Patent Strategy Update: Federal Circuit Further Defines Standard for Establishing Conception of Biological Inventions and Stresses Corroborating Evidence
September 10, 2009
Lahive’s Patent Strategy Updates report on recent developments in patent law and how they may affect your IP strategy. This Update was prepared by Giulio A. DeConti, Jr. and Briana M. Erickson.
Recent Developments
It is firmly established that “[c]onception is the touchstone of inventorship, the completion of the mental part of the invention.” Sewall v. Walters, 21 F.3d 411, 415 (Fed. Cir. 1994). But when is conception complete? The answer to this question can have far-reaching implications for determining inventorship, and, by extension, ownership, of patent rights. In a recent decision in University of Pittsburgh v. Hedrick (Fed. Cir. 2009), the Federal Circuit has further defined the requirements for demonstrating complete conception of biological inventions. In particular, the Federal Circuit stressed the importance of corroborating evidence for determining proper inventorship and establishing a date of conception.
Conception and Inventorship
In contrast with authorship of a scientific publication, inventorship of a patent is limited to those individuals who contributed to the conception of the invention, as set forth in the patent’s claims. Conception is completed when an inventor arrives at an idea of the invention that is “definite and permanent,” and is able to explain the invention in sufficient detail that a person skilled in the relevant field could practice the invention without extensive research or experimentation. See Sewall, 21 F.3d at 415; Burroughs Wellcome Co. v. Barr Laboratories, 40 F.3d 1223, 1228 (Fed. Cir. 1994). Importantly, an inventor does not need to know that his invention will actually work for his conception to be complete. Demonstrating the operability of a conceived invention constitutes “reduction to practice,” and individuals involved solely in the reduction to practice of an invention are not considered to be inventors for purposes of U.S. Patent Law.
Notwithstanding, the Federal Circuit has previously held that it is not possible to conceive of certain types of inventions, especially in complex fields such as biotechnology, until the invention is reduced to practice. For example, in Amgen v. Chugai Pharma, 927 F.2d 1200 (Fed. Cir. 1991), the court held that complete conception of an isolated DNA sequence encoding human erythropoietin required actual sequencing of the erythropoietin gene, and not merely the design of sequencing primers and an experimental plan for isolation. In this case, the court reasoned that it is not possible for inventors to have a definite mental picture of the complex structure of a nucleic acid molecule until reduction to practice occurs by determining the complete nucleic acid sequence. Accordingly, complete conception of a nucleic acid molecule requires actual sequencing.
In University of Pittsburgh, a central issue was determining inventorship, and consequently ownership, of a patent claiming stem cells that are derived from adipose tissue obtained from liposuction procedures. Two principle investigators from the University of Pittsburgh believed that adipose cells cultured under certain conditions in their laboratory had the ability to differentiate into other cell lineages. They recorded their preliminary observations in lab notebooks, together with a description of further experiments to be performed in order to confirm their suspicion. A third scientist subsequently performed these experiments and others which provided definitive evidence that the adipose cells did, in fact, have particular properties of stem cells. This third scientist argued that he was an inventor, and his company a partial owner, of the patent. Without his experimental confirmation, the scientist argued, the University of Pittsburgh investigators could not have definitively known that their cells were stem cells so as to completely “conceive” of the invention.
The court disagreed, holding that conception of the invention was completed by the University of Pittsburgh investigators prior to the confirmatory experiments, thereby awarding full ownership of patent rights to the University. This decision was based largely on the existence of extensive documentation setting forth the investigators’ preliminary data, their belief that they were observing stem cell-like properties in cells within their adipose population, and an outline of experiments that they planned to perform to confirm this theory. When taken together, this evidence demonstrated that the two University of Pittsburgh investigators “had a complete mental picture of [the invention] and could describe it with particularity,” thereby satisfying the test for complete conception.
IP Strategy Considerations
This decision highlights the importance of institutional recordation procedures designed to document the factors relevant to establishing conception, and the particular contributions made by all individuals involved in a given project. Because conception is a mental act, the existence of corroborating evidence to substantiate its occurrence is critical. Such evidence can take the form of dated laboratory notebooks or invention disclosures submitted to a technology transfer office or IP department. In addition to merely setting forth experimental results, this documentation can be particularly useful for establishing conception if it contains a description of why particular experiments were performed, as well as the probable implication of experimental observations, however preliminary. Indeed, the court’s decision in University of Pittsburgh was predicated upon various experiments, actual and prospective, as well as hypotheses memorialized in writing. This type of evidence should be carefully considered when an inventorship determination is conducted. Moreover, thought should be given to allocating ownership rights by contract at the outset to avoid disputes that may later arise with respect to inventorship.
Contact Us
The likely outcome of any case rests on the particular facts of each client’s unique situation. For more information on how case law relating to conception and inventorship might affect your IP strategy, please contact Giulio A. DeConti, Jr. in the Life Sciences Group at Lahive & Cockfield LLP at 617.994.0771 or at gdeconti@lahive.com.
To read the full decision, see http://www.cafc.uscourts.gov/opinions/08-1468.pdf.
