SUMMER 2013 A MYRIAD OF IMPACT By David Dykeman, Roman Fayerberg and Fang Xie, Ph.D., GT Boston Office SUPREME COURT EXTENDS PLIVA TO PREEMPT DESIGN DEFECT CLAIMS AGAINST GENERIC MANUFACTURERS By Robert Charrow, GT Washington, D.C. Office U.S. SUPREME COURT RULES THAT “REVERSE PAYMENTS” IN HATCH-WAXMAN LITIGATION SETTLEMENT AGREEMENTS MUST BE SCRUTINIZED UNDER ANTITRUST LAWS By Richard Pettus, Irving Scher, Jennifer Moore, GT New York Office U.S. MEDICAL ONCOLOGY PRACTICE SENTENCED FOR USE AND MEDICARE BILLING OF CANCER DRUGS INTENDED FOR FOREIGN MARKETS By Tracy Mabry, GT Orlando Office CMS ISSUES FINAL “SUNSHINE” RULE, ESTABLISHING NEW REPORTING REQUIREMENTS FOR DRUG AND DEVICE MAKERS AND SOME GPOS By William Eck, GT Washington, D.C. Office IN DEPTH VIEW: CHINA LIFE SCIENCES LAWS AND REGULATIONS UPDATE By Weisun Rao, Ph.D. and Dawn Zhang, GT Shanghai Office IN THE NEWS: GREENBERG TRAURIG MAHER ADVISES ASTRAZENECA ON US$1.15BN PURCHASE OF PEARL THERAPEUTICS IN THIS ISSUE SUMMER 2013
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SUMMER 2013
A MYRIAD OF IMPACT By David Dykeman, Roman Fayerberg and Fang Xie, Ph.D., GT Boston Office
SUPREME COURT EXTENDS PLIVA TO PREEMPT DESIGN DEFECT CLAIMS AGAINST GENERIC MANUFACTURERS By Robert Charrow, GT Washington, D.C. Office
U.S. SUPREME COURT RULES THAT “REVERSE PAYMENTS” IN HATCH-WAXMAN LITIGATION SETTLEMENT AGREEMENTS MUST BE SCRUTINIZED UNDER ANTITRUST LAWS By Richard Pettus, Irving Scher, Jennifer Moore, GT New York Office
U.S. MEDICAL ONCOLOGY PRACTICE SENTENCED FOR USE AND MEDICARE BILLING OF CANCER DRUGS INTENDED FOR FOREIGN MARKETS By Tracy Mabry, GT Orlando Office
CMS ISSUES FINAL “SUNSHINE” RULE, ESTABLISHING NEW REPORTING REQUIREMENTS FOR DRUG AND DEVICE MAKERS AND SOME GPOS By William Eck, GT Washington, D.C. Office
IN DEPTH VIEW: CHINA LIFE SCIENCES LAWS AND REGULATIONS UPDATE By Weisun Rao, Ph.D. and Dawn Zhang, GT Shanghai Office
IN THE NEWS: GREENBERG TRAURIG MAHER ADVISES ASTRAZENECA ON US$1.15BN PURCHASE OF PEARL THERAPEUTICS
By David Dykeman, Roman Fayerberg and Fang Xie, Ph.D., GT Boston Office
On June 13, 2013, the U.S. Supreme Court issued its much anticipated and unanimous decision in Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al., and ruled that patent claims covering naturally-occurring DNA corresponding to human breast cancer genes, BRCAl and BRCA2, are not patent-eligible compositions of matter. While complementary DNA (cDNA) remains patent eligible because cDNA is not naturally occurring, many in the industry believe that the Myriad decision is a blow to biotech companies that hold gene patents. However, the decision could also be a boon to the personalized medicine and diagnostics industries by opening new avenues for research and genetic testing. To read the full Article, see Myriad of Impact.
