C’est clair et net, as a French friend of mine used to say, punctuating the phrase with clarinette (French humour—don’t ask): there is immense interest in combination products. The first BIOMEDevice Europe event, co-located with Pharmapack in Paris at the beginning of the week, was tremendously successful. The show floor at the Grande Halle de la Villette was packed—attendance for the co-located events shattered last year’s numbers—and so were the conferences. I attended many of the BIOMEDevice sessions. Over the next couple of days, I will pass along some of the highlights in medtechinsider. Here is a summary of a session devoted to IP related issues.
The convergence of the medical device, biotechnology and pharmaceutical industries raises some novel issues when it comes to intellectual property (IP), noted Noel Akers at a session on Monday morning. Protecting your IP may require finding a harmonious solution to the historically dissonant drug and device regimens.
It’s no simple matter to protect the innovative aspects of a product that combines a medical device with an active ingredient, according to Akers, founder of N. J. Akers & Co. and a patent and trademark attorney admitted to practice in the United Kingdom and Europe. One of the complicating factors involves methodology.
Patent laws allow for IP protection of medical devices but not necessarily the method by which they are used, Akers told attendees. In fact, “methods of treatment are specifically excluded under European patent laws.” This area of law, however, is under constant scrutiny in the courts. One example involves drug dosage regimes.
Until fairly recently, the consensus opinion in the courts was that drug dosage is a method of treatment and could not receive IP protection. “But attitudes have changed in the last couple of years, and [this concept] is being appealed at the European level,” he said. “A door has opened in the last couple of years. The law is having to adapt as technologies evolve.”Norbert Sparrow