ASTRAZENECA LP v. Apotex, Inc.
633 F.3d 1042
| Fed. Cir. | 2010Background
- AstraZeneca owns the '603 and '099 budesonide patents and sought to block Apotex's FDA-approved generic.
- Apotex submitted an ANDA for twice-daily budesonide with a label avoiding once-daily use and downward titration language.
- AstraZeneca moved for a preliminary injunction alleging Apotex would infringe method and kit claims and induce infringement.
- The district court held the asserted kit claims invalid and found the method claims likely to withstand validity challenges, and it found inducement likely.
- The district court also considered the Thorax Thorax advertisement and the '528 Liposome patent in relation to anticipation and the depot-effect theory, and ultimately issued the preliminary injunction.
- The Federal Circuit affirmed the district court’s decision on the injunction and on the kit-claims invalidity; Judge Bryson concurred in part and dissented in part, arguing substantial questions remained about the '603 method claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Likelihood of infringement and validity of method claims | AstraZeneca argues the '603/'099 method claims will be infringed and survive validity challenges. | Apotex argues the '603 method claims are anticipated by the '528 patent and the Thorax ad. | Likely infringing and likely valid; district court correct in construing term and upholding validity against challenges. |
| Inducement of infringement | Apotex's label would induce users to infringe by downward titration to once-daily use. | Apotex asserts no specific intent to induce since FDA mandated language, and labels can be non-infringing. | Affirmed: evidence supports inducement in light of label and Apotex's distribution plans. |
| Irreparable harm | Injunctive relief is necessary due to irreparable harm from potential layoffs, loss of goodwill, and confidential settlements. | Apotex contests the magnitude and calculability of irreparable harm. | Affirmed: district court’s irreparable-harm findings upholding injunction stand. |
| Kit claims patentable weight (printed matter) | Label instructions might render kit claims patentable. | Printed matter in the label is non-functional and does not distinguish the invention. | Kit claims invalid as non-statutory printed matter; no functional relationship to substrate. |
| Anticipation by Thorax advertisement | Thorax ad discloses once-daily dosing, anticipating claims. | 1994 timing and lack of enabling evidence weaken anticipation; not enabling then. | Stayed: district court’s anticipation ruling sustained; not clearly erroneous. |
Key Cases Cited
- Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343 (Fed. Cir. 2001) (preliminary injunction standard and likelihood of success)
- Winter v. NRDC, 555 U.S. 7 (U.S. 2008) (injunction criteria; irreparable harm necessity)
- Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361 (Fed. Cir. 1997) (substantial-question standard for injunction)
- DSU Med. Corp. v. JMS Co., 471 F.3d 1293 (Fed. Cir. 2006) (inducement requires actual knowledge and specific intent)
- Grokster, Ltd. v. MGM, 545 U.S. 913 (U.S. 2005) (advertising and encouraging infringement as inducement)
- Ngai v. 367 F.3d 1336, 367 F.3d 1336 (Fed. Cir. 2004) (printed matter exception; functional relationship requirement)
- In re Ngai, 367 F.3d 1339 (Fed. Cir. 2004) (printed matter rule in kit claims)
- In re Miller, 418 F.2d 1392 (CCPA 1969) (printed matter exception and functional relationship)
- In re Chatfield, 545 F.2d 152 (CCPA 1976) (patent-eligible subject matter; printed matter generally outside §101)
- Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318 (Fed. Cir. 2005) (anticipation without utility requires enablement not needed for §102)
- Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368 (Fed. Cir. 2001) (enablement distinctions in anticipation)