PHARMACEUTICALS

The privilege of having a good number of innovative pharmaceutical laboratories in our client portfolio, and having been at their side for many years, has allowed us to obtain a solid experience and reputation in this field, and especially to ascertain exactly what are the needs of the players in this sector.

We are well aware of the changing regulatory environment of pharmaceutical laboratories and the challenges that confront them in a very competitive environment in which innovation and research have been relegated by cost control and ferocious competition. Our activity in this field extends to the times prior to the development of a drug, to the necessary steps to develop and market it, as well as to the problems presented by its marketing.

We have extensive recognized experience in the defence of the intellectual property rights of our clients, designing global strategies in which all legal and economic implications are taken into consideration and where one does not lose sight of the regulatory perspective. The integral defence of our clients' patent rights is not exhausted upon preventing the launch of violating products, but rather goes beyond that by providing a global advice in the area of protection, always in consideration of the particularities of each case.

Furthermore, we provide pharmaceutical laboratories with all the advice they require for the carrying out of their normal activity. We work hand in hand with the client in all of the procedings, simultaneous with and subsequent to the steps in the marketing of their drugs. This advice covers, as is logical, the matters related to the promotion thereof.

We provide advice on aspects such as:

  • Legal schemes for laboratories and manufacturers of pharmaceutical active ingredients.
  • Collaboration agreements for drug development.
  • Legal issues surrounding clinical trials.
  • Obtaining authorizations for marketing, setting price and protection of clinical data.
  • Transfers of marketing authorizations and pharmaceutical registrations.
  • Preventative and pre-litigious advice on pharmaceutical patents (including complementary protection certificates).
  • Advice on pharmaceutical patent litigation, both with regard to violations and validities, including the preliminary defence of the right.
  • Advice on pre-marketing, post-launch and acquisition and sale agreements in respect of pharmaceutical assets.
  • Advice on the promotion of medications and compliance with sector codes of conduct (both regarding promotion aimed at the general public as well as that aimed at specialized healthcare personnel).
  • Data protection in the pharmaceutical sector.
  • The legal and contractual framework for post-authorization studies.
  • The regulation of medical innovations.
  • Pharmaceutical trademarks and judicial defences thereof.
  • Obligations concerning drug surveillance.
  • Issues related to the supply and procurement of drugs and on parallel trade.
  • Civil liability for defective drugs.
  • Specific regulation of certain drugs (orphan drugs, advanced therapy drugs, etc.).
  • Public contracting of drugs and measures of cost control.
  • Legal issues regarding repackaging and relabeling of drugs.
  • Tax deductions for R+D+i.
  • Legal actions before competition authorities.
DISTINCTIONS

europe firm

 

 

 

"They are extremely well organised, responsive and really to the point. They have a great combination of economic understanding and legal profundity".

The firm has "a very large team that is very good for patent litigation"

The Chambers Europe 2017. Life Sciences

 

chambers partners

"The team provides valuable technical knowledge and precision in problem solving. Excellent response to urgent matters."
The Chambers Europe 2015. Life Sciences

 

legal500logo

Gómez-Acebo & Pombo Abogados is highly regarded in the healthcare and life sciences sector, primarily thanks to its rounded IP expertise.

The Legal 500 2015. Healthcare and life sciences

 

chambers partners

"The lawyers know our sector and our company extremely well an their work is great".
"The team has great technical ability; it has a good relationship with the client and understands the reality the client is facing".
The Chambers Europe 2014. Life Sciences

 

iam1000

Gómez-Acebo & Pombo deftly juggles a high-profile international caseload with an active domestic practice. Its in-depth industry knowledge and technical excellence draw in the biggest worldwide companies, winning instructions on the most complex issues.

IAM Patent 1000 2013

 

iam1000

Its fusion of in-depth industry knowledge and technical excellence ensures repeat mandates from leading pharmaceutical developers, telecommunications companies and universities.

IAM Patent 1000 2012