Category: Intellectual Property

Capsule Endoscopy Instead of Colonoscopy? The FDA Approves the PillCam COLON

Jonathan Darrow Leave a comment

By Jonathan J. Darrow

In January, the Food and Drug Administration (FDA) approved the use of the PillCam COLON 2 as a minimally-invasive means of viewing the colon, a development that is sure to be welcomed by U.S. patients who currently undergo an estimated 14 million colonoscopies each year.  While the approval represents a major step forward, the PillCam is unlikely to supplant current procedures just yet.

The colon has traditionally been examined via optical colonoscopy, a procedure perceived by many to be uncomfortable and embarrassing that involves insertion through the rectum of a 5-6 foot long flexible tube as part of an examination that can take 30 to 60 minutes. Air must be pumped in through the rectum in a process called “insufflation.” Sedatives and pain medication are generally used to help relieve discomfort. In contrast, the PillCam COLON contains a power source, light source, and two tiny cameras encapsulated in an easy-to-swallow pill that produces no pain or even sensation as it moves through the colon. Reflecting the absence of discomfort, one report from a clinical researcher noted that a few patients have insisted on X-rays to confirm that the device had passed in their stool (FDA Consumer). The pill takes about 30,000 pictures before passing naturally from the body, which usually occurs before the end of its 10-hour battery life.

The safety record of capsule endoscopy, the category to which the PillCam COLON belongs, so far appears to compare favorably with the alternatives. Capsule endoscopy may be less likely to produce accidental colonic perforations or other serious complications, which occur in less than 1% of traditional colonoscopies despite the best efforts of the treating physician. Tears of the colon wall can in turn “rapidly progress to peritonitis and sepsis, carrying significant morbidity and mortality.” (Adam J. Hanson et al., Laparoscopic Repair of Colonoscopic Perforations: Indications and Guidelines, 11 J. Gastrointest. Surg. 655, 655 (2007)). Splenic injury or other serious complications also occur rarely with optical colonoscopies. Unlike “virtual colonoscopy,” which uses computed tomography (CT) to peer into the body, capsule endoscopy does not involve bombarding the body with radiation. A leading study published in the New England Journal of Medicine reported no serious adverse events among 320 subjects given the PillCam COLON, and concluded that use of the device was “a safe method of visualizing the colonic mucosa through colon fluids without the need for sedation or insufflation.” Read More

Review of Minssen, “Assessing the Inventiveness of Biopharmaceuticals under the European and U.S. Patent Laws”

Timo Minssen Leave a comment
Harold C. Wegner reviews Petrie-Flom Visiting Scholar Timo Minssen‘s doctoral thesis. From the review:
Patent applicants seeking to gain global patent protection beyond their home country borders need a better comparative knowledge of key elements of the patent laws of the several countries. Professor Timo Minssen in his superb doctoral thesis directly challenges the seemingly identical statutory and treaty standards for patentability in Europe and the United States in his comparative study of the laws of Europe and the United States with respect to the treaty standard of an “inventive step.” Timo Minssen, ASSESSING THE INVENTIVENESS OF BIOPHARMACEUTICALS UNDER THE EUROPEAN AND U.S. PATENT LAWS (Goteborg, Sweden: Ineko AB 2012). Professor Minssen’s doctoral thesis represents required reading for anyone seeking to unmask the subtle differences between American and European practice (emphasis added).
Read the full review.

Kevin Outterson on the Search for New Antibiotics

koutterson Leave a comment

Kevin Outterson appeared on NPR’s “Here & Now” to discuss the growing problem of antibiotic resistance and possible ways to incentivize development of new antibiotics. From the interview:

On the misuse of antibiotics

“We should think of this as a global resource that needs to be conserved and taken care of. So antibiotics should never be used inappropriately. In the country right now, we have something on the order of 23 million people who are getting antibiotics for ear aches. Most of those situations would resolve on their own in a couple of days. We also give antibiotics many times for people just because they have some sort of a common cold — it’s estimated 18 million prescriptions a year — doesn’t help anyone who has the common cold. It’s a complete waste.”

On the rise of antibiotic-resistant bacteria

“It’s frightened people for more than a decade. You mentioned at the top the 23,000 Americans who are dying from resistant infections. The CDC said on top of that, there’s another 14,000 dying from a horrible disease, intestinal disease, called Clostridium difficile [C-diff] in the United States. Together, that’s larger than the number of people who die in this country each year from AIDS. And we’re not — as bad as things are now, the more troubling aspects, or what might happen in five or 10 years if some sort of a pathogen was resistant to everything we had got out to the population. It sounds like a Hollywood movie.”

