PATENT CASE OF THE WEEK
Amgen Inc. v. Amneal Pharmaceuticals LLC, et al., Appeal Nos. 2018-2414, et al. (Fed. Cir. Jan. 7, 2020)
In this appeal from Markman and summary judgment opinions by the district court in a Hatch-Waxman case, the district court clarified the law about the use of the words “comprising” and “consisting of” when used with Markush groups. A Markush group is a patent claiming technique in which a patentee claims the use of one of a number of possible options. The claims in this case used Markush groups for several of their limitations.
The claims in this case concern Sensipar®, a pharmaceutical for the treatment of hyperthyroidism. The representative claim reads as follows in relevant part:
A pharmaceutical composition comprising:
- … cinacalcet HCl …,
- … a diluent …,
- from about 1% to about 5% by weight of at least one binder selected from the group consisting of povidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, and mixtures thereof; and
- from about 1% to 10% by weight of at least one disintegrant selected from the group consisting of crospovid[o]ne, sodium starch glycolate, croscarmellose sodium, and mixtures thereof,
…
(Emphasis added).
Thus, the third element (c), which recites the “binder” limitation, recites a Markush group consisting of four different options (and mixtures thereof), and the limitation is met if at least one of these binders is used in the appropriate amount. Likewise, the fourth element (d), which recites the “disintegrant” limitation, recites a Markush group consisting of three different options (and mixtures thereof), and the limitation is met if at least one of these disintegrants is used in the appropriate amount.
Amgen sued several companies that filed ANDA applications, including Amneal. Amneal’s product uses Opadry as the binder. Opadry contains hydroxypropyl methylcellulose, one of the listed variants in the “binder” Markush group limitation, among other chemicals. But Opadry itself is not listed. Amneal’s product uses crospovidone as the disintegrant, which is one of the listed variants in the “disintegrant” Markush group, but also another, unlisted disintegrant.
The district court construed the claims, and held that “the Markush groups for the binder and disintegrant elements are closed to unrecited binders and disintegrants.” Based on its claim construction, the district court held that Amneal’s product did not infringe the binder or disintegrant limitations, because the Markush groups were “closed.”
The Federal Circuit reversed, reconciling the use of both “comprising” and “consisting of” in the same claim. As patent practitioners are aware, “comprising” is ordinarily used to denote an open term, whereas “consisting of” is used to denote a closed term. In this case, however, the claims used both terms. In the preamble there was a “comprising” term, and the “consisting of” term was used in front of each Markush group.
The Court held that the Markush groups were “open,” in that the use of additional elements not listed in the Markush group could meet both the binder and the disintegrant limitations. The Court explained, “There is no language in Amgen’s claim indicating that every binder or disintegrant in the claimed formulation must be within the Markush groups. Instead, the claim recites ‘at least one’ binder or disintegrant ‘selected from the group consisting of’ various excipients.” Rather “[t]he plain language of this claim requires ‘at least one’ of the Markush members and certainly does not indicate that the only binders and disintegrants in the claimed formulation are those listed in the groups.”
The Court held that “consisting of” was used solely to describe the members of the Markush group, not to close the claim limitation, particularly when the preamble used the term “comprising” and the claim limitations used the “at least one of” language before listing the members of the Markush groups. “Without more,” the “consisting of” language “is satisfied when an accused product contains a component that is from the Markush group and that meets the limitation’s requirements for the component. It does not forbid infringement of the claim if an additional component is present functionally similar to the component identified in the Markush group limitation.”
Having reversed the district court’s claim construction, the Court reversed for further findings concerning Amneal’s disintegrant formulation. With respect to the binder limitation, the Court reversed for a finding of whether hydroxypropyl methylcellulose is present in 1-5% by weight, as a constituent of Opadry.
The opinion can be found here.
