Three recent cases involving dietary supplement companies illustrate this: Laboratory Corporation of America (LabCorp) v. Metabolite Laboratories in June 2006; MedImmune v. Genentech in January 2007; and KSR International Corporation v. Teleflex et al in April 2007.
Historically, the U.S. Supreme Court has only been active periodically in reviewing patent laws, yet we are currently in a cycle of increased review by this court.
The decisions in these cases do not represent radical departures from precedent - the rulings correct deviations from and reinforce precedent.
Still, dietary supplement and functional foods companies looking to patent their technologies will need to ensure their applications are very precise and reflect an invention.
In LabCorp v. Metabolite, the Supreme Court concluded that you cannot patent a basic scientific relationship.
Metabolite had obtained a patent covering certain methods of detecting elevated homocysteine levels, essentially by detecting a vitamin deficiency, which suggested an increased risk for circulatory disorders.
The claims in the patent at issue were problematic because any doctor who, simply by providing health care services, considered the test data and made a diagnosis might be in violation of the patent.
Certain claims in the patent even seemed to encompass detection technologies that had not yet been developed.
The court accordingly held the patent invalid, although it restrained itself on extrapolating this case to a determination of what is patentable subject matter.
This case suggests that an inventor cannot claim technologies that don't exist at the time of filing and must reflect real invention not just scientific fact.
Thus, a patent applicant must carefully consider what is reducible to practice, what is still theoretical, and draft their application appropriately.
In MedImmune, the Supreme Court held that a licensee can challenge the validity of a patent while the license is in force.
This makes sense as a matter of policy as the licensee is in the best position to determine the quality of the patent, and the court has long supported challenges to patents in order to remove invalid patents from the marketplace.
Licensors must be aware that a license agreement does not make a patent valid, and should limit access to trade secrets, as an incentive to maintain a constructive working relationship with licensees, should the patents fail.
In KSR the Supreme Court clarified the obviousness standard, when assessing patentability of an invention.
The holding essentially reaffirmed the test as being set forth in Graham v. Deere 383 U.S. 1 (1966) and reigned in the Federal Circuit which had strayed from that precedent.
KSR requires that an invention does not merely combine the known properties of existing elements, but improves upon those elements such that a novel property is observed.
For example, a supplement that combines known compounds is probably not patentable unless, because of the combination, a unique property or potency is observed.
So, KSR didn't really raise the patentability bar, more accurately it just reset it to near the original position.
These three cases do not represent enormous deviations from existing law, but taken together, these cases encourage a kind of patent reform, which demands from applicants better precision in patent drafting, and that inventions represent true innovation rather than trivial improvements.
John M. Garvey is a partner in the Boston office of Foley & Lardner LLP, and he is a member of the Biotechnology & Pharmaceutical Practice and the Life Sciences and Nanotechnology Industry Teams.
He can be reached at wtneirl@sbyrl.pbz .