Brief of American Medical Association et al. as Amici Curiae in Support of Plaintiffs’ Opposition to Defendants’ Motion to Dismiss and in Support of Plaintiffs’ Motion for Summary Judgment, Association for Molecular Pathology v. U.S. Patent and Trademark Office

Amici seek to provide this Court with insight into the adverse effects on medical care and innovation that gene patents cause. These adverse effects could and should have been avoided, because genetic sequence and correlation patents – including all of the Myriad patents at issue – are not patentable inventions. These patents should never have been granted, and are not needed to create incentives for innovation. The Myriad patents on breast cancer genes, mutations, and correlations between mutations and disease have a direct, severe, and adverse impact on members of the Amici medical organizations and all humanity. Myriad’s announced intention to aggressively enforce its patents to foreclose other diagnostic, treatment and research options deter the Amici health care professionals and researchers from providing appropriate medical care and diagnostic services. Myriad’s patents also preclude research into better medical treatments and technologies by precluding clinical activities that would lead to additional discoveries. Myriad’s patents, and other genetic sequence and biological correlation patents like them, cast a chill on important health care practices and on innovation

Submission of American Patent and Health Law Professors on Australian Senate Community Affairs Committee Inquiry into Gene Patents

In response to the Australian Senate Community Affairs Committee’s Inquiry, the author and other American law professors submitted a brief to help the Senate Committee understand the current state of American law, and how the provision of patents on genetic technologies has and will continue to create serious problems for innovation, health care, and society at large. The brief addresses the following subjects in regard to American law, which respond generally to the issues raised by the Committee’s inquiry. 1. The questionable need for patent rights in genetic sequences and other derivatives of naturally occurring materials, certain diagnostic discoveries, and other discoveries; 2. The dubious legal status of patent claims to such discoveries; and 3. The serious harms caused by granting patents on such discoveries. The brief is not an exhaustive treatment of these issues, but rather is intended to highlight fundamental but mistaken assumptions about the need for and effects of gene patents and to identify significant problems with such patents

Patent Eligible Medical and Biotechnology Inventions After Bilski, Prometheus, and Myriad

In Bilski v. Kappos, the U.S. Supreme Court continued to require that patentable subject matter eligibility determinations under Section 101 be made by reference to three historic, categorical exclusions, for scientific principles, natural phenomena, and abstract ideas. This excluded subject matter must be treated as if already known even when newly discovered by the applicant. Unlike in other jurisdictions, the excluded subject matter thus cannot contribute creativity to the claimed inventions, either for eligibility or for patentability evaluations. The Federal Circuit has reluctantly applied eligibility doctrine after Bilski, holding in Prometheus v. Mayo that claims to treatment methods applying the new medical discoveries are eligible inventions, even though those claims include a mental step and do not require any action following that step. In Association for Molecular Pathology v. U.S. Patent and Trademark Office (commonly known as the Myriad case, and which was filed by the American Civil Liberties Union and the Public Patent Foundation), which is pending in the Federal Circuit, the District Court found that isolated DNA molecules are not patent eligible inventions. The United States Government has now admitted that for decades it has been issuing such claims without legislative authority to do so. This article uses the Prometheus and Myriad cases to describe the line-drawing decisions regarding patent eligibility that the courts, patent office officials, and the public now have to make in regard to medical and biotechnological inventions. It explains why the Federal Circuit’s approach will remain unsatisfying unless and until it explicitly confronts the requirement for invention in the application of the categorically excluded discoveries of science, nature, and abstract ideas that underlie the claimed applications and must be treated as if they were already known prior art. The article also describes the important deontological and utilitarian moral concerns that apply to such controversial subject matter as medical and biotechnological inventions. It concludes with a brief discussion of the need for greater clarity regarding the required degree of creativity and greater international understanding (if not harmonization) of differing contribution approaches

The Historic and Modern Doctrines of Equivalents and Claiming the Future: Part I (1790-1870)

From its beginning, American patent law has extended patent protection beyond the explicitly disclosed examples of an invention described in a patent specification, applying patents to some range of equivalent substituted technologies. From the middle of the 19th Century until 1950, the Supreme Court was careful to limit this historic doctrine of equivalents to products or processes that physically embody the construed language of a patent\u27s claims. In Graver Tank & Manufacturing Co. v. Linde Air Products Co., 339 U.S. 605 (1950), the Supreme Court radically altered the nature of the doctrine of equivalents, expanding patent protection beyond the scope of application of construed claim language in order to protect the value of patents from alleged fraud. In Warner-Jenkinson Co. v. Hilton Davis Chemical Co., 520 U.S. 17 (1997), and Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002), the Supreme Court extended patent protection under this modern doctrine to later-arising technologies not contemplated by the inventor. As discussed in Part I of this article - forthcoming in the Journal of the Patent and Trademark Office Society - the Supreme Court in 1853 stated that patent protection was limited to the scope of application of construed claim language. In the 1870 Patent Act, Congress codified a distinct claiming requirement that should have foreclosed the modern doctrine of equivalents. As discussed in Part II - also forthcoming in the Journal of the Patent and Trademark Office Society - until Graver Tank, the Supreme Court consistently limited the doctrine of equivalents under the 1870 Patent Act to the scope of application of construed claim language. In the 1952 Patent Act, Congress neither codified nor impliedly ratified the modern doctrine of equivalents, and did not extend it to later-arising technologies. This article is the second in a series of articles relating to the doctrine of equivalents. These articles seek to encourage and to set the context for future discussions of abolishing the modern doctrine of equivalents and of claiming later-arising technologies. The first article, to be published in the Federal Circuit Bar Journal, describes conflicts among the modern doctrine and prosecution history estoppel and additional implied disclaimer and claim scope doctrines. It explains how the modern doctrine improperly extends patent protection to equivalents that could not validly be claimed. The third article, to be published in the Berkeley Technology Law Journal discusses the lack of theoretical justification for, social costs of, and complexity created by the modern doctrine. It argues that the historic doctrine of equivalents should be restored and that additional limits on claiming later-arising technologies may be needed to promote progress