Supreme Court Extends PLIVA To Preempt Design Defect Claims Against Generic Manufacturers
By Robert Charrow, GT Washington, D.C. Office
In Mutual Pharm. Co., Inc. v. Bartlett, No. 12-142 (U.S. June 24, 2013), the Supreme Court, in a five to four decision building on PLIVA, Inc. v. Mensing(2011), held that the Food, Drug, and Cosmetic Act preempted a state law design defect action against a generic drug manufacturer that turned on the adequacy of warnings. The case involved the application of New Hampshire state law to a generic version of Clinoril, a popular non-steroidal anti-inflammatory drug (NSAID), known as Sulindac, manufactured by Mutual. To read the full GT Alert, CLICK HERE.
U.S. Supreme Court Rules that “Reverse Payments” in Hatch-Waxman Litigation Settlement Agreements Must Be Scrutinized Under Antitrust Laws
By Richard Pettus, Irving Scher, Jennifer Moore, GT New York Office
On June 17, 2013, the Supreme Court of the United States issued a 5-3 decision in FTC v. Actavis. The Court reversed an 11th Circuit decision dismissing a Federal Trade Commission (FTC) antitrust suit against Solvay Pharmaceuticals, the owner of the patent covering brand-name drug AndroGel, and generic drug manufacturers Actavis, Paddock and Par, all of which had settled their Hatch Waxman patent infringement litigations by agreements that included, inter alia, millions of dollars of so-called “reverse payments” by Solvay to the generics, in return for dropping their patent challenges, refraining from launching generic versions of Androgel until about five years before patent expiry, and providing certain promotional services. The Court ruled that while agreements in which a patentee pays a generic drug company to stay out of the market as a means of settling patent litigation are not presumptively unlawful, they may “sometimes” violate antitrust laws and, as such, must be subject to antitrust scrutiny under a “rule of reason” analysis. To read the full GT Alert, CLICK HERE.
U.S. Medical Oncology Practice Sentenced For Use and Medicare Billing of Cancer Drugs Intended For Foreign Markets
By Tracy Mabry, GT Orlando Office
In a June 28, 2013 News Release by the Office of the United States Attorney for the Southern District of California, in San Diego, it was reported that a La Jolla, California medical oncology practice pleaded guilty and was sentenced to pay a $500,000 fine, forfeit $1.2 million in gross proceeds received from the Medicare program, and make restitution to Medicare in the amount of $1.7 million for purchasing unapproved foreign cancer drugs and billing the Medicare program as if the drugs were legitimate. In pleading guilty, the practice admitted that from 2007 to 2011 it had purchased $3.4 million of foreign cancer drugs, knowing they had not been approved by the U.S. Food and Drug Administration for use in the United States. To read the full Article, CLICK HERE.
CMS Issues Final “Sunshine” Rule, Establishing New Reporting Requirements for Drug and Device Makers and Some GPOs
By William Eck, GT Washington, D.C. Office
On February 8, 2013, the Centers for Medicare & Medicaid Services ("CMS") published a final rule implementing the Affordable Care Act's “sunshine” provisions. The rule establishes new reporting requirements for payments to physicians by drug and device manufacturers, and certain others, and for physician ownership and investment interests in manufacturers and group purchasing organizations (See 78 Fed. Reg. 9458 (Feb. 8, 2013), codified at 42 C.F.R. pts. 402 & 403). We encourage manufacturers and group purchasing organizations to familiarize themselves with the requirements of this rule promptly, because data collection requirements became effective on August 1, 2013, and reporting is required by March 31, 2014. The final rule is divided broadly into two parts. The first part addresses payments and other transfers of value to physicians. The second part addresses physician ownership and Investment Interests. To read the full GT Alert, CLICK HERE.
