In a fractured en banc decision, the Federal Circuit affirmed the district court’s holding that the claims at issue in CLS Bank v. Alice Corporation are invalid under 35 USC § 101. The multiple opinions reveal the judge’s fundamental differences as to the meaning and role of the statute, and the difficulty of applying Supreme Court precedent. The court’s inability to agree on even an appropriate framework for assessing patent-eligibility guarantees that this fundamental inquiry will be a murky area of law for the foreseeable future.
In the wake of the Supreme Court oral arguments in the Myriad “gene patent” case, most commentators are predicting that the Court will uphold the patent-eligibility of non-naturally occurring DNA sequences (such as cDNA), but will decide that even “isolated” forms of naturally occurring DNA cannot be patented under 35 USC § 101. I have heard some say that such a decision would “harmonize” U.S. patent law with European patent law, but that is not correct.
On April 15, 2013, the Supreme Court heard oral arguments in one of the most controversial and publicized biotech patent cases–the “ACLU/Myriad” gene patent case (e.g., The Association For Molecular Pathology v. USPTO). While it is always risky to predict the outcome of a Supreme Court case from the oral arguments, the Justices seemed to have accepted the U.S. Solicitor General’s arguments that cDNA molecules satisfy § 101, but seem unlikely to find that human genes can be patented.Continue reading this entry
March 15, 2013 was a big deadline for patent applicants seeking to secure first-to-invent filing dates for U.S. patent applications, but April 15 will be a big day for the biotechnology industry, when the Supreme Court hears oral arguments in The Association of Molecular Pathology v. Myriad Genetics, Inc. (also known as the ACLU/Myriad “gene patent” case). Here I provide a brief summary of the parties’ briefs to the Supreme Court.Continue reading this entry
While the Supreme Court just granted certiorari in Myriad, case law surrounding the patent-eligibility of diagnostic and therapeutic personalized medicine has continued to develop in the wake of Mayo v. Prometheus. The good news for innovators is that the USPTO is still granting patents in the field of personalized medicine. The bad news is that the Federal Circuit is still invalidating claims as “indistinguishable” from those presented by Prometheus.
On November 30, 2012, the Supreme Court granted certiorari in the “ACLU/Myriad” gene patenting case (Association for Molecular Pathology v. Genetics, Inc.), guaranteeing that the debate over the patent-eligibility of human genes will continue for another round. The Court will review the August 16, 2012 Federal Circuit decision that held for the second time that Myriad’s claims directed to isolated DNA sequences satisfy 35 USC § 101.
The Association for Molecular Pathology (represented by the ACLU) has filed a petition for certiorari to the Supreme Court, seeking review of the Federal Circuit’s August 16, 2012 decision that upheld the patent-eligibility of Myriad’s “isolated DNA” claims. The petition raises three questions for Supreme Court review:
- Are human genes patentable?
- Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court’s ruling in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)?
- Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court’s decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that petitioners who have been indisputably deterred by Myriad’s “active enforcement” of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally threatened with an infringement action?
This petition will come as no surprise to those who have been following this case since the district court rendered the first decision on the merits in 2010. We should know by June whether the Supreme Court will grant certiorari, but it could be a year or more before a final decision is rendered.
On August 16, 2012, just four weeks after it heard oral arguments, the Federal Circuit issued its second decision in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case), which was on remand in view of the Supreme Court’s March 20, 2012 decision in Mayo v. Prometheus. The same three-judge panel heard the case on remand, and the judges reached essentially the same results on the interpretation of 35 USC § 101 as set forth in their July 29, 2011 decision. Thus, once again, Judge Lourie wrote the opinion for the court, Judge Moore concurred in the result, and Judge Bryson concurred in part and dissented in part.
All judges agree that at least one plaintiff has standing, that the diagnostic method claims based on “comparing” or “analyzing” DNA sequences are not patent-eligible, and that the drug screening method claim is patent-eligible. The court again held that all of the “isolated DNA” claims are patent-eligible, including those encompassing genomic DNA. Judge Bryson once again dissented with regard to the genomic DNA claims, but agreed with the majority that the cDNA claims satisfy 35 USC § 101.
While it is not surprising that the Federal Circuit reached the same conclusion in this decision, many will be relieved that they maintained the status quo as we move one step closer to final resolution of the issues by the Supreme Court.
For a more detailed review of the decision, please see this August 16, 2012 Foley & Lardner LLP Legal News Alert.
