Invalidating a european patent
An IPR, the most common procedure, may only be instituted on the basis of lack of novelty or obviousness in view of earlier patents or printed publications.Unlike IPR, PGR has a limited window of availability and applies only to newer patents. were invalidated; by comparison, 31 percent of patents in Europe were invalidated in 2015, according to data from the research database Docket Navigator and the European Patent Office annual report.Under the new "first-to-file" rule, an IPR may be filed any time after nine months have passed since the patent's issuance or after any and all PGRs pertaining to that patent have concluded, whichever comes later.Numerous changes to IPR, PGR and CBM procedures are currently under consideration.Many appear outcome-neutral: They ostensibly would not favor one side. Supreme Court is set to hear arguments this term regarding the latter change in , to determine the appropriate breadth given to patent claims considered during post-grant proceedings. Regardless of whether reforms are enacted, a number of factors suggest that a decline in the invalidation rate is inevitable and imminent.
If it is possible for the skilled person to discover the composition or the internal structure of a product and to reproduce it without undue burden, then both the product and its composition or internal structure become state of the art …. Accordingly, do not act upon this information without seeking counsel from a licensed attorney.
Pharmaceutical inventions usually require human clinical testing in order to obtain regulatory approval to market the new product. patent law provides that a “public use” of the invention within the U. can constitute prior art, a clinical trial often does not qualify as prior art, either because it was not “public” (e.g., it was conducted under confidentiality) or it qualifies as an “experimental use.” Practitioners familiar with European patent law know that the EPO takes a stricter view of prior art than the U. in many ways, applying an absolute novelty standard with no grace period. The Importance of Confidentiality and Control over Clinical Trials Although these issues are decided on a fact-specific, case-by-case basis, this case underscores the general importance of confidentiality and control over clinical trials.
Often a patent application is filed before the invention undergoes human testing, but sometimes a human clinical trial may be started—or even completed—first. Still, a recent decision by the EPO Technical Board of Appeal (T0007/07) finding that a human clinical trial constituted invalidating prior art is striking. court also rejected arguments that the clinical trial was not an experimental use, crediting testimony that the clinical trial results were necessary to determine whether the invention would work in a U. Pharmaceutical companies preparing to launch clinical trials could do well to seek the advice of patent counsel to ensure that appropriate guidelines and safeguards are in place to preserve their patent rights.
The Patent At Issue The patent at issue was EP 1 214 076, granted to Bayer Pharma Aktiengesellschaft and directed to an oral contraceptive (Yasmin®): A pharmaceutical composition in an oral dosage form comprising, as a first active agent drospirenone in an amount corresponding to a daily dosage, on administration of the composition, of from about 2 mg to 4 mg, and as a second active agent, ethinylestradiol in an amount corresponding to a daily dosage of from about 0.01 mg to 0.05 mg, together with one or more pharmaceutically acceptable carriers or excipients, wherein said drospirenone is in micronized form. The Clinical Trial A clinical trial of the claimed product was conducted in the U. between December 1996 and July 1998, well before the patent application was filed. court rejected arguments that the clinical trial constituted a public use, giving weight to the confidentiality obligations of the principal investigators, and to the fact that the invention—the use of micronized drospirenone—was not disclosed to the patients. This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only.
The following factors appear to be relevant to the EPO Technical Board decision: EPO Legal Principles The EPO Technical Board cited the following legal principles: [I]f a single member of the public, who is not under an obligation to maintain secrecy, has the theoretical possibility to access particular information, this information is considered as being available to the public within the meaning of Article 54(2) EPC. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice.