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
Category Archives: Personalized Medicine
An Update On Patenting Personalized Medicine After Prometheus
Posted in 101; Myriad; Personalized Medicine; PrometheusWhile 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.
En Banc Federal Circuit Eases Requirements For Induced Infringement Of Method Claims
Posted in Federal Circuit Decisions; Infringement; Personalized Medicine; PrometheusOn August 31, 2012, the Federal Circuit issued an en banc, per curiam opinion deciding both Akamai Technologies, Inc. v. Limelight Networks, Inc. and McKesson Technologies, Inc. v. Epic Systems Corp., which each relate to the requirements for establishing infringement when all of the steps of a method claim are not performed by a single party. The court overruled its 2007 decision in BMC Resources, Inc. v. Paymentech, L.P., and held that induced infringement can be found even if a single entity is not liable for direct infringement. While the cases before the court pertain to computer-related inventions, this decision will be important to patents in the field of personalized medicine, where a doctor, patient, and laboratory may be involved in various steps of a diagnostic or therapeutic method.
Direct Infringement Of Method Claims
The court did not disturb the principle that in order for “a party to be liable for direct patent infringement under 35 U.S.C. § 271(a), that party must commit all the acts necessary to infringe the patent, either personally or vicariously.” The court explained that, “[i]n the context of a method claim, that means the accused infringer must perform all the steps of the claimed method, either personally or through another acting under his direction or control.” Thus, “this court has rejected claims of liability for direct infringement of method claims in cases in which several parties have collectively committed the acts necessary to constitute direct infringement, but no single party has committed all of the required acts,” unless there was ”an agency relationship between the actors.”
Induced Infringement Of Method Claims
The court decided that induced infringement is best suited “to address the problem presented by the cases before us, i.e., whether liability should extend to a party who induces the commission of infringing conduct when no single ‘induced’ entity commits all of the infringing acts or steps but where the infringing conduct is split among more than one other entity.”
The court noted that to be liable for induced infringement, “the accused inducer [must] act with knowledge that the induced acts constitute patent infringement.” Moreover, “inducement gives rise to liability only if the inducement leads to actual infringement.” Revisiting and overruling its decision in BMC, the court reasoned:
Requiring proof that there has been direct infringement as a predicate for induced infringement is not the same as requiring proof that a single party would be liable as a direct infringer. If a party has knowingly induced others to commit the acts necessary to infringe the plaintiff’s patent and those others commit those acts, there is no reason to immunize the inducer from liability for indirect infringement simply because the parties have structured their conduct so that no single defendant has committed all the acts necessary to give rise to liability for direct infringement.
Applying the new interpretation to the cases before it, the court noted:
In the McKesson case, Epic can be held liable for inducing infringement if it can be shown that (1) it knew of McKesson’s patent, (2) it induced the performance of the steps of the method claimed in the patent, and (3) those steps were performed.
* * * * *
[In the Akami case,] Limelight would be liable for inducing infringement if the patentee could show that (1) Limelight knew of Akamai’s patent, (2) it performed all but one of the steps of the method claimed in the patent, (3) it induced the content providers to perform the final step of the claimed method, and (4) the content providers in fact performed that final step.
The court reversed the judgments of non-infringement in both cases, and remanded “for further proceedings on the theory of induced infringement.”
Judge Newman’s Dissent
Judge Newman dissented and criticized the court for failing to resolve the issue of divided direct infringement, and for expanding liability for induced infringement.
This en banc court has split into two factions, neither of which resolves the issues of divided infringement. A scant majority of the court adopts a new theory of patent infringement, based on criminal law, whereby any entity that “advises, encourages, or otherwise induces,” maj. op. 14, or “causes, urges, encourages, or aids the infringing conduct,” id. at 15, is liable for the infringing conduct. The majority further holds that only the “inducer” is liable for divided infringement, and that the direct infringers are not liable although the patent rights are “plainly being violated by the actors’ joint conduct.” Id. at 10. These are dramatic changes in the law of infringement.
Judge Linn’s Dissent
Judge Linn’s dissenting opinion was joined by Judges Dyk, Prost, and O’Malley. These judges disagree with the court’s decision that liability for induced infringement can exist independently of liability for direct infringement:
On this unsound foundation, the majority holds that in the present appeals there has been predicate “infringement” even though § 271(a)’s requirements are not satisfied. On that basis, the majority vacates the contrary judgments of the district courts and remands for further proceedings concerning liability under § 271(b). In my view, the plain language of the statute and the unambiguous holdings of the Supreme Court militate for adoption en banc of the prior decisions of the court in BMC … and Muniauction … , which hold that liability under § 271(b) requires the existence of an act of direct infringement under § 271(a), meaning that all steps of a claimed method be practiced, alone or vicariously, by a single entity or joint enterprise.
