Myriad's Oral Argument Before the Supreme Court

On March 29, 2010, the district court granted Plaintiffs' motion for summary judgment, invalidating each of Myriad's challenged claims under ' 101. Ass'n for Molecular Pathology v. U.S. Patent and Trademark Office, 702 F. Supp. 2d 181, 185 (S.D.N.Y. 2010). Judge Robert W. Sweet held that Myriad's composition claims were directed to prohibited subject matter under Supreme Court precedent set forth in Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980), particularly because isolated DNA was deemed a product of nature that did not possess “markedly different characteristics from any [DNA] found in nature.” Myriad's method claims were also struck down by the district court as unpatentable mental processes.

The Federal Circuit Decisions: Two Appeals with Identical Results

On July 29, 2011, a three-judge panel for the U.S. Court of Appeals for the Federal Circuit issued its first decision in the Myriad case. Ass'n for Molecular Pathology v. U.S. Patent and Trademark Office, 653 F.3d 1329 (Fed. Cir. 2011). Led by Judge Alan D. Lourie, the majority reversed the district court in a 2-1 decision finding that Myriad's composition claims to isolated DNA sequences were eligible for patent protection under ' 101 as non-naturally occurring compositions of matter. The Federal Circuit reasoned that the isolated DNA molecules at issue were “markedly different” from native DNA because they were chemically cleaved from their native source through human intervention.

Regarding Myriad's method claims, the Federal Circuit unanimously affirmed the lower court's ruling that five claims reciting methods for “comparing” or “analyzing” the BRCA gene sequences were unpatentable mental processes. The Federal Circuit reversed the district court, however, regarding one remaining method claim directed to screening cancer therapeutics that involved “growing [ ] transformed eukaryotic cell[s]” and “ determining” their growth rate, reasoning that these steps were transformative and patent-eligible under the statute.

The Supreme Court vacated the Federal Circuit's July 2011 opinion and remanded the case for reconsideration in light of Mayo Collaborative Svcs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012). On Aug. 16, 2012, the Federal Circuit issued its second decision, which was almost identical to its rulings from the previous year. Ass'n for Molecular Pathology v. U.S. Patent and Trademark Office, 689 F.3d 1303 (Fed. Cir. 2012). The panel again held that: 1) composition claims to isolated DNA were patentable subject matter, 2) method claims directed to “isolating” and “comparing” DNA sequences were ineligible mental processes, and 3) Myriad's remaining method claim directed to using man-made host cells to screen natural gene mutations was eligible for patent protection.

The Oral Argument

During the April 15, 2013 oral argument, Justice Ruth Bader Ginsburg opened the questioning by asking how Myriad's attempt to patent isolated DNA ' which starts from a natural product ' was any different from other isolated or extracted natural products, like aspirin, which have long been considered patentable. Plaintiffs' attorney responded that although everything may start with a natural product, the key to patentability under ' 101 is to employ a “further manipulation of a product of nature” to ensure that what you are patenting is different from the natural product itself.

Justice Samuel Anthony Alito continued this line of inquiry using the first of a string of nonscientific analogies ' ranging from Amazon trees, baseball bats, and even chocolate chip cookies ' to understand the complexities of genomic DNA extraction presented by Myriad. For example, Justice Alito compared Myriad's isolated DNA to that of a leaf found on a newly discovered Amazonian plant and asked whether a previously unknown extraction (i.e., sap) from this leaf would be patentable. Adding another layer to this dialogue was the proposition that, similar to the tree extract, isolated DNA has a very different form and function from native DNA, which should arguably allow Myriad's claims to pass through the ' 101 gate of patentability.

Plaintiffs' attorney maintained, however, that finding a “new use” is insufficient when the product of nature remains unchanged. Myriad's opponents therefore seemed to present a two-pronged requirement that a chemical composition (like Myriad's isolated DNA) must satisfy in order to be deemed patent-eligible under the statute. According to Plaintiffs' counsel, the natural product must: 1) have a new function; and 2) be changed in some way. The parameters of the latter, however, were not altogether clear from the challenger's oral argument.