You can listen to the full interview here.

Patent trolls/Monetizers/PAEs/NPEs and Bio/Pharma

W. Nicholson Price Leave a comment

By Nicholson Price

There’s recently been a lot of focus on patent trolls (so called by those who dislike them; they’re also known as patent assertion entities, nonpracticing entities, and monetizers, each with slightly different definitions; I describe them a bit more after the fold*): there have been Congressional hearings, a bill passed in the House, White House statements, state legislation, and quite a bit of academic attention.  Most attention, though, assumes this is mostly an issue for the high-tech and software industries; in particular, it’s usually assumed that the biotech and pharmaceutical industries are insulated from the phenomenon.  Robin Feldman (at UC Hastings) and I decided to reexamine that assumption, and argue in this piece that the conventional wisdom is wrong, and that biopharma is a relevant target for monetizers.

The basic argument of our piece is as follows: conventional wisdom holds that pharma need not worry about monetizers: even though patents are very important for drug companies, each drug is usually covered by just one or a few patents, and the company either owns them or has licensed them; otherwise it wouldn’t make the drug.  So there just aren’t patents out there that can be asserted; ergo, no monetizer problem.  And indeed, there hasn’t been much action so far.  We point to three challenges to this wisdom: (1) regulatory oversight increases the costs of inventing-around an asserted patent; (2) monetizers are spreading past low-hanging fruit; and (3) the business of selling drugs involves much more than just coming up with an active chemical compound, so that “much more” is still vulnerable to monetizers.  But the main thrust of the paper is against the assumption that there aren’t assertable patents out there.

We thought the patent holdings of universities would likely include lots of patents that might be used by monetizers against pharma, and we were right.  In a deliberately light skim across patent holdings of 5 major research university systems, we easily found many such patents.  The paper describes multiple different categories of patents that could be used, and provides examples of each.  We didn’t aim to be exhaustive, just to point out that the issue is a relevant one to biopharma (whatever you think of trolls), and that that industry should be taken into account–and should participate–in the policy debates about what happens next.  Read More

TOMORROW: Patents without Patents: Regulatory Incentives for Innovation in the Drug Industry

The Petrie-Flom Center Staff Leave a comment

February 19, 2014 12:00 PM Wasserstein Hall 1015
1585 Massachusetts Ave., Cambridge

In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs.  But patents aren’t the whole story; regulatory agencies also offer different forms of exclusivity—enforced by the agencies themselves—to encourage different forms of innovation in the industry.  This panel will discuss actual and potential roles for those rewards in the context of developing new drugs, new uses for old drugs, and new ways to make drugs, in both the United States and the European Union. Panelists include:

  • Benjamin N. Roin, Hieken Assistant Professor in Patent Law, Harvard Law School; Faculty Co-Director, the Petrie-Flom Center
  • W. Nicholson Price II, Academic Fellow, the Petrie-Flom Center
  • Timo Minssen, Associate Professor, University of Copenhagen Faculty of Law; Visiting Scholar, the Petrie-Flom Center
  • Moderator, Aaron Kesselheim, Assistant Professor of Medicine, Harvard Medical School; Director of the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital

This event is free and open to the public. Lunch will be served. For questions, contact petrie-flom@law.harvard.edu or  617-495-2316.

 

New paper on “Standardization, IPRs and Open Innovation in Synthetic Biology”

Timo Minssen Leave a comment

By Timo Minssen

I am pleased to announce that we have today published the following paper:

Minssen, Timo and Wested, Jakob Blak, Standardization, IPRs and Open Innovation in Synthetic Biology (February 14, 2014). Available at SSRN.

This brief book contribution stems from a presentation given at the 2013 conference “Innovation, Competition, Collaboration” at Bucerius Law School, Hamburg, Germany. It is currently under review by Edward Elgar.  A longer journal-version will follow.

Abstract: 

An effective and just sharing of resources for innovation needs a supportive infrastructure. One such infrastructure of both historic and contemporary significance is the development of standards. Considering recent developments within the software and ICT industries, it seems fair to assume that the process of standardization may also have significant impact on the development and adoption of Synthetic Biology (SB). Within SB different standardization efforts have been made, but few have assumed dominance or authority. Standardization efforts within SB may differ within various technical areas, and also the basic processes of standard creation can be divided into various categories. The different technical areas and processes for standardization differ in their speed, handling of interests and ability to dodge possible IPR concerns.

Out of this notion arises i.a. the following questions: How comparable is engineering in SB to more traditional fields of engineering?; What type of standards have emerged and what bearing have IPRs on these?; and, How applicable are the approaches adopted by the standards-setting organizations in the information and communication technology (ICT) to biological standards? These and further legal issues related to IP, regulation, standardization, competition law & open innovation require a careful consideration of new user-generated models and solutions.

Before this background, our paper seeks to describe IP and standardization aspects of SB in order to discuss them in the context of the “open innovation” discourse. We concentrate on describing the technology and identifying areas of particular relevance. Ultimately we also sketch out open questions and potential solutions requiring further research. However, due to the limitation of this paper we do not aim to create elaborated theories or to propose solutions in more detail. Rather this paper, which will be complemented by more extensive follow-up studies, provides a first overview on the complex questions that we are currently dealing with.

To achieve this modest goal, section 1 commences with a brief introduction to the fascinating science of SB and a description of recent technological advances and applications. This will lead us to section 2, in which we will address standard setting efforts in SB, as well as the relevance and governance of various IPRs for specific SB standards. This provides the basis for section 3, in which we debate problematic issues and summarize our conclusions.

2/19: Patents without Patents: Regulatory Incentives for Innovation in the Drug Industry

The Petrie-Flom Center Staff Leave a comment

February 19, 2014 12:00 PM Wasserstein Hall 1015
1585 Massachusetts Ave., Cambridge

In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs.  But patents aren’t the whole story; regulatory agencies also offer different forms of exclusivity—enforced by the agencies themselves—to encourage different forms of innovation in the industry.  This panel will discuss actual and potential roles for those rewards in the context of developing new drugs, new uses for old drugs, and new ways to make drugs, in both the United States and the European Union. Panelists include:

  • Benjamin N. Roin, Hieken Assistant Professor in Patent Law, Harvard Law School; Faculty Co-Director, the Petrie-Flom Center
  • W. Nicholson Price II, Academic Fellow, the Petrie-Flom Center
  • Timo Minssen, Associate Professor, University of Copenhagen Faculty of Law; Visiting Scholar, the Petrie-Flom Center
  • Moderator, Aaron Kesselheim, Assistant Professor of Medicine, Harvard Medical School; Director of the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital

This event is free and open to the public. Lunch will be served. For questions, contact petrie-flom@law.harvard.edu or  617-495-2316.

Book Review: Pharmaceutical Innovation, Competition and Patent Law – A Trilateral Perspective

Timo Minssen Leave a comment

By Timo Minssen

Following a request by the European Competition Law Review (Sweet Maxwell), I have today submitted a review of the recent publication  “Pharmaceutical Innovation, Competition and Patent Law – A Trilateral Perspective”, edited by Max Planck Director Josef Drexl and Finnish scholar Nari Lee (Edward Elgar 2013, 322 p., ISBN 978 0 85793 245 7). The full contribution (6 pp.) is curently undergoing peer-review.

In summary, I conclude that the editors, who also contributed with excellent papers, have succeeded very well in the difficult task of structuring, systemizing and arranging a compilation of very interesting papers written by high profile authors. This has resulted in a very readable book providing a superb overview and up-to-date analysis of recent developments that have such a substantial impact on a significant area of law and practice. But are there any flaws?

Considering the numerous useful case law citations, as well as the wide scope of the book, it is a little unfortunate that the book does not contain a table of cases or a bibliography of material cited by the respective authors. Also it might perhaps have been beneficial to include some contributions from the pharmaceutical industry, private practice or NGOs. There is of course no doubt that all papers have been written by very competent authors and address real-world issues with much devotion to facts, details and commercial realities. But additional contributions by the industry or “field workers” would probably have enriched the numerous debates that are placed in such an extraordinarily complex environment at the interface of business realities, competition, technological innovation, and access to health care.

Read More

New Book: “Science and Technology in International Economic Law”

kjni Leave a comment

I am pleased to post that my new book, “Science and Technology in International Economic Law: Balancing Competing Interests” (co-edited with Professor Bryan Mercurio at the Chinese University of Hong Kong), was recently published by Routledge. In addition to the introduction, the book includes thirteen articles written by scholars from the Asia-Pacific region, Middle East, and Europe. It is the first attempt to explore the status and interaction of and between science, technology and international economic law (namely, trade and investment) with a view to seeking a proper balance between promoting trade/investment liberalization and ensuring that decisions are soundly based and that technological advancement is not hampered.

On the issue of food safety, scientific evidence and trade disputes, I contributed a paper, titled ”Does Science Speak Clearly and Fairly in Trade and Food Safety Disputes? The Search for an Optimal Response of WTO Adjudication to Problematic International Standard-Making,” which appeared previously in the Food & Drug Law Journal, Vol. 68, pp. 97-114 (2013).

The following reveals a brief background and objective of the book:

Read More