Determining Patent Inventorship in a Laboratory Context
“Inventorship” is an important legal consideration in obtaining valuable and enforceable patents. The U.S. patent laws require that a patent application be filed in the name or names of the actual inventors. This client alert summarizes some important points about the determination of inventorship, especially in a laboratory research setting – but the principles apply to inventorship determinations elsewhere as well.
In academic or commercial laboratory research, it is critical to realize that determining correct inventorship for a patent application is not the same as determining authorship for a scientific article. Failure to acknowledge the correct inventive contributions of all inventors can have severe consequences in patent enforcement and value. This article presents a discussion of the legal criteria for determining proper inventorship and offers some suggestions on how to both correct and prevent two of the most common types of errors.
Assume you are the principal investigator of a cancer research laboratory at a major university, mainly responsible for writing grants and funding the lab. An esteemed professor of biochemistry, who leads the laboratory experiments, has developed antibodies for treating certain aggressive forms of cancer. In order to establish data on potential applications of the antibodies, the professor brings in two graduate students who he directs to run experiments specifically designed by him. Two lab assistants also work in the laboratory, and their sole purpose is to provide materials for the experiments. Remarkably, the experiments produce a substantial amount of data showing that application of the antibodies provides a safe, effective, and relatively inexpensive means for cancer treatment.
An academic article is published on the findings, which lists you (the investigator), the professor, the graduate students, and the lab assistants as authors. Because you are convinced that this technology has great promise as a commercially-viable product, you believe that the university should file for patent protection.
Can you take the list of authors from the publication and name them all as the inventors for purposes of the patent? Also, what are the potential ramifications of filing a patent application using an inaccurate list of inventors? These are important questions that should be carefully addressed before applying for a patent.
As in the above hypothetical, in some instances nearly everyone who participates in or contributes in some way to a successful research project may be identified as an author for a scientific article. When determining authorship of a paper, issues of internal politics, professional courtesy, or even the principle of rewarding hard work can be taken into account. In contrast, establishing the correct inventive entity for a patent application has legal implications and must involve a different factual analysis.
Under U.S. patent law, only a true and original inventor can file for a patent. Although Section 101 of the Patent Act states that “whoever invents” a new and useful invention may obtain a patent for it, Section 102(f) clarifies that a person who does not “himself invent the subject matter sought to be patented” is not entitled to patent rights. See 35 U.S.C. §101; 35 U.S.C. §102(f). An inventor can broadly be defined as a person who contributes to the “conception” of the solution to a problem. Conception is considered to be the touchstone of inventorship and has been described as “the formation in the mind of the inventor of a definite and a permanent idea of the complete and operative invention.” See BJ Services Co. v. Halliburton Energy Services, Inc., 338 F.3d 1368, 1373 (Fed. Cir. 2003). Conception is established when the invention is made sufficiently clear to enable one skilled in the art to reduce it to practice “without the exercise of extensive experimentation or the exercise of inventive skill.” Hiatt v. Ziegler, 179 USPQ 757, 763 (Bd. Pat. Inter. 1973).
The notion of “reduction to practice” of an invention can also be important in determining inventorship, especially in the context where different entities file competing patent applications directed to the same invention. However, our principal concern here is that of conception, which is paramount in most cases.
Thus, a patent application and resulting issued patent(s) must name the correct inventive entity, i.e. the sole inventor or joint inventors. Sole inventorship occurs when only one person conceives the invention (as reflected in the claims of the patent application). Joint inventorship occurs when two or more people collaborate together and each contributes to the conception of the solution. Section 116 of the Patent Act provides that “[i]nventors may apply for a patent jointly even though…each did not make the same type or amount of contribution, or each did not make a contribution to the subject matter of every claim of a patent.” See 35 U.S.C. 116. (Emphasis added.) That is, while each joint inventor must generally contribute to the conception of the invention, he or she does not need to make a contribution to every claim of a patent; a contribution to just one claim is enough.
Also, as long as an inventor maintains “intellectual domination over making the invention,” ideas, suggestions, and materials may be adopted from others. See Morse v. Porter, 155 USPQ 280, 283 (Bd. Pat. Inter. 1965). In the cancer research hypothetical above, as long as the professor maintains overall management authority over the design and function of the experiments conducted by the graduate students and lab assistants, he can most likely retain sole inventorship status for the applied antibodies technology. Extending this concept to the graduate students, who conduct the professor’s pre-designed experiments and the lab assistants, who passively contribute only by supplying materials, it follows that neither of these parties are likely to be considered true inventors for purposes of patent filing.
Indeed, the Court of Appeals for the Federal Circuit has held that a joint inventor’s contribution must consist of more than just following the instructions of another. For example, in Stern v. Trustees of Columbia University, a student who followed directions from a professor but had no collaboration with the inventor was held to not be a co-inventor. The court pointed out that although the student had conducted experiments showing that the repetitive application of a cyclic fatty acid compound (prostaglandin) to certain primates was an effective treatment for glaucoma, he neither discovered nor understood the principle by which the compound treated glaucoma through reducing intraocular pressure. See Stern v. Trustees of Columbia University, 434 F.3d 1375 (Fed. Cir. 2006).
Two common inventorship problems are “misjoinder” and “non-joinder.” Misjoinder occurs where a person who is not in fact a joint inventor has been erroneously named as an inventor. Non-joinder, on the other hand, is where a person who is a joint inventor has been excluded from the inventive entity. Both misjoinder and non-joinder are potentially fatal to the validity of a patent and therefore its enforceability. See Gemstar-TV Guide International, Inc. v. U.S. Int’l Trade Comm’n, 383 F. 3d 1352 (Fed. Cir. 2004). However, where misjoinder or non-joinder occur without deceptive intent, the Patent Act provides provisions for correction, under Sections 116 and 256. See 35 U.S.C. §116 and 35 U.S.C. §256. Even with these safeguards, however, it is critical to note that improper inventorship remains a ground for invalidating a patent that is not corrected, and that in some cases, the patent is unenforceable until the correction is made. See 35 U.S.C. §256 (“the Director may [issue a correction certificate] on application of all the parties and assignees, with proof of the facts and such other requirements as may be imposed…The court before which such matter is called in question may order correction of the patent on notice and hearing of all parties concerned”); See also American Tel. & Tel. Co. v. United States Int’l Comm’n, 626 F.2d 841 (CCPA 1980) (Emphasis added.)
Many aspects of the inventorship complications discussed above can be avoided or at least mitigated by ensuring that inventors and their employers keep good records. Research results should be clearly documented in laboratory notebooks and should be signed, dated, and witnessed. In this way, evidence of conception of an invention (and reduction to practice) can be established in the event that any questions on the correct inventive entity arise. In addition, a university or company should provide standard forms and procedures for the disclosure of ideas. For instance, a complete invention disclosure form should include input fields for the date of conception of the invention with instructions to separate out each aspect of the inventive contribution by date and by party.
Also, although as discussed above a joint inventor need only contribute to the conception of one claim, most patents have more than one claim. Conception, and thus inventorship, applies to each and every claim of a patent – on a claim by claim basis. During the prosecution of a patent application, the applicant often makes amendments to the claims, and sometimes adds or deletes claims in a patent application. The fact of amendments may require that corresponding changes be made in the named inventive entities accordingly. See 37 C.F.R. § 148(b),(c).
If you have any questions about inventorship or other issues involved in patent application filing, prosecution, correction, or maintenance, please contact any of the following attorneys: