Sustainability.pngOn May 1, the Massachusetts Biotechnology Council included a Forum on sustainability. “Addressing the Evolving Sustainability Demands in the Biotech Industry“. Sustainability has become a hot topic for many companies including pharmaceutical and other manufacturers of FDA-regulated products because of the need to provide for long-term maintenance of our earth’s resources. Sustainability broadly is the capacity to endure. In ecology the word describes how biological systems remain diverse and productive over time. Long-lived and healthy wetlands and forests are examples of sustainable biological systems. For humans, sustainability is the potential for long-term maintenance of well being, which has ecological, economic, political, and cultural dimensions.

The Forum featured a mix of industry speakers: Moderator, Wayne Bates, Ph.D., P.E., Vice President and Sustainability Director at Capaccio Environmental Engineering, Inc. and panelists:
James McCabe, Sustainability Manager, Global Operations/Services, Waters Corporation; Tony Meenaghan, Senior Director of Facilities Management, Environmental Health and Safety and Engineering, EMD Serono, Inc.; David Reilly, Global Energy Manager, Novartis; Timothy Stoll, LEED, Director for Development and Leasing, BioMed Realty Trust.

The speakers explained that sustainability programs have arisen due to the concern about how companies impact in environment. The goal is that a sustainability program “meets the needs of the present generation without compromising the ability of future generations to meet their needs.” Sustainability is not meant to be trendy, it is about environmental stewardship, social well being, and economic prosperity over long term (bearable, viable, equitable). In process, many of these programs have been random acts of sustainability rather than a coordinated plan.
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sippycup.pngLast week, the U.S. Patent and Trademark Office (“USPTO”) instituted its first inter partes review of a design patent, U.S. Patent No. D617,465 (“the ‘465 Patent”) assigned to Luv N’ Care, Ltd. Petitioners, Munchkin, Inc. and Toys “R” Us, Inc., successfully persuaded the Patent Trial and Appeal Board that “there is a reasonable likelihood that Petitioners would prevail with respect to the sole claim of the ‘465 Patent.”

The claim of the ‘465 Patent recites “the ornamental design for a drinking cup, as shown and described.” The ‘465 Patent includes five figures of a drinking cup having a vessel, collar, and spout. The Petitioners alleged that the claim of the ‘465 Patent was obvious over U.S. Published Patent Application No. 2007/0221604 published September 27, 2007 (“Hakim ‘604”) and, separately, obvious over U.S. Patent No. 6,994,225 issued February 7, 2006 (“Hakim ‘225”). The Petitioners also presented numerous combinations of references to assert that the claim of the ‘465 Patent was obvious. These additional obviousness arguments were grouped into nine categories according to the primary reference being asserted.

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Written by Shelly Fujikawa. Ph.D

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As an initial matter, the Board addressed the effective filing date of the claim of the ‘465 Patent since several asserted references were intervening prior art, in particular Hakim ‘604 and Hakim ‘225. The ‘465 Patent issued from U.S. Application Serial No. 29/292,909, which was filed on October 31, 2007, as a continuation of U.S. Application Serial No. 10/536,106 (“the ‘106 Application”), which is the national stage of PCT Patent Application PCT/US03/24400 filed August 5, 2003. The Board concluded that the claims were not entitled to the benefit of the filing date of the ‘106 Application, because the ‘106 Application did not have sufficient disclosure to demonstrate that the inventor possessed the claimed subject matter at the time of filing the ‘106 Application. In particular, the drawings of the ‘106 Application do not show the same design as the drawing of the ‘465 Patent.
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Thumbnail image for venturecafe.jpgThis week The Venture Café in Cambridge, Massachusetts hosts Life Sciences Week with a special focus on life science research in the Greater Boston area. Featured life science research speakers include Akrivis (ADAPT™ technology, which allows cancer detection much earlier by increasing the sensitivity of early biomarker detection and enabling the medical imaging of millimeter-sized cancer tumors), Human Metabolome Technologies (metabolome profiling for tumor metabolism, biomarker discovery and production optimization), Advirna (powerful and innovative tools to regulate activity of genes inside living cells), Heartbt Foundation (newly-developing non-profit seeking to boost translational research by bridging medical, professionals, big pharma, researchers, NGOs, the general public, and others), Extend Biosciences (startup biotech company with a platform technology that enables the development of long-acting peptide based drugs), Anchor Therapeutics (pre-clinical stage drug discovery company advancing Pepducin Technology, a novel approach towards allosteric modulators of G-protein coupled receptors), Lab Central (soon-to-open facility to house up to 65 scientists, in 20 individual lab stations and 9 private lab suites in the heart of Kendall Square), and Cellanyx (biomarker-based diagnostic biopsy test to determine oncogenic and metastatic potential for prostate tumors). The Venture Café will also host a Roundtable of Life Sciences Entrepreneurship in Massachusetts, featuring Peter Abair of the Massachusetts Biotechnology Council (“MassBio”), Pamela Norton from the Mass Life Sciences Center, and Peter Parker of Lab Central.

