Same Questions, Different Rubric?

Senator Patrick Leahy has now proposed draft legislation to add Obviousness-Type Double Patenting (OTDP) to IPR jurisdiction. The argument for adding this potential ground is that it is an important control to combat improperly extended drug monopolies (the justification underlying much of the legislative proposal).  Whether this provision makes it to law is far from clear given the likely push back from Bio/Pharma.

In the meantime, a Pharma dispute recently argued that OTDP is basically the same PTAB obviousness analysis under a different rubric.  An awkward argument given the coming storm.

The Delaware District Court considered the overlap between OTDP and obviousness in In re Sitagliptin Phosphate (‘708 & ‘921) Patent Litigation.  In the litigation, Patent Owner argued for the Court to preclude defendants from presenting a defense of OTDP at trial.  Patent Owner argued that based on a previously failed IPR, 35 U.S.C. § 315(e)(2) precluded OTDP.  While Patent Owner acknowledged that OTDP could not have been raised in the IPR, it argued that the questions were the same (here):

Although double patenting is a different legal rubric from the statutory anticipation and obviousness grounds presented in the IPR, the arguments that [defendants] seek to present here are substantially the same as the ones they unsuccessfully made to the Patent Trial and Appeal Board.

This is an unfortunate sound bite given the coming proposed legislation.

As to the debate, the court was “not convinced there [was] any merit to [plaintiff’s] argument” and denied the request.  The court noted that defendants could not have raised the defense of OTDP in the previous IPR (because OTDP is not an available defense in an IPR).  Thus, defendants’ OTDP defense was not barred by IPR estoppel.

The court explained, Patent Owner cited no Federal Circuit case law approving of any exception to the statute.  Rather, Patent Owner merely cited “multiple district court cases for the proposition the IPR estoppel bars ‘substantially the same’ arguments as ones that were or could have been raised in the IPR.”  But those cases involved anticipation or obviousness defenses—not OTDP.  Thus, Patent Owners request was “unprecedented.”  Here, defendants were seeking to introduce a reference patent as  grounds for its OTDP defense.  That same patent was also introduced in the previous IPR, but as an anticipatory reference.  As the court stated, “[a] patent that is not anticipatory could still be the basis for [OTDP].  Thus, I do not think [OTDP] on the basis of a single patent is substantially the same as anticipation on the basis of the same single patent.”

Thus, district court litigation will continue on a question under a slightly different rubric that might have just as easily been considered in the earlier IPR — if Congress gets it way, that is exactly what will happen going forward.