In a blog entry written over the summer, I expressed the view that the next 5-10 years will present tremendous transactional opportunities in the life sciences/health care industry. Nothing has happened to dampen that view. In fact, President Obama’s reelection, which means that the Patient Protection and Affordable Care Act is here to stay and will be fully implemented over the next few years, and our ongoing deficit reduction concerns, mandate that efficiency, cost control and strategic ways to provide better quality healthcare will be at center stage. So let’s focus in on some investment opportunities that may be interesting.

For those willing to tackle regulatory and reimbursement hurdles, there should be many opportunities in the provider world. This could take the form of hospital mergers and consolidations, spin-off of various medical and lab services that have been provided at hospitals and … Read More »

Last week’s decision in the off-label promotion case, United States v. Caronia, No. 09-5006-cr (2d Cir. Dec. 3, 2012), is an important blow to the Government’s off-label promotion efforts.  In a 2–1 decision, the Court squarely rejected the simplistic theory that the Food, Drug and Cosmetic Act (“FDCA”) imposes a blanket prohibition against off-label promotion by pharmaceutical and device manufacturers, but it does leave open the door to future prosecutions that rely in part on off-label promotion.

In Caronia, the Department of Justice obtained the conviction of Alfred Caronia, a pharmaceutical sales representative, for conspiracy to introduce a misbranded drug into interstate commerce.  The FDA prohibits the introduction into interstate commerce of a misbranded drug (or device).  31 U.S.C. § 331(a).  A drug is misbranded if, among other ways, its labeling fails to contain “adequate directions for use,” 21 U.S.C. § 352(f), … Read More »

The relationship between health care providers and drug and device manufacturers has been a focus of lawmakers at both the federal and state level.  While we continue to await final federal regulations implementing the Physician Payment Sunshine Act (federal Sunshine Act), which generally requires disclosure of financial arrangements among physicians, teaching hospitals, and drug and device manufacturers,[1] Massachusetts has refined its requirements governing relationships between physicians and drug and device manufacturers.  Amendments to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct regulations[2] (the Massachusetts Regulations) broaden the scope of permissible meals and refreshments that may be provided by manufacturers to health care practitioners and clarify issues related to preemption of the Massachusetts Regulations by the federal Sunshine Act.  The Massachusetts changes and impending release of final federal regulations underscore the continuing need for drug and device manufacturers to … Read More »

On November 14, 2012, the Department of Justice and the Securities and Exchange Commission published their much anticipated Resource Guide to the U.S. Foreign Corrupt Practices Act.1 There is little new in the Guide to clarify the circumstances under which the government will charge companies or individuals with FCPA violations. Instead, the Guide reiterates previous government pronouncements that the FCPA should be construed broadly, and cites its own charging decisions as “authority” for what the statute proscribes. Basically, the Guide is a comprehensive compilation of “authority” formerly found only in various Government press releases, settlement agreements and guilty pleas. Thus, the guidance is somewhat of a disappointment for the experienced FCPA practitioner and for companies that already have robust compliance programs. In a few areas – notably in its discussion of gifts, travel and entertainment – the Guide does offer … Read More »

St. Jude Medical and Volcano have been embroiled in a legal battle over patents held by both companies, related to pressure wire technology that is used for heart patients.  The battle began over two years ago when St. Jude Medical sued Volcano, in Delaware district court, for infringement of 5 of its patents for pressure guide wire products.  The patents in suit were U. S. Patent No. 5,938,624, U.S. Patent No. 6,196,980, U.S. Patent No. 6,112,598, U.S. Patent No. 6,167,763 and U.S. Patent No. 6,248,083.  St. Jude requested an injunction and damages for infringement of the five asserted patents.

Volcano replied by counterclaiming, alleging that St. Jude Medical had infringed four of its own patents, but later dropped one of those patents from the suit.  The three remaining patents asserted by Volcano against St. Jude were U.S. Patent No. 6,976,965, U.S. … Read More »

Tougher sanctions went into effect on October 9, 2012, that broadly expand the extraterritorial reach of the U.S. Government with regard to conducting business with Iran.  Most significantly, with the Iran Threat Reduction and Syria Human Rights Act of 2012, any business owned or controlled by a U.S. parent may expose its parent to sanctions for its business activities with Iran.

Significantly, the new law allows for the imposition of civil penalties of up to $250,000, or twice the value of the transaction, for activities completed by any foreign entity owned or controlled by a U.S. parent, if such activities would violate U.S. sanctions laws if they were to be undertaken in the U.S. or completed by a US person.  Stated another way, if a U.S.–owned or U.S.–controlled foreign entity enters into a transaction with an Iranian party that the parent … Read More »

Published by Capitol Health Record on October 3, 2012

Written by: Amy Walker

Last week, the President’s Council of Advisors on Science and Technology (PCAST) released their “Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation.” The report recommends that the United States set a goal of doubling the number of new medicines “that meet critical public health needs” over the next ten to 15 years.

PCAST, which was formed in April 2009 by President Barack Obama, is an advisory group consisting of leading scientists and engineers which makes science and technology policy recommendations to the President and the Executive Office of the President.

For the report, PCAST analyzed trends and challenges in biomedical research and development over recent years, finding that scientists need better methodologies and tools for translating discoveries and pharmaceutical developers and regulators need to incorporate efficiencies … Read More »

A recent Federal Circuit case, Momenta v. Amphastar, involves the Hatch-Waxman 271(e)(1) safe harbor, and is rousing the biologics and biosimilars industry.  In particular, the court held in Momenta, that section 271(e)(1) does apply to certain post-approval activities.

As background, Momenta Pharmaceuticals, Inc. and Sandoz Inc. filed for a preliminary injunction against Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Watson Pharmaceuticals, Inc. and Watson Pharma, Inc. in the U.S. District Court for the District of Massachusetts alleging infringement of U.S. Patent No. 7,575,886.  The ‘886 patent generally claims processes for analyzing heterogeneous populations of sulfated polysaccharides.  Momenta alleged that Amphastar infringed the claimed processes when developing and manufacturing of batches of generic Lovenox (enoxaparin), a low-molecular-weight complex polysaccharide, for commercial sale.  (Momenta used the claimed processes to gain approval of its own generic enoxaparin one year earlier.)  The district court granted Momenta a … Read More »

New reports suggest that while generic drug makers are aggressively consolidating in the United States and United Kingdom, smaller generic drug manufacturers’ viability is threatened, forcing them to seek niche therapeutic areas.  Manufacturing biosimilar biologicals may be an answer for the smaller generic drug companies, due to several factors.  First, while manufacturing complexities create market entry barriers, recent shortages of the biologics supply in the U.S. have increased the market demand.  Also, low margins are causing large manufacturing companies to exit the biologics market.  Furthermore, the patents for many top selling biologics will expire in the next 3 to 5 years, creating an opportunity for new market entrants.  Finally, the new abbreviated approval pathway for biosimilars in the U.S. may be more conducive to the needs of smaller firms: efficient approval process, lower development costs, and protection for first generation biologics.

Background

In … Read More »