Mayo Collaborative Services Research Articles

Athena Rising? Brief of Professors Jeffrey A. Lefstin and Peter S. Menell as <i>Amici Curiae</i> in Support of Petition for a Writ of Certiorari in <i>Athena Diagnostics v. Mayo Collaborative Services</i>

In Bilski v. Kappos (2010), this Court explained that its interpretation of 35 U.S.C. § 101 has been guided by over 150 years of historical practice. Yet two years later in Mayo Collaborative Services v. Prometheus Laboratories (2012), the Court triggered the most radical redefinition of patent-eligible subject matter in U.S. history by engrafting an inventive application requirement for patenting practical applications of scientific discoveries. Mayo based this requirement on three critical assumptions: (1) Congress has never addressed the question of the patentability of scientific discoveries; (2) foundational precedent of the English courts and of this Court excluded scientific discoveries and demanded inventive application as a condition of patent eligibility; and (3) a new extra-textual limitation on patentability was necessary to address the undue preemption of laws of nature and other scientific discoveries. Unfortunately, inadequate briefing in Mayo led the Court astray. The Nation’s patent statutes, stretching back to the founding era, unmistakably afford patent protection to technological innovations and scientific discoveries. Congress has expressly sought to encourage both technological inventions and scientific discoveries. The legislative concern has not been with preemption of inventive fields, which the durational limits and disclosure constraints of the Patent Act address, but rather with “min[ing]” the “exhaustless” “treasures” and “unlimited reach of science.” Specific legislative enactments in 1930, 1952, and 1954 refute any requirement of inventive application for patent eligibility. Furthermore, the Mayo briefs failed to address critical context and meaning of key cases bearing on patent eligibility of applications of scientific discoveries. Both Parker v. Flook (1978) and Mayo relied on a mistaken reading of Neilson v. Harford (1841) to conclude that English and American courts restricted patents to inventive applications of new discoveries. To the contrary, Neilson became the primary authority in England and the United States for the position that practical applications of discoveries were patentable without any invention in the means of application. Finally, contrary to Mayo’s supposition that a new extra-statutory doctrine was necessary to limit undue preemption of scientific discoveries, this Court has long held that this role was served by patent law’s express disclosure requirements. See O’Reilly v. Morse (1854) and subsequent cases. As reflected in the eight opinions in Athena Diagnostics, Inc. v. Mayo Collaborative Services, as well as clear signals in numerous other cases, the Patent Office’s frequent revision of examiner guidance documents, and legislative hearings, the Federal Circuit, district courts, Patent Office, and inventors have struggled unsuccessfully to apply the Mayo/Alice decisions coherently and predictably. These decisions have imposed massive costs upon all of these institutions and the public, thereby undermining the patent system. This case provides an ideal vehicle for the Supreme Court to revisit the standards for patent eligibility on the basis of thorough briefing of the proper statutory and jurisprudential considerations.

The Effects of Myriad and Mayo on Molecular Test Development in the US and Europe: Interviews from the Frontline

US Supreme Court decisions in Mayo Collaborative Services v. Prometheus Laboratories and Association for Molecular Pathology v. Myriad Genetics Inc. caused US and European law on what is patentable subject matter to diverge significantly. Both cases related to molecular tests and changed decades of patent practice. Whether the decisions adversely affect the development of molecular tests in the United States and Europe has been a matter of much speculation but limited empirical investigation. This interview-based study has three main findings. First, Myriad and Mayo have negatively affected the development of some molecular tests. Notably, half of the US university technology-transfer offices interviewed decided not to develop tests, and many other organizations have found the legal uncertainty following the cases problematic. Second, small patent-precarious organizations—those that rely heavily on patents for competitive advantages, such as technology-transfer offices—have been the most affected because patent protection is now often weaker and more difficult

Patenting nature-a comparative perspective.

