Processing All Things Federal Circuit
August 22, 2022 - Last Week in the Federal Circuit

Last Week In The Federal Circuit (August 15 – August 19): The Court Rebuffs Patent Owner’s Attempt To Read ANDA Application In Isolation

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We’re now in the waning days of summer, and the Court’s activity last week somewhat reflected that: two decisions and a few orders. One of those orders was for something you don’t see often: an appeal being dismissed for an appellant missing the deadline to file its opening brief by 11 days. So fair warning: an appellant that doesn’t file an opening brief may have its appeal dismissed. But rather than write about that one-line order, we’re going to discuss instead a case about numbers. Below we provide our usual weekly statistics and a detailed discussion of our case of the week—our highly subjective selection based on whatever case piqued our interest.

Precedential opinions: 2

Non-precedential opinions: 0

Rule 36: 0

Longest pending case from argument: Click-to-Call Technologies, LP v. Ingenio, Inc., No. 22-1016 (69 days)

Shortest (non-Rule 36) pending case from argument: Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc., No. 21-2342 (42 days)

Case of the week: Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc., No. 21-2342

Panel: Chief Judge Moore and Judges Prost and Hughes, with Chief Judge Moore writing the opinion

You should read this case if: you have an ANDA case involving “actual, real-world evidence” that might conflict with what the ANDA says

For our case of the week, we turn to the ANDA world. As readers know and in the simplest of terms, an ANDA is an Abbreviated New Drug Application, which a generic drug manufacturer (which we’ll off-and-on refer to as the ANDA applicant) files with the FDA to seek approval to sell a generic version of a brand name drug. Before the generic goes on the market, the brand manufacturer can file an action to enjoin the generic from reaching the market. Ordinarily, it does so under Section 271(e)(2), which makes it an (artificial) act of infringement for an ANDA applicant to file an ANDA that infringes the brand manufacturer’s patent claims. Section 271(e)(2) requires comparing the patent claims to the ANDA’s specification—as the proposed generic product must meet the ANDA’s specifications.

Here the dispute concerned only one claim requirement—the product’s pH range. If the product specified in the ANDA practiced the claimed pH range, then it infringed. So did it? Nope. The claims specified a pH between 3.7-3.9 (or 3.65-3.94 before rounding). The ANDA specified a pH range of 3.4-3.6 (or 3.35-3.65 before rounding). So close, but of course close only counts in horseshoes and hand grenades—not literal infringement.

On appeal, the patent owner argued that the real-world evidence showed that the pH of the generic manufacturer’s product would drift upward during the product’s shelf life. And it noted that the generic sought approval to release a product at 3.64 pH, just 0.01 below the patent owner’s claims—the implication being the product released at 3.64 pH would inevitably drift to 3.65 pH or higher and thereby infringe the claims. While a not completely unappealing argument (double negative intentional), the Court noted a key problem. The patent owner was looking at the ANDA’s pH range in isolation. In addition to a pH specification, the ANDA also had a stability specification. Taken together, both “restrict the pH of the proposed product to a pH range between 3.4-3.6 at release and throughout the product’s shelf life—outside the infringing range.” And to remove any doubt, the Court cited the oral argument where the ANDA applicant’s counsel acknowledged that the ANDA product must “have a pH between 3.4-3.6 throughout its shelf life, not just at release.” Thus, to the extent there was real world evidence of pH drift, that evidence didn’t matter under the Section 271(e)(2) analysis here.

In addition to alleging infringement under Section 271(e)(2), the patent owner also sought a declaratory judgment that the generic would infringe in the future, because of the pH drift. But essentially the same findings that thwarted the patent owner’s case under Section 271(e)(2) thwarted its attempt to get declaratory relief. The Court said there could be no real threat that the generic was going to infringe the patents (with upward pH drift) when the ANDA stated that the proposed product must meet both the pH and stability requirements. In addition, the Court noted that the real‑world evidence didn’t support the upward drift anyway. It noted that the district court made no clear error in several findings that there was no upward drift along the lines the patent owner was talking about.