During Life Sciences Week, FLH Partner Brian J. Malkin will host Office Hours from 3-5pm EST along with several other service providers in the healthcare field. Mr. Malkin’s Office Hours description reads:

Chat with Brian J. Malkin, Partner at Frommer Lawrence & Haug LLP. Brian specializes in FDA-regulated products, in particular pharmaceutical, biotechnology products and biosimilars. Discuss intellectual property, pathways for FDA approval, as well as life cycle management and due diligence investigations. Brian frequently speaks on a variety of IP- and FDA-oriented topics, and is editor of the FDA Lawyers Blog.

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Thumbnail image for FDLILogo.jpgThis blog is a second part to a blog here, describing Annual Conference for the Food and Drug Law Institute (“FDLI”) held on April 23 and 24, 2013, its in Washington, D.C.

On the first day, FLH Partner Brian J. Malkin spoke on a panel discussing the priorities for the Center for Biologics Evaluation and Research (“CBER”). The two key CBER presentations came from Diane Maloney, J.D.., Associate Director for Policy, and Mary Malarkey, Director, Office of Compliance and Biologics Quality. The panel also included Michael S. Reilly, Executive Director, Alliance for Safe Biologic Medicines, and Mark S. Robbins, Ph.D., Vice President, Clinical Regulatory Affairs, DiaMedica USA, Inc. and was moderated by Scott Cunningham, Partner, Covington & Burling LLP. A key issue raised by panel was the status of biosimilars. Reilly, for example, was concerned that there may be misinformation about biosimilars, especially because there is no public information concerning biosimilars applications being considered in the United States. Malkin asked when FDA planned to issue additional guidance, because FDA’s guidance has so far been very general and concerns pre-investigational or pre-biosimilars application stages, not the key issues of interchangeability and naming that have been debated. Maloney explained that CBER and the Center for Drug Evaluation and Research (“CDER”) have been discussing strategy, even though there still have been no filed biosimilar applications, and would issue additional guidances. At the same time, Malkin and others acknowledged that at the state level, legislators have been passing bills that specifically prohibit substitution of biosimilars for their referenced counterpart, unless FDA deems the biosimilar “interchangeable” and naming issues and more persist.

