Although drug formularies are ubiquitous in Medicare and the private insurance market, they’re absent in Medicaid. By law, state Medicaid programs that offer prescription drug coverage (as they all do) must cover all drugs approved by the U.S. Food and Drug Administration, however expensive they are and however slim their clinical benefits may be.
Massachusetts would like to change all that. In a recent waiver proposal, Massachusetts asked the Centers for Medicare and Medicaid Services (CMS) to allow it to adopt a closed formulary in Medicaid. That would allow Massachusetts to exclude certain brand-name drugs from Medicaid, increasing its leverage in price negotiations beyond what it can achieve through existing utilization management techniques like prior authorization.
Among Medicaid advocates, the proposal is controversial. Some fear that state budgets would be balanced on the backs of Medicaid beneficiaries, who could be denied access to expensive therapies. But Massachusetts thinks there’s room to drive down drug spending without threatening access to needed medications. In any event, the state has to do something. Drug spending in Massachusetts has increased, on average, 13 percent annually since 2010, threatening to “crowd out important spending on health care and other critical programs.”
By all rights, CMS should welcome Massachusetts’s proposal. Closed drug formularies are tried-and-true, market-based approaches to fostering competition over drug prices, and the Trump administration’s Council on Economic Advisers recently released a report saying that “government policy should induce price competition” in Medicaid. If Secretary of Health and Human Services (HHS) Alex Azar means it when he says that “drug prices are too high,” letting Massachusetts try out a formulary makes a ton of sense. […]
By Oliver Kim
After an initial procedural hiccup, the House of Representatives passed a modified version of a federal “right to try” bill, legislation that would allow pharmaceutical companies to bypass the federally-prescribed clinical trial process to allow terminally ill patients to try experimental drugs. Similar legislation passed the Senate as part of a horse-trade in order to allow the swift passage of the FDA user fee reauthorization before that program expired. A majority of the states have passed right-to-try legislation, which is largely ineffective given federal preemption.
Much has been written about the ethical and legal questions surrounding the right to try as well as the political forces behind it. Proponents argue that the right to try is based on notions of mercy, compassion, and autonomy.
What has interested me about this debate is that often those same notions are used to justify the “right to die,” or aid in dying usually for terminally ill patients. I’ve written (and will be publishing a longer piece) and will be speaking about this question and if there are lessons that proponents of the right to die can learn from the political success of the right-to-try movement.
Join us in wonderful Copenhagen at our CeBIL Kick-Off Conference: ”Innovation Gaps on Life Science Frontiers? From Antimicrobial Resistance & the Bad Bugs to New Uses, AI & the Black Box”. The Conference marks the start of the Novo Nordisk Foundation’s Collaborative Research Programme in Biomedical Innovation Law which is carried out within a unique network of international core partners, including internationally renowned experts at Harvard Law School’s Petrie Flom Center, Harvard Medical School/Brigham & Women’s Hospital, University of Cambridge, University of Michigan, and UCPH’s Department of Food and Resource Economics (IFRO).
Leading international experts, including i.a. our distinguished Bill of Health colleagues Glenn Cohen, Aaron Kesselheim; Nicholson Price, and Kevin Outterson, will discuss legal, economic, societal and scientific aspects of selected Life Science areas.
Time: Monday, 5 March 2018 09:00 – 18:00 (followed by a reception in the Gobelin Hall)
Venue: The Ceremonial Hall (Festsalen), University of Copenhagen, Main Building, Frue Plads 4, DK-1168 Copenhagen K
Biomedical innovation is experiencing changes of epic proportions. Rapid progress in many scientific areas, such as gene editing, pharmacogenomics, artificial intelligence and big data-driven precision medicine, has greatly advanced the promises and opportunities of the health and life sciences. Nevertheless, the total number of truly new and innovative drugs receiving market approval is unsatisfactory. At the same time, some of the more innovative therapies that actually could reach patients have become extremely expensive or ethically problematic. These new technological possibilities raise many complex scientific, legal and ethical issues affecting many stakeholders, such as medical practitioners, regulators, patients and the industry.
