792 F.Supp.3d 536
D. Del.2025Background
- Novo Nordisk sued Mylan under the Hatch-Waxman Act for alleged infringement of five patents covering its weight loss drug WEGOVY®, focusing on U.S. Patent No. 9,764,003 (#003 patent).
- Mylan filed an ANDA seeking FDA approval to market a generic version of WEGOVY®, prompting Novo’s infringement claims.
- Novo listed or planned to list the asserted patents, including the #003 patent, in the FDA’s Orange Book.
- Mylan moved for judgment on the pleadings under Rule 12(c), seeking a declaration of no infringement (direct, induced, or contributory) with respect to the #003 patent.
- The dispute centered on whether Mylan’s proposed generic label would induce or otherwise constitute infringement under the claimed methods of the #003 patent.
- The court decided the legal issues based on the pleadings and the content of Mylan’s proposed product label, as the generic had not yet been marketed or approved.
Issues
| Issue | Plaintiff’s Argument | Defendant’s Argument | Held |
|---|---|---|---|
| Direct Infringement (Method Claim) | Novo only alleges indirect, not direct, infringement by Mylan. | Mylan cannot directly infringe method claims as it does not treat or administer drugs to patients. | No direct infringement by Mylan. |
| Contributory Infringement | Novo agreed to stipulate to no contributory infringement. | Novo cannot state a claim for contributory infringement; parties should stipulate to this. | No contributory infringement by Mylan. |
| Induced Infringement via Proposed Label | Label warnings indirectly encourage exclusive semaglutide use. | Label does not instruct to avoid all other therapeutic agents, only certain classes or products. | Proposed label does not induce infringement; judgment for Mylan. |
| Need for Further Fact Development (Label Meaning) | Expert evidence needed on label interpretation, factual disputes exist. | No material factual disputes; label interpretation is a legal issue based on its content. | No further fact development needed; label is unambiguous. |
Key Cases Cited
- Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562 (Fed. Cir. 1997) (Section 271(e)(2) creates jurisdiction for prompt litigation of patent infringement and validity in ANDA cases)
- Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316 (Fed. Cir. 2012) (Filing an ANDA for a patented drug is an act of infringement under the statute)
- Microsoft Corp. v. Data Tern, Inc., 755 F.3d 899 (Fed. Cir. 2014) (Active inducement requires affirmative acts encouraging infringement and knowledge thereof)
- AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042 (Fed. Cir. 2010) (ANDA cases focus on whether the proposed generic label would instruct infringement of method claims)
- TEK Global, S.R.L. v. Sealant Systems International, Inc., 920 F.3d 777 (Fed. Cir. 2019) (Accused product must meet all claim limitations to infringe)