pills.jpgOn February 13 and 14, 2013, Leerink Swann (“Leerink”) held its annual Global Healthcare Conference at the Waldorf-Astoria Hotel in New York, New York. Each year the Conference highlights emerging themes and controversies in healthcare, where Leerink’s equity analysts present surveys and moderate discussions with MEDACorp Key Opinion Leaders and industry specialists to provide unique and timely insights. MEDACorp is Leerink’s network of 30,000 healthcare professionals including key opinion leaders, practitioners, clinicians, and hospital administrators. In between the main panels, senior management from some of the companies identified by Leerink as the most prominent and promising deliver “fireside chats” and presentations with company updates, including discussions of new products in their pipeline under review. This year the sole sponsor of Leerink’s Global Healthcare Conference was Latham & Watkins LLP.

Headlining the Conference was a Keynote Address entitled “Innovating Medical Product Development – FDA and Other Forward Looking Trends” delivered by Vicki L. Seyfert-Margolis, Ph.D. Seyfert-Margolis just recently was the Senior Advisor for Science Innovation and Policy in FDA’s Office of the Commissioner. Seyfert-Margolis is currently Chief Science and Strategy Officer for Precision Health, which provides services, infrastructure, and technologies to companies developing personalized medicines.

Seyfert-Margolis worked for about three and a half years in FDA’s Office of the Commissioner, where she led the effort to help develop a more coherent policy for companion diagnostic and personalized medicine, including developing guidances for personalized medicine such as “In Vitro Companion Diagnostic Devices” and “Qualification Process for Drug Development Tools“. While at FDA, Seyfert-Margolis looked at why companies were not seeing as many returns from their investments in research and development, noting that it was not FDA’s “fault” for less new chemical entity filings, because FDA can only review or approve products that are filed in new applications.
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Thumbnail image for Thumbnail image for Money in hand.jpgOn February 11, the American Medical Association (“AMA”) voiced its opinions regarding the U.S. Supreme Court’s upcoming review of pharmaceutical patent litigation settlements that include payments to patent challengers, commonly referred to as “pay for delay” settlements.

As explained here, pay-for-delay settlements occur in the context of pharmaceutical litigation under the Hatch-Waxman Act. In a nutshell, they involve payments from a patent holder to a generic manufacturer (who has filed an abbreviated new drug application (“ANDA”) relying on the patent holder’s brand-name drug product and been sued) in return for an agreement to refrain from selling the generic product for a period of time. These settlement deals have become targets of the antitrust enforcement agencies and, as widely predicted, the High Court has agreed to resolve a circuit split over their presumptive legality.

The question presented, from the 11th Circuit case FTC v. Actavis (Docket No. 12-416), is “whether reverse-payment agreements are per se lawful unless the underlying patent litigation was a sham or the patent was obtained by fraud (as the court below held), or instead are presumptively anticompetitive and unlawful (as the Third Circuit has held).” The Eleventh Circuit determined that the U.S. Federal Trade Commission’s (“FTC’s”) assertion that a patent holder was “not likely to prevail” in the underlying infringement action against generic manufacturers did not assert a valid antitrust claim because focus is “on the potential exclusionary effect of the patent, not the likely exclusionary effect,” and a settlement that imposes restraints lesser than that full potential effect do not exceed the “scope of the patent.” The Third Circuit, conversely, applied a “quick look rule of reason,” finding that “any payment from a patent holder to a generic patent challenger who agrees to delay entry into the market [is] prima facie evidence of an unreasonable restraint of trade,” rebuttable by a “showing that the payment (1) was for a purpose other than delayed entry or (2) offers some pro-competitive benefit.”
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alheimers.jpgOn February 5, 2013, FDA announced the availability of Draft Guidance relating to the development of drugs for the treatment of early stage Alzheimer’s disease. The Draft Guidance, titled, “Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease” addresses: (1) diagnostic criteria for early stage Alzheimer’s disease; (2) appropriate clinical outcome measures; and (3) ways to demonstrate disease modification. Addressing these issues in early stage Alzheimer’s disease poses unique difficulties, because patients may have little to no impairment of global functioning. FDA is seeking public comment on the Draft Guidance within sixty days.

