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GUIDANCE IS NOT ENABLEMENT OF A GENUS IF UNDUE EXPERIMENTATION IS REQUIRED. USPTO publishes clarification of enablement guidelines for 35 U.S.C. 112(a).In light of the U.S. Supreme Court decision

USPTO publishes clarification of enablement guidelines for 35 U.S.C. 112(a).

 

In light of the U.S. Supreme Court decision in Amgen Inc. et al. v. Sanofi et al., the USPTO has clarified the enablement guidelines. This is particularly relevant to bio/chem/pharm practice. It clarifies the standards we are all familiar with.

 

These guidelines do NOT change the Wands factors to ascertain whether the amount of experimentation required to enable the full scope of the claimed invention is "undue".

 

As biotech patent practitioners, we all know that to enable an invention, an inventor must provide a description sufficient that a person of skill in the art can make or use the invention without “undue experimentation.” That's fine for a single well-defined species, such as a chemical structure. However, when a patentee claims an entire genus, enablement problems occur.

 

As the Supreme Court said: "The more one claims, the more one must enable."

 

In Amgen, the Supreme Court emphasized the large number of possible embodiments (possibly millions) that are encompassed by the genus. Amgen's specification was large and included examples and guidance for identifying a large genus of antibodies. But the Court said that too much experimentation was necessary to define the invention’s scope. The Court stated that Amgen’s disclosure offered “little more than advice to engage in "trial and error.’” The Court held that Amgen’s disclosure forced scientists to engage in “painstaking experimentation” to see what works. As a result, the Court affirmed the holding of the Federal Circuit that Amgen’s claims were invalid for lack of enablement. 

 

I do not think that this ruling will come as any surprise to the experienced bio/chem/phara practitioners out there. It simply clarifies what the examiners have been telling us for a long time. If you want to enable even a small genus, you need to provide a sufficient number of representative examples and lots of explicit disclosure, even if your Markush claims are fairly extensive.

 

Also, It's worth remembering that bio etc is an "unpredictable art" where a single atom's change (eg -H to a halide, which is very common) can totally change binding/function. If you are claiming that a genus molecules can be used for the treatment of X, then it's an up-hill battle to argue that every variant has the desired biological activity.

 

On the other hand I have had consistent success requesting examination of two or more related but different genera of compounds, and their well-defined derivatives, so long as you can reasonably say that the search/examination is not a serious or unreasonable burden on the examiner.

 

Overall, a sensible and unsurprising codification of current examination practice.

 

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