Showing posts with label myriad. Show all posts
Showing posts with label myriad. Show all posts
Thursday, February 23, 2017
Myriad Genetics Files Amicus Briefs in Joint Infringement Cases Akamai and McKesson
Myriad Genetics Files Amicus Briefs in Joint Infringement Cases Akamai and McKesson
Personalized medicine company Myriad Genetics has filed amicus briefs in Akamai and McKesson, two cases currently pending before the en banc Federal Circuit that address the doctrine of joint infringement (aka divided infringement). These cases have been the subject of much discussion elsewhere, see for example the Patently-O and Patent Docs blogs. In a nutshell, the Federal Circuit seeks to delineate the circumstances under which a party will be held liable for patent infringement when multiple parties perform all steps of the patented method in concert, but no single party performs all of the steps.
In its amicus briefs, which are largely redundant, Myriad points out that while the recent joint infringement cases coming out of the Federal Circuit have tended to involve claims directed towards business methods and software, the decisions have created case law with substantial negative implications for patents on diagnostics and personalized medicine. Molecular diagnostics generally involve the discovery of a correlation between a molecular marker (e.g., a genetic variation, or the level of a metabolite) and a clinically relevant indication (e.g., whether an individual has a predisposition to a disease such as cancer, or would be likely to benefit from a particular drug or course of therapeutic treatment). Patent protection for these discoveries is generally achieved by means of a method claim reciting two steps-(1) detecting the molecular marker in a patient, and (2) recognizing the correlation. As noted in the Myriad briefs, product claims on the molecular markers themselves (e.g., isolated DNA molecules or proteins), and methods of testing for them, are generally precluded in the post-Human Genome Project era by prior art (not to mention efforts by the ACLU and others to render such products unpatentable).
The problem from the perspective of a molecular diagnostic innovator company such as Myriad is that the Federal Circuits recent joint infringement decisions would seem to dictate that such a method claim would not be infringed under circumstances where one party (e.g., a diagnostic testing laboratory) performs the first step and an independent second party (e.g., a doctor) performs the second. Under recent Federal Circuit case law, assuming that the parties are not in an agency relationship, it seems likely that in most instances no party would be found infringing, and the patent owner would be left without a remedy, even in the face of substantial infringement in competition with its business.
In its briefs, Myriad notes that the Federal Circuit has repeatedly admonished patent owners that problems of divided infringement could have been avoided if the claims have been better drafted, i.e., in a manner such that a single party performs all of the steps of a method claim. However, Myriad argues (correctly I think) that the patent eligibility doctrine effectively forecloses this course of action. The Federal Circuits recent decision in Prometheus (discussed previously on this blogs), in particular, interprets Bilski as rendering patent ineligible a claim reciting nothing more than the mere recognition of a correlation per se (which the court equates with patenting a mental step). In order to be patent eligible, Prometheus seems to require a diagnostic method claim to explicitly recite a transformative step, such as detecting the marker, or treating a patient. This creates a Catch-22 for the diagnostic inventor. The discovery of the correlation is the core of the invention, providing substantial therapeutic benefits to patients, but under Prometheus and Bilksi a claim to the correlation must also include an additional step which will often render the claim highly susceptible to circumvention by two parties separately performing the steps.
To avoid this problem, Myriad proposes the following as an appropriate test for infringement of method claims by multiple parties:
When a first party performing one or more steps of a method claim actively causes another party to perform the other steps of the same method claim, or when two parties act in a concerted manner to perform all steps of a method claim, then the first party and the parties acting in concert should each be deemed a direct infringer.
Available link for download
Tuesday, February 14, 2017
Myriad Files Brief in AMP v PTO
Myriad Files Brief in AMP v PTO
Myriad filed its brief with the Federal Circuit last Friday in its appeal of the district court decision in AMP v. PTO, which found Myriads gene patents to be patent ineligible. The brief is available here, I will provide some commentary tomorrow.
Available link for download
Friday, February 10, 2017
Myriad II Another Blow to the Patenting of Biotech Innovation
Myriad II Another Blow to the Patenting of Biotech Innovation
On December 17 the Federal Circuit issued a unanimous decision invalidating product and method claims relating to BRCA genetic diagnostic testingfor lack of patent eligibility. The decision, formally titled In re BRCA1- & BRCA2- Based Hereditary Cancer Test Patent Litigation, University of Utah Research Foundation v. Ambry Genetics Corp, has been referred to as “Myriad II,” since it involves the same patents that were at issue in “Myriad I,” the Supreme Court’s landmark 2013 decision (although the two cases involve different claims). Myriad II is yet another blow to the patenting of diagnostics and personalized medicine, and biotechnology innovation in general.
