35 USC 112 Attacks In Post-Grant Reviews (PGRs) Revisited
In my article dated December 11, 2016 (“Altaire v. Paragon Post-Grant Review (PGR): Any Lessons Learned From This Early Pharma PGR?”), I concluded that perhaps the only take-away lesson from the Altaire PGR is to make sure you consider all bases of invalidity – including 35 USC §112 – when filing a PGR. As more PGR decisions trickle in, I thought I would revisit this conclusion.
As a reminder, in a PGR at the US Patent and Trademark Office (“USPTO”), a petitioner can challenge the validity of a patent on several grounds including prior art, on-sale or public-use activity, and lack of compliance with 35 USC §112 (for example, lack of enablement, written description, or definiteness).
First, let’s look at indefiniteness under §112.
In Telebrands v. Tinnus Enterprises, the patent claimed a water balloon-filling device. The claims required a “connecting force that is not less than the weight of one of the containers [balloons] when substantially filled with water.” The USPTO found that the phrase “substantially filled with water” was too subjective and, thus, indefinite under 35 USC §112.
Now, let’s look at written description/enablement.
In US Endodontics v. Gold Standard Instruments, the patent claimed methods for making an endodontic instrument. The method included a heat-treatment step, and the claim required the method to result in an instrument having specified deformation properties. During the PGR, the petitioner presented evidence that many heat-treatments resulted in instruments that did not possess the required deformation properties (that is, the claims encompassed many inoperative species). The USPTO also found that the patent contained insufficient disclosure regarding how to obtain the required deformation properties. The USPTO ultimately concluded that the claims were invalid for lack of written description and lack of enablement.
But, the USPTO reached a different conclusion in Dr. Reddy’s v. Helsinn Healthcare. In Dr. Reddy’s, the patent claimed a composition containing palonosetron (or a salt thereof), mannitol, and a pH of 4-6. The petitioner challenged the claim under §112, asserting that the patent required stability as part of the invention, but the claims did not require stability, essentially making the claims too broad. The USPTO rejected the petitioner’s arguments and did not institute a PGR.
So in Dr. Reddy’s, the property of stability was not present in the claims, and the USPTO found that the claims were valid under §112. However, in US Endodontics, the claims required deformation characteristics, and the USPTO found that the claims were invalid.
At first blush, it might seem that specifying properties in claims makes the claims more susceptible to an attack under §112. But I don’t think this is the case. In Dr. Reddy’s, the USPTO concluded that the claim elements were well-described, and that these elements resulted in a stable composition. In contrast, in US Endodontics, the USPTO focused on the uncertainty associated with the heat-treating step and how to perform heat-treatment in a way resulting in the required deformation properties. It appears that the difference between the decisions in Dr. Reddy’s and US Endodontics is that in one (Dr. Reddy’s), the claim elements were clear and supported, whereas in the other (US Endodontics), they were not.
The bottom line is that §112 attacks are viable options in PGRs.