unifedpatentcourtmap.jpgOn December 11-12, 2013, IBC Legal Conferences held its annual International Patent Litigation Conference. This Conference has historically brought together an impressive cast of speakers, and the 2013 Conference was no exception.

Opened by the Rt. Hon. Sir Robin Jacob, Hugh Laddie Professor of Intellectual Property Law, UCL and former Lord Justice of Appeal Court of Appeal of England and Wales, the audience was regularly treated throughout to his strong views on the burning issues. Kevin Mooney, Partner, Simmons & Simmons, chaired the Conference, which began with an update on the Unified Patent Court (“UPC”) and a panel commentating on the multitude of possible scenarios and outcomes. Neil Feinson, International Policy Director of the United Kingdom’s (“UK’s”) Intellectual Property Office (“IPO”), also provided a number of updates. He expects that the UK will ratify the Unified Patent Court Agreement by March 2015, and he reiterated that the whole project was expected to be self funding in the long run, cost effective, and competitive. But there are still a lot of unknowns, Feinson explained, such as the likely number of cases and court running costs, making calculations of costs and therefore fees to be charged difficult to estimate. The UK is working on addressing the unknowns, he said, and it is expected that as the Court gets underway, there likely will be fee reviews on a regular basis. The UK IPO is ultimately responsible for the information technology system, and Feinson expects that an “off the shelf” solution will be purchased rather than a new design.

A free 361-page book covering the 15th Draft on Rules of Procedure in three languages was made available to participants, but the book is likely to be out of date fairly soon, as Mooney and his team of rules drafters are well on the way to coming out with clarifications and updates. The final version of the Rules could be out as early as June 2014.
Continue reading

Throbbing_migraine_headache.gifLast Friday, FDA allowed marketing of Cerena TMS, the first medical device to relieve pain caused by migraine headaches that are preceded by an aura. “Millions of people suffer from migraines and this new device represents a new treatment option for some patients,” said Christy Foreman, Director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health (“CDRH”).

A migraine is a chronic, neurological disorder characterized by recurrent moderate to severe headaches often in association with a number of autonomic nervous system symptoms. Typically a migraine headache is unilateral (i.e., affecting one half of the head) and pulsating in nature, lasting from 2 to 72 hours. Migraines may be associated with nausea, vomiting, photophobia (increased sensitivity to light), phonophobia (increased sensitivity to sound), and migraine headache pain is generally aggravated by physical activity. Up to one-third of people with migraine headaches perceive an aura. An aura is a visual, sensory, or motor disturbance immediately preceding the onset of a migraine attack. Occasionally an aura can occur with little or no headache following it.

Cerena TMS, manufactured by eNeura Therapeutics (“eNeura”) in Sunnyvale, California, is a prescription medical device used after the onset of pain associated with migraine headaches preceded by an aura. FDA reviewed Cerena TMS under an automatic class III designation (de novo) summary option. This option is an alternate pathway to classify novel devices of low to moderate risk that are “not substantially equivalent” to a legally-marketed predicate device. Devices that classified through the de novo process (and subsequently cleared as 510(k) type medical devices class I or II) may be marketed and used as predicate devices for future 510(k) submissions. Devices that are classified under class III otherwise require a premarket approval application (“PMA”), which is a most stringent type of medical device marketing application.
Continue reading

GW Law China IP Conference 2013

Yesterday, The George Washington University Law School hosted its third annual China Intellectual Property (“IP”) Conference: Patent and Trade Secrets: A Public Discussion on How to Protect Technologies in China. The Conference focused on the impact of the resolution and spirit of the recent Third Plenum of the 18th Communist Party on the commercial rule of law and IP. Moderated by Mark Cohen, Senior Counsel, China, United States Patent and Trademark Office (“USPTO”) and John Whealan, Intellectual Property Advisory Board Associate Dean for Intellectual Property Law Studies, George Washington Law School, the Conference featured a deep bench of legal experts from academia, government, corporations, trade associations, and domestic and international law firms. Keynote speakers included Randall R. Rader, Chief Judge, U.S. Court of Appeals for the Federal Circuit, David J. Kappos, Former Director, USPTO, and Teresa Stanek Rea, Former Deputy Director, USPTO. Rather than a typical PowerPoint-type presentation format, the Conference featured roundtable discussions with input from the audience, who included seasoned IP prosecutors and litigators with experience in China.

