In the wake of the Supreme Court oral arguments in the Myriad “gene patent” case, most commentators are predicting that the Court will uphold the patent-eligibility of non-naturally occurring DNA sequences (such as cDNA), but will decide that even “isolated” forms of naturally occurring DNA cannot be patented under 35 USC § 101. I have heard some say that such a decision would “harmonize” U.S. patent law with European patent law, but that is not correct.
On April 15, 2013, the Supreme Court heard oral arguments in one of the most controversial and publicized biotech patent cases–the “ACLU/Myriad” gene patent case (e.g., The Association For Molecular Pathology v. USPTO). While it is always risky to predict the outcome of a Supreme Court case from the oral arguments, the Justices seemed to have accepted the U.S. Solicitor General’s arguments that cDNA molecules satisfy § 101, but seem unlikely to find that human genes can be patented.Continue reading this entry
March 15, 2013 was a big deadline for patent applicants seeking to secure first-to-invent filing dates for U.S. patent applications, but April 15 will be a big day for the biotechnology industry, when the Supreme Court hears oral arguments in The Association of Molecular Pathology v. Myriad Genetics, Inc. (also known as the ACLU/Myriad “gene patent” case). Here I provide a brief summary of the parties’ briefs to the Supreme Court.Continue reading this entry
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 November 30, 2012, the Supreme Court granted certiorari in the “ACLU/Myriad” gene patenting case (Association for Molecular Pathology v. Genetics, Inc.), guaranteeing that the debate over the patent-eligibility of human genes will continue for another round. The Court will review the August 16, 2012 Federal Circuit decision that held for the second time that Myriad’s claims directed to isolated DNA sequences satisfy 35 USC § 101.
The Association for Molecular Pathology (represented by the ACLU) has filed a petition for certiorari to the Supreme Court, seeking review of the Federal Circuit’s August 16, 2012 decision that upheld the patent-eligibility of Myriad’s “isolated DNA” claims. The petition raises three questions for Supreme Court review:
- Are human genes patentable?
- Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court’s ruling in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)?
- Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court’s decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that petitioners who have been indisputably deterred by Myriad’s “active enforcement” of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally threatened with an infringement action?
This petition will come as no surprise to those who have been following this case since the district court rendered the first decision on the merits in 2010. We should know by June whether the Supreme Court will grant certiorari, but it could be a year or more before a final decision is rendered.
On August 16, 2012, just four weeks after it heard oral arguments, the Federal Circuit issued its second decision in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case), which was on remand in view of the Supreme Court’s March 20, 2012 decision in Mayo v. Prometheus. The same three-judge panel heard the case on remand, and the judges reached essentially the same results on the interpretation of 35 USC § 101 as set forth in their July 29, 2011 decision. Thus, once again, Judge Lourie wrote the opinion for the court, Judge Moore concurred in the result, and Judge Bryson concurred in part and dissented in part.
All judges agree that at least one plaintiff has standing, that the diagnostic method claims based on “comparing” or “analyzing” DNA sequences are not patent-eligible, and that the drug screening method claim is patent-eligible. The court again held that all of the “isolated DNA” claims are patent-eligible, including those encompassing genomic DNA. Judge Bryson once again dissented with regard to the genomic DNA claims, but agreed with the majority that the cDNA claims satisfy 35 USC § 101.
While it is not surprising that the Federal Circuit reached the same conclusion in this decision, many will be relieved that they maintained the status quo as we move one step closer to final resolution of the issues by the Supreme Court.
For a more detailed review of the decision, please see this August 16, 2012 Foley & Lardner LLP Legal News Alert.
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
Later today the Federal Circuit will hear 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.
In advance of today’s hearing, the Federal Circuit asked for briefing on the following issue:
What is the applicability of the Supreme Court’s decision in Mayo to Myriad’s isolated DNA claims and to method claim 20 of the ’282 patent?
You can find my articles reviewing the parties’ briefs, the government brief, Eli Lilly’s briefs, the briefs of several intellectual property associations, and two non-legal briefs here.
I plan to attend the oral arguments today, but you can listen to them yourself once the recording is made available on the Federal Circuit website (which should be by the end of the day).