Impact On Personalized Medicine Claims
Barring a Supreme Court decision that reverses or refines this holding, the Federal Circuit’s decision in Akami may make it easier to obtain patents in the personalized medicine space that both satisfy 35 USC § 101 as interpreted by the Supreme Court’s Prometheus decision, and that are enforceable against a single infringer or inducer. As I wrote previously, certain aspects of the Prometheus decision encourage method steps that would be carried out by different actors, such as one or more doctors, a testing laboratory, and/or the patient. While it is possible that an agency relationship could link those parties, the holding in Akami may make it easier to assert such patents against an inducer who encourages others to commit some or all of method steps that constitute infringement, even where the parties performing individual steps are acting independently.
Deja Vu All Over Again In Federal Circuit’s August 16 Myriad Decision
Posted in 101; Federal Circuit Decisions; Myriad; Personalized MedicineOn 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.
USPTO Issues Prometheus Examination Guidelines
Posted in 101; Personalized Medicine; PrometheusOn July 3, 2012, the USPTO issued its 2012 Interim Procedure for Subject Matter Eligibility Analysis 0f Process Claims Involving Laws of Nature. According to the introduction, the guidelines are “for use by USPTO personnel in determining subject matter eligibility of process claims involving laws of nature under 35 USC § 101,” in view of the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. The guidelines walk a careful line between following Supreme Court precedent without eviscerating the ability to obtain patents on methods that involve laws of nature, natural phenomena, or naturally occurring correlations.Continue reading this entry
What Do The IP Lawyers Have To Say In The Myriad Remand?
Posted in 101; Myriad; Personalized Medicine; PrometheusSeveral 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 Myriad And ACLU Supplemental Briefs On Remand To The Federal Circuit
Posted in 101; Myriad; Personalized Medicine; PrometheusMyriad 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 Suggests Bright-Line Rule In Myriad Amicus Brief
Posted in 101; Myriad; Personalized Medicine; PrometheusEli 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 United States Files Its Amicus Brief In Myriad
Posted in 101; Myriad; Personalized Medicine; PrometheusThe 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
Federal Circuit Sets Briefing Deadline, Oral Argument Date For Myriad Isolated DNA Case
Posted in 101; Federal Circuit Decisions; Myriad; Personalized Medicine; PrometheusPursuant to the Supreme Court’s March 26, 2012 order remanding Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case), the Federal Circuit has issued an order requesting supplemental briefing to be filed by June 15, 2012. Biotechnology companies interested in the patent-eligibility of newly discovered, biologically relevant DNA sequences (and other similar compounds) should consider filing amicus briefs to explain their views and concerns to the court.
Vlog: Why Prometheus Doesn’t Govern Myriad But Might Impact It Anyway
Posted in 101; Myriad; Personalized Medicine; PrometheusI 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:
The USPTO Examines Prometheus
Posted in 101; Bilski; Personalized Medicine; PrometheusThe day after the Supreme Court issued its unanimous decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the USPTO issued a letter to the Patent Examining Corps that provides preliminary guidance to examiners and promises that more detailed guidance is forthcoming.Continue reading this entry
My Myriad Nightmare
Posted in 101; Myriad; Personalized Medicine; Prometheus; Supreme Court DecisionsNow 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
Justice Breyer Gets The Last Word And Invalidates Prometheus Personalized Medicine Claims
Posted in 101; Personalized Medicine; Prometheus; Supreme Court DecisionsOn March 20, 2012, Justice Breyer issued the unanimous decision for the Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., holding that Prometheus’ claims directed to methods of optimizing the dose of specific drugs used in the treatment of specific conditions are invalid under 35 USC § 101 because they impermissibly claim laws of nature. The Court’s decision reverses the Federal Circuit, which had twice upheld the validity of the claims at issue. While the Court’s opinion provides additional touchstones for distinguishing claims directed to laws of nature (not patent-eligible) from claims directed to specific applications of laws of nature (patent-eligible), because it erases the bright line of the Federal Circuit’s machine-or-transformation test, stakeholders will have to undertake a fact-specific, case-by-case, and (at least for the time being) uncertain analysis in order to determine whether given personalized medicine method claims satisfy § 101.Continue reading this entry
Federal Circuit Ignores Claim Language To Identify The Underlying Invention
Posted in 101; Federal Circuit Decisions; Personalized MedicineAt first glance, the Federal Circuit decision in Cybersource Corp. v. Retail Decisions, Inc. may not be of much interest to those in the pharmaceutical field. The patent at issue relates to a “method and system for detecting fraud in a credit card transaction” and the question before the court was whether various computer-related claim limitations made the claims patent-eligible under 35 USC § 101 under the Supreme Court’s Bilksi decision. However, at least one aspect of the court’s decision may raise concerns for patent applicants in personalized medicine fields—the court’s decision to ignore carefully crafted claim language in order to assess the patent-eligibility of the “underlying” invention.