The first panel discussed overall fiscal and other developments in China and how they related to IP changes. Whealan noted that it has been difficult to develop an Chinese economy that depends on IP when the corporate managers are government employees (i.e., no “real” managerial class) and the judicial system is semi-legislative (e.g., it added copyright law before there was a formal copyright law). Rader said that the Chinese use IP as an “area of experimentation” beyond the usual, where he saw some positive movement in the judicial system. For example, Rader explained that he used to say that companies should use something other than the courts to enforce their patent rights; now, he thinks if you do “everything right,” you can win. Rader has also been involved in IP information/education exchanges with the Chinese judicial system, which has helped to lead to thoughts about developing a specialized IP court in China. He was also encouraged by the selection of a lawyer for the Supreme People’s Court. Further, over time he has witnessed a transformation from China’s manufacturing economy that undervalued IP to an economy more dependent on innovation, where there has been a need for greater IP protections.

Cohen observed that while China has been developing its IP program, there has been less emphasis to protect pharmaceutical patents and no national trade secret protection. In some sense, China approached IP protections backward: first there was IP (1983) then there was property law (2007), which never allowed IP law to develop properly. Cohen believed that the Chinese judicial system needs more transparency–important or “embarrassing” cases often are deliberately not published, leading to disclosure of “model decisions” that do not mirror what happens, and no “real Markman [claim interpretation] cases.” Added to that are provincial government control differences, Conrad Wong, Attorney-Advisor, Enforcement Unit, Office of Policy and External Affairs, USPTO, described, and differences of opinion regarding nondisclosure agreements (e.g., employees believe they are not bound by IP rights to their previous employer).
Continue reading

On December 11, 2013, FLH Scientific Advisor Howard E. Rosenberg, Ph.D. will speak on: “Patent Settlements/Pay-for-Delay – are they so incompatible?” as part of the International Broadcasting Convention (“IBC”) International Patent Litigation Conference held in London, England, at The Bloomsbury Hotel, 16-22 Great Russell Street, London WC1B 3NN.

Dr. Rosenberg’s presentation is a “Case Study” with the following description:

Both in Europe and USA there is pressure for curbing aspects of patent settlements, consequently it has resulted in hotly debated missives from both sides of the divide. Can a patent dispute be resolved in which a settlement can occur where a commercial advantage is obtained by both litigants or is it solely the public purse that has to be of concern?

troubleswallowingpills.pngOn December 9, 2013, FDA issued a new draft guidance: Size, Shape, and Other Physical Attributes of Generic Tablets and Capules. FDA said that it issued the guidance because it is concerned that patients perceive differences in the physical characteristics (e.g., size and shape of a tablet of capsule) of generic drugs in relation to its referenced listed drug (“RLD”) counterpart. FDA believes that these perceived differences are “important” and “may affect patient compliance and acceptability of medication regimens or could lead to medication errors.” FDA does not plan for the Guidance to apply to generic drugs that are already on the market, unless there are safety issues, or other oral dosage forms.

According to the Guidance, many individuals have difficulty swallowing tablets and capsules, perhaps as many as 40 percent of Americans. Of these individuals, most blamed the dosage form size as an issue. In some instances, the larger tablets or capsules have been “shown to prolong esophageal transit time,” which may lead to disintegration of the product in the esophagus or cause injury to the esophagus, or more general adverse events such as pain, gagging, choking, and aspiration. In the industry, these larger tablets or capsules have been called “horse pills.” Some tablet and capsule shapes are known to be easier to swallow and have faster esophageal transit times than similar dosage forms with the same weight, e.g., oval sizes are easier to swallow than round. In turn, patient compliance may be affected by the size and shape of a tablet or capsule. Other physical attributes that affect ease of swallowing include coatings, weight of the tablet or capsule, and surface area of the dosage form.