Several associations and organizations of intellectual property lawyers submitted amicus briefs in the Federal Circuit remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCA1 case). While many make the same arguments, there are some points that may stand out enough to get the court’s attention.
(See this article for my review of the most interesting amicus briefs, this article for my discussion of the United States amicus brief, and this article for a summary of the parties’ briefs.)Continue reading this entry
The most interesting briefs in the Federal Circuit remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCA1 case) may be those submitted by James D. Watson and Christopher M. Holman, which each present non-legal perspectives on the issues before the court.Continue reading this entry
Myriad and the ACLU filed their supplemental briefs in the remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCA1 case), addressing the Federal Circuit’s question as to the applicability of the Supreme Court’s decision in Mayo Collaborative Servs. v. Prometheus Labs., Inc. to the patent eligibility of Myriad’s isolated DNA claims and method claim 20 of Myriad’s U.S. Patent 5,747,282. While the parties’ positions are predictable, it is interesting to see how they frame the issues.Continue reading this entry
Eli Lilly filed an interesting amicus brief in the remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case). The Lilly brief focuses on claim 20 of Myriad’s U.S. Patent 5,747,282, and urges the Federal Circuit to adopt a bright-line rule that would hold any method claim that includes a step that “may be performed mentally” not eligible for patenting under 35 USC § 101. Continue reading this entry
The briefs in the remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case) were due last Friday, June 15, 2012. While the views of the parties and other amici may be of interest to the Federal Circuit, I am particularly interested in the position taken in the U.S. Department of Justice’s amicus brief. It is disappointing but not surprising that the United States asserts that the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. supports its position that isolated genomic DNA is not patent-eligible under 35 USC § 101. Continue reading this entry
After the Supreme Court decided that the personalized medicine method claims at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc. did not satisfy the patent eligibility requirements of 35 USC § 101, it was not surprising that the Court asked the U.S. Court of Appeals for the Federal Circuit to take a second look at Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case). Although Myriad’s “isolated DNA” claims raise different patent eligibility issues than Prometheus’s method claims, both patents relate to technology that is applied in the medical diagnostic/therapeutic space.
It was more puzzling when the Supreme Court also asked the Federal Circuit to reconsider Ultramercial, LLC v. Hulu, LLC, where the claims at issue relate to methods of distributing copyrighted content over the internet. True, the patent eligibility of the Ultramercial claims is at issue, but how can the Supreme Court’s explication of the non-patent eligibility of natural phenomena impact the Federal Circuit’s decision that the Ultramercial methods were not disqualified from patenting as merely claiming abstract ideas?
See what I’m afraid all this could mean in my guest commentary for The Legal Pulse Blog of the Washington Legal Foundation.
I was honored to be invited by the Washington Legal Foundation to prepare a video commentary on the recent Supreme Court decision in Prometheus and its possible impact on the Myriad isolated DNA case for their Legally Brief series.
Here’s what I had to say:
While the early arrival of spring weather has many of us turning our attention to our gardends, pharmaceutical companies are facing a number of new developments in the patent landscape. In this podcast interview for The Burrill Report, I talk about Prometheus, Myriad, the compulsory license for Bayer’s Nexvar drug in India, and the status of the implementation of U.S. patent reform.
If you’ve been spending more time enjoying nature than drawing lines between laws of nature and products of nature, I’ll get you caught up in a few minutes.
Now that the Supreme Court has issued its unanimous decision reversing the Federal Circuit decision in Prometheus, it is expected to decide the petition for certiorari in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case), as early as Monday (March 26). Many are predicting that the Court will issue a “GVR” to grant certiorari only to vacate the Federal Circuit decision that upheld the patent-eligibility of Myriad’s “isolated DNA” claims, and remand the case to the Federal Circuit for rehearing in view of Prometheus. As I try to understand how the Supreme Court’s decision that Prometheus’ method claims do not satisfy 35 § USC 101 because they “effectively claim underlying laws of nature” would impact the Federal Circuit’s decision that Myriad’s isolated DNA claims satisfy 35 § USC 101 because they “cover molecules that are markedly different—have a distinctive chemical identity and nature—from molecules that exist in nature,” I am frightened by a line of reasoning that could undermine the patent-eligibility of a host of pharmaceutical and biological products. Continue reading this entry
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.