To support the in depth study of these developments, the Novo Nordisk Foundation has awarded a grant of DKK 35 million for a new Collaborative Research Programme in Biomedical Innovation Law (CeBIL). CeBIL’s overall aim is to help translate ground-breaking biomedical research into affordable and accessible therapies by scrutinizing the most significant legal challenges to biomedical innovation and public health from a holistic cross-disciplinary perspective. CeBIL is hosted by a new Centre for Advanced Studies at the University of Copenhagen’s Faculty of Law. The research is carried out within a unique network of international core partners, including internationally renowned experts at Harvard Law School, Harvard Medical School, University of Cambridge, University of Michigan, and UCPH’s Department of Food and Resource Economics (IFRO). Moreover, CeBIL will collaborate with a broad network of stakeholder organizations and international experts within law, economics, life science, medicine, sociology and pharmacy.
This Kick-Off Conference marks the start of CeBIL which opened its’ doors on January 1st, 2018. Reflecting the research projects that will be at the focus CeBIL’s research during the first 5 years, leading international experts will discuss legal, economic, societal and scientific aspects of selected life science areas and debate future challenges and opportunities.
By Mason Marks
Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids kill an estimated 91 Americans each day and are responsible for most drug-related deaths in the US. This public health crisis requires solutions that are supported by science and reason instead of emotion and political ideology. In Part I of this three-part series, I discuss how the President’s Commission on Combating Drug Addiction and the Opioid Crisis misinterpreted scientific studies and used data to support unfounded conclusions. In this second part of the series, I explore how the Opioid Commission ignored medical interventions that are used successfully in the U.S. and abroad. In Part III, I will discuss non-medical interventions such as drug checking and safe injection sites. The Commission’s failure to consider these options is likely driven by emotions such as fear and disgust rather than a careful review of scientific evidence.
Medical marijuana is currently accepted in 29 U.S. states and the District of Columbia. It is also permitted in at least 10 countries. However, the Opioid Commission outright rejected calls to consider the use of medical marijuana as an alternative to opioids for managing pain. Prior to the Commission’s first meeting, it solicited input from industry and members of the public on how to address the opioid crisis. In response, it received over 8,000 public comments. According to VICE News, which obtained the documents by submitting a Freedom of Information Act (FOIA) request, most comments were submitted by individuals urging the Commission to “consider medical marijuana as a solution to the opioid epidemic.” A spokesman for the Office of National Drug Control Policy, a body of the Executive Branch that provides administrative support to the Opioid Commission, reports receiving “more than 7,800 public comments relating to marijuana.” Despite these comments, in its final report, the Commission dismissed the notion that marijuana should play a role in treating chronic pain and opioid addiction. Its report cited a recent study from the American Journal of Psychiatry, which concluded that marijuana use was associated with an increased risk of opioid abuse. However, this study relied on data that was collected over twelve years ago. One of its authors, Columbia Medical School Professor Mark Olfson, told CNN that if the data were collected today, they could yield different results.
By Mason Marks
The opioid crisis kills at least 91 Americans each day and has far-reaching social and economic consequences for us all. As lawmakers explore solutions to the problem, they should ensure that new regulations are based on scientific evidence and reason rather than emotion or political ideology. Though emotions should motivate the creation of policies and legislation, solutions to the opioid epidemic should be grounded in empirical observation rather than feelings of anger, fear, or disgust. Legislators must be unafraid to explore bold solutions to the crisis, and some measured risks should be taken. In this three-part series on evidence-backed solutions to the opioid crisis, I discuss proposals under consideration by the Trump Administration including recent recommendations of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. Though the Commission made some justifiable proposals, it misinterpreted the conclusions of scientific studies and failed to consider evidence-based solutions used in other countries. This first part of the series focuses on the misinterpretation of scientific data.
Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids are responsible for most of these deaths. By comparison, the National Safety Council estimates about 40,000 Americans died in auto crashes last year, and the Centers for Disease Control reports that 38,000 people were killed by firearms. Unlike deaths due to cars and firearms, which have remained relatively stable over the past few years, opioid deaths have spiked abruptly. Between 2002 and 2015, U.S. opioid-related deaths nearly tripled (from about 12,000 deaths in 2002 to over 33,000 in 2015). Last year, synthetic opioids such as fentanyl contributed to over 20,000 deaths and accounted for the sharpest increase in opioid fatalities (See blue line in Fig. 1 below). Continue reading
Looking forward to hear Professor Peter Lee’s (UC Davis) talk on “Innovation and the Firm: Vertical Integration in Patent-Intensive Industries” at the University of Copenhagen on Friday, Friday, September 8th 2017 from 10:00 – 12:00. If you are interested to join, please register here.
Abstract of Professor Lee’s talk:
Recent scholarship has highlighted the prevalence of vertical disintegration in high-technology industries, whereby distinct, specialized entities along a value chain transfer intellectual assets between them. Patents play an important role in vertical disintegration, for they lower the cost of technology transactions between upstream suppliers and downstream users.
This presentation, however, draws on empirical accounts to explore the peculiar persistence of vertical integration in patent-intensive fields. In biopharmaceuticals, agricultural biotechnology, and information technology, firms are increasingly acquiring technology providers rather than simply licensing their patents. This dynamic is even evident to a certain extent in university-industry technology transfer, where universities and commercializing firms frequently engage in institutional meshing to transfer patented technologies. Continue reading
Biobanks as Knowledge Institutions
“Global Genes –Local Concerns” Seminar with Prof. Michael Madison (University of Pittsburgh, U.S.)
Join us at the University of Copenhagen on November 3rd, 2017 to discuss the legal implications of “Biobanks as Knowledge Institutions” with Professor Michael Madison.
The presentation characterizes the material and immaterial attributes of biobanks as knowledge resources, and it characterizes the broader questions that they pose as resource governance questions rather than as questions solely of law or of public policy. Biobanks are knowledge institutions. Professor Madison argues that despite the varied and diverse nature of biobanks today (indeed, precisely because of their diversity), their social and scientific importance dictates the need for a robust program of research of a comparative nature to identify shared features that contribute to their success (where they succeed) and features that likely contribute to problems or even failure. Both their importance and the associated governance challenges have only grown larger and more complex as biobanks meet the era of data science. In that regard Professor Madison points to emerging scholarly literature that focuses on governance challenges of material and data in biobank contexts, which builds on a knowledge commons governance framework. He concludes by suggesting directions for future work. Continue reading
Join us at the Centre for Information and Innovation Law (CIIR) Faculty of Law, University of Copenhagen on 20 November, 2017 to discuss Legal Perspectives on Synthetic Biology and Gene Editing.
CALL FOR PAPERS
Emerging technologies in Synthetic Biology and Gene Editing offer incredible opportunities and promising solutions to some of the most urgent challenges faced by humanity, such as climate change, environmental protection, growing population, renewable energy and improved health care. But the emerging applications also raise exceptional ethical, legal and social questions.
This conference marks the final phase of the participation of the Copenhagen Biotech and Pharma Forum (CBPF) Research Group at the Centre for Information and Innovation Law (CIIR) in the cross-faculty research project BioSYNergy. In accordance with the goals of this large cross-faculty project on Synthetic Biology, the event explores legal perspectives on synthetic biology, systems biology and gene editing. Dealing with the legal responses to ethical and scientific challenges raised by emerging life science technology. Continue reading
Join us at yet another webinar with J. Wested at the University of Copenhagen. This time we will debate procedural issues in compulsory licensing with H. Grosse Ruse-Kahn (University of Cambridge) & M. Desai (Eli Lilly). Further information on our webinar series is available at here, here, and below:
Procedural Aspects of Compulsory Licensing under Trade-Related Aspects of Intellectual Property Rights (TRIPS)
Wednesday 28. June 2017
4-6 p.m (CEST)
Sign-up & questions: Jakob.email@example.com
This webinar on “TRIPS and the life sciences” will approach the question of compulsory licensing by looking at the technical and procedural requirements applied by courts when evaluating a petition for a compulsory license.
