Medicines Co. v. Mylan Inc.
72 F. Supp. 3d 837
N.D. Ill.2014Background
- The Medicines Company (TMC) owns U.S. Patent No. 7,582,727 (the ’727 patent) claiming "pharmaceutical batches" of bivalirudin with specified impurity limits (Asp9 ≤ ~0.6% for claim 1; dependent claims tighten to ~0.4% and ~0.3%; other dependents add D‑Phe12 limit, mannitol carrier, NaOH pH adjustment).
- Mylan submitted an ANDA seeking approval for a generic bivalirudin product with an Asp9 specification up to 2.0% (exhibit batch had 0.194% Asp9); FDA criticized thewide impurity spec and requested tightening; Mylan proposed 1.0% in draft.
- TMC sued under Hatch‑Waxman alleging ANDA infringement of the ’727 patent; bench trial addressed infringement and Mylan’s counterclaims of anticipation (on‑sale), obviousness, non‑enablement, and inequitable conduct.
- The ’727 specification described an "inefficient" Original Angiomax® compounding process (many prior commercial batches) and an "improved/efficient" process that produced lower Asp9 levels in reported batches (Table 6 v. Table 7 data). Some improved batches nonetheless showed elevated Asp9; two failed improved batches prompted investigations.
- The court concluded Mylan failed to prove invalidity or unenforceability by clear and convincing evidence, and held Mylan’s ANDA product infringes the asserted claims as a matter of law under Sunovion because the ANDA sought approval for products within the claimed impurity ranges.
Issues
| Issue | Plaintiff's Argument (TMC) | Defendant's Argument (Mylan) | Held |
|---|---|---|---|
| Anticipation / on‑sale bar (§102(b)) | Original Angiomax® sales pre‑date critical date; some sold batches met claimed Asp9 limits, so claims are anticipated | Sales are of many batches; individual sold batches are not "representative" of all commercial batches required by the claim construction, so no on‑sale bar | Mylan failed to prove by clear and convincing evidence that pre‑critical sales met every claim limitation; no on‑sale anticipation |
| Obviousness (§103) | Prior art (product insert, publications, known deamidation chemistry, and Original Angiomax®) would have motivated a skilled artisan to combine teachings to reach the claimed low‑Asp9 batches | Prior art did not disclose the problem or provide a predictable solution; internal TMC material (problem specification, investigations) is not public prior art; no reasonable expectation of success | Court: prior art did not make invention obvious; Mylan failed to show motivation + reasonable expectation of success; objective indicia did not overcome this conclusion |
| Enablement (§112) | Specification is not enabling across full claim scope because some improved batches (e.g., Lot 1344985) exceeded claimed Asp9 limits; inventors couldn't reliably make claimed batches | Specification and examples (including other experiments) enable a skilled artisan without undue experimentation; failed lots were explainable (operator error, investigation issues) | Mylan did not meet clear and convincing burden to show undue experimentation or inoperability; claims 1,7‑10,17 and 2‑3 are enabled |
| Inequitable conduct | Inventors withheld or misrepresented material facts to the PTO (e.g., Lot 1344985 Asp9 result, misleading Table 6 stats, omitted process details, undisclosed Ben Venue contributions) with intent to deceive | Inventors lacked intent to deceive; omissions were non‑material or explained (ongoing investigations, belief batch was noncompliant, collaborative development), and some disputed items were not public prior art | Court found no clear and convincing evidence of material omission plus specific intent; inequitable conduct defense fails |
| Infringement (§271(e)(2)) | Mylan's ANDA sought approval for batches that can fall within the claimed Asp9 ranges; ANDA + exhibit batch show infringing product so judgment of infringement should follow (relying on Sunovion) | Mylan argued its manufacturing process will likely produce many non‑infringing batches and that internal commitments or process realities should avoid infringement | Court held, following Sunovion, that the ANDA specification allows marketing of product within the claim ranges and thus Mylan infringes as a matter of law; internal process likelihoods or assurances do not avoid infringement under §271(e)(2) |
Key Cases Cited
- Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S. 91 (2011) (patent validity is presumed and clear‑and‑convincing proof is required to overcome presumption)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (flexible, expansive obviousness analysis and role of motivation to combine)
- Pfaff v. Wells Elecs., Inc., 525 U.S. 55 (1998) (two‑part test for on‑sale bar: commercial offer and readiness for patenting)
- Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc) (standards for inequitable conduct: materiality and specific intent to deceive)
- Sunovion Pharm. Inc. v. Teva Pharms. USA, Inc., 731 F.3d 1271 (Fed. Cir. 2013) (ANDA seeking approval for product within claim scope infringes as a matter of law)
- Netscape Commc’ns Corp. v. Konrad, 295 F.3d 1315 (Fed. Cir. 2002) (on‑sale bar requires that the subject of the sale embody every claim limitation)
- In re Wands, 858 F.2d 731 (Fed. Cir. 1988) (factors for determining whether required experimentation renders a disclosure non‑enabling)