In re Kerydin (Tavaborole) Topical Solution 5% Patent Litig.
366 F. Supp. 3d 1370
| J.P.M.L. | 2019Background
- Anacor Pharmaceuticals sued 22 generic manufacturers (via 14 ANDAs) alleging infringement of four U.S. patents covering Kerydin (tavaborole) topical solution 5% after paragraph IV ANDA filings under the Hatch‑Waxman framework.
- Three related Hatch‑Waxman actions are pending across two districts: two in the District of Delaware and one in the Northern District of West Virginia.
- Anacor moved under 28 U.S.C. § 1407 to centralize pretrial proceedings in the District of Delaware; most generic defendants in Delaware did not oppose; Mylan (West Virginia defendant) opposed.
- The Judicial Panel on Multidistrict Litigation (JPML) found common factual questions (identical infringement claims and shared patents) and significant risks of inconsistent rulings on claim construction and patent validity.
- JPML determined centralization would conserve resources, avoid overlapping pretrial burdens, and expedite resolution given the regulatory and market stakes for potential generic entry.
- The Panel selected the District of Delaware and Judge Richard G. Andrews as transferee for coordinated or consolidated pretrial proceedings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether to centralize related Hatch‑Waxman cases under 28 U.S.C. § 1407 | Centralize to avoid inconsistent rulings, reduce costs, and efficiently manage complex patent and regulatory issues | Opposed: too few cases to warrant MDL; informal coordination is adequate | Centralization granted: common questions of fact and efficiency justify transfer |
| Adequacy of informal coordination as alternative to MDL | MDL better ensures uniform claim construction/validity rulings and faster, consolidated management | Informal coordination and judge cooperation suffice given small number of actions | Panel rejected informal coordination as inadequate given complexity and stakes |
| Appropriate transferee forum | Delaware: majority of ANDA filers already litigating there; experienced judge available | Mylan favored keeping its West Virginia case local | District of Delaware chosen; Judge Andrews selected for pretrial management |
| Need for speed given Hatch‑Waxman context | Swift coordinated proceedings prevent premature market entry and streamline adjudication of paragraph IV disputes | (Defendants) argued speed can be achieved without MDL | Panel emphasized speed and regulatory context as supporting centralization |
Key Cases Cited
- Teva Pharm. USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010) (describing Hatch‑Waxman paragraph IV ANDA infringement and exclusivity scheme)
- Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (U.S. 1990) (paragraph IV ANDA filings give rise to statutory patent‑infringement jurisdiction)
- In re: Alfuzosin Hydrochloride Patent Litig., 560 F. Supp. 2d 1372 (J.P.M.L. 2008) (centralization of Hatch‑Waxman actions appropriate even with few cases)
- In re: Armodafinil Patent Litig., 755 F. Supp. 2d 1359 (J.P.M.L. 2010) (centralizing two Hatch‑Waxman cases)
- In re: Brimonidine Patent Litig., 507 F. Supp. 2d 1381 (J.P.M.L. 2007) (centralizing Hatch‑Waxman actions)
- In re: Metoprolol Succinate Patent Litig., 329 F. Supp. 2d 1368 (J.P.M.L. 2004) (centralizing Hatch‑Waxman actions)