On Friday, July 20, 2012, the Federal Circuit heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case), which is on remand in view of the Supreme Court decision in Mayo v. Prometheus. The courtroom was crowded again, but the mood seemed a bit lighter than the first oral arguments in April 2011. Reading the tea leaves from the judges’ questions and comments, I think the panel decision will depend on whether Judge Moore again concurs with Judge Lourie on the patent-eligibility of isolated DNA, or whether she feels compelled by Mayo to join Judge Bryson, who would invalidate the claims. You can listen to the recording of the oral arguments here. A decision is likely a few months away, and the case is expected to make its way to the Supreme Court again.Continue reading this entry
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
While we struggle to understand the ramifications of difficult patent eligibility cases like Prometheus and Myriad, it can be helpful to examine an application that plainly fails to satisfy 35 USC § 101. When the USPTO Board of Patent Appeals and Interferences affirmed the Examiner’s rejections in Ex parte Nerenberg, it may not have added much to § 101 jurisprudence, but its holding of non-patent eligibility means that we all are free to practice the self-improvement methods described in Nerenberg’s patent application.Continue reading this entry
Several associations and organizations of intellectual property lawyers submitted amicus briefs in the Federal Circuit remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCA1 case). While many make the same arguments, there are some points that may stand out enough to get the court’s attention.
(See this article for my review of the most interesting amicus briefs, this article for my discussion of the United States amicus brief, and this article for a summary of the parties’ briefs.)Continue reading this entry
The most interesting briefs in the Federal Circuit remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCA1 case) may be those submitted by James D. Watson and Christopher M. Holman, which each present non-legal perspectives on the issues before the court.Continue reading this entry
Myriad and the ACLU filed their supplemental briefs in the remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCA1 case), addressing the Federal Circuit’s question as to the applicability of the Supreme Court’s decision in Mayo Collaborative Servs. v. Prometheus Labs., Inc. to the patent eligibility of Myriad’s isolated DNA claims and method claim 20 of Myriad’s U.S. Patent 5,747,282. While the parties’ positions are predictable, it is interesting to see how they frame the issues.Continue reading this entry
Eli Lilly filed an interesting amicus brief in the remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case). The Lilly brief focuses on claim 20 of Myriad’s U.S. Patent 5,747,282, and urges the Federal Circuit to adopt a bright-line rule that would hold any method claim that includes a step that “may be performed mentally” not eligible for patenting under 35 USC § 101. Continue reading this entry
The briefs in the remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case) were due last Friday, June 15, 2012. While the views of the parties and other amici may be of interest to the Federal Circuit, I am particularly interested in the position taken in the U.S. Department of Justice’s amicus brief. It is disappointing but not surprising that the United States asserts that the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. supports its position that isolated genomic DNA is not patent-eligible under 35 USC § 101. Continue reading this entry
After the Supreme Court decided that the personalized medicine method claims at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc. did not satisfy the patent eligibility requirements of 35 USC § 101, it was not surprising that the Court asked the U.S. Court of Appeals for the Federal Circuit to take a second look at Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case). Although Myriad’s “isolated DNA” claims raise different patent eligibility issues than Prometheus’s method claims, both patents relate to technology that is applied in the medical diagnostic/therapeutic space.
It was more puzzling when the Supreme Court also asked the Federal Circuit to reconsider Ultramercial, LLC v. Hulu, LLC, where the claims at issue relate to methods of distributing copyrighted content over the internet. True, the patent eligibility of the Ultramercial claims is at issue, but how can the Supreme Court’s explication of the non-patent eligibility of natural phenomena impact the Federal Circuit’s decision that the Ultramercial methods were not disqualified from patenting as merely claiming abstract ideas?
See what I’m afraid all this could mean in my guest commentary for The Legal Pulse Blog of the Washington Legal Foundation.
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
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.
I was honored to be invited by the Washington Legal Foundation to prepare a video commentary on the recent Supreme Court decision in Prometheus and its possible impact on the Myriad isolated DNA case for their Legally Brief series.
Here’s what I had to say:
While the early arrival of spring weather has many of us turning our attention to our gardends, pharmaceutical companies are facing a number of new developments in the patent landscape. In this podcast interview for The Burrill Report, I talk about Prometheus, Myriad, the compulsory license for Bayer’s Nexvar drug in India, and the status of the implementation of U.S. patent reform.
If you’ve been spending more time enjoying nature than drawing lines between laws of nature and products of nature, I’ll get you caught up in a few minutes.
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
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
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