While the Supreme Court just granted certiorari in Myriad, case law surrounding the patent-eligibility of diagnostic and therapeutic personalized medicine has continued to develop in the wake of Mayo v. Prometheus. The good news for innovators is that the USPTO is still granting patents in the field of personalized medicine. The bad news is that the Federal Circuit is still invalidating claims as “indistinguishable” from those presented by Prometheus.
On Friday, July 20, 2012, the Federal Circuit heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case), which is on remand in view of the Supreme Court decision in Mayo v. Prometheus. The courtroom was crowded again, but the mood seemed a bit lighter than the first oral arguments in April 2011. Reading the tea leaves from the judges’ questions and comments, I think the panel decision will depend on whether Judge Moore again concurs with Judge Lourie on the patent-eligibility of isolated DNA, or whether she feels compelled by Mayo to join Judge Bryson, who would invalidate the claims. You can listen to the recording of the oral arguments here. A decision is likely a few months away, and the case is expected to make its way to the Supreme Court again.Continue reading this entry
On December 7, 2011, the Supreme Court heard oral arguments in Mayo Collaborative Services v. Prometheus Laboratories, Inc. While the issue before the Court is patent-eligibility under 35 USC § 101, the arguments veered into the topic of patentability under 35 USC §§ 102 and 103, whether the Court intended to raise that issue or not. Continue reading this entry
One of the few patent prosecution-related provisions of the America Invents Act (AIA) that took immediate effect is the ban on patenting human organisms, set forth in Section 33(a) of the AIA:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
On August 31, 2011, the Federal Circuit issued its second decision in Classen Immunotherapies, Inc. v. Biogen Idec, which was on remand from the Supreme Court after Bilski v. Kappos. Judge Newman wrote the opinion for the court, which was joined by Chief Judge Rader, and holds that two of the three asserted patents recite patent-eligible subject matter under 35 USC § 101. The court also finds that the “safe harbor” of 35 USC § 271(e)(1) only applies in the context of obtaining pre-marketing regulatory approval, and so did not prevent some of Classen’s infringement claims relating to studies of already-approved vaccines. While this decision raises some questions as it answers others, the Federal Circuit provides useful guidance for evaluating the patent-eligibility of method claims that involve some type of information gathering.
There is much in the Classen opinions that warrants further analysis and commentary, but for now I provide this synopsis of the main points.
As I wrote yesterday, the ACLU filed a Petition for Panel Rehearing in Association for Molecular Pathology v. USPTO, also known as the ACLU/Myriad “gene patenting” case, alleging factual and legal errors in the court’s July 29, 2011 decision on both the standing issue and the patent-eligibility issue. I was not impressed by the ACLU’s standing arguments, and now Myriad has filed its own Petition for Panel Rehearing challenging the standing of the ACLU plaintiffs. Because standing is a threshold issue, and because the factual basis of standing has changed, it is possible that the Federal Circuit will grant Myriad’s motion and rehear the case, at least on the standing issue.
As reported by Kevin Noonan on Patent Docs, plaintiffs-appellees (e.g., the ACLU) have filed a Petition for Panel Rehearing in Association for Molecular Pathology v. USPTO, also known as the ACLU/Myriad “gene patenting” case. The Petition alleges factual and legal errors in the court’s July 29, 2011 decision on both the standing issue and the patent-eligibility issue, but is not likely to be granted. While the petition may foreshadow the arguments being formulated for Supreme Court review, its most likely effect will be to delay that review, further extending the period of uncertainty that is hanging over isolated DNA claims.
I wrote previously on the apparent scientific basis for the differing opinions of Judge Lourie and Judge Bryson on the patent-eligibility of isolated genomic DNA claims in Association for Molecular Pathology v. USPTO. Here, I look at Judge Moore’s concurring opinion, which appears to agree in principal with Judge Bryson’s legal analysis, but places more emphasis on policy concerns to reach agreement with Judge Lourie.
As I wrote previously, one interesting aspect of the recent Federal Circuit decision in Association for Molecular Pathology v. USPTO, is the apparent scientific basis for the differing opinions of Judge Lourie and Judge Bryson on the patent-eligibility of isolated genomic DNA claims. Unlike many concurring and dissenting opinions that are spurred by a different view of the law, Judge Lourie and Judge Bryson also appear to part ways based on different views of the science.