On the heels of this discussion emerged a major sticking point for the panel regarding whether blocking patents on isolated DNA would frustrate growth and innovation in the biotechnology industry. Justice Elena Kagan challenged how one could possibly incentivize scientists and their financial supporters to invest both time and money for the purpose of advancing the fields of diagnostics and personalized medicine if new discoveries, once made, were not even protected subject matter under the patent laws. The Court appeared unpersuaded by the rebuttal, which claimed “curiosity,” “enormous recognition,” and winning a “Nobel Prize” as tangible reasons “for a company to do what Myriad did.” This troublesome issue seems likely to play a significant role in the outcome of the case, especially with Justice Anthony M. Kennedy recognizing that “I don't think we can decide the case on the ground, oh, don't worry about investment, it'll come ' I just don't think we can do that.”

Shifting the focus from isolated DNA to the patent-eligibility of cDNA was Justice Sonia Sotomayor, who challenged Plaintiffs' attorney to explain how cDNA, “[which] is artificially created in a laboratory,” cannot be patented. Four other Justices joined in this debate, all of whom were clearly skeptical of the proffered argument that cDNA is not “markedly different” from DNA naturally found in the body. In a standout remark, Justice Kennedy recognized that while his initial impressions were to categorize cDNA as an “economy-class gene,” his understanding of the molecule had since changed. Material to this discussion was the idea that the functionality of cDNA may likely go beyond that of isolated DNA, which indicated the panel's reservations about striking down Myriad's composition claims drawn to these synthetic molecules.

Further paving the way for a more middle-ground approach on the patentability of cDNA was the Solicitor General, arguing for the United States as amicus curiae, who supported Myriad's position that cDNA should be protected under ' 101 as an artificially synthesized product of human ingenuity. As for isolated DNA, the Solicitor General opposed a grant of patentability on the grounds that members of the scientific and medical communities would be effectively pre-empted from using the gene itself for future research.

Myriad's attorney disagreed that isolated DNA was undeserving of patent-eligibility under ' 101, emphasizing that the claimed BRCA1 and BRCA2 gene sequences were previously unknown to the world until Myriad's scientists decided where to begin and end the isolation of these molecules. Still, the question for many of the Justices was not how much effort or human ingenuity was required to find a particular product. Instead, the real question was whether Myriad had created a new use or product from the basic ingredients pre-existing in nature. Justice Antonin Scalia asserted that Myriad had not.

To advance her line of questioning, Justice Sotomayor sought the use of a more simplistic analogy, comparing isolated DNA to the ingredients found in chocolate chip cookies. The Justice then asked Myriad's attorney to explain why a company should be allowed to patent isolated DNA, but not the salt, flour, or sugar were they to be extracted from the cookie. Bypassing this argument, Myriad's attorney instead referred to yet another analogy of isolating a baseball bat from a tree arguing that just as deciding where to begin and end the bat in order to isolate it from the tree was patent-eligible under ' 101, so too was Myriad's decision of where to begin and end the BRCA1 and BRCA2 gene sequences to produce isolated DNA.

Nevertheless, Chief Justice John G. Roberts contended that all Myriad did was “snip off the top and snip off the bottom and there you've got [the gene].” Comments along these lines were made by other Justices.

Statements by Justice Stephen G. Breyer offered some additional insight into finding the balance between allowed and disallowed subject matter under the statute, implying that perhaps the lesson from Myriad should be that one can obtain a method of use or process patent on a particular chemical composition, but not on the molecule itself. Justice Breyer explained, “Of course, if you get a new satisfying process to extract the sap from the plant in the Amazon, patented. Of course, if you get the sap out and you find that you can use it, you manipulate it, you use it, you figure out a way to use it to treat cancer, wonderful, patented. But what you can't patent is the sap itself.” This statement was aimed at the heart of the product of nature exception to patentability under ' 101 ' a doctrine that Myriad's counsel subtly attempted to undermine throughout oral argument, which was a proposition that the Justices seemed less than willing to consider. What did interest the panel was the extent to which other sections of the Patent Act, such as ' 103 related to obviousness, might be better suited to address the patentability of not only Myriad's claims to isolated gene sequences and cDNA, but biotechnology claims in general.

