397 F.Supp.3d 579
D. Del.2019Background
- Vectura sued GlaxoSmithKline (GSK) alleging direct infringement of claim 3 of U.S. Patent No. 8,303,991, which claims composite active particles (CAPs) for pulmonary administration where the additive is magnesium stearate and "promotes dispersion" upon actuation.
- The court construed key terms: the dispersion limitation requires increased dispersion versus unmodified active particles; "composite active particles" (CAPs) means a single particulate entity with additive fixed to active such that they do not separate in the airstream.
- After a five‑day jury trial, the jury found infringement of claim 3, no obviousness, willful infringement, and awarded an ongoing 3% royalty totaling $89,712,069 through Dec. 31, 2018.
- GSK moved post‑trial for JMOL or a new trial on noninfringement, obviousness, willfulness, and damages (including challenges to expert apportionment and prejudice from repeated revenue references).
- Plaintiff relied on comparative dispersion testing (Study 2) and analytical evidence (SEM‑EDX, ToF‑SIMS, SPAMS) to show CAPs and dispersion; Plaintiff also introduced secondary considerations (Novartis license) and evidence about contemporaneous safety concerns regarding magnesium stearate.
- The court denied GSK's motions, finding substantial evidence supported the jury on infringement, nonobviousness, willfulness, and damages, and that trial conduct did not warrant a new trial.
Issues
| Issue | Vectura's Argument | GSK's Argument | Held |
|---|---|---|---|
| Infringement — dispersion limitation | Study 2 and expert testimony showed increased dispersion attributable to CAPs; circumstantial evidence suffices | No direct comparative testing of accused products; Study 2 not representative | Denied JMOL; jury could credit Study 2 and expert testimony as sufficient circumstantial evidence |
| Infringement — CAPs ("fixed" additive) | Analytical tests proved magnesium stearate was fixed to actives and did not separate in airstream | Evidence only showed "co‑association," not fixed attachment per claim construction | Denied JMOL; SEM‑EDX, ToF‑SIMS, SPAMS testimony provided substantial evidence of CAPs |
| Obviousness | Secondary considerations and technical distinctions (e.g., hydrophilic colloidal silica vs. hydrophobic magnesium stearate) rebut motivation to combine prior art | Prior art (Kawashima, Fults, Musa) disclosed CAPs or magnesium stearate uses; would have motivated combination | Denied JMOL and new trial; jury reasonably could find no clear and convincing proof of obviousness and give weight to secondary considerations |
| Willful infringement | Evidence of pre‑suit contacts, internal testing, and GSK's knowledge supported subjective recklessness | Jury instruction and evidence insufficient to show willfulness | Denied JMOL/new trial; instruction proper and record contained substantial evidence of subjective willfulness |
| Damages — apportionment & prejudice | Reasonable‑royalty expert relied on comparable licenses and total sales base; testimony addressed comparability | Expert failed to apportion patented feature; repeated references to "billions" prejudiced jury | Denied new trial; expert's license‑based approach acceptable and overall revenue was a permissible base here; references not so prejudicial as to warrant retrial |
Key Cases Cited
- Marra v. Phila. Housing Auth., 497 F.3d 286 (3d Cir. 2007) (standard for reviewing JMOL motions and deference to jury verdict)
- Pannu v. Iolab Corp., 155 F.3d 1344 (Fed. Cir. 1998) (standard for renewed JMOL after jury trial in patent cases)
- Perkin‑Elmer Corp. v. Computervision Corp., 732 F.2d 888 (Fed. Cir. 1984) (definition of substantial evidence)
- Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995) (claim construction followed by infringement fact‑finding)
- Kahn v. General Motors Corp., 135 F.3d 1472 (Fed. Cir. 1998) (literal infringement requires every claim limitation present)
- Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241 (Fed. Cir. 2000) (JMOL of noninfringement requires at least one missing claim limitation)
- Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363 (Fed. Cir. 2009) (circumstantial evidence can satisfy functional claim comparison requirement)
- Halo Electronics, Inc. v. Pulse Electronics, Inc., 136 S. Ct. 1923 (2016) (standard for enhanced damages and focus on subjective willfulness)
- KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) (framework for obviousness analysis)
- Uniloc USA, Inc. v. Microsoft Corp., 632 F.3d 1292 (Fed. Cir. 2011) (caution against using entire market value to skew jury damages assessment)
- Laser Dynamics, Inc. v. Quanta Computer, Inc., 694 F.3d 51 (Fed. Cir. 2012) (warning about admission of overall revenues and jury distortion)
- Commonwealth Sci. & Res. Org. v. Cisco Sys. Inc., 809 F.3d 1295 (Fed. Cir. 2015) (license‑comparison approach to reasonable royalty is permissible when licenses are comparable)
- ResQNet.com, Inc. v. Lansa, Inc., 594 F.3d 860 (Fed. Cir. 2010) (need to tie damages proof to the patent's market footprint)