Background
Myriad I dealt primarily with two types of patent claims: product claims directed towards isolated DNA molecules, and method claims broadly ditected towards the comparison of a human subject’s BRCA gene sequence with the wild-type sequence. Early in the Myriad I litigation, the Federal Circuit declared the “comparison” method claims patent ineligible. The Supreme Court subsequently declared the product claims directed towards isolated genomic DNA molecules patent ineligible, while upholding the patent eligibility of claims directed towards isolated cDNA, which the Court characterized as man-made and sufficiently removed from their native counterpart to qualify for patent protection.Myriad II picks up where Myriad I left off, by addressimg the patent eligibility of product and method claims that were not challenged by the plaintiffs in Myriad I, and which lie farther along the spectrum towards patent eligibility than the claims invalidated in Myriad I. In particular, while the method claims in Myriad I merely recited a single step of “comparing” two DNA sequences, the method claims at issue in Myriad II further recite specific DNA analysis steps such as amplification by PCR or hybridization to a DNA probe. The product claims in Myriad II are directed towards “pairs” of PCR primers, which are by definition synthetic molecules. In contrast, the product claims found to be patent ineligible in Myriad I were directed towards single DNA molecules, which were not necessarily synthetic (Myriad’s patent specifications defined “isolated” so as to encompass native origin genomic DNA).
Method Claims
The Federal Circuit’s invalidation of the method claims in Myriad II was unfortunate but not surprising. Prior to the Supreme Court’s recent decisions in Mayo and Alice, many practitioners (including myself) would have thought that the inclusion of clearly patent eligible claim limitations (such as the use of hybridization probes and PCR amplification) would have rendered the claims clearly patent eligible. In fact, this was the position taken by the Federal Circuit when it first decided Prometheus v. Mayo, when the court upheld the patent eligibility of what were essentially diagnostic method claims. However, in Mayothe Supreme Court reversed the Federal Circuit, holding that the inclusion of patent eligible claim limitations (i.e., administering a drug and determining level of metabolite) does not necessarily render a claim otherwise directed towards a fundamental principle (i.e., a natural phenomenon, law picture or abstract ideas) patent eligible, if the patent eligible limitaations are “well understood, routine and conventional.”In Myriad II, the Federal Circuit characterized the comparison of subject and wild-type DNA sequences to be an abstract idea, which contrasts with Mayo, wherein the physiological correlation at the heart of the claims was characterized as a natural phenomenon. But whether characterized as an abstract idea or natural phenomenon, the ultimate question under the new patent eligibility jurisprudence (Mayo and Alice) is whether additional claim limitations introduce sufficient “further ‘inventive concept’ to take the claim into the realm of patent eligibility.” In Myriad II, the Federal Circuit determined that the use of hybridization probes and PCR in genetic diagnostics is “well understood, routine and conventional,” and thus insufficient to render the claim patent eligible.
This is precisely what happened in Ariosa Diagnostics v. Sequenom, a district court decision I discussed in a previous post. Ariosa Diagnostics is currently on appeal to the Federal Circuit. It will be interesting to see how that case is decided, but based on the decisions in Mayo and now Myriad II, it seems likely that the district court’s decision will stand.
An interesting side note: I
n Myriad I, Judge Bryson of the Federal Circuit identified specific method claims in Myriad’s patents that were not at issue in Myriad I, but which Judge Bryson assumed would be patent eligible. His point was that Myriad did not need the patent claims at issue in Myriad I in order to protect its business, since alternative (presumably valid) claims would nonetheless be available for the company. In writing the opinion of the Supreme Court majority in Myriad I, Justice Thomas specifically cited to Judge Bryson’s remark, opining that Myriad was in an excellent position to obtain alternative patent claims which presumably would be valid and would provide adequate protection.In Myriad II, Myriad pointed to these statements by Justice Thomas and Judge Bryson, and argued that its method claims are very similar to a claim specifically identified as patent eligible by Judge Bryson. Judge Dyk (author of Myriad II) rejected this argument, but it seems clear that under the Federal Circuit’s analysis as set forth in Myriad II, the claim which Judge Bryson and Justice Thomas assumed to be patent eligible is in fact not patent eligible.