The balancing of the instrumental application of patent rights as a stimulator of innovation and the public interest in having access to these innovations form a controversial trajectory of discourse, which is as old as patent law. Compulsory licenses are one of the means that have been applied throughout the history of patent law, to condition this complex intersection of interests. The TRIPS agreement is no exception and art 31 contains the provision for member states to grant CL. In 2013, the Indian authorities granted a compulsory license to NATCO Pharmaceuticals for Bayers patented pharmaceutical product Carboxy Substituted Diphenyl Ureas, useful for the treatment of liver and kidney cancer. This decision raised several issues regarding the procedures and requirements to be met in order to grant a compulsory license. Furthermore, in January 2017 an amendment to TRIPS agreement entered into force allowing compulsory licensors to export their generic pharmaceuticals to least developed countries, further recalibrating the intersection of the monopoly power of the patent and public interest. Continue reading
By Timo Minssen
I am happy to announce the publication of our new working paper on “Patenting Bioprinting Technologies in the US and Europe – The 5th element in the 3rd dimension.” The paper, which has been co-authored by Marc Mimler, starts out by describing the state of the art and by examining what sorts of bioprinting inventions are currently being patented. Based on our findings we then discuss what types of future innovations we can expect from the technological development and how far these would and/or should be protectable under European and US patent laws.
The paper is forthcoming in: RM Ballardini, M Norrgård & J Partanen (red), 3D printing, Intellectual Property and Innovation – Insights from Law and Technology. Wolters Kluwer, but the working paper is already available on SSRN. Continue reading
By Timo Minssen
I am happy to announce the publication of our collaborative paper with Helen Yu and Jakob Wested on “Innovation and intellectual property policies in European Research Infrastructure Consortia (part I)” in the Journal of Intellectual Property Law and Practice (Oxford University Press). Taking the European Spallation Source ERIC as an example, our paper investigates ERIC Regulations and EU policies and discusses what issues and perspectives ERICs need to consider in their IPR policies to balance the core-objectives of multiple stakeholders and achieve sustainability in various research areas, including the health and life sciences.
The authors would like to express their special gratitude to Dr. Ohad Graber Soudry, Head of Legal, European Spallation Source ESS-ERIC in Lund, Sweden, for all his support and valuable comments. This paper is supported by the CoNeXT project (see http://conext.ku.dk/ last visited July 23, 2016) under the University of Copenhagen’s Excellence Program for Interdisciplinary Research.
Research and innovation are key pillars of the EU’s strategy to create sustainable growth and prosperity in Europe. Research infrastructures (RIs) are central instruments to implement this strategy. They bring together a wide diversity of expertise and interests to look for solutions to many of the problems society is facing today, including challenges in the health and life sciences. To facilitate the creation and operation of such RIs, the EU adopted legal frameworks for European Research Infrastructure Consortia (ERIC). On August 31, 2015, the European Spallation Source (ESS) was established as an ERIC. Under the ERIC Regulations and ESS Statutes, the European Spallation Source ERIC is required to adopt various policy documents relating to the operation and management of the facility. These cover a wide variety of issues such as user access, public procurement, intellectual property rights (IPR), data management, and dissemination. One of the main goals of the ESS policies is to ensure that the research environment at ESS is compatible with a wide variety of international users’ obligations to multiple stakeholder-interests. But how can these policies best be aligned with the EU objective to achieve economic growth and scientific excellence by encouraging international research collaborations? The complex relationship between scientific excellence, innovation, and IPRs must be carefully considered. Taking the European Spallation Source ERIC as an example, this article investigates ERIC Regulations and EU policies and discusses what issues and perspectives ERICs need to consider in their IPR policies to balance the core-objectives of multiple stakeholders and achieve sustainability. In Part II, we will analyze and compare the different IPR policies of the various ERICs in a subsequent article.