In this second part of a three-part series, I focus on the views of Judge Bryson.
Judge Bryson’s Dissent
Judge Bryson joined the court’s decision regarding standing, the method claims, and the cDNA claims, but disagreed with the holding that the “BRCA gene claims” are patent-eligible.
Judge Bryson read the Supreme Court’s Chakrabarty decision as requiring consideration of two factors:
- [T]he similarity in structure between what is claimed and what is found in nature and
- [T]he similarity in utility between what is claimed and what is found in nature.
(This appears to be the same test that Judge Moore applies, although she finds that the isolated genomic DNA claims are patent-eligible for policy reasons.)
Considering genomic DNA, Judge Bryson finds its to be “the same, structurally and functionally, in both the native gene and the isolated form of the gene.” Thus, Judge Bryson believes that claims directed to isolated genomic DNA (as opposed to cDNA) do not satisfy § 101.
The Insignificance Of Breaking Covalent Bonds
Judge Bryson acknowledges that covalent bonds are broken to obtain isolated genomic DNA from its natural state, but does not believe that this difference answers the patent-eligibility question. Quoting Linus Pauling, Judge Bryson writes,
[T]here is no magic to a chemical bond that requires us to recognize a new product when a chemical bond is created or broken, but not when other atomic or molecular forces are altered. . . . A chemical bond is merely a force between two atoms or groups of atoms strong enough “to make it convenient for the chemist to consider [the aggregate] as an independent molecular species.”
Judge Bryson criticizes Judge Lourie’s test for conferring patent eligibility based on the breaking of covalent bonds, but not other types of chemical bonds such as hydrogen bonds or ionic bonds, finding no logical reason or precedent for drawing such a distinction.
Using Genetics, Not Chemistry, To Evaluate The Claims
Judge Bryson suggests that Judge Lourie’s analysis took a wrong turn when it used principles of chemistry to evaluate the claimed subject matter. Judge Bryson explains that the both the language of the claims at issue and the focus of the claimed invention warrant the use of genetic principles instead.
For example, Judge Bryson points out the that the broadest gene claims do not recite specific DNA sequences, but rather recite isolated DNA coding for specific amino acid sequences. Because those claims encompass “[a]n almost incalculably large number” of DNA molecules that “share only one unifying characteristic,” they should be evaluated based on that shared, genetic characteristic—encoding the naturally occurring BRCA1 gene.
Applying such a framework, isolated genomic DNA is no different from the naturally occurring gene:
The isolated BRCA genes are identical to the BRCA genes found on chromosomes 13 and 17. They have the same sequence, they code for the same proteins, and they represent the same units of heredity.
Judge Bryson also emphasizes that isolated genomic DNA has been isolated according to its natural boundaries:
In the case of the BRCA genes . . . nature has defined the genes as independent entities by virtue of their capacity for protein synthesis and, ultimately, trait inheritance. Biochemists extract the target genes along lines defined by nature so as to preserve the structure and function that the gene possessed in its natural environment. In such a case, the extraction of a product in a manner that retains the character and function of the product as found in nature does not result in the creation of a human invention.
Similar Function More Important Than Different Structure
Judge Bryson’s views on the relative importance of structure and function are completely opposite from Judge Lourie’s. While Judge Lourie found structural differences alone sufficient to support patent-eligibility, Judge Bryson reached the opposition conclusion:
The structural differences between the claimed “isolated” genes and the corresponding portion of the native genes are irrelevant to the claim limitations, to the functioning of the genes, and to their utility in their isolated form. The use to which the genetic material can be put, i.e., determining its sequence in a clinical setting, is not a new use; it is only a consequence of possession. In order to sequence an isolated gene, each gene must function in the same manner in the laboratory as it does in the human body. Indeed, that identity of function in the isolated gene is the key to its value.
Judge Bryson concludes:
The naturally occurring genetic material thus has not been altered in a way that would matter under the standard set forth in Chakrabarty. For that reason, the isolation of the naturally occurring genetic material does not make the claims to the isolated BRCA genes patent-eligible.
The Hypothetical Analogies Are Instructive
While Judge Lourie was not concerned with the analogies of a “leaf plucked from a tree” or elemental lithium, Judge Bryson indicates that these analogies should not be ignored.