ABSTRACTThe landscape for patenting products and processes tied to the natural world has changed dramatically in recent times as a result of a series of decisions of the US Supreme Court, particularly Mayo Collaborative Services v Prometheus Laboratories 566 U.S. 66 (2012) and Association for Molecular Pathology v Myriad Genetics, Inc. 569 U.S. 576 (2013) (Myriad). This article critically analyses these decisions and the multitude of lower court decisions that have followed them. This analysis provides support for the growing concern in the United States that it will be increasingly difficult to use the patent system to encourage the development of therapies and research intermediates useful in developing new therapeutic interventions. One option being posited in the industry to deal with this problem is to lobby Congress to reform the threshold patent eligibility standard in US patent law. It is argued in this paper that a more nuanced approach is preferable. Using the experience in Australia as a case study, this paper argues that such an approach is feasible. Australia has been chosen for analysis because the threshold patent eligibility standard is similar in both countries, much more so that with the European Union, and because the highest court in Australia has ruled on essentially the same patent as in Myriad, in D’Arcy v Myriad Genetics, Inc [2015] HCA 35. In addition to the nuanced approach to eligibility currently exercised by the Australian courts and patent office, Australia also has a number of post-grant options for addressing the dynamics of patent monopolies. These include experimental use, compulsory licensing, and government use. It is concluded that, while it would be impractical to attempt to replicate the Australian environment in the United States, there is no reason why some lessons can’t be learned from the Australian experience with patenting nature.

Should We Change EU Law to Disallow DNA Patents?

In the first half of the current decade, the US Supreme Court substantially restricted the patentability of isolated DNA sequence patents and methods of genetic diagnosis through its decisions in Mayo Collaborative Services v Prometheus Laboratories Inc in 2012, and in Association for Molecular Pathology v Myriad Genetics Inc in 2013. A key question for Europeans – and Britons – is whether European law should follow the legal directions in the US: should we also disallow DNA patents? Relatedly, should we disallow genetic diagnostics patents? This paper set the scene for an expert debate on this topic. It focusses on the patentability of DNA sequence patents. The debate was held on 18 November 2016 at the University of Cambridge before a general academic audience.

Biotech Patent Eligibility: A New Hope

The practical effect of the Supreme Court’s decisions in Mayo Collaborative Services v. Prometheus Laboratories, Inc. and Alice Corporation Pty. v. CLS Bank International has been to deny patent eligibility to innovative patent applications and patents, particularly in the fields of biotechnology and computer software. On July 5, 2016, the Federal Circuit in Rapid Litigation Management Ltd. v. CellzDirect, Inc. ruled that the claimed methods of cryopreserving hepatocyte cells are patent eligible under 35 U.S.C. § 101 because they are not directed to a natural phenomenon. The patentees discovered that some cells in a hepatocyte pool could survive multiple freeze-thaw cycles. The claims recite a method of producing a preparation of hepatocytes that can be frozen and thawed at least twice. The method steps include freezing and thawing a sample of hepatocytes, performing density fractionation to separate viable and non-viable cells, recovering the viable hepatocytes, and refreezing the recovered hepatocytes.The Federal Circuit decided that, although dependent on a natural phenomenon, the inventors’ claims were a patent eligible application of their natural discovery. As a result, the court may have opened up a new avenue for patent seekers to circumvent the restrictive eligibility requirements established by the Supreme Court. This Note provides a brief history of patent eligibility doctrine and the cases leading up to the decision in CellzDirect. It next analyzes the CellzDirect decision and its possible interpretations. Finally, it argues that this case represents an effort by the Federal Circuit to limit the Supreme Court’s extreme anti-patent position in Mayo and Alice by cabining the eligibility restrictions to diagnostic discoveries.

Final Report of the Berkeley Center for Law & Technology Section 101 Workshop: Addressing Patent Eligibility Challenges

Over the past five years, the Supreme Court has embarked upon a drastic and far-reaching experiment in patent eligibility standards. Since the founding era, the nation’s patent statutes have afforded patent protection to technological innovations and practical applications of scientific discoveries. However, the Supreme Court’s 2012 decision in Mayo Collaborative Services v. Prometheus Laboratories imposed a new limitation on the scope of the patent system: that a useful application of a scientific discovery is ineligible for patent protection unless the inventor also claims an “inventive” application of the discovery. The following year, the Court ruled that discoveries of the location and sequence of DNA compositions that are useful in diagnosing diseases are ineligible for patent protection. And in its 2014 Alice Corp. v. CLS Bank International decision, the Court ruled that software-related claims are ineligible for patent protection unless the abstract ideas or mathematical formulas disclosed are inventively applied. These decisions sent shock waves through the research, technology, business, and patent communities. Medical diagnostics companies experienced a dramatic narrowing of eligibility for core scientific discoveries. Reactions within the information technology community have been mixed, with some applauding the tightening of patent eligibility standards on software claims and the opportunity to seek early dismissal of lawsuits, particularly those filed by non-practicing entities, and others criticizing the shift in patent eligibility. Several members of the Federal Circuit bluntly criticized the Supreme Court’s shift in patent eligibility standards on jurisprudential and policy grounds. Additionally, the Patent Office has struggled to apply the Supreme Court’s new and rapidly evolving standards. As this sea change unfolded, many patent practitioners, scholars, PTO officials, and jurists hoped that the Supreme Court would provide fuller and clearer guidance on patent eligibility standards. In the aftermath of the Supreme Court’s rejection of the invitation to reexamine its Mayo decision, many stakeholders have shifted their attention toward legislative reforms. This Report summarizes the presentations and discussion of a workshop of leading industry representatives, practitioners, scholars, policymakers, and a retired jurist exploring the legal background and effects bearing on legislative action. Part I contains a lightly edited version of the background document circulated to participants prior to the workshop. Part II summarizes the four workshop sessions leading up to the discussion of legislative proposals: (A) legal background; (B) effects on research and development (RD (C) effects on patent prosecution; and (D) effects on patent assertion, litigation, and case management. Part III summarizes the discussion of legislative proposals and sets forth a framework for seeking compromise on reform legislation.

