Unión Europea
Estados Unidos de América
Observancia de los derechos de propiedad intelectual
3. Given the fact that the quality of the United States Patent and Trademark Office’s examination procedures is compromised by scarce resources and large volumes of patent applications, and that there is no provision for independent re examination of a patent, a United States patent may issue without undergoing a rigorous examination to ensure validity. Nevertheless, any patent issued by the Patent Office is entitled to a presumption of validity in any subsequent enforcement action, and invalidity must be shown by "clear and convincing" evidence. Please explain how applying the presumption of validity and a high evidentiary standard in these circumstances complies with the requirement of Article 41.2 of the TRIPS Agreement that procedures concerning the enforcement of intellectual property rights shall be "fair and equitable".
The European Communities' question is again based not upon facts, but upon unsupported assertions. All United States patents are subjected to a rigorous, comprehensive examination prior to issuance. There is no basis for the suggestion that patents in the United States are not entitled to the presumption of validity provided by 35 U.S.C. 282. The legal presumption of validity of patents has been part of US patent statute since 1 January 1953, when the preceding judicial doctrine was codified. The purpose of the presumption of validity is to place the burden of proof on the party asserting invalidity of a patent, rather than requiring patentees to provide evidence demonstrating the validity of their patents in every enforcement action, which is difficult, time-consuming and unnecessary. The presumption of validity is a sensible approach shared by many countries that provides for substantive examination of patents. The presumption also ensures that a patentee has notice of a defendant's intention to challenge the patent, prior to trial. It should go without saying that providing a legal presumption of validity for patents can only serve to lessen the complexity of patent litigation. The concern expressed by the delegation of the European Communities over the "clear and convincing evidence" standard is likewise misplaced. This standard lies between the legal standards of "preponderance of the evidence" and "beyond a reasonable doubt". It recognizes that the patent has already been subjected to a rigorous search and examination before the US Patent and Trademark Office. While higher than the "preponderance of the evidence" standard, the standard does not prejudice the accused infringer. Once a prima facie case of invalidity is presented by the party challenging a patent's validity, the patent owner must come forward with evidence to counter that showing. If the fact-finder concludes that the prima facie case is established and not overcome by the patent owner, the patent, or the particular claims challenged, will be declared invalid by the court. Finally, while patents are by law presumed valid, courts given evidence challenging validity never find that a patent is "valid". They find either that the patent is "invalid", or "not invalid". The latter finding allows subsequent defendants to contest the validity of the patent. On the other hand, once a court holds a patent (or more properly, specific claims in the patent) to be invalid, those claims cannot thereafter serve as the basis of a challenge against other parties. We believe that this balance of rights between patentee and potential defendants is fully consistent with Article 41.2 of the TRIPS Agreement.