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Category Archives: Prometheus

Federal Circuit Remands Sequenom Down Syndrome Test Platform Patent For Consideration Under Myriad

Posted in 101; Claim Construction; Federal Circuit Decisions; Personalized Medicine; Prometheus

In Aria Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit vacated and remanded the district court’s decision denying Sequenom’s motion for a preliminary injunction relating to a patent covering the non-invasive Sequenom Down Syndrome test. The Federal Circuit found that the district court had “incorrectly interpreted the asserted claims and improperly balanced factors regarding issuance of a preliminary injunction.” The Federal Circuit also directed the district court to reexamine the patent eligibility issues in view of the Myriad Supreme Court decision, but I do not understand how the claims at issue could be invalid under 35 USC § 101.Continue reading this entry

An Update On Patenting Personalized Medicine After Prometheus

Posted in 101; Myriad; Personalized Medicine; Prometheus

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.

Continue reading this entry

Myriad Marches Towards The Supreme Court (Again)

Posted in 101; Myriad; Prometheus; Supreme Court Decisions

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:

  1. Are human genes patentable?
  2. 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)?
  3. 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.

En Banc Federal Circuit Eases Requirements For Induced Infringement Of Method Claims

Posted in Federal Circuit Decisions; Infringement; Personalized Medicine; Prometheus

On 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.

Myriad Oral Arguments: Deja Vu?

Posted in 101; Myriad; 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

USPTO Issues Prometheus Examination Guidelines

Posted in 101; Personalized Medicine; Prometheus

On 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; Prometheus

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 Myriad And ACLU Supplemental Briefs On Remand To The Federal Circuit

Posted in 101; Myriad; Personalized Medicine; Prometheus

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 Suggests Bright-Line Rule In Myriad Amicus Brief

Posted in 101; Myriad; Personalized Medicine; Prometheus

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 United States Files Its Amicus Brief In Myriad

Posted in 101; Myriad; Personalized Medicine; Prometheus

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

Smoke Signals or Smokescreen: The Ultramercial GVR

Posted in 101; Myriad; Prometheus; Supreme Court Decisions

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.

Puzzled By Prometheus

Posted in 101; Prometheus

Last Wednesday I attended an excellent roundtable on Prometheus hosted by The George Washington University Law School and The Biotechnology Industry Organization (BIO). The roundtable was moderated by Hans Sauer of BIO and John M. Whealan of GW Law, and the panelists included The Honorable Paul R. Michel, intellectual property law professors, industry representatives, and practitioners (including my colleagues Hal Wegner and Andrew S. Baluch). While the program offered lots of food for thought, one point in particular (made by Daryl Joseffer of King & Spalding) had people talking during the reception.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; Prometheus

Pursuant 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.

Continue reading this entry

Vlog: Why Prometheus Doesn’t Govern Myriad But Might Impact It Anyway

Posted in 101; Myriad; Personalized Medicine; Prometheus

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:

WLF Legally Brief: Supreme Court Prometheus Patent Decision

The USPTO Examines Prometheus

Posted in 101; Bilski; Personalized Medicine; Prometheus

The 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 Decisions

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

Justice Breyer Gets The Last Word And Invalidates Prometheus Personalized Medicine Claims

Posted in 101; Personalized Medicine; Prometheus; Supreme Court Decisions

On 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

Who’s On First? The Supreme Court Struggles With The Patent-Eligibility Of Personalized Medicine Claims

Posted in 101; Prometheus; Supreme Court Decisions

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

Federal Circuit Issues Mixed Decision On Myriad Claims

Posted in 101; Federal Circuit Decisions; Myriad; Personalized Medicine; Prometheus

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.

Continue reading this entry

Supreme Court Grants Cert In Mayo v. Prometheus

Posted in 101; Prometheus; Supreme Court Decisions

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.

Mayo Petitions for Certiorari Against Prometheus

Posted in 101; Myriad; Personalized Medicine; Prometheus

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.

Continue reading this entry

Cruisin’ for a Bruisin’ on Metabolite?

Posted in 101; Federal Circuit Decisions; Personalized Medicine; Prometheus

To 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

  1. obtaining test results and
  2. 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.

Federal Circuit Upholds Personalized Medicine Claims

Posted in 101; Federal Circuit Decisions; Myriad; Personalized Medicine; Prometheus

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

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

  1. obtaining test results and
  2. 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.

Pick Your Poison: Patent-Ineligibility or Inherency?

Posted in 101; 102; Bilski; Federal Circuit Decisions; Personalized Medicine; Prometheus

The Supreme Court’s Bilksi decision recognized three exceptions to 35 USC § 101: “laws of nature, physical phenomena, and abstract ideas.” The Federal Circuit’s decision in King Pharmaceuticals, Inc. v. Eon Labs., Inc. warns us that although satisfying the machine-or-transformation test might prove to be an effective antidote against § 101 defects, a patent claim still may be poisoned by 35 USC § 102 if the method at issue inherently flows from a prior art method—such as if it recites a newly discovered law of nature or physical phenomenon that naturally results from the prior art method.

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