Alcon Research Ltd. v. Barr Laboratories Inc.
837 F. Supp. 2d 364
D. Del.2011Background
- Alcon sued Par and Barr for patent infringement relating to Travatan and Travatan Z eye drops.
- Four patents at issue: two castor oil (287, 062) and two borate-polyol (497, 253) patents.
- Following a Markman ruling, a bench trial occurred Nov 2011 with Barr as the remaining defendant.
- Barr stipulated it infringed the borate-polyol patents and that those patents were not invalid.
- The castor oil claims were adjudicated with Barr denying infringement and the court evaluating enablement, written description, indefiniteness, anticipation, and obviousness.
- Alcon’s evidence focused on whether Barr’s PECO-containing formulation chemically stabilizes Travoprost; Barr’s product is BAC-free Travatan Z®; Barr settled with Par regarding the borate-polyol patents but remained in dispute on the castor oil patents.
- The court held Barr does not infringe the castor oil claims, but Barr infringes borate-polyol claims and the castor oil claims are not enabled or adequately described; the court also held the castor oil claims are definite and not anticipated or rendered obvious; FDA approval timing is linked to the expiration of the last-expiring borate-polyol patents.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Infringement of castor oil claims by Barr | Alcon contends Barr’s PECO stabilizes Travoprost, infringing Claims 12/19 | Barr argues no chemical stabilization of Travoprost, only physical stability; no infringement | Barr does not infringe castor oil claims |
| Enablement under 35 U.S.C. § 112, first paragraph | The castor oil disclosures enable broad stabilization using PECO | Enablement is lacking due to unpredictable art and limited guidance | Castor oil claims not enabled |
| Written description under 35 U.S.C. § 112, first paragraph | The specification conveys possession of the claimed invention | Written description inadequate for broad castor oil claims | Written description inadequate (fails for lack of sufficient disclosure) |
| Indefiniteness under 35 U.S.C. § 112, second paragraph | Terms are sufficiently definite | Terms like “enhancing the chemical stability” indefinite | Not insolubly ambiguous; terms construed to be definite |
| Anticipation/Obviousness of castor oil claims | Prior art anticipates/renders obvious the PECO-based stabilization | Prior art does not teach the claimed chemical stabilization by PECO; hindsight | Not anticipated or made obvious by clear and convincing evidence |
Key Cases Cited
- Rohm & Haas Co. v. Brotech Corp., 127 F.3d 1089 (Fed.Cir.1997) (burden and framework of infringement with two-step analysis (claim construction then comparison))
- Texas Instruments Inc. v. Cypress Semiconductor Corp., 90 F.3d 1558 (Fed.Cir.1996) (two-step infringement analysis; claim construction first, then comparison)
- Glaxo, Inc. v. Novo Nordisk A/S, 110 F.3d 1562 (Fed.Cir.1997) (ANDA litigation framework for infringement; premarket relief considerations)
- Sitrick v. Dreamworks, LLC, 516 F.3d 993 (Fed.Cir.2008) (written description and enablement considerations; evidentiary standards)
- Pharm. Res., Inc. v. Roxane Labs., Inc., 253 F. App’x 26 (Fed.Cir.2007) (enablement in highly unpredictable arts; multiple embodiments)
- Boston Scientific Corp. v. Johnson & Johnson, 647 F.3d 1353 (Fed.Cir.2011) (enablement/written description framework in complex claims)
- Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed.Cir.2010) (separate written description requirement from enablement; quid pro quo)
- In re Wands, 858 F.2d 731 (Fed.Cir.1988) (8-factor test for enablement)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (Supreme Court 2007) (flexible, expansive approach to obviousness; rejection of rigid TSM)
- Ortho-McNeil Pharma., Inc. v. Mylan Labs., Inc., 520 F.3d 1358 (Fed.Cir.2008) (flexible approach to obviousness; hindsight risk)
- Abbott Labs. v. Baxter Pharm. Prods., Inc., 334 F.3d 1253 (Fed.Cir.2003) (meaning of claim terms; definiteness)
- Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed.Cir.2003) (claim construction and enablement principles)
- Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361 (Fed.Cir.1997) (comparison of claim scope with enabling disclosure)
- Spansion, Inc. v. Intl. Trade Comm’n, 629 F.3d 1331 (Fed.Cir.2010) (definiteness and claim scope considerations)
- Eli Lilly & Co. v. Teva Pharms. USA, Inc., 619 F.3d 1329 (Fed.Cir.2010) (written description jurisprudence)