Legal

Determining a company’s acquisition/merger value requires an intensive due diligence process. Attorney Gregg Metzger discusses salesforce contracts which, especially for life science companies, cannot be overlooked.

The looming shift to cross-border compliance in Europe puts the spotlight on the evolving role of chief compliance officers.

Inter Partes Review can potentially offer a more economical and streamlined litigation strategy for pharma and biotech players, writes David Dalke.

Long before a deal is signed in ink, a company's compliance and legal team should be involved in the vetting process, writes Severin Wirz.

As the pacing picks up around dealmaking as the alternative to organic growth, Pharm Exec brings together experts from big Pharma and biotech to dissect the road ahead for M&A, licensing, and partnership activity.

Europe follows the United States with a harsh new spotlight on agreements that slow generic entry for medicines losing exclusivity.

As small biotech firms test the water in partnerships with Big Pharma, the best calling card is a well-framed strategy on intellectual property.

Caronia decision shows the staying power of Sorrell v. IMS Health.

Courts across the country are making it easier to prove that a drug is unsafe, warning label notwithstanding.

Compliance officers have risen into management's highest ranks, by choice in some organizations, and by government decree in others. Either way, their importance as a strategic partner can hardly be understated.

With the costs of data storage poised to increase, pharmaceutical companies need to break their pack rat mentality with respect to data, writes Lorrie Luellig.

IP must adapt to new ways of extracting value from assets the industry never knew it had, writes William Looney.

Pharmaceutical trade dres is an effective marketing tool that helps boost product recognition for consumers. It's worth protecting.

State tech transfer laws giving universities automatic ownership of employees' inventions represent a threat to pharma partnerships-but the Supreme Court is poised to intervene in the industry's favor.

Time to stop and think about CMS's 'Proposed Rule' on transparency and what it means for the life sciences business model.

Pharma must coordinate the efforts of medical, legal, HR, global partners and many other players in the regulatory compliance space to keep itself afloat in choppy seas.

When faced with legislative scrutiny, be prepared, be truthful, and don't be afraid to say 'I don't know'...

To what extent are generics companies obligated by law to request labeling changes with FDA?

The Federal Circuit court continues its trend in tightening the standards for establishing patent damages by leapfrogging a stalled legislative process

Stepped-up enforcement of the Foreign Corrupt Practices Act requires enhanced global coordination of compliance

If companies aren't careful with their marketing spend, they could, in fact, wind up getting too much bang for their buck

A recent Supreme Court decision leaves open the debate on patent eligibility requirements.

The final part in our series on how to draft enforceable post-employment restriction agreements that will protect trade secrets and customer goodwill.

Courts are often hesitant to enforce such restrictions, so employers should take certain steps prior to and in the process of filing such a lawsuit.

How to draft enforceable post-employment restriction agreements that will protect trade secrets and customer goodwill.

A little-known provision in a new law rewards employees for blowing the whistle on tax fraud. Pharma should examine its tricky tax situation-and work out the issues on a global level.

The State of Arkansas filed suit against Risperdal manufacturer Johnson & Johnson, claiming promotion of the drug for nonmedical uses has led to increased prescriptions being written and bigger payouts by Medicaid.

If it looks too good to be true.... The price is unbeatable, the Web site proudly displays an accreditation seal of approval, medicines are advertised as "generics" of the branded versions (implying bioequivalence with respect to safety and efficacy), and patients never have to leave their homes. Marcia Bergeron, a 57-year-old Canadian resident likely had these things in mind when she purchased antianxiety and sedative medication from an online pharmacy. The pills she received from the Web site, however, caused hair loss and vision problems, and ultimately resulted in her death. The coroner's toxicology report showed that the pills she purchased online were laced with traces of dangerous metals, including uranium, strontium, selenium, aluminum, and arsenic. Bergeron, like many others around the world, was a victim of the counterfeit-medicine business, an industry that the US-based Center for Medicine in the Public Interest (CMPI) predicts will reach $75 billion in sales globally by 2010.

Compliance requires overcoming cultural barriers. To start with, in some countries the taboo against bribery is not as strong as it is here.

Documents from R&D, clinical affairs, regulatory, and sales and marketing can be in the millions. Throw electronic information into the mix, and the number of documents required for litigation increases exponentially.