Webinar, 6/28: Procedural Aspects of Compulsory Licensing under TRIPS

I am very happy to host 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.blak.wested@jur.ku.dk

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

Patenting Bioprinting Technologies in the US and Europe – The Fifth Element in the Third Dimension

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

Innovation and Intellectual Property Policies in European Research Infrastructure Consortia

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.

Abstract:

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.

Bold New Policies for The Brave New Biologies: IPRs and Innovation in Synthetic Biology and Gene editing

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.

Programme

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

Venue: Meeting Room 7A-2-04 , Faculty of Law, Njalsgade 76, DK-2300 Copenhagen S

Registration:
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.

Organizer: Copenhagen Biotech & Pharma Forum, at CIIR, Faculty of Law, University of Copenhagen

Global Genes, Local Concerns: A Symposium on Legal, Ethical and Scientific Challenges in International Biobanking

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.

A detailed program and further information is available here and here.

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.

Speakers:

  • 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.

Best wishes/

Timo Minssen

Call for Papers – European Pharmaceutical Law Review (EPLR)

Dear Colleagues,

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

“That I Don’t Know”: The Uncertain Futures of Our Bodies in America

By Wendy S. Salkin

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

Standards, Data Exchange and Intellectual Property Rights in Systems Biology

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

Biosimilars – In The Pipeline or Still a Pipe Dream?

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.

Continue reading

Amicus brief in Sequenom v. Ariosa: Why the U.S. Supreme Court should grant the petition for a writ of certiorari

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.

 

What do doctors know about FDA drug approval standards and the breakthrough therapy designation? Less than we’d hope.

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.

Continue reading

Treasury Targets Corporate Inversion, Pfizer-Allergan Deal Falls Through

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).

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Sequenom vs. Ariosa and international approaches to the patent eligibility of biomedical innovation

By Timo Minssen

With a potential petition for writ of certiorari in the Sequenom v. Ariosa case approaching, it appears as if the US Supreme Court  will once again have to consider crucial patent eligibility questions with a great significance for biomedical innovation and diagnostic methods.

The claims at issue (see U.S. Patent No. 6,258,540 ) are directed to 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 non-invasive prenatal diagnostic test, patients were placed at much higher risk and maternal plasma was routinely discarded as waste.

In an earlier decision the district court ruled that the method claims were patent ineligible and an – apparently reluctant  – Federal Circuit agreed in Ariosa Diagnostics, Inc. v. Sequenom, Inc. 788 F.3d 1377 (Fed Cir. 2015). Judge Linn, for example, wrote that the innovation deserves patent protection, but also that the “sweeping language of the test” established in Mayo v. Prometheus requires a determination that the claims are patent ineligible. Continue reading

Jacobus and Catalyst Continue to Race for Approval of LEMS Drug

By Dalia Deak

The latest development in the race for approval between Jacobus Pharmaceutical Company and Catalyst Pharmaceuticals is a ‘refuse to file’ letter that the FDA issued to Catalyst indicating that Catalyst’s New Drug Application for Firdapse was incomplete. Both companies are competing for approval of slightly modified forms of a drug—3,4-diaminopyridine, or 3,4-DAP— to treat Lambert-Eaton myasthenic syndrome (LEMS). The winner will receive 7 years of exclusive marketing rights to the drug.

LEMS is an autoimmune disorder that affects an estimated 3,000 people in the United States. It is a rare, debilitating disorder that is marked by progressive weakening of the muscles that often begins in young adulthood. The drug in question was initially discovered in the 1970s in Scotland, with researchers in Sweden demonstrating its use in LEMS patients in the 1980s. Jacobus Pharmaceutical Company has been providing a free base form of the drug to patients with a LEMS diagnosis since the early 1990s at no cost (with the exception of postage), though the drug had never received FDA approval.

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Peeling the Onion: How to Promote Pharmaceutical Innovation and Access to Medicine

By Timo Minssen

As mentioned in my earlier blog post, I decided to conclude this year by publishing a introductory speech that I gave on April 14th, 2015 at the 2015 Broad Institute Innovation & Intellectual Property Symposium. The speech was part of the session “Bringing Therapies to the Patients” and introduced a panel-discussion with Entrepreneur and Professors of Law and Business about the failures of the patent system to support new therapeutics. The text is below:

Peeling the Onion:
How to Promote Pharmaceutical Innovation and Access to Medicine

Speaking about frustrations over the IP system in pharmaceutical innovation, sometimes feels like – to lend the words of the late German Nobel Prize winner Günter Grass – “peeling an onion:” Continue reading

Happy New Year: From “Weltschmerz” to Pharmaceutical Innovation

Gallery

By Timo Minssen Dear readers and colleagues, I would like to take this opportunity to wish you all a very happy, healthy and peaceful year 2016. Reaching the end of 2015, I cannot stop thinking about the year that has passed. Being … Continue reading

A Conversation about… Tax Rates?: The Pfizer and Allergan Deal

By Dalia Deak

Last week, Pfizer and Allergan announced a $155B merger that has the health care and policy world talking. The contours of the deal—in particular, where the new company will be based and the implications it has for the company’s tax rate— have raised important questions.

