Chemical and Life Sciences Patenting – New Considerations After the KSR VS Teleflex Decision

In its KSR VS Teleflex decision, the Supreme Court acknowledged that nearly all innovations rely upon building blocks discovered long ago but ruled that patentability requires more than predictable combinations of prior art. The court opined that if a prior art combination merely yields results expected by those of ordinarily skill in the art, then the combination is not deserving of a patent – even if innovative. Furthermore, disqualifying prior art can come from any field – and reviews of prior art elements require consideration of "functionality." The "Teaching, Suggestion, or Motivation" test for obviousness was further constrained when the Federal Circuit was chided for stating "obvious to try" is not the same as Sec. 103 obviousness.

The KSR v. Teleflex decision will likely stunt patenting, promote heavier reliance upon trade secrets, encourage validity challenges, and require more reliance upon formerly secondary arguments for allowance. Chilling effects will likely be felt heaviest in the mechanical arts, where component functionality and / or substitutes are often well-known and viewable in concrete form, and where reverse engineering often mutes the advantages of trade secrets.

KSR v. Teleflex's effects should be less pronounced in chemistry and life science patenting for several reasons.

o Expert innovators in life science and chemical fields often do not reasonably know what to expect when they combine a particular set of elements from prior art, or what will happen when they replace one chemical with another known to be a good substitute in a totally different application. Even with a very specific goal, an innovator may have a myriad of reasonable potential solutions with no way of accurate predicting results. Often, extensive experimentation is necessary, with the discarding of many possibilities before a promising possibility emerges.

o Life sciences and chemical innovators can often only speculate as to the exact mechanisms or mode of actions of their own innovations. Although innovators are free to propose some theory for how or why their innovation works, they are not generally required to do so. Such theorization rarely helps secure a patent, but it may encourage patent challengers to point out-in 20/20 hindsight-that the innovation does indeed work as expected, and is therefore obvious and not patentable. When there is uncertainty as to why or how an innovation works, there is often concomitant uncertainty as to how a particular additive or substitute will function.

o Even if an altered composition and its uses are obvious, the method of manufacture or synthesis may not be clear.

o Often, life sciences and chemical innovations are not created by people of ordinary skill in their art, but are the culmination of cutting-edge work by very highly skilled individuals.

Conversely, KSR v. Teleflex will likely stymie certain life sciences and chemical patenting.

o Closely related imitation drugs (pejoratively known as "me-too" drugs) may be deemed obvious even if they offer some substantial improvement.

o Opportunities for drug companies to effectively extend the patent and business life of their innovations through patenting of relatively minor changes (eg, formulations or administration method) will likely be limited. Even innovations providing definitive improvements (eg, certain purified isomers, etc.) may have patentability limited merely to the method of manufacture rather than to the improved composition or usage.

o Innovators are less likely to pay patent licensing fees for improvements on their own technology. Such refusals are bolstered by court commentary on how patents for innovations merely combining prior art in ordinary ways actually detract from the value of other patents.

o As innovators weigh the pros and cons of including a theory for how or why their innovation works, they are likely to err on the side of providing little or no explanation, which unfortunately limits the base of knowledge shared by potential innovators.

Like many judicial decisions, KSR v. Teleflex does not provide a perfect solution. Patent practitioners will now need to rely upon more complicated allowance arguments, including normally secondary considerations. Obviousness determinations will likely be less uniform. New litigation issues will arise.

Expect a surge of interest in the working definition of a "person of ordinary skill in the art." Innovators will generally wish to have the art defined as broadly as possible, then argue that the generalists would not have combined the prior art in the same manner as the innovator. The KSR v. Teleflex decision did not dispute the original court's determination that a person of ordinary skill in the art had the equivalence of a mechanical engineering undergraduate degree with familiarity in the field of pedal control systems for vehicles. This implies that someone with "ordinary skill" would be assumed to have specialized knowledge within the very specific field of the disputed invention.

Some of the following questions may arise or be revisited: If it is not "obvious" to try a potential solution, then why would someone elect to experiment with the potential solution in the first place? Does a requirement for (extensive) experimentation indicate that the solution or combination was not clear? How "closely related" do different chemicals need to be before the obviousness of choosing one for a particular application makes others similarly clear? Who judges the similarity of different chemicals, and by what standard? If specialized consultation is required, is the innovation non-obvious? Does a synergistic effect automatically indicate "unexpected results," or can synergy simply be a typical, expected result? If a synthesis / separation method for a novel composition is non-obvious (eg, method to produce / purify a specific isomer) should the composition and its uses likewise be patentable despite any potential arguments of obviousness due to previously existing closely related chemicals?

The Federal Circuit and USPTO will need to find ways to reasonably answer these questions by refining and interpreting KSR v. Teleflex in a manner that does not destroy financial incentives for R&D and patenting. Institutional pressures will likely prompt decisions and policies which tend to (1) broadly interpret each technical "art", (2) accept plausible assertions that an innovator's insight is the result of "expert" vs. "ordinary" insight, and (3) specify that "obvious to try" is still not Sec. 103 obviousness if more than a few simple possibilities exist and considerable experimentation is necessary to determine the most promising candidates.

This aritcle is a creative property of Source by Anthony Wilson