Legal

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.

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.

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.

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.

When one company purchases another's branded trademarks as keyword search terms, the goal is to lure consumers to the buyer's site.

In cases that reached a verdict between 2002 and 2006, the branded pharma industry won six of six cases by verdict in Delaware, but lost six of eight in New Jersey, all by summary judgement. Despite what judges say, it's no coincidence.

Indeed, at this time, we are aware of no evidence that the practice of authorized generics has actually deterred any Paragraph IV certification or post-180 day generic entry, let alone a challenge to an invalid patent.

Scott Gottlieb called RFID implementation "disappointing." Now, FDA is moderating its view of RFID as a cure-all for the industry.

Criminal penalties for violating the Foreign Corrupt Practices Act can be substantial. Businesses found guilty may be fined upwards of $2.5 million for each offense, or twice the amount gained as a result of the violation.

Drug manufacturers should have policies against sexual harassment of sales reps. Such a policy may also help counter charges that a company is implicitly encouraging its reps to use their sexuality as a sales tool.