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Category Archives: 101

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

Myriad Sues Ambry For Offering BRCA1/BRCA2 Breast Cancer Genetic Testing

Posted in 101; Myriad; Personalized Medicine

On July 9, 2013, Myriad Genetics, Inc. brought suit against Ambry Genetics Corporation, alleging that Ambry is infringing ten (10) patents by offering breast cancer genetic testing for the BRCA1 and/or BRCA2 mutations associated with aggressive forms of breast and ovarian cancer. While Association for Molecular Pathology v. Myriad Genetics, Inc. was making its way to the Supreme Court, Myriad said that it has other patent claims protecting its market position. This case could put those claims to the test.Continue reading this entry

Judge Rader Explains 35 USC 101 in Ultramercial v Hulu

Posted in 101; Federal Circuit Decisions

In the June 21, 2013 Federal Circuit decision in Ultramercial, Inc. v. Hulu, LLC, the court again reversed the district court’s finding that the claims at issue fail to satisfy § 101. Writing the opinion for the court, Judge Rader delves into patent eligibility jurisprudence and provides guideposts that stakeholders wrestling with § 101 issues may find useful.Continue reading this entry

A Look At The Myriad Gene Patent Claims And The USPTO Memo To Examiners On Myriad

Posted in 101; Myriad; Supreme Court Decisions

Now that the Supreme Court has issued its decision in the “ACLU/Myriad” gene patents case (Association For Molecular Pathology v. Myriad Genetics, Inc.), people are wondering what the decision means for the Myriad patents and BRCA1/BRCA2 genetic testing. If you missed it, this article provides an overview of the Supreme Court Myriad decision. Here, I review the claims of the seven patents that were at issue, and highlight how they may or may not be affected by the Supreme Court decision. My comments are provided for discussion purposes only, and do not constitute any legal determinations of validity, invalidity, or freedom to operate.

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Supreme Court Decides Myriad Gene Patents Case, Holds Isolated Human Genes May Not Be Patented

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

On June 13, 2013, the Supreme Court issued its long-awaited decision in the “ACLU/Myriad” gene patents case (Association For Molecular Pathology v. Myriad Genetics, Inc.). In a unanimous opinion authored by Justice Thomas, the Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.”Continue reading this entry

Federal Circuit Issues Fractured Affirmance In CLS Bank v. Alice Corporation

Posted in 101; Federal Circuit Decisions

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.

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Dispelling The Myriad Gene Patent Harmonization Myth

Posted in 101; International Patent Practice; Myriad

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.

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Supreme Court Oral Arguments in ACLU Myriad Gene Patent Case

Posted in 101; Myriad; Supreme Court Decisions

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

Briefing The Supreme Court In Myriad

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

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

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.

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Supreme Court Grants Cert In Myriad To Decide If Human Genes Can Be Patented

Posted in 101; Myriad; Supreme Court Decisions

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.

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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.

Deja Vu All Over Again In Federal Circuit’s August 16 Myriad Decision

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

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.

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

An Easy Patent Eligibility Exercise

Posted in 101; Bilski; Myriad; USPTO Board Decisions

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

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

Non-Legal Perspectives On Isolated DNA: The Watson And Holman Amicus Briefs In The Myriad Remand

Posted in 101; Myriad

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

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.

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