The Continuing Imperative (But Only From a National Perspective) for Federal Environmental Protection

Background: Abuse of patients by health care staff (AHC) is a cause of unnecessary suffering, which is inconsonant with the premise in medicine of not doing harm to the patient. The understanding of AHC in this thesis is considered two-dimensional: as a patient’s subjective experience and as violation of a patient’s dignity. Patients’ experiences of these events are rather well studied and are characterized by feelings of neglect and a loss of their human value. However, little is known about staff’s perspectives on AHC and what they can do to counteract it. Aim: The overall aim of this thesis is to approach AHC from the perspective of health care staff in order to develop and test a model for enabling health care staff to recognize and take action in situations where AHC is about to happen and to handle it professionally once it has happened. Methods: To explore professionals’ formal perspectives on AHC, five sets of ethical guidelines for staff working within gynecology and obstetrics were examined in study I, using an analytical framework based on empirical studies regarding issues related to AHC. Data for studies II and III were collected at a women’s clinic that had chosen to host an intervention model based on Forum Play (FP) as a method for counteracting AHC. In FP, an improvisational theater method, based on Boal’s Forum Theater, staff together stage problematic situations from their own experience and test different ways of acting. In study II, qualitative interviews with 21 staff members from the target clinic were conducted, to capture the staff’s perception of AHC before the intervention. Study III evaluated the impact of 16 FP workshops by means of questionnaires focusing on the occurrences of AHC and the perceived effects of FP, sent to all staff (n=137) before, during, and after the intervention. In study IV, ten participants of an FP course, consisting of a mixed group of employees working within health care, were interviewed about their experiences of the FP course. Results: In study I, it was shown that all guidelines failed to address issues related to AHC, mainly structural issues such as power imbalances between professionals. In study II, the staff’s described perception of AHC was best categorized as ethical lapses, integrating theoretical descriptions of AHC with a defensive staff-centered position that rejected responsibility for AHC. In study III, no indication of an increased awareness of AHC was found, but an increase in the staff’s ability to act in situations with a moral dilemma was confirmed, even one year after the intervention. The findings of study IV suggest that FP has the potential to develop a response ability, enabling staff to become active in AHC situations. The power to intervene when witnessing AHC was emphasized. Conclusions: Assuming that clinical practice is a moral activity with the good of the patient as its end, it is important for staff to be able to understand AHC from the patient’s perspective. To accomplish this, even structural aspects such as power imbalances between professionals have to be considered. By failing to address these important aspects, ethical guidelines appear to be a limited resource for helping to counteract AHC. FP enables staff participants to adopt a patient’s perspective and to develop an understanding of their power and responsibility to act when in a situation involving AHC. Furthermore FP seems to provide a useful tool for staff learning to display and overcome structural obstacles in order to intervene when witnessing AHC. If counteracting AHC is understood as a matter of acting professionally, practical training such as FP needs to be prioritized

Correcting Misunderstandings of Literal Infringement Scope Regarding After-Arising Technologies Protected by the Doctrine of Equivalents

Based on conflicting Federal Circuit case law, many academics have written, and many practitioners likely believe, that claim meanings or their applications may expand over time for purposes of literal infringement. But this common wisdom is wrong. Under existing Federal Circuit rules, the first precedent controls in the event of a conflict over doctrine, unless and until reversed en banc. The first precedent on the issue, the 2000 Schering Corp. v. Amgen, Inc. case, held that claim scope does not reach after-arising technologies for literal infringement and suggested that if it did, then such claims would lack written description support. Under existing validity precedents, temporally expanding claim scope would violate both § 112(a)’s enablement and written description requirements, as explicitly held in the 1977 In re Hogan decision and as implied by the more recent 2010 Ariad Pharmaceuticals v. Eli Lilly & Co. en banc decision. Further, were claims able to expand over time for literal infringement, they would violate the axiomatic equivalency of claim scope for validity and infringement. Once it is recognized that claim scope for literal infringement does not protect against after-arising technologies, further resort will be made to seek such protection under the doctrine of equivalents. This not only highlights the importance of the Ariad Pharmaceuticals decision but also will cause a big change to current practices and will lead to increased uncertainty regarding the scope of patent protection. This Article explains why academics and practitioners may be confused regarding the U.S. law of literal infringement’s temporal scope. It describes the conflicting cases that have led to that confusion. And it explains why § 112(f)’s rule of construction for functional claiming language may be understood to limit all claim scope to temporally fixed, known-to-be equivalent technologies. This Article concludes by noting potential conflict with the pioneering invention doctrine and concerns should the law be changed to permit claiming the futur