|
What questions are at issue in current discussions on PTO policy?
Patents and Human Genes
There has recently been considerable public discussion about the granting of patent rights to human genes. A misunderstanding of the patenting process has generated much of the discussion.
Patents may be granted for human-gene-based inventions if they meet all the standard criteria for a patent. Availability of patent protection for chemical compounds, such as proteins, polypeptides and nucleic acids (including genes), is critical to the success of modern biotechnology. Without strong and effective patent protection, commercial development of new treatments, diagnostic tools, pharmaceuticals and other products would not be possible.
Utility Needed for Patents to Be Granted
Recognizing the critical role of patents in the biotech industry, the PTO has recently issued guidelines concerning the amount of usefulness, or "utility," a prospective patent requires as well as the content of a patent's written description necessary to be awarded a patent. These guidelines allow DNA coding sequences to be patented when the specific function or characteristics of the sequences are described, while denying patents for uncharacterized nucleic acids.
Current Patent Policies
Congress is also keenly aware of the need for contemporary and effective patent policies. In November 1999, Congress amended the patent statute to provide early publication of U.S. applications-18 months after the filing date. This early publication process is similar to that found abroad and will help disseminate new biotech inventions to the public. Additionally, Congress has provided extensions of the patent term beyond 20 years from the filing date to compensate for delays caused by PTO inefficiency, interferences, secrecy orders or appeal processes (see "How long does a patent last?"). These patent-term extensions will greatly benefit the biotech patentee, who often loses valuable patent term due to such delays.
PTO Five-Year Strategic Plan
In June 2002, the PTO released a five-year strategic plan in the hope of increasing patent quality while decreasing patent pendency. To meet these goals, the PTO plans to implement an electronic application-filing system and revise the system of filing fees. The proposed fee system attempts to decrease the burden on PTO examiners by exerting increased fees on longer and more complex patent applications. Currently, the PTO is working with biotech industry leaders to develop a fair fee structure, one that does not place undue burden on high-tech industries, such as biotechnology, that submit more complex patent applications.
|
Printer Friendly YES
