The US Court of Appeals for the Federal Circuit this morning seemed far more interested in the third ground presented by appellant Bayer Pharma Aktiengesellschaft than the two which came before. They zeroed in on the Patent Trial and Appeal Board’s construction of a claimed “First Product Comprising Rivaroxaban and Aspirin” limitation in a patent associated with "Xarelto" as inclusive of not only one capsule containing both products, but also separate doses of rivaroxaban and aspirin. That could spell trouble for Mylan Pharmaceuticals, who Bayer says infringes with its proposed generic blood thinner.
Mylan Pharmaceuticals’ successful inter partes review of a Bayer Pharma Aktiengesellschaft patent could be in jeopardy.At oral arguments this morning, Chief US Circuit Judge Kimberly Moore signaled a potential problem with the Patent Trial and Appeal Board’s claim construction of Bayer’s US Patent No. 10,828,310 — but not the patent owner’s main argument on appeal (see here), that “clinically proven effective” was wrongly construed by the board as non-limiting.
Instead, Moore took issue with the board’s construction of a claimed “First Product Comprising Rivaroxaban and Aspirin” limitation in the ‘310 patent as inclusive of separate doses of rivaroxaban and aspirin.
That fits with arguments made to the board by Mylan, whom Bayer accuses of infringement in connection with a proposed generic version of the blood thinning drug Xarelto, but did not resonate with Moore earlier today.
Wendy Devine, representing Mylan, pointed to the specification of the ‘310 patent which defines “combination” as “not only dosage forms which comprise all the components (so-called fixed dose combinations), and combination packs or kits which comprise the components separate from one another in a package together,” but also “components administered simultaneously or sequentially.”
But Moore was unconvinced, telling Devine, “I think a first product has to be a capsule or a caplet or a pill that has those two things combined in it.”
Rivaroxaban is the active ingredient in Xarelto, the only direct-acting oral anticoagulant approved for preventing heart attack and stroke in patents with coronary artery disease or peripheral artery disease.
The ‘310 patent discloses twice-daily 2.5 mg rivaroxaban combined with daily 75-100 mg aspirin in claim 1, or 2.5 mg rivaroxaban combined with 100 mg aspirin in claim 2.
After Mylan and others sought approval to make a generic version of the brand name drug, Bayer filed several lawsuits asserting infringement which were ultimately consolidated by the Judicial Panel on Multidistrict Litigation.
The ‘310 patent, meanwhile, is not included in the MDL but is asserted by Bayer in separate litigation against Mylan in the US District Court for the District of Delaware. There, Judge Richard G. Andrews stayed proceedings in September 2023.
Dov P. Grossman, representing Bayer, opened oral arguments with his client’s chief complaint regarding the board’s cancellation of the ‘310 patent — that “clinically proven effective” requires no clinical proof of efficacy.
According to Grossman, per Federal Circuit 2019 precedent in Allergan Sales, LLC v. Sandoz, the proper inquiry is whether a limitation is material to patentability, and “clinically proven effective” changes how the claimed method is performed.
Moore disagreed, characterizing the term as little more than a descriptor, not unlike “Best New Drug” or “Safest Car on the Road.”
The concern, she continued, is that treating such language as a limitation could lead to scenarios in which drugmakers patent precise dosages and then unfairly extend their patent terms with the addition of “science-y” superlatives.
Moore was equally unimpressed by Bayer’s second grounds for appeal, that a printed publication known as Foley — which teaches twice-daily 2.5 mg rivaroxaban and daily 100 mg aspirin in its discussion of Bayer’s clinical trial design — did not inherently anticipate the ‘310 patent, nor could it by publishing Bayer’s own clinical trial results.
“That’s a stupid argument,” Moore told Grossman. “You had the power. You could have filed your patent application promptly ... so as not to have your own publication become prior art.”
Just how far Moore and her fellow panel members Circuit Judge Tiffany Cunningham and Judge Mark C. Scarsi of the Central District of California, sitting by designation, will go in addressing the outcome of the IPR remains to be seen.
Should they disagree with Bayer on its “clinically proven effective” and Foley-related inherent anticipation grounds but side with the patent owner on the construction of “first product,” the cancellation of independent claim 5 and dependent claims 6-8 of the ‘310 patent will likely require reversal.
But that, in turn, could also necessitate remand to the board to consider grounds one and two of Mylan’s petition, which rely on different prior art and were not substantively reached by the board in view of their findings that all eight claims of the ‘310 patent are either anticipated by Foley or rendered obvious by Foley when combined with “Rivaroxaban: A Review of Its Use in Acute Coronary Syndromes,” a reference known as Plosker.
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