Conclusion

The oral argument brings another chapter in Myriad's history, leaving many wondering whether the Supreme Court's opinion, expected later this spring, will be the last word in the long line of complex biotechnology and patent issues raised by this case. While it is impossible to predict the final outcome, certain observations can be made.

In particular, the Justices seemed very uneasy with granting Myriad's composition claims in their entirety, but were also noticeably adverse to Plaintiffs' inflexible position that all types of human genes were patent-ineligible under ' 101. Also to be considered is the possibility that the opinion may offer no definitive answers at all, as the Supreme Court may well decide to defer to Congress for legislation on these controversial matters.

Although it does not look promising that gene patents will come out on top, one factor that may bode well for Myriad, at least to some degree, is the Supreme Court's recognition of a need for compromise. As Justice Breyer stated, “The patent law is filled with uneasy compromises, because on the one hand, we do want people to invent; on the other hand, we're very worried about them tying up some kind of whatever it is, particularly a thing that itself could be used for further advance.”

Compromise appears to be the key word here, as commentators following the oral argument are seemingly in agreement that, whatever the Supreme Court's final decision will be, it will likely be one that takes the middle ground. As such, the Myriad opinion on whether the human genome is patent-eligible subject matter under ' 101 will be awaited with interest.

Jeffrey S. Ginsberg is a partner at Kenyon & Kenyon LLP and an editor of The Intellectual Property Strategist. Brooke Hazan is an associate at the firm.

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On April 15, 2013, the Supreme Court heard oral argument in Ass'n for Molecular Pathology v. U.S. Patent and Trademark Office (hereinafter “Myriad“). The sole question before the Supreme Court, following its grant of certiorari on Nov. 30, 2012, is whether human genes are patent-eligible subject matter under 35 U.S.C. ' 101.

Background

On May 12, 2009, a coalition of scientific and medical groups along with patients previously diagnosed with breast cancer (collectively “Plaintiffs”) brought a declaratory judgment action against the U.S. Patent and Trademark Office, Myriad Genetics, and the University of Utah Research Foundation (collectively “Myriad”) in the Southern District of New York seeking to invalidate 15 claims contained in seven Myriad patents directed to isolated DNA from Breast Cancer Susceptibility Genes, referred to as BRCA1 and BRCA2. The BRCA1 and BRCA2 genes are significant in that mutations in these genes have been linked to a woman's increased risk of developing breast and ovarian cancer. Myriad's disputed claims were categorized as: 1) composition claims directed to isolated DNA containing all or portions of the BRCA1 and BRCA2 gene sequence; and 2) method claims directed to “comparing” or “analyzing” the sequences of these two genes.

On March 29, 2010, the district court granted Plaintiffs' motion for summary judgment, invalidating each of Myriad's challenged claims under ' 101. Ass'n for Molecular Pathology v. U.S. Patent and Trademark Office , 702 F. Supp. 2d 181, 185 (S.D.N.Y. 2010). Judge Robert W. Sweet held that Myriad's composition claims were directed to prohibited subject matter under Supreme Court precedent set forth in Diamond v. Chakrabarty , 447 U.S. 303, 309 (1980), particularly because isolated DNA was deemed a product of nature that did not possess “markedly different characteristics from any [DNA] found in nature.” Myriad's method claims were also struck down by the district court as unpatentable mental processes.

The Federal Circuit Decisions: Two Appeals with Identical Results

On July 29, 2011, a three-judge panel for the U.S. Court of Appeals for the Federal Circuit issued its first decision in the Myriad case. Ass'n for Molecular Pathology v. U.S. Patent and Trademark Office , 653 F.3d 1329 (Fed. Cir. 2011). Led by Judge Alan D. Lourie, the majority reversed the district court in a 2-1 decision finding that Myriad's composition claims to isolated DNA sequences were eligible for patent protection under ' 101 as non-naturally occurring compositions of matter. The Federal Circuit reasoned that the isolated DNA molecules at issue were “markedly different” from native DNA because they were chemically cleaved from their native source through human intervention.

