Last month, the Court of Appeals for the Federal Circuit (“CAFC”) handed down their decision on the case of McRO, Inc. v. Bandai Namco Games Am. Inc (Fed. Cir. Sep. 13, 2016) (“McRO”). Commentators have already hailed the decision as providing significant clarity and guidance on subject-matter eligibility for patents under 35 U.S.C. §101 (“§101”) and on pre-emption. It has been lauded by Erich Andersen of Microsoft for providing key guidance for software developers. Others have remarked on the implications for those seeking patents on methods of medical diagnosis. Though not binding on the Supreme Court (and by no means a guarantee of the direction that Court might eventually take), I believe inventors in the medical arena can draw critical guidance on drafting patent claims from McRO. The decision might also signal a shift in attitude in the CAFC, towards a much more welcoming view of diagnostic patents.
In this post, I’ll briefly address the facts and decision in McRO. During that discussion, I believe a discussion of the facts and decision of last year’s CAFC case of Ariosa Diagnostics, Inc. v. Sequenom, Inc. 788 F.3d 1377 (Fed Cir. 2015) (“Sequenom”) will be illustrative. I’ll then briefly compare the two and discuss what the implications might be for biomedical patents moving forward.
Last week, a patent application in India was refused, apparently on the basis that the invention under review could have been used to counterfeit money. This practice of denying patents on the basis of public policy or morality is almost as old as the practice of granting patents. For example, the State of Monopolies was enacted in England in 1624 to prohibit monopolies where they would be “mischievous to the State”. In many other jurisdictions, patents on food and medicines were prohibited, on the basis that the public good served by these products outweighed any claims of monopoly rights by the inventor. The other approach is preferred in the US. Cases like Diamond v Chakrabarty removed much of the normative question from American patent law and it has been strongly argued that a patent application “is not an ethical event.”
Whether a patent can be refused on the basis of morality is a difficult enough question, but the problem is compounded once the “morality” in question is not confined to a single jurisdiction. The harmonization of patent law across Europe in the last fifty years has forced the European Patent Office (EPO) to consider how to make a moral judgement on behalf of all the contracting states to the European Patent Convention. Its approach has been neither consistent between cases nor consistent with the underlying treaties. I would like to give a quick sketch of the contrast between the European legal framework and its manifestation in the decisions of the EPO.
The underlying policy is made explicit in the first paragraph of the Strategy’s Executive Summary (p4):
The policy of the United States Government is to seek regulatory approaches that protect health and the environment while reducing regulatory burdens and avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers
Apart from clarifying the current roles of the FDA, EPA and USDA and setting out the path for future developments, both documents make it clear that they aim
to help the public understand how the safety of biotechnology products is evaluated and
to help businesses navigate the current regulatory structure.
Last week, Organovo might just have revolutionised the pharmaceutical industry. The San Diego-based company specialises in producing structures that mimic the behaviours and functions of human tissue, using 3D bioprinting. They announced last week that they were beginning the commercial manufacture and sale of their ExVive Kidney. The product models the proximal tubule of the human kidney and holds significant promise for clinical trials of new drugs. The commercialization of the ExVive Kidney follows the release of ExVive Human Liver Tissue in 2014.
In essence, Organovo is using 3D printing technology to produce samples of “human” tissue that can be used to test the toxicity of new drugs. The printing process, known as 3D bioprinting, involves extracting human cells, culturing them and suspending them in a solution. The resulting “bioink” is fed through a modified 3D printer. Layer by layer, the printer deposits cells, producing a mass with a similar structure and density to a sample of, for example, human liver. Just like “organ on a chip” technology, these synthetic liver and kidney samples present significant advantages over traditional clinical testing.
The Petrie-Flom Center is pleased to welcome our new 2016-2017 Student Fellows. In the coming year, each fellow will pursue independent scholarly projects related to health law policy, biotechnology, and bioethics under the mentorship of Center faculty and fellows. They will also be regular contributors here at Bill of Health on issues related to their research.
Seán Finan is an LLM candidate from Ireland at the Harvard Law School. He recently graduated from the LLB programme at Trinity College, Dublin, where he served as a Senior Editor of the Trinity College Law Review. His research interests include the ethical implications of emerging biotechnologies. For his Fellowship project, he intends to investigate the use of morality tests on patent applications as a means of indirect regulation of research.
Wendy Salkin is a Ph.D. candidate in the Department of Philosophy at Harvard University. Her primary research is in political philosophy, moral philosophy, social philosophy, and philosophy of law. She also works on questions in feminist philosophy and bioethics. She is writing a dissertation on informal political representation under the supervision of Tommie Shelby, T.M. Scanlon, Richard Moran, and Eric Beerbohm. She holds a J.D. from Stanford Law School and a B.A. in Philosophy and Africana Studies from New York University. For her Fellowship project, she will examine new directions in the debate over lifespan extension.
Brad Segal is currently a medical student at Harvard Medical School where he is enrolled in a dual MD/Master of Bioethics degree program. Brad received his BA and BS from UC San Diego where he double majored in Philosophy and Physiology/Neuroscience. In his first year at HMS Brad’s paper on the ethics of organ transplantation was awarded the Henry K. Beecher Prize in Medical Ethics. He has also studied the ethical implications of our evolving understanding of the brain, and has published on whether and when individual genetics and neurobiology should mitigate a criminal defendant’s moral culpability. During his Fellowship he will be studying what ‘harm’ means in the medical context.
Shailin Thomas is a second year law student in a joint MD/JD program between Harvard Law School and the New York University School of Medicine. He received a B.S. from Yale University, where he studied cognitive neuroscience — exploring the anatomy and physiology behind social phenomena. His interests lie at the intersection of clinical medicine and the legal forces that shape it. Prior to law school, Shailin worked on both the administrative and clinical sides of health care, and as a research associate at the Berkman Center for Internet & Society. He is currently an affiliate of the Berkman Center and Outreach Editor for the Harvard Journal of Law & Technology. A fervent proponent of privacy and freedom of expression, Shailin has also served on the Board of Directors of the American Civil Liberties Union of Connecticut. For his Fellowship project, he will focus on a tort solution for faulty eyewitness testimony procedures.