Brits go Bolar, with some helpful guidelines

"Changes to the patents research exceptions" is the title of a media release issued by the UK Intellectual Property Office which has some cheery news for researchers who lose sleep over the prospect of their laboratory work leading them into the uncomfortable position of being defendants in patent infringement proceedings.   The good news reads thus:

Guidance on changes to patent law made by the Legislative Reform (Patents) Order 2014 which will come into force on 1 October 2014.

The Legislative Reform (Patents) Order 2014 No.1997 was approved by Parliament in July 2014 and will come into force on 1 October 2014. The Order clarifies that activities relating to medicinal product assessments are within scope of the experimental use exception (also known as the research exception).

The changes will allow companies to use a patented product, when carrying out medicinal product assessments, either to provide information to the regulatory authorities or for health technology assessment.

The changes meet a government commitment to ensure the IP system supports the life sciences sector.

Changes to patent law

The Legislative Reform (Patents) Order introduces changes to the Patents Act which clarifies that medicinal product assessments are exempt from patent infringement by virtue of the existing research exception.

Supporting information

Further information can be found in our guide.on changes to patents legislation made by the Legislative Reform (Patents) Order 2014.

The guide contains, inter alia, the following information:

Is work done to obtain approval for a drug abroad covered by the change? 
Yes. If the purpose of the work is medicinal product assessment, as defined in the Order, it is within scope of the amendment.  

Which activities are covered by the new exception?
Although the exact scope of the new exception to infringement will be a decision for the Courts [this is an important caveat], the following activities are considered to be in its scope:
• Activities carried out to provide data on new medicines to UK or non-UK regulatory
authorities.
• Activities carried out to provide data on new medicines to UK or non-UK bodies carrying out health technology assessments.
• Post approval studies to comply with UK or non-UK regulatory requirements.
• Activities carried out to amend a UK or non-UK authorisation for a medicine.
• Activities done to obtain a UK or non-UK authorisation for a new indication of an existing drug.
• Any tests or studies required by UK or non-UK regulatory bodies.
• Activities carried out for the purposes of obtaining full authorisation in the EU of a generic drug or biosimilar i.e. where the abridged procedure exempted by section 60(5)(i) of the Patents Act (the "Bolar exception" is not used).
• Activities related to health technology assessment of a generic or biosimilar product.
• Activities carried out to provide data for obtaining regulatory approval outside of the EU for a generic or biosimilar product.  

Does the amendment cover commercial use of a patented drug in a product?
The new provisions do not extend to commercial activities, such as sale, commercial supply, or manufacture in preparation for sale or supply. A licence, or other agreement, will be required from the patent holder before a product can be sold or supplied commercially. 

Does the amendment cover the use of a patented medicine as a comparator?
Yes. The use of a patented medicine as a comparator in a medicinal product assessment, as defined in the Order, is covered by the amendment. 

Are combination products covered by the amendment?
Medicinal product assessments on a combination are within the scope of the new provision. This includes instances where a patented drug is part of the combination.  

Can I supply a patented drug to a person for use in a medicinal product assessment without a licence from the patent owner? 
Sections 60(2) and (6) of the Patents Act 1977 have not been amended. The consent of the patent owner would be needed to supply a patented drug to a person for use in a medicinal product assessment.

Bolar CJEU reference: Poles say no, Germans say yes

Paul England

Via Paul England (Taylor Wessing LLP) comes news that the Düsseldorf Court of Appeal, Germany, has referred some questions to the Court of Justice of the European Union (CJEU) for a preliminary ruling as to whether and, if so, under what conditions, the supply of patent-protected substances by a third party to a generic company, which intends to use the substance for obtaining a marketing authorization, is covered by the Bolar exemption. Paul explains:

While it is undisputed that generics themselves are allowed to manufacture the patent protected substance for marketing authorization purposes under the Bolar exemption, it was unclear whether active pharmaceutical ingredient (API) suppliers may sell a protected substance to generics for Bolar purposes. The question is crucial for the API suppliers and the generic industry in Europe. If a supply in the development phase is not possible under the Bolar exemption, European API suppliers will be forced out of Europe and the supply sources for generic companies and their ability to enter the market immediately after patent expiry will be seriously limited. The objectives of the Bolar exemption to strengthen the generic industry in Europe and allow immediate market entry of generic products after patent expiry would be at risk.

Cases

Decision of the Polish courts

The Polish Supreme Court recently confirmed decisions of its lower instance courts and decided that third party supply is not covered by the Polish implementation of the Bolar exemption. The Court also refused to refer the case to the CJEU.

Decision of the German courts

The district court Düsseldorf decided that such a third party supply is only exempted by the Bolar provision under very restrictive conditions, namely if the supplier is co-organiser of the tests and studies carried out by its customer and allowed under the Bolar exemption. The district court of Düsseldorf refused to refer the question of third party supply to the CJEU.

The Düsseldorf Court of Appeal has now disagreed with the first instance decision and referred the question to the CJEU. According to the Düsseldorf Court of Appeal, third party supply shall be allowed under certain conditions, namely if the supply is aimed at the privileged purposes.

Paul promises that Taylor Wessing will report further details of this reference as they are made public.