Research Seminar at the University of Copenhagen debating intellectual property and innovation in synthetic biology, systems biology & gene editing.
New technologies in biology offer a brave new world of possibilities. Promising solutions to some of the most urgent challenges faced by humanity: climate change, environmental protection, growing population, renewable energy and improved health care. Scientific and technological progress has been remarkable. Simultaneously, emerging life science technologies raise outstanding ethical, legal and social questions.
In this research seminar, Prof. Esther Van Zimmeren from the University of Antwerp joins Prof. Timo Minssen, Postdoc Ana Nordberg and Ph.D. Student Jakob Wested from the Centre for Information and Innovation Law, debating bold new policies for intellectual property law and incentive to life science innovation.
|15:00 – 15:10||Welcome
Prof. Timo Minssen, CIIR, Faculty of Law, University of Copenhagen.
|15:10 – 15:30||Waiting for the Rumble in the Jungle: – An overview of current CRISPR/CAs9 patent disputes, central legal issues and some thoughts on conditioning the innovation system.
PhD Student Jakob Wested, CIIR, Faculty of Law, University of Copenhagen.
|15:30 – 15:50||From FRAND to FAIR for Synthetic and Systems Biology? The Implications of Openness, IP Strategies, Standardization and the Huawei-case.
Prof. Esther van Zimmeren, Faculty of Law, University of Antwerp.
|15:50 – 16:10||Keeping up with the technologies: IP Law and Regulation in the age of gene editing.
Postdoc Ana Nordberg, CIIR, Faculty of Law, University of Copenhagen.
|16.10 – 17.00||Questions and panel debate|
Time: 13 March 2017, 15:00 – 17:00
The event is free to attend. Registration is mandatory. Please use this registration form no later than Monday, 13 March 2017, 11:00 at the latest.
I am happy to announce our “Global Genes, Local Concerns Symposium on Legal, Ethical and Scientific Challenges in International Biobanking” to be held at the University of Copenhagen (DK) on 16 March 2017, 08:00-18:30. Among the many prominent experts speaking at this conference we find the PFC’s very own Glenn Cohen and several speakers with a PFC “history” or close PFC links, such as Bartha Knoppers, Tim Caulfield, Nicholson Price and Jeff Skopek.
This Symposium marks the final phase of the Global Genes-Local Concerns project. In accordance with the goals of this large cross-faculty project, the Symposium deals with legal, ethical and scientific challenges in cross-national biobanking and translational exploitation. Leading international experts and invited speakers will discuss how national biobanks contribute to translational research, what opportunities and challenges regulations present for translational use of biobanks, how inter-biobank coordination and collaboration occurs on various levels, and how academic and industrial exploitation, ownership and IPR issues could be addressed and facilitated. Special emphasis will be laid on challenges and opportunities in addressing regulatory barriers to biobank research and the translation of research results, while at the same time securing ethical legitimacy and societal interests.
These issues will be dealt with in 4 main sessions covering (1) BIG DATA AND MODES OF COLLABORATION; (2) PATIENT INVOLVEMENT; (3) TRANSLATIONAL MEDICINE & TECH TRANSFER, as well as (4) GUIDELINES & GOOD GOVERNANCE.
- Bartha Knoppers, Mc Gill University (Canada)
- Glenn Cohen, Harvard University (US)
- Timo Minssen, University of Copenhagen (DK)
- Tim Caulfield, University of Alberta (Can)
- Michael Madison, University of Pittsburgh (US)
- Jeff Skopek, University of Cambridge (UK)
- Brian Clark, Director, Human Biosample Governance, Novo Nordisk A/S (DK)
- Jane Kaye, University of Oxford (UK)
- Anne Cambon-Thomsen, INSERM, Toulouse / CNRS Director (Fr)
- Klaus Høyer, University of Copenhagen (DK)
- Aaro M. Tupasela, University of Copenhagen (DK)
- M. B. Rasmussen, University of Copenhagen (DK)
- Åsa Hellstadius, Stockholm University (Sweden)
- Peter Yu, A&M Texas University (US)
- Esther van Zimmeren, University of Antwerp/Leuven (Belgium)
- Nicholson Price, University of Michigan Law School (US)
- Karine Sargsyan, BBMRI/Head of Biobanking-Graz (Austria)
- Eva Ortega-Paino, BBMRI, Lund University (Sweden)
- Nana Kongsholm, University of Copenhagen (DK)
- Klemens Kappel, University of Copenhagen (DK)
- Helen Yu, University of Copenhagen (DK).