In other words, it appears that Judge Bryson and Justice Thomas (and likely other Justices on the Supreme Court) decided Myriad I on the basis of a flawed premise, i.e., that their decision would not fundamentally undercut the ability of companies like Myriad to effectively patent their inventions. Unfortunately, that is not the way the Court’s patent eligibility jurisprudence is playing out.Product Claims
In Myriad II, Myriad essentially argued that the Supreme Court’s holding in Myriad I should be read as limited to isolated DNA molecules of native origin, and not extending to synthetic DNA molecules such as the claimed PCR primers. I think that this was a reasonable argument - the isolated DNA claims invalidated by the Supreme Court encompassed native DNA, i.e., DNA isolated from human tissue. In Myriad I the Court never explicitly addressed the patent eligibility of a claim limited to synthetic genomic DNA. Still, most people (including the PTO) have inferred that Myriad I applies to synthetic versions of naturally occurring DNA (and other biomolecules), so it was not surprising that the Federal Circuit rejected Myriad’s argument and held that the synthetic nature of the claimed PCR primers was insufficient to render them patent eligible.What I found more significant with respect to the PCR primer claims is that the claims were directed towards a combination of primers, rather than to a single isolated DNA molecule. It’s one thing to declare isolated natural products patent ineligible; it’s quite another to declare combinations of natural products patent ineligible. After all, at some level most product claims are directed towards inventive combinations of natural products.
For example, the foundation of biotechnology is recombinant DNA, which typically involves involved the recombination of naturally occurring genetic elements. It cannot be the case that any combination of synthetic versions of naturally occurring biomolecules is patent ineligible, but in Myriad II the Federal Circuit provides no guidance with respect to the threshold for patent eligibility.
Interestingly, patent eligibility guidance published by the PTO on March 4, 2014 (which the PTO refers to as the “March 2014 Procedure”) included a specific example of a claim directed towards a pair of PCR primers, and concluded that the claim was not patent eligible because the sequence of the primers is the same as naturally occurring DNA. I always found this example particularly problematic, because it failed to acknowledge the distinction between a claim directed toward a natural product and a claim directed toward a nonnaturally occurring combination of natural products.
The PTO’s most recent “Interim Eligibility Guidance” (published December 16, 2014) specifically supersedes the March 2014 Procedure, and does not include the PCR primer claim example. To the contrary, the Interim Eligibility Guidance specifically notes that “when [a] nature-based product is produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts.” (Emphasis added).
Unfortunately, in Myriad II, the Federal Circuit has essentially adopted the PTO’s original position in the March 2014 Procedure, focusing on the components recited in the PCR primer claims rather than the claimed combination. A step backwards, introducing more uncertainty into the misguided doctrinepatent eligibility , and in all likelihood more difficulties for biotechnology innovators seeking effective patent protection for their inventions.
Available link for download
Myriad and the ACLU Disagree over Claim Scope But Apparently Not over Patent Eligibility of Genetic Diagnostic Methods
Myriad and the ACLU Disagree over Claim Scope But Apparently Not over Patent Eligibility of Genetic Diagnostic Methods
After reading the briefs submitted by Myriad and the ACLU/PubPat in AMP v. PTO (the challenge to Myriad’s gene patents, described in previous posts to this blog), one thing that struck me was that the parties do not appear to disagree over the patent eligibility of genetic diagnostic methods. In fact, with respect to these method claims, the only dispute is with respect to the proper interpretation of the claims.
The challenged diagnostic method claims recite processes of either "analyzing" or "comparing" nucleotide sequences. For example, claim 1 of US patent number 6,033,857 claims:
A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequence identifies a mutant BRCA2 nucleotide sequence.
Myriad argues for a relatively narrow interpretation of the claims, under which the claims are limited to methods which require actual physical analysis of DNA molecules. Under their interpretation, the term "nucleotide sequence," as used in the claims, refers to actual polynucleotides, i.e., DNA or RNA molecules, and the step of comparing these molecules necessarily requires physically isolating polynucleotides from a patients tissue sample, and then processing and analyzing the molecules. Myriad argues that these processes are all clearly transformative of physical molecules, and because the transformations are “central to the purpose of the claims,” the claims satisfy the machine or transformation test. They cite to Prometheus for the proposition that transformative steps that are central to the purpose of the claims cannot be disregarded in the analysis as mere "data-gathering steps,” and argue these transformative steps render the claim patent eligible.