A question was raised about a pending Citizen Petition that includes an argument that it was a taking for biosimilar applicants to file applications referencing biologic products before the passage of the Biologics Price Competition and Innovation Act (“BPCIA”) (March 23, 2010). In this Petition, Abbott argued that before this date, when biologics license applications (“BLAs”) were submitted, their sponsors had “reasonable, investment-backed expectations that the trade secrets in their applications would not be used to approve competing products.” Abbott asserts, therefore, that FDA’s use of trade secrets in these BLAs to support biosimilar approvals “would constitute a taking under the Fifth Amendment to the U.S. Constitution. FDA should not implement the BPCIA in any manner that would raise constitutional issue.” While most panel members declined to respond, Malkin hazarded a guess that based on comments FDA has made (see for example here) and in the context of FDA’s Citizen Petition response for a similar issue concerning 505(b)(2) new drug applications (where a similar takings argument has been made), FDA wanted to decide that there was no “taking,” but FDA has not answered the petition in part because no biosimilar application has been filed to date.
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Thumbnail image for FDLILogo.jpgOn April 23 and 24, 2013, the Food and Drug Law Institute (“FDLI”) held its Annual Conference in Washington, D.C. As expected, FDLI’s Conference featured the FDA Commissioner, Margaret A. Hamburg, M.D., presentations from leaders from all of FDA’s Centers and the Chief Counsel, Elizabeth Dickinson, and leaders from industry, academia, and the legal bar. Unlike previous years, however, there were far fewer FDA attendees due to budget cuts, and FDA seemed more reluctant to use the Conference as a platform for announcing new policy or initiatives.

Hamburg kicked off the Conference with her recognition that FDA’s budget was cut, along with other government agencies, noting that it would make times tight but that there are no planned furloughs. Hamburg said that this fiscal year, FDA lost about $209 million-$126 million in budget authority and $83 million in user fees. FDA will continue to collect user fees, but FDA cannot use them this fiscal year due to the sequesteration issue. Hamburg said that the reduced budget would mean reductions in programs but did not specify which ones. Yet, at the same time, Hamburg emphasized that FDA has been busy implementing its new regulatory authorities, including the new Center for Tobacco Products and authorities in the Food and Drug Administration Safety and Innovation Act (“FDASIA”).

Hamburg stressed that it has become more and more apparent that its regulated industries need to build quality in their products. She highlighted that quality issues have caused two out of three drug shortages, and FDA has uncovered “shockingly unsafe drugs” at compounding pharmacies. Over the past several months, Hamburg explained, FDA has been inspecting compounding pharmacies and has found unidentified black particles in what were supposed to be sterile injectable products, rust and mold in sterile rooms, and products being processed with bare hands. At the same time, FDA has encountered increased resistance during its inspections, resulting in at least two cases needing administrative warrants. Hamburg said that FDA believes there should be a distinction between traditional and nontraditional compounding–traditional is individualized to patient; nontraditional is sterile product prepared out of state compounded and anticipated without a prescription. For nontraditional compounding, FDA has asked Congress for more clear FDA authority to monitor and examine records in the “patchwork” of compounding rules.
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On April 23, FLH Partner Brian J. Malkin will speak at FDLI’s Annual Meeting in Washington, D.C. in the Concurrent Breakout Session for the Center for Biologics Evaluation and Research (“CBER”). During the Concurrent Breakout Session, representatives from each FDA center will discuss the three most important developments from last year and their three most important goals in 2013. Following the FDA center representative presentations, food and drug law stakeholders responding to their presentations. This year Diane Maloney, Esq., Associate Director for Policy, CBER, will be presenting for CBER, and Mr. Malkin will be responding as a food and drug law stakeholder. Scott Cunningham, Partner, Covington and Burling, will moderate the session. The Concurrent Breakout Sessions are always a big draw for attendees at FDLI’s Annual Conference, and Mr. Malkin hopes to see you there and at the CBER Breakout Session.

mortar and pestle.jpgThe U.S. Food and Drug Administration (“FDA”) announced last Tuesday that it would not approve any generic versions of the original formulation of the prescription narcotic painkiller OxyContin® (“original Oxycontin®”). OxyContin® is a brand name for oxycodone hydrochloride, an opiate-based pain medication. Original Oxycontin® has been marketed by Purdue Pharma since 1995 and is notorious for its user misuse and abuse.

OxyContin® contains a large amount of oxycodone because it is designed to release the pain-relieving drug over an extended 12-hour period. However, original Oxycontin® can easily be crushed and then snorted or injected (or even sprinkled on food) to produce a rapid and intense euphoric high. The abuse of original OxyContin® in this manner can lead to addiction and dependence and has reportedly earned the product the nickname “hillbilly heroin.” Its accessibility has magnified abuse rates; FDA reports that half a million people over age twelve began using original OxyContin® for non-medicinal purposes in 2008 alone. According to the Center for Disease Control, the death toll from prescription painkiller overdoses tripled in the first decade of the 21st century, and such overdoses “now kill more Americans than heroin and cocaine combined.”