ALSO THIS WEEK
Genentech Inc. v. Hospira Inc., Appeal No. 2018-1933 (Fed. Cir. Jan. 10, 2020)
A panel of the court affirmed the PTAB’s finding that a patent directed to methods of purifying certain antibodies and other proteins was invalid as anticipated and obvious. Anticipation of two claims turned on an overlapping temperature range between the claims and the prior art. The prior art range was from 18 to 25 degrees Celsius, and the claimed range was from about 10 to about 18 degrees Celsius. The Board found that the prior art range anticipated the claims and the Federal Circuit affirmed, analyzing its precedent concerning overlapping ranges in the context of anticipation. The Board also held that the claims were invalid as obvious, citing to In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003), which recites the broader standard for assessing overlapping ranges in the context of obviousness. The Court also revisited its holding in Celgene Corp. v. Peter, 931 F.3d 1342, 1356–63 (Fed. Cir. 2019) that the America Invents Act procedures, including IPRs, apply equally to patents issued prior to the passage of that act.
Judge Newman issued a lengthy dissent arguing that the patent is neither anticipated by nor obvious over the prior art, and that the panel had fallen into hindsight in its analysis of the overlapping range issues under both the anticipation and obviousness tests.
The opinion can be found here.
Molon Motor and Coil Corporation v. Nidec Motor Corporation, Appeal No. 2019-1071 (Fed. Cir. Jan. 10, 2020)
In this case, the Federal Circuit affirmed a ruling that the plaintiff was barred from enforcing the asserted patent against the defendant by virtue of a prior covenant not to sue unilaterally delivered to the defendant’s predecessor. At issue was whether the covenant was subsumed by an integration clause in a later settlement agreement between the plaintiff and predecessor, providing that prior “covenants concerning the subject matter hereof” were of no further force or effect. The covenant not to sue concerned the patent at issue on appeal—as well as one other patent owned by plaintiff—and covered all products made, used, or sold in the United States. By contrast, the settlement agreement granted the predecessor an exclusive license to more than a dozen patents and applications—including the patent at issue on appeal—within a narrow market of defined customers. Applying Illinois law, the Federal Circuit rejected plaintiff’s argument that “the subject matter” of the settlement agreement was the right to practice the patent at issue. Instead, the Court found that given the differences in scope and nature between the two instruments, the covenant did not “concern[] the subject matter” of the settlement agreement, and as such remained in effect to bar the plaintiff’s infringement claims.
Judge Reyna dissented, agreeing with the plaintiff that the two instruments involved the same subject matter, i.e., the right to practice the asserted patent, and arguing that because their terms were inconsistent with one another, the settlement agreement was properly interpreted as extinguishing the covenant not to sue.
The opinion can be found here.
Personal Audio, LLC v. CBS Corp., Appeal No. 2018-2256 (Fed. Cir. Jan. 10, 2020)
The Federal Circuit affirmed a dismissal of a district court suit after the parties stipulated to end the litigation following a PTAB determination that the claims were unpatentable. Personal Audio sued CBS in 2013. Later that year, a third party petitioned for an IPR concerning the claims at issue. The Board instituted review, but the district court case proceeded to trial, and a jury found CBS liable and awarded $1.3 million in damages. The Board thereafter issued a final written opinion that the claims were unpatentable, and the parties agreed to stay proceedings in the district court pending disposition of Personal Audio’s appeal from its loss at the PTAB. The Federal Circuit affirmed the PTAB’s finding. The parties thereafter stipulated to judgment in CBS’s favor in the district court. Personal Audio appealed. The Federal Circuit held that any attack on the IPRs was improper, and that any other arguments were forfeited when Personal Audio agreed to entry of judgment against it.
The opinion can be found here.
Hospira, Inc. v. Fresenius Kabi USA, LLC, Appeal Nos. 2019-1329, 2019-1367 (Fed. Cir. Jan. 9, 2020)
In this ANDA infringement case, the Federal Circuit affirmed the judgment of the district court, following a bench trial, that a claimed pharmaceutical composition was obvious over the prior art. The district court’s judgment turned on a determination that a limitation concerning shelf-life stability was inherent in the prior art combination. The Federal Circuit found that the district court did not err in considering data from samples prepared using a method disclosed in the challenged patent, as extrinsic evidence can be used to demonstrate what is “necessarily present” without itself being prior art, and there were no limitations in the challenged claim concerning the manufacturing process to be used. In response to the patentee’s argument that the district court improperly applied a “reasonable expectation of success standard” in its inherency findings, the Federal Circuit found that where the challenger also showed that the limitation was “necessarily present,” it was harmless error for the district court to go on to find that a POSITA would also have had a reasonable expectation of achieving it.
The opinion can be found here.