Federal Circuit Upholds Many Classen Method Claims, Also Limits Reach Of Safe Harbor
Posted in 101; Federal Circuit Decisions; Patent Term Extension; Personalized MedicineOn 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.
Myriad Calls ACLU Bluff On Standing
Posted in 101; Myriad; Personalized MedicineAs 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.
ACLU Files Petition For Panel Rehearing In Myriad
Posted in 101; Myriad; Personalized MedicineAs 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.
Federal Circuit Issues Mixed Decision On Myriad Claims
Posted in 101; Federal Circuit Decisions; Myriad; Personalized Medicine; PrometheusOn 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.
Federal Circuit Hears Oral Arguments in Myriad
Posted in 101; Myriad; Personalized MedicineOn 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.
Mayo Petitions for Certiorari Against Prometheus
Posted in 101; Myriad; Personalized Medicine; PrometheusOn 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.
Solicitor General Asks To Argue Myriad on April 4
Posted in 101; Myriad; Personalized MedicineIn 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.”
Who Will Infringe That Method Claim?
Posted in Federal Circuit Decisions; Personalized MedicineIn Akamai Technologies, Inc. v. Limelight Networks, Inc., the Federal Circuit clarified the requirements for establishing joint infringement—a theory of direct infringement that may be used when a single party does not perform all of the steps of a method claim. The decision provides a good reminder to consider "who" is likely to perform each step of a method claim. This analysis can be particularly important in the context of diagnostic and personalized medicine methods.
The Patents At Issue
The patent involved in the joint infringement issue (U.S. 6,108,703) relates to web page content delivery services, whereby a host stores and serves embedded objects displayed on a content provider’s web site. Claims 19 and 34 were the independent claims at issue:
19. A content delivery service, comprising:
replicating a set of page objects across a wide area network of content servers managed by a domain other than a content provider domain;
for a given page normally served from the content provider domain, tagging the embedded objects of the page so that requests for the page objects resolve to the domain instead of the content provider domain;
responsive to a request for the given page received at the content provider domain, serving the given page from the content provider domain; and
serving at least one embedded object of the given page from a given content server in the domain instead of from the content provider domain.
34. A content delivery method, comprising:
distributing a set of page objects across a network of content servers managed by a domain other than a content provider domain, wherein the network of content servers are organized into a set of regions;
for a given page normally served from the content provider domain, tagging at least some of the embedded objects of the page so that requests for the objects resolve to the domain instead of the content provider domain;
in response to a client request for an embedded object of the page:
resolving the client request as a function of a location of the client machine making the request and current Internet traffic conditions to identify a given region; and
returning to the client an IP address of a given one of the content servers within the given region that is likely to host the embedded object and that is not overloaded.
As reflected in the highlighted steps, the embedded objects must be "tagged" in order to be served from the host in accordance with the claimed methods.
Akamai’s Theory of Joint Infringement
Akamai relied on the theory of joint infringement to establish direct infringement by Limelight, because Limelight did not itself tag embedded objects. Rather, Limelight’s customers were contractually required to select and tag the embedded objects that Limelight would host and serve. Limelight also provided its customers with detailed tagging instructions.
Akamai relied on these contractual terms and cited the Federal Circuit’s analysis in BMC Resources, Inc. v. Paymentech, L.P. (Fed. Cir. 2007), where the court stated that joint infringement can be established when one party "control[s] or direct[s]" the activities of another.
The jury reached a verdict of infringement, after which Limelight moved for judgment as a matter of law (JMOL) of non-infringement.
While the case was pending at the district court, the Federal Circuit issued its decision in Muniauction, Inc. v, Thomson Corp. (Fed. Cir. 2008), which held that "an accused infringer’s control over its customers’ access to an online system, coupled with instructions on how to use that system, was not enough to establish direct infringement."
