May 2011

Fixing a hole

 

Improving the U.S. patent system. 

 

For an invention to be patentable, it must, along with being useful and nonobvious, be novel enough to differ from what is called “prior art.” Applying those definitions to laboratory discoveries has become one of the most challenging aspects in the patent field, dividing experts from industry, academia, government and law.

For scientists, patents complete the bench-to-bedside process by bridging the gap between basic research and industrial commercialization. Yet there is concern that patents on scientific discoveries impede research by instituting legal and procedural barriers that limit access to materials, thereby hindering experiments and preventing the advancement of knowledge. While a 2006 report from the National Research Council concluded that “access to patented inventions or information inputs into biomedical research rarely imposes a significant burden for biomedical researchers,” there are several examples that indicate otherwise.

Case in point

The Wisconsin Alumni Research Foundation holds patents on several of the initial human embryonic stem cell lines derived by University of Wisconsin researcher James Thompson in 1998 as well as certain techniques used in the derivation process of the cells. Researchers in the field protested that the patents imposed a significant administrative burden on their work, requiring them to file loads of paperwork just to use the cell lines or attempt to derive their own lines. The patents eventually were appealed on the basis of not differing enough from techniques used for the derivation of mouse embryonic stem cells that already were in the public domain. After a succession of court challenges, the WARF patents finally were overturned in May.

Defining what constitutes patentable material remains a challenge. Consider gene patenting: After the advent of cloning in the 1970s, the U.S. Supreme Court ruled in 1980 that products of genetic engineering were eligible to be patented, allowing groups to file patents for individual genes over the objections of researchers who argued that products of nature should not be patentable. This ruling went virtually unchallenged until last year, when a federal judge ruled in favor of a consortium of advocacy groups, scientists and patients looking to invalidate patents held by Myriad Genetics for two breast cancer genes. After the company appealed, the U.S. Department of Justice surprisingly filed a brief stating its support for the plaintiffs, a drastic change in policy that is encouraging for basic scientists.

Patents: not all bad

Patents do hold beneficial value. In addition to sparking creativity and protecting innovation, patents also represent a quantitative measure of intellectual capital. By this measure, the U.S. is far ahead of the rest of the world; it has been granted twice as many biology-related patents from the U.S. Patent and Trademark Office in 2008 as every other country combined. The U.S. also was awarded nearly 10 percent of patents granted by the European Patent Office in 2009, the same number as Germany, the most productive European Union country. A major source of American innovation has been universities, which have dramatically increased their filings since passage of the federal Bayh-Dole Act in 1980, which allowed academic institutions to claim intellectual property rights from work carried out on their premises using federal funding.

2011 budget update

The fiscal 2011 budget was finally passed by Congress in April, with approximately $38 billion in cuts made from the previous year. $260 million was cut from the NIH budget, $50 million from the facilities and maintenance budget, with the remaining cuts likely to be spread across the 27 institutes.  Sources indicate it is likely that extramural research will not be affected by these cuts. $53 million was cut from the NSF budget, $43 million from research-related programs and $10 million from educational programs.

Even acknowledging these advantages, the American system has its flaws, some of which finally are being addressed. The National Academies released a study last year that recommended updating the Bayh-Dole Act to promote sharing of technologies while de-emphasizing any potential financial gains from university-based intellectual property. Meanwhile, Congress is working to change the American patent system from a first-to-invent system to the first-to-file setup that is used by the rest of the world. The move theoretically will decrease costs and improve efficiency in the patent process by removing the need to prove priority of invention and streamline transnational patent filings. Across the Atlantic Ocean, the EU also is trying to remove barriers between countries, recently voting to create a unified patent that would cover all of its 27 constituent members, thereby removing the need for inventors to file patent applications with each individual country. As legislators and bureaucrats continue to refine and improve the patent system, scientists can turn their focus back to what they do best: science. 

Geoff HuntGeoffrey Hunt (ghunt@asbmb.org) is the ASBMB science policy fellow.


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