China’s Patent Re-Examination Board Says Pharmaceutical Salts Not Patentable Over Pure Compounds
By Weisun Rao, Ph.D., GT Chicago and Shanghai Offices
In July 2013, the Patent Re-Examination Board of China’s State Intellectual Property Office invalidated the U.S. biotech company, Gilead Sciences’, Chinese patent covering Tenofovir Disoproxil Fumarate (TDF or PMPA), which is the active ingredient in Gilead Sciences’ drug for treating HIV, AIDS and hepatitis B – sold in the market under the trade name Viread. The Chinese patent, CN 100384859C, has claims that cover a genus of
REGULATORY DEVELOPMENTS
IN DEPTH VIEW: CHINA LIFE SCIENCES LAWS AND REGULATIONS UPDATE
compounds (including Tenofovir and Tenofovir Disoproxil) and their pharmaceutically acceptable salts, isomers and hydrates, second medical use with the compounds, and methods for making these compounds. Although the Re-Examination Board’s decision has not been published, it is believed that the Board sided with the patent challenger and accepted its argument that the active ingredient of Viread does not possess an inventive step over prior art, a Czech patent issued in 1985. Specifically, the challenger argued that compared to the prior art disclosure, the active ingredient of Viread, i.e., the fumarate salt, only renders Tenofovir Disoproxil better bioavailability and makes the compound easier to be absorbed, not more. Gilead Sciences has the option to appeal but has not indicated its intention. To read the full GT Alert, CLICK HERE.
CFDA Reform- A New Food and Drug Regulator In China
By Dawn Zhang, GT Shanghai Office
To deepen government reform and improve government efficiency and transparency, the State Council of the People's Republic of China recently released the Plan for Government Institutional Reform and Function Change (the Restructuring Plan), which was approved by the People's Congress at its first session. In the food and drug section, according to the Restructuring Plan, the former State Administration of Food and Drugs (SAFD) has been elevated to the ministry level, and is now renamed as China Food and Drugs Administration (CFDA). On April 10, 2013, the PRC State Council further extended the reform to the local level and promulgated the Guiding Opinions on the Reform and Improvement of Food and Drug Administration Systems by Local Governments (the Opinions). Two months later, on May 16, 2013 the newly-branded CFDA released a detailed plan on internal organizations and staff, as well as transformation of functions (the Plan). All of these efforts are suggesting that the Chinese government is paying more attention to the food and drug safety issues. The CFDA, now elevated and expanded as a full ministry organization directly reporting to and supervised by the State Council, has become a single safety agency to supervise the whole process of food production, circulation and use, and exercise the drug administration in China. To read the full GT Alert, CLICK HERE.
CFDA Clarifies Inspection and Acceptance Standards for Trading Enterprises for In-Vitro Diagnostic Reagents (Medical Devices)
By Dawn Zhang, GT Shanghai Office
On May 16, 2013, CFDA released the Circular on Inspection and Acceptance Standards for Trading Enterprises for In-Vitro Diagnostic Reagents (Medical Devices) (the Circular). According to the Circular, in-vitro diagnostic reagents (medical devices) trading companies should prepare for quality management system and standard documents concerning the administration of the purchase, storage, transportation, sales and after-sale services of in-vitro diagnostic reagents. To read the full GT Alert, CLICK HERE.
Joint Efforts In Combating False and Illegal Medical Advertisements
By Dawn Zhang, GT Shanghai Office
On April 23, 2013, eight ministries and departments at the central level, including the State Administration for Industry and Commerce (SAIC) and CFDA, jointly issued the Notice on Launching a Special Action to Combat False and Illegal Medical Advertisements (the Notice). Under the special action scheme set forth in the Notice, from April 25th to July 25th, local branches of the aforementioned ministries will investigate the medical
treatment, drug, medical device and health care food ads as well as allegedly curative health care product ads. To read the full GT Alert, CLICK HERE.
CFDA Approves the First Phase I Clinical Trial for a Foreign Drug Manufacturer
By Dawn Zhang, GT Shanghai Office
Under the currently effective Rules on Administration of Drugs Registration (2007), if a foreign applicant wants to conduct an international multicenter clinical trial in China, the drug used for the international multicenter clinical trial must have already been registered in a country outside of China or has entered into phase II or phase III clinical trials. According to public news, recently CFDA has approved the preliminary clinical trial (including part of Phase I clinical trial) for a new drug called “CMET Kinase Inhibitors” for Lung Cancer treatment, developed by Novartis, which makes it possible to bring this new drug to both the global market and the China market simultaneously. To read the full GT Alert, CLICK HERE.