Judge Bryson believes that “extracting a gene is akin to snapping a leaf from a tree,” and so does not confer patent-eligibility.
[T]o argue that the isolated BRCA gene is patentable because in its native environment it is part of a much larger structure is no more persuasive than arguing that although an atom may not be patentable, a subatomic particle is patentable because it was previously part of a larger structure, or that while a tree is not patentable, a limb of the tree becomes a patentable invention when it is removed from the tree.
Thus, Judge Bryson bases his decision that the isolated, genomic DNA claims do not satisfy § 101 on his understanding that an isolated gene does not exhibit a materially different function from a native gene. Judge Bryson also would have invalidated the claims reciting fragments of genomic DNA, because the claims use open-ended language that encomasses naturally occurring, full-length sequences.
One interesting aspect of the recent Federal Circuit decision in Association for Molecular Pathology v. USPTO, is the apparent scientific basis for the differing opinions of Judge Lourie and Judge Bryson on the patent-eligibility of isolated genomic DNA claims. Unlike many concurring and dissenting opinions that are spurred by a different view of the law, Judge Lourie and Judge Bryson also appear to part ways based on different views of the science.
In this first part of a three-part series, I focus on the views of Judge Lourie.
On July 29, 2011, the Federal Circuit issued its decision in Association for Molecular Pathology v. USPTO, also known as the ACLU/Myriad “gene patenting” case. In a mixed decision, the court held that “isolated DNA” claims are patent-eligible under 35 USC § 101, but that the “comparing” or “analyzing” method claims are not. With a 55 page opinion authored by Judge Lourie, a 31 page concurrence-in-part authored by Judge Moore, and a 19 page dissent-in-part authored by Judge Bryson, there is much to be analyzed before the full impact of this decision—and the contours of the holdings—will be understood.
Today (June 20, 2011), the Supreme Court granted Mayo’s petition for certiorari in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, which means that the Supreme Court will review the Federal Circuit decision that upheld the patent-eligibility of Prometheus’ personalized medicine claims against a Bilski-type challenge. As I wrote last week, it will be interesting to see if Justice Breyer will be able to use this case to resurrect the anti-patent views he expressed in his opinion dissenting from the GVR in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc.
You can read my summary of the Federal Circuit’s Prometheus decision here and my separate discussion of the court’s treatment of Justice Breyer’s Metabolite opinion here.
Justice Breyer’s dissenting opinion in Board of Trustees of Leland Stanford Junior University v. Roche Molecular Systems, Inc. is interesting for more than his views on inventor rights and the Bayh-Dole Act. As I was reviewing it, I was struck by his negative comments about patents and his citation of his own 2006 opinion dissenting from the dismissal of the grant of certiorari in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc.
On April 4, 2011, Judges Lourie, Bryson and Moore at the U.S. Court of Appeals for the Federal Circuit heard oral arguments in Association for Molecular Pathology v. USPTO, also known as the ACLU/Myriad “gene patenting” case. This case has garnered extraordinary attention from the biotech, pharmaceutical, and health care industries, from academic and government researchers, from breast cancer patients and their families, and from the U.S. Department of Justice (DOJ) itself.
These groups disagree on the fundamental legal question of whether isolated DNA should be eligible for a patent, and also disagree on the fundamentally political question of whether the patenting of genes promotes or stifles innovation and development of new diagnostics and therapies. While the Federal Circuit’s decision in this case will be important, further resolution of the issues is likely to come from the Supreme Court. The ultimate decision could have a profound effect on existing intellectual property rights, and could impact current and future patent strategies, particularly in biotechnology-related fields.
On March 17, 2011, Mayo Collaborative Services filed a petition for certiorari to the U.S. Supreme Court, challenging the Federal Circuit’s December 2010 decision in Prometheus Laboratories, Inc. v. Mayo Collaborative Services. Mayo asserts that the case raises the question “whether a patentee can monopolize basic, natural biological relationships,” and urges the Court to decide the issue on which it has twice granted certiorari, and yet failed to address.
In an unusual (if not unprecedented) move, the Solicitor General of the United States wrote a letter to the Federal Circuit asking that oral argument in Association for Molecular Pathology v. Myriad Genetics be scheduled for April 4, 2011. The Solicitor General (Neal Katyal) noted that “the United States will file an unopposed motion to participate in the oral argument” and that he intends to ”personally be presenting the oral argument on behalf of the United States.”