The Draft Guidance provides FDA’s current thinking on useful diagnostic criteria for early Alzheimer’s disease. FDA cited useful research in developing diagnostic criteria, such as the research criteria for prodromal Alzheimer’s disease and preclinical Alzheimer’s disease. Specifically, FDA also cited as useful efforts by the research community to incorporate biomarkers into the diagnostic criteria. FDA concluded that, “we support the concept of enriching trial populations with patients most likely to progress to more overt dementia, using both clinical biomarker-based criteria.” FDA also indicated, however, that FDA could not formally endorse any specific diagnostic framework, because more work was necessary to assess the specificity and sensitivity of these criteria, as well as the validation of these methodologies.

The Draft Guidance also provides FDA’s current thinking on ways to establish clinical efficacy in trials involving patients suffering from early stage Alzheimer’s disease. While FDA requires a co-primary outcome measure to demonstrate efficacy on both cognitive and functional levels for clinical trials on the dementia stage of Alzheimer’s disease, in the draft guidance, FDA acknowledged that these endpoints may be impractical for patients suffering from early stage disease. Therefore, FDA indicated that for early stage disease “clear evidence of an effect on delaying cognitive impairment may provide sufficient evidence of effectiveness.”
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venturecafe.jpgThis Thursday, FLH Partner Brian J. Malkin will host Legal Office Hours at The Venture Café in Cambridge, Massachusetts. Mr. Malkin’s Legal Office Hours description reads:

Learn how you can protect your start-up with patent and trademark protection from intellectual property Partner Brian J. Malkin, Frommer Lawrence & Haug LLP. Mr. Malkin is an expert on FDA-regulated products, in particular pharmaceutical/biotechnology products and biosimilars, and can discuss pathways for FDA approval, as well as life cycle management and due diligence investigations. Mr. Malkin recently published a chapter on biosimilars, has a primer on the drug and biologics approval process, frequently speaks on a variety of IP- and FDA-oriented topics, and is the editor of FDA Lawyers Blog, a blog that focuses on legal and scientific developments for FDA-regulated products.

Mr. Malkin welcomes members of The Venture Café community to stop by his Legal Office Hours to help discuss ways to develop and protect your innovative ideas.

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Frommer Lawrence & Haug LLP is proud to announce that the Food and Drug Law Institute (“FDLI”) just published the FDLI Primer, “The Drug/Biologics Approval Process” authored by FLH Partner Brian J. Malkin and Associate Scot Pittman. Mr. Malkin has been a member of the Primer Committee for several years now. Recently, FDLI decided to make each Primer separately available for purchase ($119 for nonmembers, $95 members) rather than an entire series for its predecessor FDLI Monograph publication. FDLI asked Mr. Malkin to author this Primer based on a previous FDLI publication authored by Geoffrey M. Levitt, Senior Vice President and Associate General Counsel, Regulatory and Policy, Pfizer, Inc. Updates in the FDLI Primer include adaptations based on recent FDA legislation, including the latest user fees acts for generic drugs and biosimilars and the Food and Drug Administration Safety and Innovation Act (“FSASIA”). According to FDLI, Primers are:

[E]xtensively researched, referenced, and edited by some of the most experienced and respected professionals in the field. … The Primers are designed to provide you with information and proprietary analysis to enable you to advise your clients or help your company comply with vexing issues, regulations, and guidance.

For this particular FDLI Primer, FDLI writes:

This publication will explain, in practical terms, the approval processes for drugs and biologics. It will describe the various FDA premarket requirements and pathways for drug and biologics application reviews, including changes enacted under the Food and Drug Administration Safety and Innovation Act (FDASIA). Topics addressed will include the New Drug Application (NDA) process, non-NDA routes to market, generic drugs and the abbreviated new drug application process, as well as over-the-counter drugs and biologics. With this Primer, pharmaceutical stakeholders will feel confident that they have a helpful overview to support successfully navigating the FDA drug and biologics review processes.