The district court found "’no material difference between Limelight’s interaction with its customers and that of Thomson in Muniauction," and so granted JMOL of non-infringement.
The Federal Circuit’s Statement of Joint Infringement Law
The Federal Circuit began its analysis by emphasizing that "direct infringement requires a single party to perform every step of a claimed method." The court explained that the "direct or control" language in BMC stemmed from legal principles of vicarious liability and the notion that a party should not be able to avoid infringement liability "simply by contracting out steps of a patented process to another entity." The court explained that the relationship between the parties must be "such that acts of one may be attributed to the other."
This court therefore holds as a matter of Federal Circuit law that there can only be joint infringement when there is an agency relationship between the parties who perform the method steps or when one party is contractually obligated to the other to perform the steps.
Applying this test to the case before it, the Federal Circuit found no joint infringement:
- The Federal Circuit found that the tagging instructions that Limelight provided to its customers did not create an agency relationship. In particular, the court found no evidence that Limelight had any right to control its customer’s actions.
- The Federal Circuit found that Limelight’s customer contracts did "not obligate [its] customers to perform any of the method steps. It merely explains that the customer will have to perform the steps if it decides to take advantage of Limelight’s service."
The court concluded that Limelight’s customers "acted principally for their own benefit and under their own control" and so their actions could not be attributed to Limelight.
A Problem of Claim Drafting?
The Federal Circuit decision includes a discussion that raises red flags for patent practitioners:
While acknowledging the difficulty of proving infringement of claims that must be infringed by multiple parties, this court has noted that such concerns “can usually be offset by proper claim drafting. A patentee can usually structure a claim to capture infringement by a single party.”
The court noted:
Here, the asserted claims were drafted so as to require the activities of both Limelight and its customers for a finding of infringement. Thus, Akamai put itself in a position of having to show that the allegedly infringing activities of Limelight’s customers were attributable to Limelight.
Of course, we do not know why these claims were drafted this way, and it can be too easy to second-guess any claiming strategy with 20/20 hindsight in view of an unfvorable court decision!
A Problem Of Infringement Theory?
The Federal Circuit decision notes that Akamai "waived any assertion of indirect infringement before trial." Thus we do not know whether Akamai might have been successful with a claim of contributory infringement or induced infringement. On the other hand, even contributory infringement and induced infringement usually require that someone was a direct infringer.
Questions for Diagnostic & Personalized Medicine Method Claims
Akamai brings to mind a discussion in the Federal Circuit’s recent decision in Prometheus Laboratories, Inc. v. Mayo Collaborative Services. Prometheus’s claims were directed to
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.
(Not all claims recited the "administering step.)
The Federal Circuit acknowledged that "the final ‘wherein’ clauses are mental steps and thus not patent-eligible per se," but reasoned that "when viewed in the proper context, the final step of providing a warning based on the results of the prior steps does not detract from the patentability of Prometheus’s claimed methods as a whole." The court continued:
No claim in the Prometheus patents claims only mental steps. Therefore, contrary to Mayo’s assertions, a physician who only evaluates the result of the claimed methods, without carrying out the administering and/or determining steps that are present in all the claims, cannot infringe any claim that requires such steps.
Viewing this passage through the lens of Akamai raises several questions:
- Who would perform each of the method steps of Prometheus’s claims?
- If the patient self-administers the drug, does he or she do so as an agent of the doctor?
- If a lab determines the metabolite level, does it do so as an agent of the doctor, or under a contractual obligation to do so?
- If a doctor orders a test from a lab to determine the level of metabolite, does the doctor do so as an agent of the patient, and the lab do so as an agent of the doctor or under a contractual obligation to do so?
- Do the requirements for induced infringement or contributory infringement need to be satisfied to find a lab (or test kit manufacturer) liable for infringement (as Mayo was)?
- Would you chose the doctor or the patient as the underlying direct infringer?
Cruisin’ for a Bruisin’ on Metabolite?
Posted in 101; Federal Circuit Decisions; Personalized Medicine; PrometheusTo many following the application of 35 U.S.C. § 101 to diagnostic and personalized medicine method claims, the Federal Circuit’s decisions in Prometheus Laboratories, Inc. v. Mayo Collaborative Services seem to be at odds with Justice Breyer’s dissent from the dismissal of the grant of certiorari in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc. In both of its decisions (before and after Bilski), the Federal Circuit addressed Metabolite only in a footnote, which makes me wonder whether the court is setting itself up for a confrontation with Justice Breyer. (Justices Stevens and Souter, who joined the dissent, have since retired from the Court.)