Pfizer is a company with a long history in the United States that dates back to the mid-1800s when it sold antiparisitics and then painkillers during the Civil War. In the modern era, Pfizer is perhaps best known for blockbusters drugs like Viagra and Lipitor. Yet, expiring exclusivities and patent protections have threatened to knock the drugmaker from its No.1 spot. In January of this year, revenues were higher than expected but still down 3% year-over-year, with a forecasted decline in sales from $49.6B in 2014 to between $44.5B and $46.5B expected in 2015. Without blockbusters to replace Lipitor and Celebrex in particular (which fell 6% and 31% respectively), the company has been looking for a deal, even trying to push through a $118B acquisition of UK-based Astrazeneca in 2013, though that deal ultimately failed.

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A Cost Conundrum for Treating Small Patient Populations

By Dalia Deak

The issue of drug pricing has been thrust center stage (again) after Turing Pharmaceuticals raised the price of daraprim from $13.50 to $750 per dose. The public issued a loud outcry, the pharmaceutical industry condemned the move, and presidential candidates are now discussing drug prices (as discussed previously on this blog). The reactions were so swift and loud that Turing eventually backed down, indicating that they will lower the drug’s price, though it is unclear by how much.

The drug in question in this debate, daraprim, is a 62-year old drug used to treat toxoplasmosis, a parasite that is particularly dangerous in infants, AIDS patients, and cancer patients. The curiosity of this case in particular is that the usual host of development incentives implicated in driving up the cost of a drug (e.g., patents, market exclusivity) was not in play. The reason Turing was able to raise the cost of daraprim is because no other generic competitor for the drug is on the market to drive down the cost. This is largely a result of the small market for daraprim, which had 13,000 prescriptions filled for it last year. This begs the questions: specifically for disease areas where populations are small, will drug prices, even for generics, remain stubbornly high?

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Bureaucracy Can Save Lives – The Legacy of Dr. Frances Kelsey

By Robert Field

What adjective would most people associate with the word “bureaucrat”? For many, it would be “inefficient,” “inept,” or “incompetent.” But another that is just as descriptive is “lifesaving.”

Dr. Frances Kelsey, who died this month at the age of 101, was celebrated as an American hero for her work as a medical officer at the Food and Drug Administration (FDA). She saved thousands of lives and prevented untold suffering by using techniques that earn bureaucrats a bad name, delay and obstruction, to keep the drug thalidomide from reaching the market in the United States in 1961.

Thalidomide is a sedative that had been approved for sale in Europe four years earlier and was prescribed for morning sickness during pregnancy. The American manufacturer, Richardson-Merrell, saw a large potential market in the United States. However, Dr. Kelsey, who was assigned to review its application for marketing approval, was troubled by questionable safety data. The law in effect in 1961 required that she issue a decision within 60 days, but she was able to buy more time by asking for additional information.

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The Impact of Broccoli II and Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: A grand finale of a juicy patents tale?

By Timo Minssen

I am pleased to announce our recent paper entitled “The Impact of Broccoli II & Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: The grand finale of a juicy patents tale?”, which is available on SSRN, and forthcoming in Biotechnology Law Report, Vol. 34, Number 3 (June 2015), pp. 1-18.

Our analysis deals with a seminal judgment on the controversial and sometimes even emotionally debated European “Broccoli” and “Tomato” patents, which has captivated the European patent and plant science communities for many years: On March 25, 2015, the EBA of the European Patent Office (EBA) finally issued its much awaited decisions on the consolidated referrals G2/12 (“Tomato II”) and G2/13 (“Broccoli II”), clarifying the exclusion from patentability of essentially biological processes, such as conventional crossing and selection, and in particular its impact on the patentability of claims for products resulting from such processes. The so-called “Tomato II” case concerned an invention entitled “method for breeding tomatoes having reduced water content and product of the method,” whereas the so-called “Broccoli II” case involved an invention of a “method for selective increase of the anticarcinogenic glucosinolates in brassica species”. Continue reading