Patentable Biotechnology
Limitations on Patent Owners' Rights: Research and Experimental Use

Following its adoption by Parliament on June 22 2007, the new Patent Act entered into force on July 1 2008. In line with the EU Directive on the Protection of Biotechnological Inventions (98/44/EC), the new act includes fundamental provisions aimed at promoting and securing investments in the field of biotechnology by clearly defining what is patentable. This is part of a package of reforms that includes implementation of Switzerland’s international treaty obligations and separate pieces of legislation on the creation of a patent court and the regulation of the patent attorney profession. 

Patentable Biotechnology

In accordance with the EU directive, it is possible to patent neither the human body (at any stage of development) nor elements of the human body which have not been isolated or produced by a technical process. The new act extends this prohibition to include the embryo, regardless of the purpose of the patent (under the directive the non-patentability of the embryo is limited to industrial or commercial purposes). Under the new act, the human genome – the cornerstone in providing new avenues for advances in medicine and biotechnology – is non-patentable and thus accessible for research.

Elements of the human body produced by means of a technical process are patentable. Thus, sequences deriving from a naturally occurring sequence or partial sequence of a gene are patentable as inventions if they are produced by means of a technical process and their research function is disclosed in concrete terms.

However, the new act adopts an original approach regarding the scope of protection of such patents. In contrast to German, French and Italian law, wherein the patent protection for a gene or sequence of genes is limited to the specific product claims, the new Swiss act grants an absolute product claim, strictly limited to the necessary sequence of the gene performing the described function. This will allow the Patent Office to request all documentation and information necessary to determine which sequences are relevant to performing the described function and to withdraw those that are not relevant from the product claims.

Subject matter is excluded from patentability under the new act where its commercial exploitation would be contrary to public order or morality. Processes for cloning human beings and producing unmodified human embryonic stem cells fall into this category. 

Limitations on Patent Owners' Rights: Research and Experimental Use

The new act places limitations on the exclusive rights granted to the patent owner. One of the most important exemptions applies to the research and experimental use of a patented invention. The research exemption – previously an unwritten principle enforced in the Swiss courts – is now codified by the new act. All research aimed at gaining new knowledge on the subject matter of an invention (where the patented invention is the object of research) is possible without a licence. On the other hand, when the patented invention is the instrument of the research rather than its object, the researcher is obliged to obtain a licence. If negotiations between the patent owner and researcher fail, the latter may request a court to grant a non-exclusive licence to the patented invention. In this way a balance between the interests of the patent owner and those of the researcher is reached. For example, the polymerase chain reaction, a patented invention which enables researchers to produce millions of copies of a specific DNA sequence, will be accessible through a non-exclusive patent licence.

The new act also marks the introduction into Swiss law of the so-called ‘Bolar exemption’. The use of a patented invention to perform research and tests for preparing, filing and obtaining regulatory approval of a pharmaceutical product (eg, a generic drug) is now authorized. In such a scenario, clinical trials and production of specimens are possible, but the commercial production of the new generic drug can take place only after the patent has expired (unless the patent owner has previously authorized such use).

Compulsory non-exclusive licences may also be granted for diagnostic testing to remedy anti-competitive behaviour which would constitute a breach of the Cartel Act. This allows access to reliable diagnostic methods for diseases caused by specific gene sequences or single nucleotide polymorphisms and when the diagnostic method is based on a patented nucleotide sequence.

However, embryonic stem cells are now patentable once they have been modified, as are the procedures used to obtain them. Because of their plasticity and potentially unlimited capacity for self-renewal, embryonic stem-cell therapies have been proposed for regenerative medicine and tissue replacement after injury or disease. Their patentability for pharmaceutical and biotechnological firms is therefore extremely important.

For further information on this topic please contact Frédéric Serra or Roger Staub at Froriep Renggli by telephone (+41 44 386 6000) or by fax (+41 1 383 6050) or by email ([email protected] or [email protected]).