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For companies that want to capture their intellectual property and prevent forfeiture of their domestic patent rights, we now have clarity from the U.S. Court of Appeals for the Federal Circuit on how to establish patent priority. In February, in Medichem S.A. v. Rolabo S.L. , 437 F.3d 1157 (Fed. Cir. 2006), the Federal Circuit decided which of two companies to award a patent when both had filed interfering patent applications (i.e. both patent applications disclosed the same invention). In deciding this case, the Federal Circuit set forth general guidelines for creating a record (including inventors’ notebooks) sufficient to evidence patent priority. The U.S. patent system awards patents to inventors who are the first to invent, while foreign patent systems reward inventors who filed their applications first. In the United States, the first to invent is the inventor who first reduces an invention to practice, unless another inventor can show that he conceived of the invention first and exercised reasonable diligence in later reducing the invention to practice. Reduction to practice can either be constructive (i.e. fictional) or actual. Filing a patent application is equivalent to constructive reduction to practice. Actual reduction to practice is accomplished by constructing a working model or prototype of the invented product, carrying out the steps of the invented method or producing the composition of the invented material. Evidence of actual reduction to practice and inventive conception is of paramount significance in establishing priority of invention to obtain domestic patent rights. Such evidence is often necessary to establish patent priority to overcome relevant prior art or to prevail in an interference proceeding. An interference is a U.S. Patent and Trademark Office quasi-judicial proceeding between different parties who filed applications claiming substantially the same invention, to determine which party is the first inventor entitled to the patent. The need for such evidence is exactly why inventors should document their research and development. To prevail in an interference proceeding, the following conditions must be satisfied: The party constructed the claimed embodiment or performed the claimed process that met every element of the interference count; the embodiment or process functioned for the purpose intended; and sufficient evidence was provided to corroborate inventor testimony regarding the first two requirements. The question of patent priority relies on the evidence for its answer, and therefore it is imperative to understand how to create an appropriate record that tracks inventive acts. The issue of evidence sufficient to establish inventive acts arose in the Medichem case, in which Medichem and Rolabo each owned separate patents that claimed the process for making loratadine (the active ingredient in the allergy medication Claritin). Thus, the Medichem and Rolabo patents “interfered,” and the question of patent priority had to be determined. Because neither party relied on a date of conception, priority hinged on the first reduction to practice. Rolabo’s patent application had an earlier filing date than Medichem’s application, and hence Rolabo constructively reduced its invention to practice before Medichem. Medichem, however, claimed that it had actually reduced the invention to practice before Rolabo. The evidence before the court Medichem relied on its laboratory data and its inventors’ and one noninventor’s notebooks to prove actual reduction to practice, and hence priority of invention. The inventors and a noninventor recorded scientific data pertaining to the claimed invention in laboratory notebooks. (The noninventor was a former colleague of the inventors, although she did not contribute to the subject matter claimed in Medichem’s method patent for making loratadine.) Credibility and sufficiency of the evidence showing Medichem’s actual reduction to practice were at issue in the case. In reviewing the evidence in this case, the Federal Circuit set forth a general framework for evidence sufficient to demonstrate corroboration of actual reduction to practice. The court found that the dated laboratory data (nuclear magnetic resonance spectra data) showed that Medichem adequately corroborated reducing the disclosed chemical compound to practice. However, because the laboratory data were silent about the claimed process of making the compound, it alone did not corroborate that Medichem actually reduced the claimed process to practice. Additionally, the court held that because the inventors’ notebooks were not witnessed, they had minimal corroborative value for proving actual reduction to practice. The court provided further guidance on proving actual reduction to practice, stating that while an unwitnessed notebook is insufficient on the notebook’s own to support a claim for actual reduction to practice, an “actual over-the-shoulder observer” is not necessary. The court stated that “sufficient circumstantial evidence of an independent nature can satisfy the corroboration requirement” of actual reduction to practice. The court also considered the noninventor’s notebook, which was dated but was neither signed nor witnessed. Also, an inventor testified that she and the noninventor made entries in each other’s notebooks. The noninventor did not testify as to the genuineness of her notebook’s contents, thereby diminishing its corroborative value. Furthermore, the court questioned the credibility of the inventors as they had admitted to fraudulently backdating entries in notebooks. Therefore, the Federal Circuit held that Medichem’s evidence of actual reduction to practice was insufficient, and hence credited Rolabo with priority of invention. This case turned on the formalities of the inventors’ entries into laboratory notebooks. The outcome might have been different had the inventors made entries, which were properly dated and independently witnessed, in only their own notebooks and/or had the noninventor corroborated inventor entries in her notebook. This case provides an impetus for companies to institute a notebook-keeping procedure to establish inventive acts. Not only can a notebook-keeping procedure help establish priority of invention over an interfering patent, but it can also facilitate establishing a date of invention to overcome relevant prior art. The notebook-keeping procedure should satisfy the general guidelines that the Federal Circuit set forth in the Medichem case, to create an independent, accurate, and credible record of inventive acts.
INTELLECTUAL PROPERTY Counterfeits: Beyond the Knockoff FTC’s recent ruling in ‘Rambus.’ Cases decided since ‘Philips.’ Open-source software disputes. Emergence of Science Commons. Global patent-filing options. Keeping inventive-act records.

Standards for notebooks To ensure that these guidelines are satisfied, a notebook-keeping procedure should incorporate the following standards: Inventors should use bound notebooks (as opposed to notebooks with perforated pages). Inventors and noninventors should make entries in separate notebooks. Each page of the notebook (both front and back) should be numbered in the upper-right hand corner in permanent ink. All notebook entries should be written in permanent ink. All entries should be consecutively entered and in chronological order. Entries should begin on the first page and then be entered from left to right to fill the page. Lines or pages should not be skipped. There should be no writing in the margins. If a line is inadvertently skipped, then the inventor should draw a line across that line and initial and date it. To correct an entry, a line should be drawn through it and the correction should be initialed and dated. An inventor should sign and date each page of the notebook with permanent ink. One or more disinterested, informed noninventors should sign and date each page of the notebook with permanent ink. Once a page has been signed and dated, further information should not be inserted on that page. Information should not be erased from the notebooks. Pages should not be torn out of the notebooks. The inventor should indicate the last entry by writing “LAST ENTRY” and initial and date this. The entries should contain as much detail as possible-including experiments, observations and conclusions related to the invention (e.g., the method of making and using the invention, properties of the invention and possible applications of the invention.) Supplemental materials related to the invention (e.g., charts, photographs, computer-aided design drawings, etc.) should be explained; there should be a description of the material and its specific location in a supplemental appendix. One trusted person should maintain exclusive control of the notebooks for safekeeping purposes and allow only authorized access to them. Companies should institute and abide by these notebook-keeping procedural guidelines to evidence all inventive acts and avoid forfeiture of potentially valuable intellectual property. Ami D. Gadhia is an associate practicing in the intellectual property group of Ober

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