As a result, FDA recommends that as part of its quality initiatives for generic drug products, generic oral tablets and capsules should be of a similar size to their corresponding RLD. In particular:

  • If the RLD is less than or equal to 17 mm in it largest dimension, the generic product should be no more than 20 percent larger than the RLD in any single dimension (resulting dimention not to exceed 17 mm) and no more than 40 percent larger than the RLD in volume.
  • If the RLD is greater than 17 mm in its largest dimension, the generic product should be no larger than the RLD in any single dimension or volume.
  • We recommend the largest dimension of a tablet or capsule should not exceed 22 mm and that capsules should not exceed a standard 00 size

.
Continue reading

is a beneficial yet challenging task. In May 2013 Prometheus Laboratories submitted a Citizen Petition to the FDA, requesting more guidance on rulemaking on the standards and processes for establishing a single, shared Risk Evaluation and Mitigation Strategies (“REMS”) System. One of the stated reasons why Prometheus asked for greater clarification of the single, shared REMS process is the concern over antitrust risk. Antitrust issues associated with REMS and the benefits and challenges of a collaboration in a single shared REMS are two hot topics on the agenda of the

6th Risk Evaluation and Mitigation Strategies Summit

at the Westin Alexandria, January 28-29th 2014 in Alexandria, VA

FDA.bmpFDA issued a draft guidance Wednesday that provides its recommendations for generic-drug makers seeking to show bioequivalence to a reference listed drug. The document–Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA–does not represent a significant change or shift in FDA policy/opinion, but it covers many approaches and revises and replaces parts of two existing FDA Guidances (see here and here). And, most notably perhaps, the document is a consolidation of many of FDA’s previous opinions and guidances on establishing bioequivalence that concludes with an attachment providing a summary of general approaches for the design and data handling of bioequivalence studies with pharmacokinetic endpoints. The document should provide would-be generic-drug applicants with a good starting place.

FDA’s advice is very general, as the Agency states that companies should see FDA’s product-specific guidances for information on individual drugs. But despite the lack of product-specific advice, the guidance provides significant detail about common study parameters. FDA starts with a general discussion of how best to establish bioequivalence. The Agency notes that applicants can establish bioequivalence using in vivo and/or in vitro methods, which include–in descending order of preference–pharmacokinetic, pharmacodynamic, clinical, and in vitro studies.

Regarding pharmacokinetic studies, FDA suggests that applicants use: (1) a two-period, two-sequence, two-treatment, single-dose, crossover-study design; (2) a single-dose-parallel-study design; or (3) a replicate-study design. To establish bioequivalence from the studies, FDA urges applicants to use the average bioequivalence method of analysis. The guidance provides that, if possible, the study population should consist of enough subjects–18 years and older and representative of the entire population, considering age, sex, and race–to provide adequate statistical power.
Continue reading

23andme.jpg23andMe, the Google-backed direct-to-consumer genetic testing provider, has suspended its health-related genetic testing in response to FDA’s November 22, 2013 Warning Letter. In the Warning Letter, FDA directed 23andMe to “immediately discontinue marketing [its Saliva Collection Kit and Personal Genome Service, “PGS”] until such time as it receives FDA marketing authorization for the device.” While 23andMe will discontinue access to health-related services, 23andMe will continue to provide access to raw genomic data as well as ancestry-related applications. Also, customers who purchased 23andMe prior to FDA’s Warning Letter will still have access to health-related results.