The Federal Circuit decided for the second time that the personalized medicine claims at issue in Prometheus Laboratories, Inc. v. Mayo Collaborative Services satisfy the requirements for patent-eligibility set forth in 35 U.S.C. § 101, even under the Supreme Court’s decision in Bilski v. Kappos. In so doing, the court followed a two-part analysis that provides a framework for analyzing other method claims that may raise similar issues.
Prometheus’s claims relate to personalized methods of optimizing the dosing of specific drugs used to treat gastrointestinal autoimmune diseases. Representative claims from the Prometheus’s patents are set forth below.
1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
46. A method of optimizing therapeutic efficacy and reducing toxicity associated with treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) determining the level of 6-thioguanine or 6-methylmercaptopurine in a subject administered a drug selected from the group consisting of 6-mercaptopurine, azathiop[u]rine, 6-thioguanine, and 6-methyl-mercaptoriboside, said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject, and
wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells or a level of 6-methylmercaptopurine greater than about 7000 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
Thus, while many claims recite both an “administering” step and a “determining” step, some claims recite only a “determining” step.
The Road to the Supreme Court – The District Court & The Metabolite Dissent
The district court had invalidated Prometheus’s claims under 35 U.S.C. § 101, applying the rationale from Supreme Court Justice Breyer’s 2006 dissent to the dismissal of certiorari in Laboratory Corp. of American Holdings v. Metabolite Labs., Inc.
The claims at issue in Metabolite recited:
A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:
assaying a body fluid for an elevated level of total homocysteine; and
correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.
Justice Breyer summed up the claimed methods as involving only
- obtaining test results and
- thinking about them.
He opined that the claims “embody only the correlation between homocysteine and vitamin deficiency that the researchers uncovered. In my view, that correlation is an unpatentable ‘natural phenomenon.’”
The Road to the Supreme Court – The Federal Circuit’s 2009 Decision
Prometheus appealed to the Federal Circuit, who reversed the district court in a decision issued in 2009. The Federal Circuit found that the claims satisfied § 101 under its machine-or-transformation test, because the methods “transform a particular article into a different state or thing.”
The “administering” claims do so because they “are in effect claims to methods of treatment, which are always transformative.”
The “determining” claims do so, because the level of 6-thioguanine or 6-methylmercaptopurine “cannot be determined by mere inspection,” but requires transformative chemical analysis, such as high-performance liquid chromatography (HPLC).
The Federal Circuit rejected arguments that the administering and determining steps were “insignificant post-solution activities” or merely “data gathering,” but found instead that they were “central to the claims,” “part of a treatment protocol” and “transformative.” The Federal Circuit also stated that the “mental steps” embodied in the “wherein” clauses were not fatal to patentability when the claims were considered as a whole.
The Supreme Court GVR Order
Mayo petitioned the Supreme Court for certiorari, which the Court granted, but only to vacate the Federal Circuit decision and remand to the Federal Circuit in view of its decision in Bilski v. Kappos. (This is referred to as a “GVR order” for “grant,” “vacate,” and “remand.)
Back at the Federal Circuit
On remand, the Federal Circuit requested new briefs from the parties, and accepted seven amicus briefs. Prometheus argued that its claims should be found to be patent-eligible because the Supreme Court did not invalidate the machine-or-transformation test, while Mayo argued that the claims do not satisfy § 101 because they preempt all practical uses of a natural phenomenon.
The Federal Circuit began its analysis by noting that the Supreme Court has consistently construed § 101 broadly, in accord with Congressional intent, as reflected in the “expansive terms” used in the statute. The Federal Circuit nevertheless acknowledged that § 101 is not unlimited, because Supreme Court precedent provides three specific exceptions to § 101’s broad patent-eligibility principles:
laws of nature, physical phenomena, and abstract ideas.
On this point, the Federal Circuit noted that Supreme Court precedent also holds that “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.”
Turning to case before it, the Federal Circuit characterized the issue on remand as “whether Prometheus’s asserted claims are drawn to a natural phenomenon, the patenting of which would entirely preempt its use . . . or . . . only to a particular application of that phenomenon,” which would be patent-eligible.