Restoring the Legislative Framework for Patenting Applications of Scientific Discoveries

In Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012), the Supreme Court triggered the most radical redefinition of patent-eligible subject matter in U.S. history by engrafting onto § 101 an inventive application requirement for patenting practical applications of scientific discoveries.The Nation’s patent statutes, stretching back to the founding era, unmistakably afford patent protection to technological innovations and practical applications of scientific discoveries. The legislative record contains no hint of a second, “inventive application” hurdle for patent-eligibility of scientific discoveries. To the contrary, statutory text and legislative history reflect the clear intention to encourage “inventors and discoverers” to reveal the “mysteries of nature,” whether or not they are inventively applied.The Supreme Court derived the “inventive application” requirement from Neilson v. Harford (1841). This brief explains the profound misinterpretation that led the Supreme Court astray and urges the Court to grant certiorari in Sequenom v. Ariosa Diagnostics so as to restore the patentability framework that Congress intended.

Mayo, Myriad, America Invents Act and BPCIA: how has the United States biopharmaceutical market been affected?

This paper discusses how the United States biopharmaceutical market has been affected by recent changes in patent law resulting from United States legislations (Biologics Price Competition and Innovation Act and the Leahy-Smith America Invents Act) and Supreme Court precedents (Mayo Collaborative Services v. Prometheus Laboratories, Inc. and Molecular Pathology v. Myriad Genetics). The authors interviewed eight key opinion leaders from the United States knowledgeable in biopharmaceuticals, including industry veterans, patent counsel, senior scientists and jurists. This paper summarizes the opinions of the key opinion leaders. This paper explains the impact of these Supreme Court decisions - i.e., broadening the exceptions to patent eligibility for law of nature and natural phenomenon - on biopharmaceutical innovations and provides future perspectives.

Abstract Ideas Under Mayo Collaborative Services v. Prometheus Laboratories, Inc.

Biotechnology Law ReportVol. 34, No. 3 Original ArticlesAbstract Ideas Under Mayo Collaborative Services v. Prometheus Laboratories, Inc.John RogitzJohn RogitzSearch for more papers by this authorPublished Online:18 Jun 2015https://doi.org/10.1089/blr.2015.29002AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 34Issue 3Jun 2015 InformationCopyright 2015, Mary Ann Liebert, Inc.To cite this article:John Rogitz.Abstract Ideas Under Mayo Collaborative Services v. Prometheus Laboratories, Inc..Biotechnology Law Report.Jun 2015.103-106.http://doi.org/10.1089/blr.2015.29002Published in Volume: 34 Issue 3: June 18, 2015PDF download

The implication of the 'Mayo Collaborative Services v. Prometheus Labs., Inc.' judgement to the Korean medical business methods patents

The implication of the 'Mayo Collaborative Services v. Prometheus Labs., Inc.' judgement to the Korean medical business methods patents

The impact of Myriad and Mayo: will advancements in the biological sciences be spurred or disincentivized? (Or was biotech patenting not complicated enough?).

For years, purified and isolated naturally occurring biological substances of great medical importance--including genes--have been the subject of U.S. patents. Similarly, methods in which the detection of a biological substance (e.g., in a blood sample) dictates subsequent actions, as in disease diagnostics and treatment, have long enjoyed patent protection. However, two recent Supreme Court cases, Association for Molecular Pathology v. Myriad Genetics, Inc. (133 S. Ct. 2107) (2013) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (132 S. Ct. 1289) (2012), have shaken up the status quo of biotech patenting. The highest court in our land unanimously agreed with patent challengers that much of what we took for granted as patentable subject matter is not, as a matter of law, eligible for patenting after all. This review discusses the Myriad and Mayo cases, their impact on which biology-based innovations we may or may not continue to patent, and whether the altered status quo is benignly corrective or gravely disruptive. Is what happened here a good thing or not?