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Treatment for HIV/AIDS generally requires patients to take a large number of drugs. For HIV therapy, for example, at least three active drugs, usually from two different classes are required to suppress the virus, allow recovery of the immune system, and reduce the emergence of HIV resistance. As a consequence, medicines are being developed that combine these drugs into fixed dosages, thus providing a combination therapy that simplifies dosing and helps patient compliance.

Gilead Citizen Petition by FDA Lawyers Blog

Gilead Sciences (“Gilead”) has developed a new fixed dose combination (“FDC”), STRIBILD®, which contains four distinct drugs: elvitegravir (“EVG”), cobicistat (“COBI”) , emtricitabine (“FTC”) and tenofovir disoproxil fumarate (“TDF”). EVG and COBI have not been approved before by FDA but both FTC and TDF have been.

Generally when a drug containing a new active ingredient is approved for the first time by FDA, it is considered a new chemical entity (“NCE”), which enables it to receive 5 years of market exclusivity, preventing third parties referencing that drug for their own applications for 5 years (or 4 years if their application includes a Paragraph IV certification / patent challenge).
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Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for dna.jpgOn January 28, The New York Times reported that biotechnology companies are actively lobbying state legislatures to limit access to biosimilar versions, i.e., “highly similar” versions of previously-approved, innovator biological products (“biologics”). According to the author, Andrew Pollack, Amgen and Genentech are proposing bills that would make it more difficult for pharmacists to substitute biosimilar versions for the innovator’s products, unless FDA determines that a particular biosimilar version is “interchangeable” with the innovator’s product.

For instance, the Virginia House of Delegates reportedly already passed such a bill last week by a 91-to-6 vote. Other bills in the works require patient consent for substitution, pharmacist notification of the patient’s physician if a switch is made, and for both the pharmacist and patient’s physician to maintain records of any such substitutions for years.

The Generic Pharmaceutical Association (“GPhA”) and insurers generally accept that biosimilar substitution for a biologic should follow similar methods as with drugs only if deemed interchangeable by FDA but find that many of the bills go further to discourage use of biosimilars. “All of these things are put in there for a chilling effect on these biosimilars,” commented Brynna M. Clark, Director of State Affairs for GPhA, adding that many of the limits “don’t sound too onerous but undermine confidence in these drugs and are burdensome.” GPhA and insurers would prefer that legislatures leave biosimilar regulation to FDA, which has been entrusted with using its regulatory prowess to determine the necessary requirements for biosimilars and “interchangeable” biosimilars, as well as when to waive those requirements based on what is know about a particular biosimilar product.
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eye.jpgOn January 24 to a packed house, the Food, Drug and Cosmetic Law Section of the New York State Bar held its annual meeting. This year, the agenda featured presentations on medical devices, a Supreme Court update, an in-house/outside counsel panel to discuss effective relations for FDA/regulatory advice, a discussion of the Federal Sunshine Act, and “A View from the Inside” retrospective of some hot issues at FDA from a recent high-level official at FDA, including the new food and pharmacy initiatives under development.

In the Supreme Court update called “Pivotal Court Cases for FDA Practitioners 2012-2013 Updates”, FLH Partner Brian J. Malkin, spoke on two cases to watch in the first quarter of 2013, Mutual Pharm. Co., Inc. v. Bartlett , No. 12-142 (U.S., cert. granted Nov. 30, 2012, argument scheduled Mar. 19, 2013) and Bowman v. Monsanto Co., No. 11-796 (U.S., cert. granted Oct. 5, 2012, argument scheduled Feb. 19, 2013). The question presented in Mutual v. Bartlett is:

Whether the First Circuit erred when it created a circuit split and held–in clear conflict with this Court’s decisions in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); and Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)–that federal law does not preempt state law design-defect claims targeting generic pharmaceutical products because the conceded conflict between such claims and the federal laws governing generic pharmaceutical design allegedly can be avoided if the makers of generic pharmaceuticals simply stop making their products.

