Biotechnology Patent Protection Act of 1993 : report (to accompany S. 298).
- United States Senate Committee on the Judiciary
- Date:
- [1993]
Licence: Public Domain Mark
Credit: Biotechnology Patent Protection Act of 1993 : report (to accompany S. 298). Source: Wellcome Collection.
15/24 (page 15)
![under current law for both product and process inventions, without cotermination. Thus, applicants have the option of either demonstrating the independent patentability of a process (as must be done under cur- rent law) or proceeding under the nonobviousness rule established by this legislation. Independent patentability may be dem- onstrated, for example, by showing the nonobviousness of the proc- ess (for example, through proof that the process demonstrates un- predictable results). Applicants who unsuccessfully attempt to demonstrate independ- ent patentability do not forfeit their right to amend their applica- tion to one that relies upon the rule established by this legislation. However, an applicant who so amends his application is required to have his process claims coterminate with his product claims. In such cases, patent term extension will continue to be available to er the term beyond the termination date otherwise estab- ished. Section 101 would simplify and provide certainty in the deter- mination of patentability of biotechnological processes using or making novel and nonobvious products, for applicants who comply with its requirements. This legislation would also make our oaent law consistent with the patent granting process now practiced in the European and Japanese Patent Offices. Under the law of these trading partners, process claims are granted automatically. Section 102. Presumption of validity Since an application may rely on the nonobviousness rule estab- lished in this legislation to expedite issuance of his or her process claims rather than risk the costs and delays involved in overcoming a Durden rejection, section 102 provides that there is no presump- tion that process claims are invalid if the product claims, which form the basis for invoking the nonobviousness rule, are invali- dated. This does not mean that such process claims will be treated as not obvious; rather the inventor must show that such a process is not obvious without relying on this legislation. Any litigation should provide the patentee with the opportunity to prove that the process claims are independently patentable. Section 103. Effective date The amendments made by this act are effective on the date of en- actment. The amendments apply to all patents granted on or after the date of enactment, all patent applications pending on the date of enactment, and all patent applications filed after the date of en- actment. Patent applications include applications for reissuance of a patent. TITLE II]. BIOTECHNOLOGICAL MATERIAL PATENTS Section 201. Infringement by importation, sale or use Section 201 would close the loophole that currently allows foreign exploitation of patented biotechnological material (through the un- fair use of such materials offshore tomake a commercial product) by amending section 271 of title 35, United States Code, to provide](https://iiif.wellcomecollection.org/image/b32230370_0015.jp2/full/800%2C/0/default.jpg)