For participation in the event please use this registration form no later than Friday, 10 March 2017, 12:00 at the latest.
We are looking very much forward to welcoming you in wonderful Copenhagen on 16 March 2017.
I am happy to announce that I have just joined the Board of Editors of the new journal “European Pharmaceutical Law Review” (EPLR). One of my first tasks is to spread the news about our “Call for Papers”. Further information is available here.
The European Pharmaceutical Law Review (EPLR) reports on key legislative developments in the EU and the Member States, and identifies and analyses important judgments that shape the interpretation and application of EU pharmaceutical law, in particular those by the European Courts, international courts and tribunals such as the WTO’s Dispute Settlement Body, and higher national courts.
In order to establish itself as a forum for dialogue between different stakeholders in pharmaceutical regulation and governance, it will invite contributions from academics, practitioners, regulators and civil society representatives. Topics covered by EPLR include:
- Pharmaceutical law and policy in all jurisdictions (regional, national, international);
- Commission decisions (EMA opinions) and regulatory guidelines;
- National EU, and International Jurisprudence;
- Medical devices;
- Borderline cases: pharmaceuticals/food/cosmetics/chemicals
- Patents /Trademarks;
- Health Technology Assessment and pricing/reimbursement;
- Digital health/Big data;
All contributions will be subject to double blind peer-review before acceptance for publication and are required to conform to the author guidelines.
We are looking forward to receive and review the first submissions!
Best wishes/ Timo
I. Our Bodies, Our Body Politic
On March 30, at a town hall meeting in Green Bay, Wisconsin, an audience member asked then-presidential-hopeful Donald J. Trump: “[W]hat is your stance on women’s rights and their right to choose in their own reproductive health?” What followed was a lengthy back-and-forth with Chris Matthews. Here is an excerpt from that event:
MATTHEWS: Do you believe in punishment for abortion, yes or no as a principle?
TRUMP: The answer is that there has to be some form of punishment.
MATTHEWS: For the woman.
TRUMP: Yeah, there has to be some form.
MATTHEWS: Ten cents? Ten years? What?
TRUMP: I don’t know. That I don’t know. That I don’t know.
Much has been made of the fact that President-Elect Trump claimed that women who undergo abortion procedures should face “some sort of punishment.” Considerably less has been made of the fact that our President-Elect, in a moment of epistemic humility, expressed that he did not know what he would do, though he believed something had to be done. (He later revised his position, suggesting that the performer of the abortion rather than the woman undergoing the abortion would “be held legally responsible.”)
I am worried about the futures of our bodies, as, I think, are many. That a Trump Presidency makes many feel fear is not a novel contribution. Nor will I be able to speak to the very many, and varied, ways our bodies may be compromised in and by The New America—be it through removal from the country (see especially the proposed “End Illegal Immigration Act”), removal from society (see especially the proposed “Restoring Community Safety Act”), or some other means (see especially the proposed “Repeal and Replace Obamacare Act”).