Bowman v. Monsanto is a case that my firm, Frommer Lawrence & Haug LLP, is arguing on behalf of petitioner Bowman, where the question presented is:

Patent exhaustion delimits rights of patent holders by eliminating the right to control or prohibit use of the invention after an authorized sale. In this case, the Federal Circuit refused to find exhaustion where a farmer used seeds purchased in an authorized sale for their natural and foreseeable purpose–namely, for planting. The question presented is: Whether the Federal Circuit erred by (1) refusing to find patent exhaustion in patented seeds even after an authorized sale and by (2) creating an exception to the doctrine of patent exhaustion for self-replicating technologies?

Mr. Malkin’s summaries of these two cases may be found here. His presentation for these two cases, including topics for consideration by the Food, Drug, and Cosmetic Section may be found here.
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Frommer Lawrence & Haug LLP Partner Brian J. Malkin will speak on two topics at the 2013 Annual Meeting of the New York State Bar Association, Food, Drug, and Cosmetic Law Section in New York City on January 24, 2013 : 1) Pivotal Cases for FDA Practitioners: 2012-2013 Updates and 2) In-House/Outside Counsel Panel: Effective Communication Regarding FDA/Regulatory Advice. For the Pivotal Cases, Mr. Malkin will be joined by Janet Linn from Eckert Seamans Cherin & Mellott, LLC, and Mr. Malkin’s In-House/Outside Counsel Panel includes Geoffrey Levitt, Senior Vice President and Associate General Counsel, Worldwide Regulatory and Policy Law, Pfizer, Inc.; Michael DiBello, Vice President and Associate General Counsel – Regulatory, Aceto Corp.; and Afia Konadu Asamoah, Associate, Covington & Burling LLP. Mr. Malkin hopes the In-House / Outside Counsel panel will be of interest for advancing effective interactions between FDA regulatory affairs professionals.

Thumbnail image for 3699948229_d7732f8df0_o.jpgYesterday, FDA issued two new items to help clarify combination products: 1) a Final Rule published in the Federal Register entitled, “Current Good Manufacturing Practice Requirements for Combination Products” and 2) a Draft Guidance entitled, “Guidance for Industry and FDA Staff:
Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA”, also announced in the Federal Register.

The Final Rule is intended to clarify which good manufacturing practice (“CGMP”) requirements apply when drugs, devices, and biological products are combined to create combination products. The Rule also provides a mechanism that FDA describes as “transparent and streamlined regulatory framework” for companies to use when demonstrating compliance with CGMP requirements for “single-entity” and “co-packaged” combination products. “Single-entity” combination products are two or more regulated components, e.g., drug/device, biologic/device, drug/biologic/device, which are physically, chemically, or otherwise combined or mixed and produced as a single-entity. Two or more separate products packaged together in a single package or as a unit and comprised of two or more regulated products is a “co-packaged” combination product. The Final Rules started as a Draft Guidance announced on October 4, 2004 (69 FR 59239), entitled “Current Good Manufacturing Practices for Combination Products.” Based on comments and FDA’s own internal review, FDA decided that “rulemaking was warranted” and issued Proposed Rules on September 23, 2009 (74 FR 48423).

The concept behind the CGMP Rule is simple for parts that are separately manufactured and marketed: each of the constituent parts of a combination product are subject only to the CGMP regulations applicable to that part, e.g., drug, biologic, or device. The two categories of combination products mentioned above, however, “single-entity” and “co-packaged” are slightly different due to the possibility for overlapping CGMP requirements for the different regulated components. Companies have two basic options for these types of products: 1) demonstrate compliance with the specifics of all CGMPs to each of the parts, or 2) demonstrate compliance with the specifics of either the drug CGMPs at 21 C.F.R. Parts 210 and 211 or the quality system (“QS”) regulation at 21 C.F.R. Part 820 rather than both, for drug/devices under certain conditions. For combination products including biologics, the specific regulations are 21 C.F.R. parts 600 through 680, and for product including any human cell, tissue, and cellular tissue-based products, the regulations are 21 C.F.R. Part 1271.
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