Khader: Does patenting research change the culture of science?

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The Author Feroz Ali Khader is an advocate and the author of the book 'The Touchstone Effect: The Impact of Pre-grant Opposition on Patents.' In this piece in The Hindu he looks into the new IP bill in India in the lines of the US Bayh-Dole Act. As per Khader the Bill titled 'The Protection and Utilisation of Public Funded Intellectual Property Bill, 2008' has already seen its share of brickbats for blindly emulating the Bayh-Dole Act when the conditions of basic research in India do not warrant such imitation and that too without some of the measures for protecting public interest contained in the US Act.

 

Does patenting research change the culture of science?

 

The Bayh-Dole Act does not encourage sharing of results

The 'experimental use' of patented invention is solely for amusement

 

"Dr. Georges Kohler, Nobel laureate and co-inventor of the hybridoma technique, did not care much about patents. As a result, the hybridoma technique -- a technique for developing monoclonal antibodies of exceptional purity and specificity that are able to recognise and bind a specific antigen -- remained in the public domain. This paved the road for using it in numerous diagnostic tools to test for cancer and AIDS.

Unlike the hybridoma technique, the native and recombinant forms of Taq DNA polymerase (Taq), an important tool used commonly in DNA sequencing, is protected by patents held by Hoffman-La Roche. In 1995, the Taq patents became the cause for a legal action against more than 40 U.S. universities and research institutes and hundreds of individual scientists. Roche's cause of grievance pertained to the purchase of Taq by scientists for use from an unauthorised source.

Biomedical research in the U.S. underwent a major change in 1980. The U.S. Congress passed the Bayh-Dole Act which encouraged universities and other institutions to patent discoveries arising from federally supported research and permitted the transfer of these technologies to the private sector. Patent filings increased manifold. But the new law also changed the culture of science.

Before the Act was passed, much of biomedical research followed a shared approach. Researchers were free to use research results as they were all in the public domain. Federal funded research discoveries remained unpatented and formed the foundation for many applied (downstream) research. Drug companies used them for developing cures. The Act, however, changed it. Results were kept secretive.

The Bayh-Dole Act encouraged private participation in basic research, allowed the patenting of basic research, and permitted licensing of the research to private hands for exclusive commercialisation. Even after nearly three decades of its existence, the effect of the Bayh-Dole Act remains controversial.

The Indian Government is presently deliberating on a new IP bill in the lines of the US Bayh-Dole Act. The Bill titled 'The Protection and Utilisation of Public Funded Intellectual Property Bill, 2008' has already seen its share of brickbats for blindly emulating the Bayh-Dole Act when the conditions of basic research in India do not warrant such imitation and that too without some of the measures for protecting public interest contained in the US Act.

The Bill would certainly qualify for an untimely piece of legislation though proposed with the laudable objective of allowing universities to patent and commercialise public funded research. One significant impact of the Bill is strangely not be seen or noticed within the provisions of the Bill. If the Bill is enacted it would severely undermine the 'experimental use' exception which grants immunity to universities and research institutions which are involved in research from patent infringement actions.

Section 47(3) of the Patents Act, 1970 provides exemption from infringement liability when the use of a patented invention is for research or experimental use which includes imparting instructions to pupils.

The US patent law also acknowledges the 'experimental use' exception but the new role of universities as profit-making organisation introduced by the Bayh-Dole Act has significantly weakened the immunity enjoyed by universities.

Since the Bayh-Dole Act came into force the number of US universities involved in patent infringement suits rose drastically. Many universities, such as University of California, University of Minnesota, Emory University, Columbia University, Harvard University, Cornell University, and MIT have been parties to infringement suits.

In Madey v Duke University (2002), the Court of Appeals for the Federal Circuit rejected the 'experimental use' defence taken by Duke University.

It narrowed the research defence to exclude any unauthorised use of intellectual property in the course of university research, particularly when university research and development efforts were targeted at the commercialisation of new biomedical research tools.

The Court held that experimental use defence will apply only if the use of the patented invention is solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry. The Court refused to entertain the defence if the use was in furtherance of the alleged infringer's legitimate business.

Deterring discovery

Many legal experts are of the view that narrowing down the experimental use exception to mean research for 'amusement' and 'philosophical inquiry' will deter scientific discovery.

Scientists and researchers who use patented research tools without authorisation will now do so at the risk of being made parties to future litigation.

And clearing the way will involve licensing patented research tools which will further add to the transaction cost of conducting research.

Commercial exploitation and 'experimental use' immunity do not go together. Universities and research institutes will have to choose between the two. By allowing universities to patent and commercialise their research, the proposed Bill will expose the universities to the rigmarole of patent litigation, either to enforce their patents or to defend themselves against charges of infringement.

Universities will pay a heavy price the day they are prevented from pursuing a line of research for the fear of infringing patents. Developing economies cannot afford to give up or even dilute the 'experimental use' exception enjoyed by its universities.

Ideally, the move to commercialise university research must have come after removing all the barriers that hinder research and restrict its produce. Till such time, the temptation of putting the horse before the cart must be resisted."

About this Entry

This page contains a single entry by Shashwat Purohit published on March 20, 2009 6:25 AM.

EXPERT VIEWS: Prof. Karen Hersey on "Royalty Sharing: A Matter of Law or a Matter of Policy" was the previous entry in this blog.

Afro- IP: Database on African Theses and Dissertation (DATAD) programme is the next entry in this blog.

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