACLU’s briefing announcement and associated letter to Congress on this topic.

The ACLU excerpts referenced below are available in their entirety here and here.

ACLU: “We will hold a joint telephone briefing to discuss a recent legislative proposal that would reverse 150 years of court precedent—as well as three recent unanimous Supreme Court decisions—and allow corporations to patent genes.”

Sherry Knowles (SK):

• The doctrine of statutory stare decisis (i.e., 150 years of court precedent), if at all, ONLY pertains to litigation between parties in court, according to the Supreme Court. It has NO effect at all on policy discussions in Congress. Any entity arguing to Congress that it must maintain the Supreme Court’s judicially created exceptions and the Alice rubric because of the Court’s 150 years of statutory stare decisis is flat wrong as a matter of law. Even the Supreme Court does not believe that. Congress is free to legislate any patent policy it decides is in the country’s best interest regardless of prior Supreme Court law. See Kimble v. Marvel Entertainment (135 S. Ct. 2401; 2015)

• Isolated gene segments (not human full-length DNA) were patentable in the United States for 15 years prior to Myriad. They are currently patentable in China, Europe, Russia, Japan, South Korea and other countries, which handle such inventions in the normal course, and these countries have not had serious issues with it. It is absolutely reasonable and appropriate for Congress (and their responsibility under the Constitution) to consider whether the Myriad decision is correct or whether it has caused the U.S. to be less competitive globally, to have a research infrastructure that motivates fewer inventions in the area of personal diagnostics, and fewer new cancer drugs and antibiotics (which may be isolated natural products).

• The proposed bill in fact would restore patent eligibility to the state that it was historically for over 200 years of American history.  Many are convinced it is the historic, pre-Myriad, Mayo, Alice application of patent eligibility that made the U.S. the successful country it is today. Many take the position that the unanimous Supreme Court decisions which ACLU references were contrary to decades of case law and USPTO practice, invalidated thousands of patents, demotivated investment in American companies and stopped fundamental research in certain areas. This is worthy of a Congressional discussion.

ACLU: “The draft legislation would amend Section 101 of the Patent Act to permit the patenting of products and laws of nature, such as human genes, other naturally occurring matter and relationships, and abstract ideas.”

SK:

• The use of the words “human genes” or “genes” is inappropriate because the public can get that confused with genes and whole DNA in their body. This can lead to incorrect emotionalism. The issue relates solely to isolated gene segment outside of the body. At that point it is a chemical just like any other biotech product. To the extent that an isolated segment contains “information” then all chemicals, and certainly biotech products, contain “information”.
• There is NOTHING in this legislation that would allow for the patenting of laws of nature or abstract ideas. Those have always been excluded based on the literal wording of Section 101 as interpreted by legislative history. Only APPLIED discoveries and inventions are patent eligible under Section 101. See draft Sec. 100(k), referring to “human intervention”.
• Isolated products of nature were patentable prior to the Supreme Court’s Myriad case and it is reasonable for Congress to consider whether to restore the law to its original state.
• Nonlimiting examples of life-saving or disease curative drugs that are naturally occurring and would not be patent eligible, and thus would likely not have been developed under the Supreme Court case of AMP v. Myriad Genetics, include penicillin, Amoxil, tetracycline, cyclosporin, cephalosporin, streptomycin, chloramphenicol, insulin, Taxol, doxorubicin, vincristine, vinblastine, and many others.
• Further, any isolated gene segment outside the body would still have to pass the tests of novelty, non-obviousness and being fully described.
• If an isolated gene segment outside of the body is patent eligible, it will almost certainly be used to advance healthcare in the area of personalized diagnostics with the potential to save many lives. We all share the same goal that we only want medicine given to those who will respond to the medicine. Personalized medicines provide the opportunity to reduce side effects and also reduces cost by limiting the spend on drugs for the people who can benefit from that therapy. Isolated gene segment products can also be used to create tests to determine if a person has cancer.
• Congress will be discussing whether practical application of isolated natural products should be patent eligible, which is its responsibility under the Constitution. Patents in this area will still be subject to the other patentability requirements, which are sufficient to eliminate bad patents.

ACLU: “It would, in effect, pave the way for businesses to own exclusive rights to genes, giving them the right to prohibit all others from providing and developing genetic testing and pursuing research.”

SK:

• Again, the nomenclature of the term “genes” or “human genes” is an unfortunate distraction. The proper nomenclature refers only to isolated gene segments outside of the body.
• The necessary motivation to create new products that improve our lives was recognized as early as 1787 in this country, when our founding fathers drafted the U.S. Constitution. The need for that motivation has not changed.
• Companies will only spend the time and money to discover such treatments, and undertake the arduous task of human clinical trials at the Food and Drug Administration, with assurance that they will be reimbursed and obtain a return on investment.
• Therefore, without patent protection, these treatments might well not be discovered to begin with, and thus not available for generic use when the patent expires.

ACLU: “By permitting patent-holders to dictate who can and cannot engage in genetic testing and research, this legislation will undermine patient access to genetic testing and targeted therapies and block the promise of precision medicine.”

SK:

• The ACLU completely misses the point with this argument. It skips over the motivation to actually create the genetic testing product and it goes directly to the need to make it available after it is created. It is the responsibility of Congress to investigate whether personal diagnostics will be created at all under the current Supreme Court precedent and how, if at all, the research has been and will be damaged by this case. It is also the responsibility of Congress to use its sole power under the Constitution to motivate the creation of inventions and applied discoveries. Pricing and availability are downstream issues that can be addressed separately
• ACLU argues that if isolated natural products are patent eligible subject matter (as required by statute), then other companies or universities cannot enter that market until the patent expires. This is technically true. The Constitution itself, going back to 1787, embeds this principle as the core means to motivate inventions and discoveries. Our founding fathers knew that our country’s success depends on the ability to promote the progress of science and the useful arts by securing for limited time the exclusive right to discoveries. If ACLU disagrees with this, it will have to amend the Constitution. Absent that, this framework stays as the highest law of our land. It is also the framework that made this country the most successful innovator in the world.

ACLU: “Next week, the Senate Judiciary Intellectual Property Subcommittee, led by Sens. Tillis and Coons, will also hold a series of hearings on the draft legislation in an effort to rush through a deeply flawed bill to the floor.”

SK:

• This statute is the result of years of debate and consideration by groups representing a wide variety of community interests, following very strong criticism of the recent Supreme Court law on patent eligibility. It has been vetted by a wide range of stakeholders and is still under discussion.
• The Subcommittee has taken the extraordinary step of conducting three days of hearings with 45 witnesses representing all views. It should be commended for this work, which is exactly what is required under the Constitution.

ACLU: “We, the undersigned civil rights, medical, scientific, patient advocacy, and women’s health organizations, write to express our opposition to the recent proposal to amend Section 101 of the Patent Act. The draft legislation if enacted would authorize patenting products and laws of nature, abstract ideas, and other general fields of knowledge.”

SK:

• There are at least as many, and in fact, many more, experts that are against the current Supreme Court 101 case law. Some are also involved with civil rights, medical, scientific, patient advocacy and women’s health issues. The ACLU does not have the corner on smart, concerned people, some of whom are even cancer victims or survivors (such as me), or family members of such. Congress is conducting fair and balanced hearings to listen to all views before reaching any conclusions.

ACLU: “Most troublingly, the legislation would permit patenting of human genes and naturally-occurring associations between genes and diseases. These statements are wrong as a matter of fact.”

SK:

• Again, vague and overbroad nomenclature when using the term “human genes”.
• Under the draft legislation, naturally-occurring associations between genes and diseases are not patent eligible because they are NOT the subject of human intervention, and are not APPLIED.

ACLU: “Allowing these patents will prevent the discovery of novel treatments for diseases including cancer, muscular dystrophy, Alzheimer’s disease, heart disease, and other rare and common diseases.”

SK:

• Research that may lead to data given to the FDA to create a new medical product is exempt from patent infringement under 35 U.S.C. 271(e).
• The current draft of Section 101 has no effect on basic research. It is a motivation for basic research.

ACLU: “It would also create barriers to patients’ access to potentially lifesaving genomic tests, eliminate access to confirmatory testing and dramatically increase the cost of tests that have benefited from innovation that led to reduced costs of DNA sequencing technology.”

SK:

• None of these issues pertain to motivation for basic research. Issues of pricing and availability can be addressed in other ways, and perhaps by other kinds of legislation.

ACLU: “Further, it will stymie competition for developing and improving diagnostic and medical tests and increase the cost and hinder advancement of targeted therapeutics involving genomic markers. That means higher costs for patients, payers, and the healthcare system overall.”

SK:

• Completely false. Research that may lead to data given to the FDA to create a new medical product is exempt from patent infringement under 35 U.S.C. 271(e).
• The U.S. Constitution itself provides the framework to motivate innovation by providing temporary exclusivities to researchers to add to the storehouse of science and the useful arts. It is Congress’ role and responsibility to carry out the intent of the Constitution.
• Pricing and availability are separate issues that can be addressed in different ways.

ACLU: “Recent cases from 2012-2014, all issued by a unanimous Supreme Court, affirm and clarify these important exceptions to patent-eligibility. Specifically, in Mayo Collaborative Services v. Prometheus Laboratories, the Court unanimously held that a naturally occurring relationship between certain metabolite levels in the blood and the likelihood of whether a drug dosage is effective was not patent-eligible.”

SK:

• The Supreme Court agrees with Congress that if it has made errors, it is up to Congress to fix them. The Court has said “An argument that we got something wrong—even a good argument to that effect—cannot by itself justify scrapping settled precedent…..All of our interpretive decisions, in whatever way reasoned, effectively become part of the statutory scheme, subject (just like the rest) to congressional change. Absent special justification, they are balls tossed to Congress’s court, for acceptance or not as that branch elects.” Kimble v. Marvel (supra)

ACLU: “The biological relationship between the metabolite level and the appropriate drug dosage was a natural law, not one invented by the patentee.”

SK:

• Relationships between metabolites and drug dosages would be subject to the same requirement as all other potential innovations, which require human intervention and an applied discovery.

ACLU: “In Association for Molecular Pathology v. Myriad Genetics, a fully united Court extended its reasoning in Mayo to human genes isolated from the body, finding that the genes were not significantly altered by isolation, and that such patents lock up genetic information, preventing others from scientific and medical work.”

SK:

• While the Court may have been unified, there has been tremendous criticism of the decision from many and varied groups. Therefore, the American people are not united in favor if this decision. The huge amount of controversy caused by the Myriad decision in itself requires Congress to investigate. And as the Supreme Court has said, if it made an error in patent law, it is up to Congress to fix it.