In late April, the U.S. Supreme Court decided an important case-KSR International v. Teleflex Inc.-that addressed the test for determining whether a patent is obvious and therefore invalid.
As is often the case, the court's opinion set off considerable speculation about how broadly it should be interpreted: Does it establish a broad, general principle? Is it creating a trend that patents are more likely to be found obvious in the future? Or is its significance limited to the patent in that case or a particular class of patents?
In general, because it is recognized that life sciences are more unpredictable than other disciplines, patents in the life sciences should have a better chance of surviving obviousness challenges, especially where there is evidence that the patent produced unexpected results.
The patent in the KSR case covered an automotive gas pedal designed for use with a computer-controlled engine. It claimed placing an electronic control on a fixed portion of the pedal assembly. The Court of Appeals had ruled that a trial was necessary to decide the validity of the patent, but the Supreme Court disagreed. The Supreme Court reviewed several earlier patents on gas pedals and found that, among them, they included all the elements of the claimed invention.
The court found the patent was obvious without the need for a trial. It stated that "[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results."
The court's analysis of its prior decisions and the patent at issue referred several times to the predictability of the result of the combination of known elements alleged to constitute an invention.
The court's opinion included several other important pronouncements on the test for obviousness. Among these, the court noted that "inventions in most, if not all, instances rely upon building blocks long since uncovered, and claimed discoveries almost of necessity will be combinations of what, in some sense, is already known."
Thus, to avoid invalidating nearly all patents as obvious, "it can be important to identify a reason that would have prompted a person ... to combine the elements in the way the claimed new invention does."
In other words, a patent claim will not be invalid simply because all its elements can be found somewhere in earlier literature. On the other hand, the court said that a claim can be obvious if its combi nation of elements was one of a finite number of possible solutions that was "obvious to try."
Impact on life sciences
The court's emphasis on whether the results of a claimed combination are "predictable" suggests that, in general at least, patents in the life sciences have a greater chance of surviving an obviousness challenge than patents in other areas such as the mechanical arts represented by the gas pedal at issue in KSR.
The law has long recognized that biology and chemistry are less predictable than mechanics and electronics. This is borne out by familiar examples of the huge differences that can arise from subtle changes to biological or chemical compounds. For example, sickle cell anemia arises from a change in only one of more than 140 amino acids in a hemoglobin subunit and cystic fibrosis from the deletion of only one of 1,480 amino acids.
In its first case applying KSR to a life sciences patent-Takeda Chemical Industries Ltd v. Alphapharm (June 28)-the Federal Circuit rejected an obviousness challenge to a patent covering pioglitazone, a therapy for Type 2 diabetes sold by Takeda under the brand name Actos.
The difference between pioglitazone and the closest prior art, known as compound b, was arguably minor.
The court upheld the patent on two grounds. First, the court found there was no reason to try to make the changes to compound b that lead to pioglitazone. The existing evidence suggested compound b caused increases in body weight and brown fat, both negative conditions for diabetics. Second, there was evidence of "unexpected results" in the form of reduced toxicity from pioglitazone. The arguably minor differences between compound b and pioglitazone led to unpredictable results and thus the patent was not obvious.
Similarly, the first jury in a case involving an obviousness defense based on KSR to a life sciences patent returned a verdict that the patent in dispute was not obvious. The instructions included the Supreme Court's statement that a patented combination of elements can be obvious if it was "obvious to try."
Although two cases are an insufficient basis to support any broad conclusions, they should at least be encouraging to owners of patents in the life sciences arena. The Supreme Court's emphasis on predictable results and the accepted view that life sciences are unpredictable also bodes well for the validity of patents in this field. Owners defending their patents against an obviousness challenge should develop and present evidence on this key factor.
Tyler is a partner in the Indianapolis office of Barnes & Thornburg LLP, practicing in the firm's Intellectual Property Department. Views expressed here are the writer's.