In addition to a patent for original OxyContin, which expired on Tuesday, Purdue Pharma also owns a patent for a reformulated, abuse-deterring version (“reformulated Oxycontin®”). This newer version was designed to resist being crushed and to form a gel that is difficult to inject when dissolved. Notably, FDA approved an updated label for this product last week, specifying the tablets’ crush-resistant properties and warning of the fatal risks of misuse. (The label information is available here.) Purdue withdrew original OxyContin® from the market when its new version was approved in 2010 but retained the trade name.
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FDLILogo.jpgNext week, FLH Partner Brian J. Malkin will speak at Center for Biologics Evaluation and Research (“CBER”) Panel at FDLI’s Annual Meeting held in Washington, D.C. on April 23-24. The CBER Panel will be held on the first day of the Conference, Tuesday, April 23, from 2-3:30 p.m. FDLI has posted the key two presentations by CBER Representatives Diane Maloney, Esq., Associate Director for Policy, and Mary Malarkey, Director, Office of Compliance and Biologics Quality. The panel will be moderated by Scott Cunningham, Partner, Covington & Burling LLP, and also includes Michael S. Reilly, Executive Director, Alliance for Safe Biologic Medicines, and Mark S. Robbins, Ph.D., Vice President, Clinical Regulatory Affairs, DiaMedica USA, Inc.

As demonstrated by the presentations already posted by Maloney and Malarkey, the panel has a lot of ground to cover, and we as panel members have been providing feedback for additional topics to address as time permits. All of us hope for a lively discussion following the initial presentations and hope to see you there!

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Written by Brian J. Malkin

EMA Logo.jpgThe European Medicines Agency (“EMA”) has released their report giving detailed information regarding numbers of patients, sites and inspections with respect to pivotal clinical trials submitted in marketing authorization applications (“MAA”) between January 2005 and December 2011.

As we noted in a previous blog there has been an increase in concern amongst regulators and the public about how well clinical trials are conducted from an ethical and scientific/organizational standpoint, and especially with regard to good clinical practice (“GCP”) compliance. An applicant has to provide information in every MAA regarding the location, conduct and ethical standards applied in respect of the clinical trials conducted in third countries.

The report relates mainly to new applications (485), line extensions (95), and variations where new clinical trial information was provided (97). Generic applications are included as part of the new applications, but they generally do not add much to the number of patients, because these applications are mainly based on small bioequivalence trials, but they do provide information on the locations where these trials were conducted.
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supreme court.jpgOn April 15, the U.S. Supreme Court heard oral arguments in Assoc. for Molecular Pathology v. Myriad Genetics, Inc. et al., the famous case concerning the patent-eligibility of human gene patents. At issue is the validity of Myriad’s patents on the human genes, BRCA1 and BRCA2, but ruling would surely cover the patent eligibility of all animal and plant genes and impact various biotechnology industries. Additional details may be found in previous blogs, for instance here and here.

The Justices appeared skeptical of Myriad’s argument that isolated DNA is patent-eligible subject matter. Isolated DNA is DNA that is cut from a chromosome, resulting in an “isolated” piece of DNA that has the same nucleotide sequence as the naturally-occurring genomic DNA.

The Justices compared Myriad’s isolated DNA to the discovery of plants with medicinal properties. Justice Breyer commented that it was long-standing patent law that while particular applications of such a plant can be patented, the plant cannot be. If someone discovers a medicinal plant “he gets a patent on the process, on the use of the thing, but not the thing itself.” Justice Sotomayor expressed her understanding that to obtain a patent “you had to take something and add to what nature does” and wondered, “how do you add to nature when all you are doing is copying its sequence?”
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