Regarding Myriad's method claims, the Federal Circuit unanimously affirmed the lower court's ruling that five claims reciting methods for “comparing” or “analyzing” the BRCA gene sequences were unpatentable mental processes. The Federal Circuit reversed the district court, however, regarding one remaining method claim directed to screening cancer therapeutics that involved “growing [ ] transformed eukaryotic cell[s]” and “ determining” their growth rate, reasoning that these steps were transformative and patent-eligible under the statute.

The Supreme Court vacated the Federal Circuit's July 2011 opinion and remanded the case for reconsideration in light of Mayo Collaborative Svcs. v. Prometheus Labs., Inc. , 132 S. Ct. 1289 (2012). On Aug. 16, 2012, the Federal Circuit issued its second decision, which was almost identical to its rulings from the previous year. Ass'n for Molecular Pathology v. U.S. Patent and Trademark Office , 689 F.3d 1303 (Fed. Cir. 2012). The panel again held that: 1) composition claims to isolated DNA were patentable subject matter, 2) method claims directed to “isolating” and “comparing” DNA sequences were ineligible mental processes, and 3) Myriad's remaining method claim directed to using man-made host cells to screen natural gene mutations was eligible for patent protection.

The Oral Argument

During the April 15, 2013 oral argument, Justice Ruth Bader Ginsburg opened the questioning by asking how Myriad's attempt to patent isolated DNA ' which starts from a natural product ' was any different from other isolated or extracted natural products, like aspirin, which have long been considered patentable. Plaintiffs' attorney responded that although everything may start with a natural product, the key to patentability under ' 101 is to employ a “further manipulation of a product of nature” to ensure that what you are patenting is different from the natural product itself.

Justice Samuel Anthony Alito continued this line of inquiry using the first of a string of nonscientific analogies ' ranging from Amazon trees, baseball bats, and even chocolate chip cookies ' to understand the complexities of genomic DNA extraction presented by Myriad. For example, Justice Alito compared Myriad's isolated DNA to that of a leaf found on a newly discovered Amazonian plant and asked whether a previously unknown extraction (i.e., sap) from this leaf would be patentable. Adding another layer to this dialogue was the proposition that, similar to the tree extract, isolated DNA has a very different form and function from native DNA, which should arguably allow Myriad's claims to pass through the ' 101 gate of patentability.

Plaintiffs' attorney maintained, however, that finding a “new use” is insufficient when the product of nature remains unchanged. Myriad's opponents therefore seemed to present a two-pronged requirement that a chemical composition (like Myriad's isolated DNA) must satisfy in order to be deemed patent-eligible under the statute. According to Plaintiffs' counsel, the natural product must: 1) have a new function; and 2) be changed in some way. The parameters of the latter, however, were not altogether clear from the challenger's oral argument.

On the heels of this discussion emerged a major sticking point for the panel regarding whether blocking patents on isolated DNA would frustrate growth and innovation in the biotechnology industry. Justice Elena Kagan challenged how one could possibly incentivize scientists and their financial supporters to invest both time and money for the purpose of advancing the fields of diagnostics and personalized medicine if new discoveries, once made, were not even protected subject matter under the patent laws. The Court appeared unpersuaded by the rebuttal, which claimed “curiosity,” “enormous recognition,” and winning a “Nobel Prize” as tangible reasons “for a company to do what Myriad did.” This troublesome issue seems likely to play a significant role in the outcome of the case, especially with Justice Anthony M. Kennedy recognizing that “I don't think we can decide the case on the ground, oh, don't worry about investment, it'll come ' I just don't think we can do that.”

Shifting the focus from isolated DNA to the patent-eligibility of cDNA was Justice Sonia Sotomayor, who challenged Plaintiffs' attorney to explain how cDNA, “[which] is artificially created in a laboratory,” cannot be patented. Four other Justices joined in this debate, all of whom were clearly skeptical of the proffered argument that cDNA is not “markedly different” from DNA naturally found in the body. In a standout remark, Justice Kennedy recognized that while his initial impressions were to categorize cDNA as an “economy-class gene,” his understanding of the molecule had since changed. Material to this discussion was the idea that the functionality of cDNA may likely go beyond that of isolated DNA, which indicated the panel's reservations about striking down Myriad's composition claims drawn to these synthetic molecules.

