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Patent Intelligence Briefings

Pharmaceutical Patents

Supplementary Protection Certificates (SPCs)

Paediatric Extensions

Data & Marketing Exclusivity

Exclusivity vs. Patent Cover

Paediatric Use Marketing Authorisations

The Specific Mechanism

Patents, Trademarks, Copyrights

Product, Process & Formulation Patents

Key Patent Definitions



Singulair - Sigma Pharmaceuticals Plc vs Merck Sharpe & Dohme

Specific Mechanism – Ambiguity, Confusion and Conflict

Medeva and Georgetown - Combination Drugs and SPCs


<< Patent Intelligence Briefings / << Patent Application Progressions / Background to and Purpose of EU SPCs >>

Patent Enforcement

It is up to the patent holder to ensure that the patent is not infringed by third parties. The patenting authorities do not monitor for infringing acts. The extent to which patents can be upheld depends upon the local patent laws. For instance, in some countries compulsory licences are available. This means that if a third party requests a licence to use the patent, the patent holder (patentee) cannot refuse to grant the licence. For many years Canada had a compulsory licensing provision for pharmaceuticals so the originator did not get marketing exclusivity although licensees had to pay royalties to the originator.

Usually, if a patent holder sues a company for infringement, then the defendant in the case counter-sues that the patent is invalid in the first place. In many countries it is up to the alleged infringers to prove that they are not infringing the patent; this is known as burden of proof reversal.

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