Boehringer Ingelheim Pharma Gmbh & Co. Kg v. United States Food and Drug Administration
195 F. Supp. 3d 366
| D.D.C. | 2016Background
- Boehringer owns the ’380 patent covering Pradaxa; FDA granted clinical-trial exemption on Aug 6, 2003 (start of testing phase).
- Boehringer submitted NDA materials on a rolling basis; it represented Dec 15, 2009 as the date the application was “complete.”
- FDA issued a "refuse to file" letter on Feb 12, 2010 citing serious data errors and deficiencies; Boehringer provided multiple supplements and on April 19, 2010 submitted materials the agency deemed sufficient to commence substantive review.
- FDA treated April 19, 2010 as the date the application was "initially submitted" for purposes of 35 U.S.C. § 156(g)(1)(B)(ii), published the regulatory-review-period determination, and notified the PTO; Boehringer sought revision and was denied.
- Boehringer sued under the Administrative Procedure Act challenging the FDA’s date determination (seeking ~62 additional patent-extension days); District Court granted summary judgment to defendants.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Proper meaning of “date an application was initially submitted” under 35 U.S.C. § 156 | "Initially submitted" means the date applicant submits all materials it considers complete (Dec 15, 2009) | Statute is ambiguous; agency may require submission sufficient to commence substantive review | Court: statute ambiguous; defer to FDA under Chevron; FDA’s interpretation reasonable (initially submitted = sufficient for substantive review) |
| Consistency with FDA regulation 21 C.F.R. § 60.22 (definition of "initially submitted") | FDA applied regulation incorrectly; Dec 15, 2009 met the regulation | Regulation defines initial submission as when FDA can commence review; FDA reasonably concluded Dec 15 materials were insufficient | Court: FDA’s interpretation of its regulation entitled to deference and is not plainly erroneous; FDA reasonably found April 19, 2010 controlling |
| Arbitrary and capricious / inconsistent treatment compared to past agency practice | FDA’s decision conflicts with historical practice (relies on 1985 Tonocard decision) | Agency has numerous consistent determinations and explained differences from Tonocard; this case-specific review warranted deference | Court: not arbitrary or capricious; agency explained reasons and treated similar cases consistently where appropriate |
| Scope of judicial review / deference (Chevron / agency expertise) | Court should enforce statutory text as unambiguous | Agency interpretation deserves Chevron deference; substantive assessments of data sufficiency are technical and agency-peculiar | Court: applied Chevron, found ambiguity at step one, upheld FDA under step two and declined to substitute its judgment for agency expertise |
Key Cases Cited
- AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042 (Fed. Cir.) (describes FDA approval/NDA process)
- Astra v. Lehman, 71 F.3d 1578 (Fed. Cir.) (explains regulatory-review-period framework)
- Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077 (D.C. Cir.) (district court reviews agency action as an appellate tribunal)
- FCC v. Fox Television Stations, Inc., 556 U.S. 502 (U.S. 2009) (APA procedural-review principles)
- Motor Vehicle Mfrs. Ass’n v. State Farm, 463 U.S. 29 (U.S. 1983) (arbitrary-and-capricious standard)
- Chevron U.S.A., Inc. v. NRDC, 467 U.S. 837 (U.S. 1984) (two-step framework for agency deference)
- Mead Corp. v. United States, 533 U.S. 218 (U.S. 2001) (when agency interpretations merit Chevron deference)
- Wyeth Holdings Corp. v. Sebelius, 603 F.3d 1291 (Fed. Cir.) (analogous patent-term-extension deference to FDA)