The Warning Letter deemed the PGS a medical device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). 21 U.S.C. 321(h). Section 201(h) defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article” that is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease” or is “intended to affect the structure or any function of the body.” FDA determined that the PGS fell within this definition, because it was marketed as providing, “health reports on 254 diseases and conditions.” In particular, 23andMe was marketed as a “first step in prevention” for diseases like diabetes, coronary heart disease, and breast cancer.

FDA is particularly concerned about the “potential health consequences that could result from false positive or false negative assessments for high-risk indications.” For example, a false positive BRCA-related risk assessment [A BRCA mutation is a mutation in either of the genes BRCA1 and BRCA2. Harmful mutations in these genes produce a hereditary breast-ovarian cancer syndrome in affected families.] Mutations in BRCA1 and BRCA2 are uncommon, and breast cancer is relatively common, so these mutations consequently account for only five to ten percent of all breast cancer cases in women.[may lead to unnecessary prophylactic surgery or chemoprevention. On the other hand, a false negative may lead to a failure to appreciate actual risk. FDA was also concerned about drug response assessments, such as warfarin sensitivity or clopidogrel response. For example, a false positive BRCA-related risk assessment [a BRCA mutation is a mutation in either of the genes BRCA1 and BRCA2 that is associated with a hereditary breast-ovarian cancer syndrome in affected families] may lead to unnecessary prophylactic surgery or chemoprevention.
Continue reading

Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for dna.jpg[Update: The Workshop was cancelled on December 10, 2013, due to weather-related closure of the federal government. On December 30, 2013, FTC announced the Workshop would be held on February 4, 2014, at the FTC Conference Center at 601 New Jersey Avenue, NW, Washington, D.C. and will be webcast. FTC will publish an updated agenda and list of speakers. The comment period is unaffected by the rescheduling of the event, i.e., due by March 1, 2014.]

On December 10, 2013, the Federal Trade Commission (“FTC”) will host a Workshop on the Competitive Impacts of State Regulations and Naming Conventions Concerning Follow-on Biologics. FDA has yet to receive its first biosimilar application filed under the Biologics Price Competition and Innovation Act of 2010 (“BPCIA”). Despite this, the FTC believes that some state legislatures have already passed laws that may affect substitution of biosimilars for their referenced innovator biologic products. As a result, the FTC is concerned that these laws may deter the development of biosimilars and raise the costs for consumers without biosimilar options.

FTC’s Workshop plans to cover some of the following questions:

  • How would the new state follow-on biologic substitution laws passed this year, or similar proposals pending in other states, affect the competition expected between or among biosimilar, interchangeable and reference biologic medicines?
  • What are the rationales behind new state proposals and laws for regulating follow-on biologic substitution?

Continue reading

Thumbnail image for Thumbnail image for Q1 ProductionisAddressing Industry Concerns Regarding FDA Regulation and Compliance While Improving Utilization of Clinical Outcome Assessments via Increased Instrument Efficiency and Use of Innovative Technologies to Ensure FDA Label Inclusion
Clinical outcome assessments within the pharmaceutical industry provide critical data to researchers to support a variety of claims, from safety to cost effectiveness, to regulatory bodies as well as healthcare providers and third-party payers. Pharmaceutical executives are eager to maximize the use of outcome assessments, but must understand the optimal tools that will enable them to effectively collect, validate, and analyze the information gathered from patients, clinicians and proxy caregivers.

The Maximizing Patient, Observer & Clinical Reported Outcomes Conference will provide an opportunity for executives throughout the industry for high-level education and networking, blending perspectives from academia, industry-veterans, and regulatory authorities. This event will take place in Alexandria, VA on January 13-14, 2014. Sessions will cover a range of topics, including presentations highlighting various instruments that can be utilized to collect reported outcomes, as well as new applications and mobile technologies, modernizing the methods through which this information is gathered. Insightful commentary will also provide detail on validation methods, as well as techniques for working with the range of observers and with the most appropriate tools for those populations.
Continue reading