Ineffective Skinny Label Leaves Generic Liable Despite Effort to Carve Out the Patented Indication
In Glaxosmithkline LLC v. Teva Pharmaceuticals Usa, Inc., Appeal No. 18-1976, the Federal Circuit held that substantial evidence supported the jury verdict of induced infringement when testimony indicated that a generic failed to carve out a potentially infringing use from a label and the generic’s advertisements provided further evidence of an intent to encourage the patented use.
GlaxoSmithKline (GSK) sued Teva for inducing patent infringement based on Teva’s sale of generic carvedilol. GSK’s carvedilol product is approved, inter alia, for treating congestive heart failure (CHF) and left ventricle dysfunction (LVD). The patent at issue related to the use of carvedilol to treat CHF and GSK represented to the FDA that this patent covered the treatment of CHF. Teva’s label for generic carvedilol included the LVD indication but it excluded the CHF indication by seeking a “skinny label” that carved the CHF indication from the label. The jury returned a verdict for GSK, finding that Teva’s skinny label induced infringement of the patented treatment of CHF. The district court, however, granted Teva’s JMOL motion of no inducement based on a lack of evidence that Teva actually caused physicians to directly infringe the patented use for treating CHF. On appeal, the Federal Circuit reversed, finding that there was substantial evidence to support the jury’s verdict on infringement. Teva filed a motion for en banc review, which the original panel construed as a request for panel rehearing that it granted.
On panel rehearing, the Federal Circuit again reinstated the jury’s verdict. The Federal Circuit held that substantial evidence supported the jury’s factual finding that Teva’s attempt to carve-out the patented use with a skinny label was ineffective. In particular, the court found that the jury was entitled to credit expert testimony explaining that the LVD indication along with additional sections of Teva’s label disclosed each of the claim limitations, and that Teva’s label, marketing materials, and press releases constituted substantial evidence from which the jury could reasonably infer an intent to encourage infringement. The Federal Circuit further noted that GSK’s representations to the FDA concerning the scope of the patent were not fully dispositive of infringement. However, the court indicated that issues of fact remained regarding Teva’s contention that these representations were at odds with GSK’s infringement allegations and remanded to the district court to consider Teva’s arguments concerning equitable estoppel.
Judge Prost dissented, arguing that the majority weakened the intentional-encouragement requirement of induced infringement, eviscerated the requirement to prove causation for inducement, and has created confusion as to the “skinny label” practice for generic drugs.
Clear Intrinsic Evidence Forecloses Extrinsic Evidence of Special Meaning
In Seabed Geosolutions (US) Inc. v. Magseis Ff LLC, Appeal No. 20-1237, the Federal Circuit held that where a claim term’s meaning is clear from the intrinsic evidence, no extrinsic evidence of special meaning is considered.
Seabed filed a petition for inter partes review challenging certain claims of Magseis’ patent related to seismometers. The Board issued a final written decision finding that Seabed failed to prove that the challenged claims were anticipated or obvious. The Board based its decision on its construction of “geophone internally fixed within [the] housing” as requiring a “non-gimbaled geophone.” Seabed appealed.
On appeal, Seabed argued that the Board erred in its construction of the geophone limitation by relying on extrinsic evidence of a special meaning of “fixed” in the relevant art. The Federal Circuit agreed, stating that clear intrinsic evidence precluded consideration of extrinsic evidence. The Federal Circuit first looked to the claim language, noting that the language surrounding the term “fixed” supported a plain and ordinary meaning of “mounted or fastened.” The Federal Circuit then looked at the specification, which described mounting the geophone inside the seismometer’s housing as a key feature, but did not mention anything about the geophone being gimbaled or non-gimbaled. Lastly, the Federal Circuit explained that each time the word “fixed” came up in the prosecution history, both the applicant and the examiner understood it as meaning “mounted or fastened.” Thus, the Federal Circuit held that the ordinary meaning of “fixed” applied, i.e., attached or fastened, and this ordinary meaning did not exclude gimbaled geophones. Accordingly, the Federal Circuit vacated and remanded for the Board to consider anticipation and obviousness under the correct construction.
One Abstract Idea + Another Abstract Idea = An Abstract Idea
In Re PersonalWeb Technologies LLC, Appeal No. 20-1543, the Federal Circuit held that a patent directed to a medley of mental processes with no inventive concept is patent ineligible under 35 U.S.C. § 101.
PersonalWeb sued EMC, VMware, Facebook, Google, and YouTube for patent infringement of three patents. The patents are directed to data-processing systems that assign unique names to data items based on the data’s content, referred to as content-based identifiers. The defendants moved for judgment on the pleadings that the patents were patent ineligible under 35 U.S.C. § 101. The district court found that the patents were directed to a three-step process of 1) receiving a content-based identifier, 2) comparing that content-based identifier against something else such as another content-based identifier or a request for data, and 3) providing access to, denying access to, or deleting data. The district court found that the claims were patent ineligible under 35 U.S.C. § 101 after applying the two-step framework in Alice.
The Federal Circuit affirmed. The Federal Circuit held that each step of the claimed three-step process was an abstract idea of a mental process. Although step one in Alice looks at the claims as a whole, the Federal Circuit held that adding one abstract idea to another abstract idea merely amounts to yet another abstract idea. Proceeding with step two in Alice, the Federal Circuit held that any improvements purported by PersonalWeb that could transform the claim into a patent-eligible application were merely restatements of the abstract ideas of the claims themselves. As such, the claims failed step two by lacking an inventive concept that was significantly more than the abstract idea itself. The Federal Circuit agreed with the district dourt that there was nothing inventive about any claim details, individually or in combination, that was not itself abstract.