Written Confirmation for Active Substances to be issued by Provincial Branches of CFDA
By Dawn Zhang, GT Shanghai Office
On May 7, 2013, CFDA announced on its official website that, the provincial branches are responsible for issuing written confirmations for exporting active pharmaceutical ingredients to EU by drug manufacturers. Starting from July 2, 2013, active pharmaceutical ingredients to be exported to the EU should satisfy the following requirements: i) manufactured in accordance with GMP standards at least equivalent to the GMP of EU; and ii) accompanied by a written confirmation from the competent authority of the exporting third country certifying that 1) GMP standards are applied; 2) the manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of GMP; and 3) any information on the findings relating to non-compliance should be also supplied by the exporting third country without any delay. To read the full GT Alert, CLICK HERE.
Registered Patients Groups May Thrive In China
By Dawn Zhang, GT Shanghai Office
In China, many patients suffering from the same disease are spontaneously forming self-help associations to share information on the effective medical treatments for such disease. Generally, there are two approaches to legally create a non-governmental patients' group in China: registered as either profit-driven companies or so-called “private non-enterprise entities.” According to some public news, the Chinese government is striving to simplify the registration procedures of private non-enterprise entities to encourage more social patients’ groups to obtain governmental recognition and legal identity. To read the full GT Alert, CLICK HERE.
Greenberg Traurig Maher advises AstraZeneca on US$1.15bn purchase of Pearl Therapeutics
International law firm Greenberg Traurig Maher LLP (GTM) advised AstraZeneca on its US$1.15bn (£740m)
acquisition of Pearl Therapeutics, a privately held US company developing inhaled combination therapies for the treatment of respiratory diseases. AstraZeneca announced that on June 27, 2013 it had completed its acquisition of Pearl. AstraZeneca said the acquisition would give the company access to a potential new treatment for chronic obstructive pulmonary disease (COPD), thereby strengthening its respiratory portfolio.
AstraZeneca acquired 100% of Pearl's shares for initial consideration ofUS$560m cash, with further funds of up to $450m payable if specified development and regulatory milestones in respect of any triple combination therapies and selected future products that AstraZeneca develops using Pearl's technology platform are achieved. Sales related payments of up to a further $140 million are payable if pre-agreed cumulative sales thresholds are exceeded resulting in a total potential acquisition cost of up to $1.15 billion. To read the full Press Release, CLICK HERE.
Roman Fayerberg [email protected] Boston Office Direct: 617.310.5206
Jennifer Moore [email protected] New York Office Direct: 212.801.2142
Fang Xie, Ph.D. [email protected] Boston Office Direct: 617.310.5273
Our Life Sciences & Medical Technology Group supports clients ranging from start-ups to large multinational public companies and not-for-profit care providers, as well as investors, venture capital and private equity funds, investment banks and public agencies. Our wide-ranging work encompasses numerous industry sectors, including biomedical engineering, biotechnology, chemistry, cosmetics, dietary supplements, disease management, drug delivery, EMR, billing and coding, immunology, medical devices, microbiology, nanotechnology, pharmaceuticals, stem cells and vaccines. For more information on our Life Sciences and Medical Technology Group, please visit http://www.gtlaw.com/Experience/Industries/Life-Sciences-Medical-Technology.
Greenberg Traurig, LLP is an international, full-service law firm with approximately 1750 attorneys serving clients from 36 offices in the United States, Latin America, Europe, the Middle East and Asia. In the U.S., the firm has more offices than any other among the Top 10 on The National Law Journal's 2012 NLJ 250. For additional information, please visit www.gtlaw.com.
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