MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC.
3:15-cv-06075
| D.N.J. | Sep 29, 2017Background
- Merck sued Actavis under 35 U.S.C. § 271(e)(2) after Actavis filed an ANDA with a Paragraph IV certification challenging Merck’s U.S. Patent No. 5,661,151 (the ’151 patent) covering posaconazole (Noxafil®). The dispute proceeded to a seven‑day bench trial in July 2017.
- Actavis defended by arguing claim 11 (the posaconazole compound) is inherently anticipated by European Patent Application EP 0 539 938 A1 (EP ’938) and that claim 12 (a pharmaceutical composition containing posaconazole) is obvious in view of EP ’938. The parties later stipulated that claim 12 is not inherently anticipated.
- Merck countered that the inventive concepts were conceived on April 14, 1993 and diligently reduced to practice thereafter, antedating EP ’938 (published May 5, 1993), so EP ’938 is not prior art under pre‑AIA § 102(a).
- The court focused on conception, possession of an operative method to make posaconazole, actual/constructive reduction to practice, and diligence between conception and reduction to practice under pre‑AIA law (this case arose before the AIA effective date).
- Key factual findings: Schering scientists identified a metabolite (Metabolite A) in April 1993; contemporaneous lab notes and internal documents show a conceived structure on April 14, 1993; racemic mixtures containing posaconazole were synthesized by May 26, 1993 and pure posaconazole was synthesized in August 1993; Merck demonstrated corroborating contemporaneous documentation and continual work.
Issues
| Issue | Plaintiff's Argument (Merck) | Defendant's Argument (Actavis) | Held |
|---|---|---|---|
| Whether Merck can antedate EP ’938 under pre‑AIA §102(a) by showing conception before May 5, 1993 and diligent reduction to practice | Merck: inventors conceived posaconazole on April 14, 1993, had an operable route to synthesize it, and exercised diligence to reduce to practice (racemate by May 26; pure by Aug 20) | Actavis: inventors lacked corroborated operable method on April 14; initial work produced racemates not the claimed pure stereoisomer; reduction to practice dates post‑date EP ’938 and involved extensive nonroutine chemistry | Held for Merck: court finds conception on April 14, 1993, corroboration of an operable route, and sufficient diligence; EP ’938 antedated and not prior art |
| Whether claim 11 is inherently anticipated by EP ’938 (if EP ’938 is prior art) | Merck: EP ’938 is not prior art once antedated; even if considered, Actavis failed clear-and-convincing proof of inherent anticipation | Actavis: EP ’938 discloses Compound IIc which inevitably metabolizes to posaconazole in mice, making posaconazole inherently disclosed | Held: Court did not need to reach a separate anticipation holding because EP ’938 was antedated; claim 11 not invalid under pre‑AIA §102(a) |
| Whether claim 12 is obvious under pre‑AIA §103(a) in view of EP ’938 (if EP ’938 is prior art) | Merck: antedating removes EP ’938 as prior art; secondary considerations and lack of clear-and-convincing proof defeat obviousness | Actavis: a POSA would combine Compound IIc with a carrier with reasonable expectation of success | Held: Because EP ’938 was antedated, Actavis’s obviousness defense fails; claim 12 not invalid under pre‑AIA §103(a) |
| Standard/burden for invalidity challenges based on prior art and antedating | Merck: pre‑AIA rules apply; challenger must prove invalidity by clear and convincing evidence; patentee may antedate §102(a) references via conception/reduction evidence | Actavis: (same burden on challenger) argues Merck’s proof insufficient | Held: Court applied clear‑and‑convincing standard; found Merck met antedating burden under established conception/reduction/diligence law |
Key Cases Cited
- Pfizer, Inc. v. Apotex, 480 F.3d 1348 (Fed. Cir.) (presumption of patent validity; challenger bears clear-and-convincing burden)
- Microsoft Corp. v. i4i Ltd. P’ship, 131 S. Ct. 2238 (U.S. 2011) (clear-and-convincing evidence required to invalidate issued patent)
- In re Steed, 802 F.3d 1311 (Fed. Cir.) (requirements for antedating a prior art reference: possession, documentation, conception/reduction/diligence)
- Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367 (Fed. Cir.) (priority depends on conception and reduction to practice)
- Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272 (Fed. Cir.) (anticipation requires every claim element in single prior art reference, expressly or inherently)
- Graham v. John Deere Co., 383 U.S. 1 (U.S. 1966) (framework for obviousness analysis — Graham factual inquiries)