Further paving the way for a more middle-ground approach on the patentability of cDNA was the Solicitor General, arguing for the United States as amicus curiae, who supported Myriad's position that cDNA should be protected under ' 101 as an artificially synthesized product of human ingenuity. As for isolated DNA, the Solicitor General opposed a grant of patentability on the grounds that members of the scientific and medical communities would be effectively pre-empted from using the gene itself for future research.

Myriad's attorney disagreed that isolated DNA was undeserving of patent-eligibility under ' 101, emphasizing that the claimed BRCA1 and BRCA2 gene sequences were previously unknown to the world until Myriad's scientists decided where to begin and end the isolation of these molecules. Still, the question for many of the Justices was not how much effort or human ingenuity was required to find a particular product. Instead, the real question was whether Myriad had created a new use or product from the basic ingredients pre-existing in nature. Justice Antonin Scalia asserted that Myriad had not.

To advance her line of questioning, Justice Sotomayor sought the use of a more simplistic analogy, comparing isolated DNA to the ingredients found in chocolate chip cookies. The Justice then asked Myriad's attorney to explain why a company should be allowed to patent isolated DNA, but not the salt, flour, or sugar were they to be extracted from the cookie. Bypassing this argument, Myriad's attorney instead referred to yet another analogy of isolating a baseball bat from a tree arguing that just as deciding where to begin and end the bat in order to isolate it from the tree was patent-eligible under ' 101, so too was Myriad's decision of where to begin and end the BRCA1 and BRCA2 gene sequences to produce isolated DNA.

Nevertheless, Chief Justice John G. Roberts contended that all Myriad did was “snip off the top and snip off the bottom and there you've got [the gene].” Comments along these lines were made by other Justices.

Statements by Justice Stephen G. Breyer offered some additional insight into finding the balance between allowed and disallowed subject matter under the statute, implying that perhaps the lesson from Myriad should be that one can obtain a method of use or process patent on a particular chemical composition, but not on the molecule itself. Justice Breyer explained, “Of course, if you get a new satisfying process to extract the sap from the plant in the Amazon, patented. Of course, if you get the sap out and you find that you can use it, you manipulate it, you use it, you figure out a way to use it to treat cancer, wonderful, patented. But what you can't patent is the sap itself.” This statement was aimed at the heart of the product of nature exception to patentability under ' 101 ' a doctrine that Myriad's counsel subtly attempted to undermine throughout oral argument, which was a proposition that the Justices seemed less than willing to consider. What did interest the panel was the extent to which other sections of the Patent Act, such as ' 103 related to obviousness, might be better suited to address the patentability of not only Myriad's claims to isolated gene sequences and cDNA, but biotechnology claims in general.

Conclusion

The oral argument brings another chapter in Myriad's history, leaving many wondering whether the Supreme Court's opinion, expected later this spring, will be the last word in the long line of complex biotechnology and patent issues raised by this case. While it is impossible to predict the final outcome, certain observations can be made.

In particular, the Justices seemed very uneasy with granting Myriad's composition claims in their entirety, but were also noticeably adverse to Plaintiffs' inflexible position that all types of human genes were patent-ineligible under ' 101. Also to be considered is the possibility that the opinion may offer no definitive answers at all, as the Supreme Court may well decide to defer to Congress for legislation on these controversial matters.

Although it does not look promising that gene patents will come out on top, one factor that may bode well for Myriad, at least to some degree, is the Supreme Court's recognition of a need for compromise. As Justice Breyer stated, “The patent law is filled with uneasy compromises, because on the one hand, we do want people to invent; on the other hand, we're very worried about them tying up some kind of whatever it is, particularly a thing that itself could be used for further advance.”

Compromise appears to be the key word here, as commentators following the oral argument are seemingly in agreement that, whatever the Supreme Court's final decision will be, it will likely be one that takes the middle ground. As such, the Myriad opinion on whether the human genome is patent-eligible subject matter under ' 101 will be awaited with interest.

Jeffrey S. Ginsberg is a partner at Kenyon & Kenyon LLP and an editor of The Intellectual Property Strategist. Brooke Hazan is an associate at the firm.

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