Articles for the ‘General’ Category

Legal Digest: Patent Disputes in Life Sciences (November 2023)

Published 16 November 2023 by Boris Malakhov Lidings, Russia

Global pharmaceutical industry has become the field for serious patent-related battles between producers of original drugs and manufacturers of generics.

Particularly this trend is widely observed in EAEU and CIS, where the regulatory bodies and courts have not yet developed an efficient mechanism for maintaining the balance of interests between the pharmaceutical businesses, state and patients.

Having vast expertise in providing legal protection to large Russian and international pharmaceuticals and healthcare companies in EAEU and CIS, Lidings publishes Legal Digest highlighting the most notable patents disputes in Life Sciences that have been recently taking place in those jurisdictions.

... Read more

The Return of a Compliance Classic: Hospitality for Healthcare Professionals – What is currently to be observed?

Published 14 November 2023 by Dr. Oliver Stöckel SKW Schwarz, Germany

During the Covid 19 pandemic, a healthcare compliance “classic” has largely faded into the background: The permissibility of hospitality for healthcare professionals by representatives of the pharmaceutical and medical device industries. After the end of the pandemic, however, face-to-face meetings are coming back to life. And so it is not surprising that the question now also arises again as to whether and to what extent physicians, dentists, pharmacists, nurses, practice staff and other healthcare professionals (“HCPs” for short) may actually be invited to lunch or dinner. Some changes have happened recently, particularly with regard to value limits – including new versions for important codes.

... Read more

Healthcare Compliance Whitepaper

Published 13 November 2023 by Dr. Oliver Stöckel SKW Schwarz, Germany

In the ever-evolving world of medical device manufacturing, companies face the difficult task of ensuring innovation and progress every day. However, the pressure to use the latest technologies in healthcare is often in conflict with limited financial resources. In this complex environment, legal problems and risks often arise that can have a direct impact on pharmaceutical and medical device companies, hospitals and healthcare professionals. Pragmatic and safe legal solutions are required to resolve these issues.

We would like to offer you the opportunity to take advantage of our exclusive and free white paper on healthcare compliance.

... Read more

Case No C-473/22: Upcoming CJEU decision will regulate national liability regimes in PI proceedings

Published 26 October 2023 by Ben Rapinoja Borenius Attorneys Ltd, Finland

The Advocate General recently gave its opinion in the case No C-473/22 between Mylan AB (“Mylan”) and Gilead Sciences Finland Oy, Gilead Biopharmaceutics Ireland UC and Gilead Sciences Inc (“Gilead”).

The referral was made by the Finnish Market Court in proceedings concerning a claim for damages resulting from an unfounded preliminary injunction (“PI”) issued against Mylan. Under the Finnish system, the liability for such damages is deemed “strict”. In other words, the party that has enforced an unfounded PI is liable for any damages shown irrespective of other circumstances such as the level of care it has taken when evaluating the likelihood of infringement.

The case holds implications for all jurisdictions in the EU in which the same or similar strict liability regime is adopted into national law.

... Read more

Bolar Provision in Ukraine: Update Required

Published 29 September 2023 by Julia Semeniy Asters, Ukraine

The so-called Bolar provision is generally understood as the rule allowing generic and biosimilar manufacturers to get prepared for launching a drug by the time the relevant patent expires, thereby offering broader options to patients as early as possible.

... Read more