But, I am like President-Elect Trump in this way: Like him, “I don’t know.” I don’t know what to say about what will happen to our bodies or to our body politic. So instead, today, I will take this opportunity to point to one aspect of the changing face of access to reproductive technologies that has already become a battleground in the fight over women’s bodies and will, I suspect, take center stage in the debate over the right and the ability to choose in coming years. Continue reading
By Timo Minssen
I am happy to announce that our recent paper on “Standards, Data Exchange and Intellectual Property Rights in Systems Biology” has been published in the Biotechnology Journal Vol 11, Issue 12, pp. 1477-1480. The paper was co-authored by Esther Van Zimmeren from the University of Antwerp, Berthold Rutz from the European Patent Office and me. Please find a summary below:
Intellectual property rights (IPRs) represent a key concern for researchers and industry in basically all high-tech sectors. IPRs regularly figure prominently in scientific journals and at scientific conferences and lead to dedicated workshops to increase the awareness and “IPR savviness” of scientists. In 2015, Biotechnology Journal published a report from an expert meeting on “Synthetic Biology & Intellectual Property Rights” organized by the Danish Agency for Science, Technology and Innovation sponsored by the European Research Area Network (ERA-Net) in Synthetic Biology (ERASynBio), in which we provided a number of recommendations for a variety of stakeholders. The current article offers some deeper reflections about the interface between IPRs, standards and data exchange in Systems Biology resulting from an Expert Meeting funded by another ERA-Net, ERASysAPP. The meeting brought together experts and stakeholders (e.g. scientists, company representatives, officials from public funding organizations) in systems biology (SysBio) from different countries. Despite the different profiles of the stakeholders at the meeting and the variety of interests, many concerns and opinions were shared. In case particular views were expressed by a specific type of stakeholder, this will be explicitly mentioned in the text. This article reflects on a number of particularly relevant issues that were discussed at the meeting and offers some recommendations. Continue reading
By Jonathan Larsen, JD, MPP and Adrienne R. Ghorashi, Esq.
The US Food and Drug Administration (FDA) approved the first biosimilar for use in the United States in March 2015. The approval came after several years of regulatory process development authorized by the Biologics Price Competition and Innovation (BPCI) Act of 2009, a component of the Affordable Care Act.
Biosimilars are highly similar, but not identical, copies of FDA-approved biologics, known as “reference” products. Biologics are used to treat a variety of diseases and medical conditions, including cancer. For many years, biosimilar development was thought to be too complex and too costly to advance, and exclusivity patents for reference biologics prohibited developers from marketing competing biosimilars. Now that those patents have started to expire, biosimilar development can finally begin, at a potentially huge benefit to patients.
By Timo Minssen
I am happy to announce that on April 20th the New York attorney Robert M. Schwartz and I have filed an amicus brief at the US Supreme Court with Berkeley-based Andrew J. Dhuey as Counsel of Record. The brief, which was signed by 10 prominent European and Australian Law Professors as amici curiae, adds a European perspective to the many amicus briefs that have been submitted in support of Sequenom’s petition for certiorari to the United States Supreme Court. Sequenom’s petition in Case No. 15-1182 was filed on March 21, 2016 and seeks review of the Federal Circuit’s controversial decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, reh’g denied, 809 F.3d 1282 (Fed. Cir. 2015). The case concerns the revocation of Sequenom’s patent claims directed to inventive methods of genetic testing by detecting and amplifying paternally inherited fetal cell-free DNA (cffDNA) from maternal blood and plasma. Before the development of this highly beneficial, non-invasive prenatal diagnostic test, patients were placed at higher risk and maternal plasma was routinely discarded as waste. Distinguishing this case from previous Supreme Court decisions and highlighting the mitigating effects of other patentability requirements, we are concerned that the Federal Circuit’s overly rigid approach to claims eligibility decision might jeopardize the development of new therapies in an increasingly important area of modern medicine.
As most Bill of Health readers know, the US Supreme Court has in a recent series of cases (i.e. the combined effect of Bilski, Prometheus, Myriad and Alice) barred the patent eligibility for many genetic inventions as “products and processes of nature”. In Sequenom the CAFC interpreted these to mean – in essence- that “laws of nature” had to be entirely eliminated from the test of patent eligibility under §101 of the Patent laws. Should this interpretation be institutionalized it will contravene the tests for exclusions and exceptions under the EPC, arguably contradict longstanding US treaty policy and disrupt international patent harmonization. More importantly, we fear that the broader impact of such an restrictive interpretation may have grave consequences for a sustainable global drug delivery system, which should involve both public and private actors.