The Federal Circuit’s Two-Part Analysis
The Federal Circuit rejected Mayo’s argument (which has been echoed in speculation from the patent bar) that the Supreme Court’s Bilksi decision or its remand of this case required a “wholly different analysis or a different result.” To the contrary, the Federal Circuit stated that the Supreme Court’s Bilksi decision “did not undermine our preemption analysis” and “did not disavow the machine-or-transformation test.”
The Federal Circuit reconsidered Prometheus’s claims under a two-part analysis:
1. The court explained that the claimed methods “recite a patent-eligible application of naturally occurring correlations between metabolite levels and efficacy or toxicity, and thus do not wholly preempt all uses of the recited correlations.”
In reaching this conclusion, the court noted:
[T]he claims recite specific treatment steps, not just the correlations themselves. And the steps involve a particular application of the natural correlations: the treatment of a specific disease by administering specific drugs and measuring specific metabolites.
2. The court confirmed that the claimed methods satisfy the machine-or-transformation test.
Again, the court expressed its belief that “administering a drug” always involves a transformation, because “[t]he drugs do not pass through the body untouched without affecting it” or without being metabolized.
The court emphasized that the fact that the method “relies on natural processes does not disqualify the administering step from the realm of patentability.” The court agreed with Prometheus that “every transformation of physical matter can be described as occurring according to natural processes and natural law.” But, the court said, ”[t]he transformation here . . . is the result of the physical administration of a drug to a subject to transform—i.e., treat—the subject, which is itself not a natural process.”
With regard to the “determining” claims that do not include an “administering” step, the court noted that “[s]ome form of manipulation, such as the high pressure liquid chromatography method specified in several of the asserted dependent claims . . . is necessary to extract the metabolites from a bodily sample and determine their concentration.” Thus, these claims satisfy the test as inherently involving a transformation.
This two-part analysis is similar to the USPTO’s Interim Bilski Guidance (promulgated July 27, 2010), which advises examiners to evaluate patent-eligibility of method claims by (1) considering whether the claimed method is directed to an abstract idea and (2) determining if it satisfies the machine-or-transformation test.
Other Exclusions Ruled Out
The Federal Circuit (again) rejected arguments that the “administering” and “determining” steps were mere “data gathering” steps or “insignificant extra-solution activity.” To the contrary, the court found that the steps were “central to the purpose of the claims, which the court found to be “optimizing efficacy and reducing toxicity of treatment regimes.”
The Federal Circuit also (again) made clear that the presence of the “mental steps” in the “wherein” clauses did not defeat patent-eligibility, because the claims must be evaluated as a whole:
A subsequent mental step does not, by itself, negate the transformative nature of prior steps.
Because “[n]o claim in the Prometheus patents claims only mental steps” the prohibition against patenting mental steps per se did not impact Prometheus’s claims.
The Bottom Line
The Federal Circuit wrapped up its opinion with this query:
[W]hen asked the critical question, “What did the applicant invent?,” . . . the answer is a series of transformative steps that optimizes efficacy and reduces toxicity of a method of treatment for particular diseases using particular drugs.
By emphasizing these characteristics in this case, the court may be leaving itself room to reach different results in different cases, including Classen Immunotherapies, Inc. v. Biogen Idec (PDF) and Association for Molecular Pathology v. USPTO (the ACLU/Myriad BRCA1 case).
While much of this Prometheus decision reiterates the analysis from the 2009 Federal Circuit decision, the fact that there is “nothing new here” is news. The Supreme Court’s GVR order had cast a shadow of uncertainty over the patent-eligibility of personalized medicine methods, even as health care innovators and practitioners are promoting personalized medicine as offering the promise of more effective—and more cost-effective—treatments. Now the Federal Circuit has provided some guidance on the types of claims that can be found to satisfy § 101 post-Bilski, and has hinted at the types of claims that may be found to go too far.
In a move that surprised many in the U.S. patent community, the Department of Justice filed a brief in the Federal Circuit appeal of Association for Molecular Pathology v. USPTO, arguing against the patentability of isolated genomic DNA sequences. This brief may raise the stakes in the appeal, and certainly shines a brighter spotlight on a case that already has garnered far more general media attention than any other patent case.