Category Archives: Legal

Antitrust Issues in Life Science

LathamStackedLogoRecent court cases dealing with antitrust issues in both the US and international markets provide valuable guidance.

Latham and Watkins, the law firm, provides a very content-rich webinar on this topic.

Please click here to go to the webinar signup page (registration required).

Webinar Introduction by Latham & Watkins

In this 60-minute complimentary webcast, a team of Latham & Watkins antitrust partners with experience at the FTC, DOJ and litigating novel and complex nationwide cases at the intersection of Antitrust and IP will discuss the key takeaways from these and other recent important events in the US and in Europe and what to look out for going forward.

Over the last month, there have been several significant developments relating to antitrust enforcement in the pharmaceutical and biotech sectors, including the $1.2 billion settlement of the FTC’s Cephalon pay-for-delay case, the California Supreme Court’s revival of the pay-for-delay litigation in In re Cipro I & II and the Second Circuit’s decision upholding the preliminary injunction the New York v. Actavis product hopping litigation. These events, plus the DOJ’s ongoing criminal investigation into the pharma sector and the other post-Actavis cases that address the interplay between antitrust law, IP rights, the Hatch-Waxman Act, and the FDA process, underscore the importance of staying on top of antitrust issues in the life sciences industry.

Another Foreign Corrupt Practices Act Prosecution in Life Sciences

StuffingCashinPocketThe life science industry has been a frequent target of prosecution of Foreign Corrupt Practices Act (FCPA) violations.

Another company, Bio-Rad, just settled with both the Department of Justice (DoJ) and Securities Exchange Commission (SEC), which involved a payment of $55 million.

Life science pharmaceutical and medical device companies have been the target of government scrutiny because in most foreign countries, the purchase of these products is controlled by a “foreign official” as defined in FCPA.

Paul Hastings, the law firm, prepared a helpful article on this recent case and the derivative regulatory and legal actions typically resulting from a settlement.


“As of last year, approximately one out of every four FCPA investigations involved a life sciences company.”

“Given the U.S. government’s continued FCPA enforcement efforts, as well as the ongoing risk of related shareholder litigation and rapidly evolving threat of so-called “carbon copy” foreign prosecutions, it remains imperative that pharmaceutical, medical device, and biotechnology companies be even more proactive in ensuring compliance with the FCPA and other anti-corruption laws.”

This is a challenging issue for companies who use independent distributors in international markets but merits careful management attention to avoid being another example.

Click here to read the Paul Hastings article.

For those who would like more on this topic, I recommend a series of articles, so far, Parts I though III, by Thomas Fox in his “FCPA Compliance and Ethics Updates” on JDSupra, the online legal source (Click here for Part I).

Marketing Unapproved Uses

ReprintCartoonA life science company’s marketing of unapproved or “off-label” use of drugs and devices has been regulated largely by the FDA’s 2009 Guidance.

On March 3, 2014, the FDA issued new 2014 Draft Guidance which clarifies certain rules and requires life science companies to provide additional detailed information.  The comment period on this 2014 Draft Guidance runs to May 2, 2014.

Latham & Watkins, the law firm, has prepared a helpful article on the regulatory history of “off-label” marketing as well as the important elements of the 2014 Draft Guidance.  Please click on the button below to download the Latham & Watkins “Commentary”.

Download the PDF

Illinois Court Holds Drug Brand Manufacturer Owes Duty of Care to Generic User



An Illinois court has held that GlaxoSmithKline (GSK), the maker of a brand name drug, owes a duty of care to a patient who took the generic version.

In this case, the plaintiff proved that GSK improperly conducted a clinical trial which underestimated the risk of suicide for a patient taking the drug.  The warning label, created by GSK and mandated to be used by the generic manufacturer therefore, was incorrect.  This fact situation resulted in the court holding that GSK owed a duty of care just as if the patient had taken the branded drug.

While the facts in this case may not be broad enough to change the industry’s risk perception, it certainly illustrates that branded drug manufacturers need to continue to review and update, if necessary, the warning labels on drugs even when patent protection expires.

Click here to read an excellent “Client Alert” on this case prepared by Morrison Foerster, the law firm.

Life Science Fraud Reported at Higher Level by Kroll


Kroll, the risk management consulting firm, released its 2013 survey of the life science industry.

“After having some of the lowest fraud figures in the 2012 survey, in this year’s report the healthcare, pharmaceutical and biosciences sector has the third-highest overall sectoral incidence of fraud (74%), along with one of the largest proportions of respondents seeing an increase in fraud exposure (85%).”

Read more.

Anti-trust Calculation Includes All Patent Rights

Our friends at Bryan Cave have prepared the following update.




The Federal Trade Commission (“FTC,” together with the Department of Justice Antitrust Division, the “Agencies”) has published its final rule implementing amendments to its regulations under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (“HSR Act” or “Act”).

The amendments, which will become effective on December 16, 2013, provide that the transfer of exclusive patent rights in the pharmaceutical industry may be reportable under the HSR Act where “all commercially significant rights” to that patent, for use in any therapeutic area or indication, are transferred.

While it has long been the Agencies’ position that transfers of exclusive patent rights can potentially be reportable under the Act, the amendments formalize that approach and also clarify that the retention of limited manufacturing rights or co-rights does not impact the potential reporting obligation that may arise as a result of the proposed transfer.

Read more.

HIPAA Compliance Gap

CoalfireLogoMore stringent HIPAA compliance rules went into effect on September 23rd following their announcement last January.

While many in the healthcare industry are compliant, a survey by Coalfire, a risk assessment firm, indicates that many firms that serve the healthcare industry and now fall under the definition of “Business Associates” are not fully compliant.

This gap in compliance by business associates, while likely unintentional, opens their healthcare industry customers to liability.

Please click here or copy and paste the link below to go to the Coalfire survey summary.
 By Dennis McCarthy

New First Inventor to File Regime

KenleyHooverThe America Invents Act brings many significant changes to US patent law, the most fundamental of which is the shift from a first-to-invent system to a first-inventor-to-file system. Kenley K. Hoover, Ph.D., a director at the intellectual property law firm Sterne, Kessler, Goldstein & Fox P.L.L.C., discusses issues and challenges the First-Inventor-to-File regime has brought to the biotechnology industry, as well as the strategies that members of the biotechnology sector have adopted in response to these challenges.​

Click this link to take you to the article and video by Kenley Hoover. 

Click this link to take you to an article by William Mitchell College of Law.
 By Dennis McCarthy

Genes not Patentable per Supreme Court

twitstedDNAKing & Spaulding, the law firm, provided an update on a key US Supreme Court life science  ruling.

“On June 13, the U.S. Supreme Court handed down a ruling in Association for Molecular Pathology et. al. v. Myriad Genetics, the outcome of which was considered crucial in the development of genetic research.

The Supreme Court, in ruling against Myriad, held that isolated human genes in and of themselves are not patentable. Separating the gene from its surrounding genetic material is not an act of invention as contemplated by the controlling statute. But the Court found that a synthetic version of the gene created in the lab could be protected by patent. It also hinted that the process employed to isolate the genes could perhaps be patented, though the genes themselves could not.”

Click here to go to the article.
 By Dennis McCarthy