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The importance of keeping research records

aa25-dec-jan-2007-08-the-importance-of-keeping-research-recordsIn the spring of 1997, Alberto Stampa filed a US provisional patent application claiming a process for making loratadine, the active ingredient in the allergy medication Claritin®. A director and co-founder of the pharmaceutical company Medichem, Stampa knew that a strong intellectual property portfolio was pivotal to the growth of his company.
Unbeknown to Stampa, another Spanish pharmaceutical company, Rolabo S.L., had already filed a patent application claiming the same chemical process, some three months earlier.
In most countries, Rolabo S.L. would have a right to a patent for the invention as they were the first to file a patent application (this is usually referred to as a “first to file” system). In the United States, however, the situation is not as clear cut.
Under US practice, if two or more patent applications are filed for the same invention, the patent will be granted to the application with the earliest date of invention. If the date of invention is in dispute, the patent will typically be awarded to the inventor who can show that they were the first to conceive the invention and reduce it to practice.
Proof of conception and reduction to practice must be in the form of documentary evidence, preferably as a laboratory notebook. It is vital, however, that inventors ensure that their laboratory notebooks meet the stringent US requirements for conception and reduction to practice.
Conception” takes place when the inventor has a definite and permanent idea of the complete and operable invention, but has not made a working model. To prove conception, the inventor should provide in the notebook a complete written description of the invention, including drawings (if applicable), ensuring that all aspects covered by the invention are recited. The inventor should also provide a description envisaging how the invention will be put into effect. Entries made in a laboratory workbook should be witnessed and the witness should state that they understood the conception of the invention.
Reduction to practice
Reduction to practice” is taken when a working model of the invention is made and shown to work. The invention need not reach the stage of perfection required for commercial exploitation. However, the inventor must be able to show that the invention does operate, even if poorly, in its intended functional setting. Preferably, the reduction to practice of an invention should be either directly observed by a witness, or a witness should independently reproduce the results.
Where there is a lack of corroborative evidence to substantiate a claim of actual reduction to practice, reduction to practice of an invention is deemed to have occurred when a patent application is filed.
The dispute between Stampa and Rolabo S.L. came to a head before the United States Court of Appeal for the Federal Circuit. During the proceedings, Stampa submitted several documents in support of his claim to the earlier date of invention; namely that he was in possession of the claimed process for making loratadine before the filing date of Rolabo’s application. The documents submitted included NMR data and inventors’ notebooks.
While the Court of Appeal acknowledged that the NMR data showed that Stampa was in possession of the compound loratadine before Rolabo, the notebooks provided no evidence whatsoever that the compound was manufactured by the claimed process. The Court of Appeal also held that the laboratory notebooks had minimal corroborative value because they had not been witnessed! As a result, the Court of Appeal found that Rolabo S.L. had the earlier date of invention and thus retained the right to the patent for this invention.
The Stampa case clearly shows that in the event a laboratory notebook cannot be used as corroborative evidence, the date of the invention may be shifted to the date of filing of the US patent application.
A laboratory notebook is an important document that could play a pivotal role in deciding who has rights to an invention in the United States. To ensure that the entries in a laboratory notebook have good corroborative value, all entries in a notebook should:
  1. clearly describe conception and reduction to practice
  2. be signed by the researcher on a daily basis
  3. be witnessed by another party who understands the work but who would not be considered an inventor; and
  4. demonstrate that reasonable diligence was carried out in moving from conception to reduction in practice.
Dr Alex Tzanidis is an Associate of Phillips Ormonde & Fitzpatrick, patent & trade mark attorneys, specialising in the field of biotechnology.
The information contained in this article is not legal advice. If you do have a legal enquiry you should talk to a Solicitor or Trade Mark Attorney before making a decision about what to do.