Supreme Court rules on patentability of naturally occurring and synthetic complementary DNA

Posted
by John Chapman

Section 101 of the Patent Act provides:

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

The Supreme Court has long held that this provision contains an important implicit exception: “Laws of nature, natural phenomena, and abstract ideas are not patentable.” Mayo Collaborative Services v. Prometheus Laboratories, 132 S.Ct. 1289, 1293 (2012).Rather, “they are the basic tools of scientific and technological work'” that lie beyond the domain of patent protection. Id. Without this exception, there would be considerable danger that the grant of patents would “tie up” the use of such tools and thereby “inhibit future innovation premised upon them.” Id. Of course, the very point of patents is to promote creation. See Diamond v. Chakrabarty, 447 U. S. 303, 309 (1980) (Products of nature are not created, and “manifestations . . . of nature [are] free to all men and reserved exclusively to none”).

The rule against patents on naturally occurring things is not without limits, however, for “all 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.” Mayo, 132 S.Ct. at 1293. Patent protection thus strikes a delicate balance between creating “incentives that lead to creation, invention, and discovery” and “imped[ing] the flow of information that might permit, indeed spur, invention.” Id.

The Supreme Court recently considered how the rule against patents on naturally occurring things applies in the context of DNA. Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12–398. (U.S. Jun 13, 2013)

Myriad Genetics, Inc. discovered the precise location and sequence of two human genes, now known as the BRCA1 and BRCA2 genes. Mutations in these genes can dramatically increase an individual’s risk of developing breast and ovarian cancer. Myriad obtained a number of patents based upon its discovery.

The average American woman has a 12- to 13-percent risk of developing breast cancer, but for women with certain genetic mutations, the risk can range between 50 and 80 percent for breast cancer and between 20 and 50 percent for ovarian cancer. Before Myriad’s discovery of the BRCA1 and BRCA2 genes, scientists knew that heredity played a role in establishing a woman’s risk of developing breast and ovarian cancer, but they did not know which genes were associated with those cancers.

Knowledge of the location of the BRCA1 and BRCA2 genes enabled Myriad to develop medical tests that are useful for detecting mutations in a patient’s BRCA1 and BRCA2 genes and thereby assessing whether the patient has an increased risk of cancer. As isolation is necessary to conduct genetic testing, Myriad was not the only entity to offer BRCA testing after it discovered the genes. The University of Pennsylvania’s Genetic Diagnostic Laboratory and others provided genetic testing services to women.

Myriad filed patent infringement suits against other entities that performed BRCA testing, resulting in settlements in which the defendants agreed to cease all allegedly infringing activity. Then, some years later, a group of medical patients, advocacy groups, and other doctors, filed suit seeking a declaration that Myriad’s patents are invalid.

The case presented two main questions. First, Myriad argued it was entitled to the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes. Second, Myriad claimed the exclusive right to a particular synthetic DNA created in the laboratory. The Supreme Court answered the questions different. The court held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that the synthetic cDNA is patent eligible because it is not naturally occurring.

The Supreme Court began by noting it was undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. Rather, the location and order of the nucleotides existed in nature before Myriad found them. Myriad also did not create or alter the genetic structure of DNA. Instead, Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2. The court held that this claim fell squarely within the law of nature exception. Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, the court held does not render the BRCA genes “new … composition[s] of matter” that could be patent eligible.

On the other hand, the court held that synthetic cDNA did not present the same obstacles to patentability as naturally occurring, isolated DNA segments. Although cDNA retains the naturally occurring exons of DNA, it is distinct from the DNA from which it was derived. It contains only the exons that occur in DNA, omitting the intervening introns. Thus, creation of a cDNA sequence results in an exons-only molecule that is not naturally occurring. According to the Supreme Court, “the lab technician unquestionably creates something new when cDNA is made.” As a result, the court ruled that cDNA is not a “product of nature” and is can be patent eligible.

The Supreme Court also emphasized several questions that were not before the court. First, there were no “method” claims before this Court. The court noted that “an innovative method of manipulating genes while searching for … genes … could possibly [support] a method patent.”

Second, this case does not involve patents on new “applications of knowledge” about the BRCA1 and BRCA2 genes. Thus, the court did not consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Rather, the court held only that genes and the information they encode are not patent eligible under § 101 simply because they have been isolated from the surrounding genetic material.

Patent Law and Intellectual Property Cases at Heygood Orr & Pearson

At Heygood, Orr & Pearson, our attorneys have handled numerous patent matters including prosecuting claims for infringement, as well as for interfered-with patent rights. We have handled claims brought by a large local company for infringement of its rail car patent, claims by a local inventor for infringement of her patent for a childcare product and claims by an Israeli company against a Fortune 500 company for infringement of its wireless technology patent. Our firm has also represented a client suing a large American pharmaceutical company for interfering with its patent rights to liposome technology. We are currently representing an international diamond and jewelry company in a trademark dispute in federal court.

Our attorneys are capable of litigating patent infringement claims throughout the country. In addition, firm attorney John “Jay” Pate is licensed to prosecute patents before the U.S. Patent and Trademark Office.

Beyond our specific experience in the field of intellectual property, our ability to prosecute patent infringement action is aided by our extensive trial experience in general. While technical knowledge and familiarity with patent rules is a must for attorneys handling patent infringement claims, there is no substitute for courtroom experience. At Heygood, Orr & Pearson, our seasoned litigators have the experience to take even the most complex patent case and explain it in terms a jury can understand. We have a track record of proven success representing businesses large and small. Several of our trial lawyers are board certified* and many of them have been selected as Super Lawyers in the State of Texas for several years in a row.** Our firm is AV rated, the highest legal and ethical ranking available from the leasing law firm ranking service, Martindale-Hubbell.

If you or your company is in need of representation in an intellectual property matter, contact us for a free consultation by calling toll-free at 1-877-446-9001, or by completing the free case evaluation form located on this page.

———————————————————————————————————————————-

Michael Heygood, James Craig Orr, Jr. and Eric Pearson are all Board Certified in Personal Injury Trial Law — Texas Board of Legal Specialization.

** Michael Heygood, James Craig Orr, Jr. and Eric Pearson were selected to the Super Lawyers List, a Thomson Reuters publication, for the years 2003 through 2013.