Prometheus v. Mayo has had its day at the Supreme Court, but the Court has yet to render a verdict. This leaves everyone with a couple of months on their hands to speculate as to what the outcome might be. Let's take a quick look at some of the opinions that have been offered on this subject.

In a Dec. 8 posting at IPWatchdog.com, attorney Ryan Chiromas of Westerman Hattori Daniels & Adrian (Washington) said he was “surprised at how little Bilski was mentioned,” a reference to the business method patents case that seemed to send the message that the machine-or-transformation test was just the starting point for an examination of patentability. Chiromas said the justices will no doubt “be thinking of the impact a decision might have on the healthcare industry as well as the information technology industry.” He said his best guess “is that the court is leaning toward the position that §101 should be a coarse filter and that §102 and §103 would be more appropriate to challenge the validity of the claims in this case.”*

Robin Feldman, a professor of law at the University of California Hastings College of the Law (San Francisco) told Medical Device Daily in a December interview that the court may well issue a decision that seems to cut somewhere down the middle between the two parties to the suit. Giving Bilski as an example, Feldman said the court, "understood there were a lot of ramifications" of any hard-and-fast rules applied to that case, adding, "I can see the same thing happening here" assuming the sense of the Court is indeed that "they don't have a solution yet."

This in essence gives the court the option of sending Prometheus back to the Court of Appeals for the Federal Circuit “with limited guidance,” Feldman said. That guidance may consist of a message that, when boiled down, says “we don't want to see pre-emption of an entire field or a natural phenomenon,” such as is attributed to the patent held by Prometheus, but also that the nine justices in Washington want CAFC to offer a bit more detail “about where that line should be,” she remarked.

However, there are those who believe there is a risk that the court could turn sharply against life sciences in this case. Denise DeFranco of the law firm of Finnegan (Cambridge, Massachusetts) also gave Medical Device Daily her take on the proceedings of that day in court. DeFranco, who argued on behalf of Bilski in 2008, said Chief Justice John Roberts seemed skeptical of Prometheus's claims. "I'm concerned that he's having a hard time getting himself there," DeFranco said, adding that if the court goes against Prometheus (San Diego), the damage to diagnostic patents and to personalized medicine could be substantial.

A reversal of the outcome at CAFC “could have major implications,” DeFranco said. “If they say this claim is invalid, no matter how narrowly they state that, there are a lot of claims like this one" that would be eliminated entirely or at least badly damaged.

One of the interesting aspects of the outcome is that some firms may have to go to court to defend their patents, but there might be quite a few patents that are abandoned over an unfavorable outcome in Prometheus. The lawsuits will certainly be announced while the abandoned patents probably will not be. However, the abandoned patents might be the real story when all is said and done.

*American patent law is found in Title 35 of the United States Code, and section 101 of 35 USC states that anyone who “invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvements thereof, may obtain a patent,” whereas sections 102 and 103 delve a bit deeper. Section 102 describes the conditions under which a patent may not be granted, including whether the item is of sufficient novelty. The passages in section 102 include that a patent cannot be obtained if “the invention was known or used by others in this country,” or if the invention “was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application” at PTO.

Section 103 deals with matters of obviousness, stating among other things that a patent might not be available “if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.”