Although we believe that patents will remain the backbone of the industry, we acknowledge in our brief that there are certain areas of biomedical innovations, such as antibiotics and orphan drugs, where the patent system does not work particularly well. We further recognize that both in Europe and in the US concerns have been raised about overly pre-emptive patents scope, but these are addressed at different levels. In contrast to Europe, the CAFC has interpreted the uncodified exception as part of a “threshold test” for patent-eligibility applied before other patentability requirements can be assessed. A strict and coherent application of these requirements, however, would invalidate overly-broad patent claims (including some of Sequenom’s arguably too broad and badly drafted claims), while also permitting, well-defined, narrower claims on diagnostic technology. In our view, the current approach conflates the patent eligibility test with issues that can be more sensibly addressed within a strict and coherent assessment of novelty, non-obviousness and sufficient disclosure criteria or at the post-grant level. We believe that, the Federal Circuit’s threshold test has not sufficiently considered the manner in which today’s statutory requirements have developed in both the U.S. and Europe to address policy rationales for patentability exceptions. To entirely transplant those issues into the patent eligibility assessment would categorically close the patentability door on many well-defined and beneficial inventions that deserve patent protection. In absence of sufficient public involvement and appropriate alternative incentives we risk that the wells driving technological progress run dry and that companies engage in business strategies, such as increased reliance on trade secrecy, that are not necessarily beneficial for our innovation system.
Accordingly, we urge the Supreme Court to clarify a patent eligibility test in line with its longstanding jurisprudence and in harmony with international and European law.
If the CAFC’s restrictive interpretation should prevail, however, I believe that it will be crucial to swiftly optimize the framework for PPPs and alternative innovation incentives, such as prizes and regulatory exclusivities. This would have to be done on an international level to allow for greater flexibilities and encompass further technological areas, such as biomedical diagnostics. Regarding regulatory exclusivities, Article 39 of the TRIPS agreement should provide sufficient leeway for such changes. The pros and cons of the different alternative approaches would of course have to be carefully considered.
The Amici curiae have no stake in the parties or in the outcome of the case. A full list of the Amici is appended at the end of the brief.
By Dalia Deak
A study published this week in JAMA examined how much physicians know about FDA approval standards for new drugs and the breakthrough therapy designation. The investigators found major gaps in understanding with regard to both issues, despite intuitive beliefs to the contrary.
For the study, Kesselheim et al. conducted a national survey of board-certified internists and specialists. They selected a random sample of 300 clinically active internists and 900 specialists in endocrinology, hematology, and infectious diseases from the American Board of Internal Medicine’s diplomate list. Of the 1,148 physicians contacted, 692 physicians, or 60%, responded.
By Dalia Deak
The Treasury Department published regulations on Monday that took aim at corporate inversions – and, they hit their mark. Two days later, the merger of pharmaceutical giants Pfizer and Allergan, the largest planned inversion in history of the pharmaceutical industry, fell through.
The temporary and proposed regulations put forth on Monday make it more difficult for U.S.-parented multinational groups to change their tax residence to a low-tax country. This practice, the Treasury noted, is typically not to grow the underlying business or pursue other commercial benefits that may arise, but primarily to reduce their taxes. Companies will often follow up corporate inversions with another tactic—earnings stripping. This is where the company will seek to further minimize U.S. taxes by paying deductible interest to the new foreign parent or its affiliates in the low-tax country.
Specifically, the regulations attempt to curb inversions and earnings stripping by doing the following:
- Limiting inversions by disregarding foreign parent stock attributable to certain prior inversions or acquisitions of US companies (under section 7874);
- Targeting transactions that increase related-party debt that does not finance new investment in the US (under section 385); and
- Allowing the IRS on audit to divide a purported debt instrument into part debt and part stock (under section 385).