Metabolite
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.There can be little doubt that the correlation between homocysteine and vitamin deficiency set forth in claim 13 is a “natural phenomenon.”
The patent-eligibility issue was not raised at the Federal Circuit, but was raised in the petition for certiorari that was granted and then dismissed as improvidently granted. It was in that context that Justice Breyer wrote his "Metabolite dissent."
Justice Breyer framed the issue that he would have liked the Court to address:
The researchers who obtained the present patent found that an elevated level of homocysteine in a warm-blooded animal is correlated with folate and cobalamin deficiencies. As construed by the Federal Circuit, claim 13 provides those researchers with control over doctors’ efforts to use that correlation to diagnose vitamin deficiencies in a patient. Does the law permit such protection or does claim 13, in the circumstances, amount to an invalid effort to patent a “phenomenon of nature”?
Factually, Justice Breyer found that "[t]here can be little doubt that the correlation between homocysteine and vitamin deficiency . . . is a ‘natural phenomenon.’" He rejected Metabolite’s arguments that the method claims nonetheless were patentable because they "recite a ‘process’ for detecting vitamin deficiency, with discrete testing and correlating steps."
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.’”
Prometheus
The claims at issue in Prometheus recited:
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.
The First Prometheus Decision
In its 2009 pre-Bilski decision, the Federal Circuit upheld Prometheus’s claims under the machine-or-transformation test. It addressed Justice Breyer’s Metabolite dissent in a brief footnote:
In reaching its conclusion, the district court relied heavily on the opinion of three justices dissenting from the dismissal of the grant of certiorari in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U.S. 124 (2006) (Breyer, J., dissenting). See Invalidity Opinion, 2008 WL 878910, at *8 (discussing the dissent in Laboratory Corp. at length and stating that although the dissent “does not have precedential value, the Court finds Justice Breyer’s reasoning persuasive”). That dissent is not controlling law and also involved different claims from the ones at issue here.
The Second Prometheus Decision
In its recent 2010 post-Bilski decision (which I wrote about in more detail here) the Federal Circuit again upheld Prometheus’s claims, reiterating its machine-or-transformation analysis and explaining that the claimed methods “recite a patent-eligible application of naturally occurring correlations."
Metabolite was once again relegated to a footnote:
Mayo, as did the district court, points to the opinion of three Justices dissenting from the dismissal of the grant of certiorari in Lab. Corp., 548 U.S. 124 (Breyer, J., dissenting from dismissal of certiorari as improvidently granted). See Invalidity Opinion, 2008 WL 878910, at *8 (discussing the dissent in Lab. Corp. at length and finding Justice Breyer’s reasoning persuasive). Again, with respect, we decline to discuss a dissent; it is not controlling law, and it involved different claims from the ones at issue here. Mayo further claims that five Justices in two concurrences cited Lab. Corp. with approval in Bilski, but such citations fail to transform a dissent into controlling law. Moreover, one concurrence cites Lab. Corp. for the proposition that “too much patent protection can impede rather than ‘promote the Progress of . . . useful Arts,’” in arguing for a categorical rule that business method patents do not qualify as patent-eligible processes under § 101. Bilski, 130 S. Ct. at 3255 (Stevens, J., concurring). But this case does not involve business method patents.
Setting Up A Supreme Confrontation?
Mayo has until mid-March to file a petition for certiorari at the Supreme Court, and is expected to do so. After all, the Supreme Court granted certiorari after the 2009 Federal Circuit decision, and Justice Breyer’s Metabolite dissent outlines potentially useful arguments.
While the footnote in the 2010 Federal Circuit decision makes it look like the court again did not address Justice Breyer’s concerns head on, the court did provide an analysis that in essence rebuts Justice Breyer’s views. The court explained how Prometheus’s claims satisfied § 101 under the difficult patchwork of Supreme Court precedent, related to a patent-eligible, specific application of a natural phenomenon, and passed the machine-or-transformation test that the Supreme Court itself recently affirmed in Bilski as a useful tool for applying § 101.
If the Supreme Court grants certiorari this time around, I’m sure there will be speculation that the Court disagrees with the Federal Circuit’s analysis. Only time will tell if Justice Breyer will reach a different decision in a case where the issue is fully briefed and illuminated by the Federal Circuit’s analysis.