Economic regulation of next-generation sequencing.

Next-generation sequencing broadens the debate about appropriate regulatory oversight of genetic testing and may force scholars to move beyond familiar privacy and health and safety regulatory issues to address new problems with industry structure and economic regulation. The genetic testing industry is passing through a period of profound structural change in response to shifts in technology and in the legal environment. Making genetic testing safe and effective for consumers increasingly requires access to comprehensive genomic data infrastructures that can support accurate, state-of-the-art interpretation of genetic test results. At present, there are significant barriers to access and there is no sector-specific regulator with power to ensure appropriate data access. Without it, genetic testing will not be safe for consumers even when it is performed at CLIA-certified laboratories using tests that have been FDA-cleared or approved. This article explores the emerging structure of the genetic testing industry and describes its present economic regulatory vacuum. In view of this gap in regulation, the article explores whether generally applicable law, particularly antitrust law, may offer solutions to the industry's data access problems. It concludes that courts may have a useful role to play, particularly in Europe and other jurisdictions where the essential facilities doctrine enjoys continued vitality. After Verizon Communications v. Law Offices of Curtis V. Trinko, the role of U.S. federal courts is less certain. Congress has demonstrated willingness to address access issues as they emerged in other infrastructure industries in recent decades. This article expresses no preference between legislative and judicial solutions. Its aim is simply to highlight an emerging economic regulatory issue which, if left unresolved, presents real health and safety concerns for consumers who receive genetic tests.

Prometheus bound, but myriad loose ends

Prometheus bound, but myriad loose ends

Patent portfolios after myriad, how to fit in those new genes?

The recent US Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. clarified what is considered patentable subject matter. Patent claims limited to the composition of isolated nucleic acid sequences are now considered a product of nature and not patent eligible, while man-made variants of nucleic acid sequences may still be patentable. The decision is consistent with an earlier ruling in Mayo Collaborative Services v. Prometheus Laboratories., Inc. related to diagnostic methods. In Prometheus, the Court held that a method simply reciting known steps used to observe a natural event is not patentable subject matter. Taken together, the Court's decisions provide guidance as to what constitutes a natural phenomenon outside patent protection and what is considered a man-made creation worthy of protection. Despite misgivings, both decisions will provide impetus for increased genetic research and development of new therapeutics and diagnostics, especially in genomic and personalized medicine.

Are Human Genes Patentable?

This commentary reviews the events leading to the Supreme Court decision regarding Myriad Genetics patents on the BRCA1 and BRCA2 genes. Those developing molecular diagnostics will have to comport ...

Diagnostic Claims post- Mayo and Myriad : the pile-up Begins

Schwegman, Lundberg & Woessner, 1600 TCF Tower, 121 South Eighth Street, Minneapolis, MN 55402, USA *Author for correspondence: Tel.: +1 612 373 6903 Fax: +1 612 339 3061 E-mail: wwoessner@slwip.com Just as the initial collision of two or three vehicles on a foggy freeway can trigger a multicar pile-up that jams traffic for miles, so have recent decisions by the Supreme Court and the Federal Circuit suddenly thrown up a road block to a wide variety of conventional diagnostic claims that are based on the discovery that marker ‘a’ correlates to medical condition ‘b’. These decisions were Association for M olecular Pathology v. United States PTO (Myriad) [1] and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo) [2]. The pile-up has begun. In PerkinElmer, Inc. v. Intema, Ltd (PerkinElmer) [3], a panel of the Federal Circuit reversed the district court and invalidated all of the claims of US Patent No. 6573103 [101] as patent ineligible ([3] at 16) in view of Myriad and Mayo. The claims were found to both ‘claim a law of nature’ and to recite ‘the mental process of comparing data to determine a risk level’ ([3] at 11). The doomed claims were directed to an improved method to diagnose Down’s syndrome by measuring known biomarkers and/or ultrasound data taken during both the first and the second trimester of pregnancy, and then subjecting the data to multivariate analysis based on reference parameters to determine the odds that the fetus has Down’s syndrome. The method was ‘improved’ because some markers are more predictive at different stages of pregnancy. It is not easy to tell if the Court applied Mayo or Myriad as the dominant precedent, in part because these two cases found ineligibility on different grounds. The Myriad panel found the diagnostic method claims patent ineligible as attempts to claim ‘abstract ideas’, while in Mayo, the Supreme Court ruled the diagnostic claims ineligible as embracing ‘natural phenomena’. According to the Myriad panel, claims directed to comparing a patient’s DNA sequence with a reference sequence, to identify mutations and thus patients with a propensity to develop breast cancer, were patent ineligible as an attempt to patent ‘abstract ideas’ ([1] at 1334–1335). In Mayo, the Supreme Court held the claims patent ineligible as embracing a natural phenomenon because the claims were drawn to determining if a dose of an immunosuppressant drug given to a patient was too high or too low by measuring metabolite levels ([2] at 1297–1298). Thus, the PerkinElmer panel relied on the Myriad reasoning to characterize the claims as involving only mental steps, stating that “[t]he stricken claims [in Myriad] are indistinguishable from those before us... The [Myriad] claims were not over an application of the mental process of comparing. Rather, the step of comparing two DNA sequences [was] the entire process that [was] claimed” ([3] at 10; the authors note that this statement is only true if the diagnostic conclusion reached in one of the disputed claims is completely ignored as a limitation).