The ACLU, on the other hand, argues for a much broader interpretation of the method claims. They argue that the term "nucleotide sequence" in the claims refers to sequence information, not to molecules, and that the claims cover the purely mental process of "comparing" or "analyzing" DNA sequence information. Under this broad interpretation, the claims clearly do not require any sort of physical transformation, and on this basis the ACLU argues they fail the machine or transformation test, which they correctly note remains "a useful and important clue" to patent eligibility (using the language of the Supreme Court).
Interestingly, the ACLU never suggests in their brief that the diagnostic method claims would be patent ineligible if limited to methods involving actual isolation and processing of DNA molecules, i.e., the only processes covered by the claims under Myriads interpretation of the claims. Conversely, Myriad never argues that a method claim that encompasses purely mental processes for comparing DNA sequence information would be patent eligible. Thus, both parties seem implicitly to agree on a consensus approach under which a claim directed toward a genetic diagnostic method is patent eligible if limited to diagnostic methods that involve actual isolation and manipulation of DNA molecules, but patent ineligible if the claim would also cover merely comparing DNA sequence information.
Notably, the district court adopted the ACLUs broad interpretation of the claims, and held that the claims cover a process of comparing or analyzing DNA sequence information. However, in dicta the district court went even further, stating that "[e]ven if the challenged claims were read to include the transformations associated with isolating and sequencing human DNA, these transformations would constitute no more than ‘data-gathering step[s]’ that are not central to the purpose of the claimed process.. . . . Consequently, even if the method claims-in-suit were construed to include the physical transformations associated with isolating and sequencing DNA, they would still fail the ‘machine or transformation’ test under Section 101 for subject matter patentability."
In my analysis of the district court decision, I pointed out that this dicta seems clearly wrong, and is inconsistent with the Federal Circuits decision in Prometheus. Clearly, these data-gathering steps are central to the purpose of the claim and should be included in the machine or transformation analysis. I suspect that the ACLU agrees with my assessment, and is not even trying to argue for more extreme position taken by the district court.
It seems to me that the implicit consensus between Myriad and the ACLU is correct, i.e., method of genetic diagnostic claims are patent eligible if they include steps involving the actual physical manipulation of DNA molecules, but patent ineligible if they would cover the wholly mental process of analyzing DNA sequence information.
As a side note, another point of contention regarding claim interpretation exists with respect to whether some of the claims are limited to cDNA molecules. In its amicus brief, the United States government has argued that claims to isolated genomic DNA are patent ineligible, but claims limited to cDNA molecules are patent eligible (as reported in an earlier post to this blog). For some reason, in its brief the ACLU argues that the United States is mistaken, and that none of the challenged claims is limited to cDNA. ACLU seems to be clearly mistaken on this point--for example, Claim 2 of US patent 5,747,282 (one of the challenged claims) recites "DNA [having] the nucleotide sequence set forth in SEQ ID NO:1.” The Sequence Listing section of the patent specification explicitly identifies SEQ ID NO:1 as a cDNA.
Available link for download
Monday, January 23, 2017
More Myriad Briefs
More Myriad Briefs
Here are some more briefs recently filed in the remanded Myriad case.
ACLU and the Public Patent Foundation have filed their supplemental brief on behalf of plaintiffs, available here. Not surprisingly, they argue that the challenged isolated DNA claims, and claim 20 of the 282 patent (these cell based assay claim) are all patent ineligible under Prometheus, and for affirmance of the district court decision.
Knowledge Ecology International and Universities Allied for Essential Medicines have filed an amicus brief in support of the plaintiffs, available here. They argue that isolated DNA patents hinder science and harm healthcare, and that adequate non-patent incentives for pharmaceutical innovation are available (such as FDA data/marketing exclusivity), and ask the Federal Circuit to affirm the District Courts decision.
Gilead Sciences, Confluence Life Sciences and Euclises Pharmaceuticals have filed a joint amicus brief that focuses exclusively on claim 2 of the ‘282 patent, i.e., the cDNA claim, and argues that cDNA is clearly man-made patent eligible subject matter. The brief, available here, asks the Federal Circuit not to reverse its earlier decision.
Available link for download
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