In Re Cyclobenzaprine Hydrochloride
794 F. Supp. 2d 517
D. Del.2011Background
- The action involves ANDA filings by Mylan, Barr, Impax, and Anchen to market a generic cyclobenzaprine ER capsule for AMRIX®, owned by Eurand and Anesta.
- Patents at issue are US 7,387,793 ('793) and 7,544,372 ('372) directed to multi-particulate ER cyclobenzaprine formulations and uses.
- Plaintiffs allege infringement; defendants concede some infringement or noninfringement under their claim construction positions.
- The case was consolidated into MDL, bench trial occurred Sept 29–Oct 7, 2010; Impax was later dismissed.
- The court undertook claim construction, then evaluated infringement, validity (obviousness), and related defenses; judgment favored Barr and Mylan infringing under construed terms but the patents were found invalid for obviousness.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Barr and Mylan infringe asserted claims under the court’s construction | Eurand/Barr/Mylan rely on construction aligning with 'about' and PK terms | Barr/Mylan contend noninfringement under their proposed scope | Infringement found for Barr's 30 mg and Barr's 15 mg under respective claims, with Barr's 15 mg under 372 |
| How key terms should be construed | Preambles and terms like 'a multi-particulate' and 'substantially corresponding' should be limited by the claims | Defendants urge narrower or broader readings | Terms construed to reflect ordinary meaning with specification-guided limitations; 'about' = approximately; 'therapeutically effective plasma concentration' = amount to produce therapeutic result |
| Whether the asserted claims were obvious | Invention not obvious; PK/PD profile and extended release were nonobvious | Combination of Urban, 215 patent, and PK data renders obviousness | Claims held obvious; patents invalid for obviousness; secondary considerations insufficient |
| Best mode and inequitable conduct findings | No concealment of best mode; IDS disclosures not proving inequitable conduct | Best mode concealment and inequitable conduct proven | Best mode not violated; inequitable conduct not proven; but overall obviousness invalidates the patents |
Key Cases Cited
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (claims must be read in light of intrinsic record; ordinary skill in the art)
- Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996) (intrinsic evidence governs claim construction)
- Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995) (claim construction is a matter of law)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (U.S. Supreme Court 2007) (obviousness requires motivation to combine and reasonable expectation of success)