Isolated human genes and related therapeutic treatment methods held patent-eligible

Patents on isolated genes are big business. In the past three decades, the United States Patent and Trademark Office (USPTO) has issued over 2500 patents claiming isolated DNA, and 40000 DNA-related patents in nonnative form, for genes in the human genome. Thus in 2010, when a US district court judge found claims to isolated DNA and related method claims patent-ineligible, the industry was shocked and mobilized to respond: see Ass’n for Molecular Pathology v US Patent & Trademark Office, 702 F Supp 2d 181, 220–37 (SDNY 2010) (‘Myriad I’). At first, on appeal, the majority of a three-judge panel of the US Court of Appeals for the Federal Circuit reversed the district court decision and found all of the composition claims, as well as one method claim directed to screening potential cancer therapies based upon changes in the growth rates of transformed cells, patent-eligible: Ass’n for Molecular Pathology v US Patent & Trademark Office, 653 F 3d 1329 (Fed Cir 2011) (‘Myriad II’). This result was shortlived: the US Supreme Court, in Mayo Collaborative Services v Prometheus Laboratories, Inc, 132 S Ct 1289 (2012) (‘Mayo’), granted certiorari, vacated Myriad II and remanded for further consideration in view of Mayo. Ass’n for Molecular Pathology v Myriad Genetics, Inc, 132 S Ct 1794 (2012) (‘Myriad III’). This past August, in Myriad IV, the Federal Circuit, on remand, quickly set a new briefing schedule to address the impact of Mayo on its prior Myriad II decision, held oral argument, and then the same panellists reissued a substantively similar decision. While each of the panellists considered Mayo, it had little impact on their ultimate conclusions as to whether isolated DNA claims and related method claims were patent-eligible.

The Mayo v. Prometheus Decision

Fitzpatrick, Cella, Harper & Scinto, 1290 Avenue of the Americas, NY 10104 3800, USA *Author for correspondence: Tel.: +1 212 218 2293 Fax: +1 212 218 2200 Email: lperry@fchs.com For at least 30 years, the Supreme Court has struggled with the question of what constitutes patentable subject matter under 35 U.S.C. §101 (Inventions patentable). While “ laws of nature, natural phenomenon, and abstract ideas” are not patentable subject matter under §101, “an application of a law of nature ... to a known structure or process may [deserve] patent protection” [1]. The latest Supreme Court decision of Mayo Collaborative Services v. Prometheus Laboratories was related to this issue of patentable subject matter under 35 U.S.C. §101 and grappled with patent claims drawn to a law of nature [2]. In this case, however, the Supreme Court held the patents to be invalid as claiming a law of nature that was ineligible subject matter under §101. This article discusses this recent Supreme Court decision and its potential implications in the biotechnology and pharmaceutical fields.

Initial thoughts on Mayo v. Prometheus and software patents

In the aftermath of an important decision by the Supreme Court of the United States, the first impressions on the significance of the Mayo Collaborative Services v. Prometheus Laboratories, Inc. over the software patents debate in the United States. An excerpt of the most relevant parts of the opinion is attached

Mayo Collaborative Services, DBA Mayo Medical Laboratories, et al. v Prometheus Laboratories, Inc. (U.S. Supreme Court 10-1150)

<i>Mayo Collaborative Services, DBA Mayo Medical Laboratories, et al. v Prometheus Laboratories, Inc.</i> (U.S. Supreme Court 10-1150)