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Reference drug patent infringement: can new law stop generic drug approval?

Reference drug patent infringement: can new law stop generic drug approval?

Last month Portuguese lawmakers enacted new measures to protect the intellectual property (IP) rights of reference drug manufacturers: Law No. 62/2011, of 12 December (hereinafter, the “New Law”), institutes compulsory arbitration for drug patent and supplementary protection certificate issues.

How will this work in practice?

The National Authority of Medicines and Health Products (INFARMED) is the Government regulatory agency responsible for approving the introduction for sale, in the Portuguese market, of all drugs for human consumption.

Under the New Law, 15 days (as a general rule) after submission, the following relevant information pertaining to a generic drug application is disclosed on INFARMED’s website: applicant’s name; date of application; substance, dosage and route of administration of the drug; identification of the reference drug.

Any legitimate party who wishes to uphold his or her IP rights, on the grounds of patent infringement ­ or violation of a supplementary protection certificate, pursuant to Regulation (EC) No. 469/2009 of the European Parliament and of the Council, of 6 May – by the generic drug application, must do so within the next 30 days, through compulsory arbitration proceedings brought against the applicant, either via institutionalised arbitration or at ad hoc tribunals.

Failure by the applicant/defendant to respond, no later than 30 days from service of the motion, entails the immediate suspension of the industrial and commercial use of the applicant’s generic drug, for the duration of the plaintiff ‘s invoked IP rights, and irrespective of their existence, validity or actual infringement.

If, however, the applicant/defendant does respond in a timely fashion, the arbitration tribunal shall conduct the evidentiary hearing within 60 days. The arbitration award is subject to review by the geographically competent Appeals Court.

These relatively speedy proceedings are further governed by the rules of an arbitration centre chosen by agreement between both parties, or, lacking thereof, by the general framework on voluntary arbitration. (Coincidentally, Law No. 63/2011, of 14 December, published just two days after the New Law, but entering into force only on 14 March 2012, revised this framework.)

The new disclosure rules apply to all ongoing procedures pending approval by INFARMED. In other words, in cases where the drugs under assessment are generic in nature, the abovementioned information on the respective applications shall likewise be released online, no later than 30 days from the date of coming into force of the New Law (i.e., the deadline was 16 January 2012).

Similarly, interested parties may, in 30 days from such disclosure, defend their IP rights in accordance with the aforesaid arbitration procedure.

A question arises: does the New Law allow for the suspension mechanism and/or for arbitration awards favourable to plaintiffs to have a negatory effect on the approval procedure of a generic drug undergoing at INFARMED?

The answer is no. The New Law also establishes that INFARMED’s required approval for the introduction and sale of drugs is an administrative procedure designed solely to ensure the quality, safety and effectiveness of drugs, with the exclusion of issues concerning IP rights.

In essence, the outcome of the arbitration proceedings and the INFARMED approval procedure are mutually non-exclusive and non-binding.

A reference drug manufacturer may prevent a generic drug company from selling its products, but may not ipso facto stop it from obtaining regulatory approvals from INFARMED.

The IP and the pharmaceutical regulatory realms are indeed separate. Only time will tell whether this attempt at balancing the IP rights of reference drug companies and the interests of generic drug consumers is a move in the right direction.

 

Armando Isaac

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