Photocure v. Kappos (CAFC 2009-1393) precedential

This case concerns the applicability of the statute governing patent term extension, 35 U.S.C. §156, to the drug product having as its active ingredient the chemical compound methyl aminolevulinate hydrochloride ("MAL hydrochloride"), brand name Metvixia®. The Director of the United States Patent and Trademark Office (PTO) denied the extension, and Photocure sought review in the district court under the Administrative Procedure Act, 5 U.S.C. §702. The United States District Court for the Eastern District of Virginia held that the PTO's ruling was "not in accordance with law," and that the patent on MAL hydrochloride is subject to term extension. The Director appeals, stating that the district court did not correctly define or apply the statutory terms "drug product" and "active ingredient." We affirm the decision of the district court.

The Patent Term Extension statute was enacted in recognition of the lengthy procedures associated with regulatory review of a new drug product, for the patent term continues to run although the product cannot be sold or used until authorized by the Food and Drug Administration (FDA). The statute was designed to restore a portion of the patent life lost during the period of regulatory review, in order to preserve the economic incentive for development of new therapeutic products. See H.R. Rep. No. 98-857, at 15 (1984), reprinted in 1984 U.S.C.C.A.N. 2647, 2670 (discussing policy purposes of patent term extension). The following provisions are relevant to this case:

35 U.S.C. §156(a) The term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended in accordance with this section . . . , if--
* * * *
(a)(4) the product has been subject to a regulatory review period before its commercial marketing or use;
(a)(5)(A) except as provided in subparagraph (B) or (C) [not here relevant], the permission for the commercial marketing or use of the product after such regulatory review period is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred;
* * * *
§156(f) For purposes of this section:
(1) The term "product" means:
(A) A drug product.
* * * *
(2) The term "drug product" means the active ingredient of--
(A) a new drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act), . . .
including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.

MAL hydrochloride was a new chemical compound, and was patented in U.S. Patent No. 6,034,267 ("the '267 patent") on the basis of its improved therapeutic properties as compared with the known compound aminolevulinic acid hydrochloride ("ALA hydrochloride").

The product containing MAL hydrochloride was a "new drug" in terms of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §321(p), and required full FDA approval. The clinical and other tests for demonstration of safety and efficacy of the MAL hydrochloride product consumed four and a half years. After FDA approval was received, Photocure applied for the statutory extension of the term of the '267 patent.

The PTO denied the request, on the grounds that the what the FDA considered new was actually old.

The PTO then denied the requested term extension, stating that "active ingredient" in §156(f)(2) does not mean the product that was approved by the FDA, but rather means the "active moiety" of that product. The PTO held that MAL hydrochloride is the "same 'product'" as ALA hydrochloride because the "underlying molecule" of MAL is ALA, and the PTO stated that "ALA is simply formulated differently in the two different drugs." Final Decision Regarding Patent Term Extension Application Under 35 U.S.C. §156 For U.S. Patent No. 6,034,267 at 3, 5 (May 13, 2008). The PTO held that since a drug product containing ALA hydrochloride was previously approved by the FDA, the FDA's marketing approval of the MAL hydrochloride product was not the first commercial marketing or use of that "product."

By contrast to the PTO, the courts took reality into account.

Applying the provisions of the patent term extension statute, the district court considered the separate chemical composition, the separate patentability, and the separate FDA approval of MAL, and held that MAL hydrochloride is the active ingredient of a new drug product that required FDA approval, §156(f)(2)(A); that the MAL hydrochloride product was subject to a full regulatory review period before commercial marketing and use was permitted, §156(a)(4); that this review permitted the first commercial marketing and use of the MAL hydrochloride product, §156(a)(5)(A); and therefore that the statutory requirements for term extension were met.

Affirmed.

Wyeth v. U.S. (Health & Human Services, FDA, USPTO) (CAFC 2009-1368) precedential

New animal drugs must receive FDA approval before they can be commercially marketed. Because the regulatory process often spans several years, in 1988 Congress provided for patent term extensions to restore patent life lost during FDA's review of new animal drugs. See Generic Animal Drug and Patent Term Restoration Act, Pub. L. No. 100-670, 102 Stat. 3971 (1988). Regulatory review proceeds in two phases: a testing phase followed by an approval phase. The shift from the testing to the approval phase occurs when a sponsor "initially submit[s]" an application for approval of a new animal drug. See 35 U.S.C. § 156(g). A patent holder may obtain an extension equal to half of the duration of the testing phase plus the entire duration of the approval phase, not to exceed five years, exclusive of any regulatory review period occurring before the patent issues. See 35 U.S.C. § 156(c), (g)(6). Thus, the date on which a sponsor initially submits an application marks the beginning of the approval phase and directly affects the length of a patent term extension. At issue on appeal is the proper determination of that date in FDA's phased review process.

The first phase of regulatory review, the testing phase, begins when the sponsor obtains FDA's permission to begin clinical testing of the drug or initiates a major health or environmental effects test, whichever is earlier. See 35 U.S.C. § 156(g)(4)(B)(i); see also 21 C.F.R. § 60.22(d)(1). During the testing phase, the sponsor submits investigational data to FDA, which FDA files in an Investigational New Animal Drug (INAD) file.

The testing phase ends, and the approval phase begins, when the sponsor submits a New Animal Drug Application (NADA) to FDA. See 35 U.S.C. § 156(g)(4)(B)(ii); see also 21 C.F.R. § 60.22(d)(2). The NADA must contain the information required by 21 U.S.C. § 360b(b) and the corresponding FDA regulation, 21 C.F.R. § 514.1(b). Section 360b(b) requires, among other things, full reports of investigations concerning the safety and efficacy of the drug, a description of the methods and facilities used to manufacture the drug, and a description of a method to determine the quantity of the drug that winds up in food. 21 U.S.C. § 360b(b)(1).

In the traditional regulatory review process, determining the date that a sponsor submits a NADA is straightforward: the sponsor gathers all of the information required by § 360b(b) and sends it all to FDA in a single submission, and this is the date that the application is initially submitted. FDA may require additional information from the sponsor in support of the NADA; but minor amendments will not affect the "initially submitted" date or the onset of the approval phase.

In 1989, FDA began offering sponsors the choice of "phased review." In phased review, rather than gathering the information required by § 360b(b) and submitting it to FDA in one package, the sponsor may submit various technical sections directly to the section of FDA's Center for Veterinary Medicine (CVM) responsible for evaluating the technical material. FDA treats technical sections as submissions to the INAD file. As of 1995, FDA recognized six technical sections: (1) Effectiveness, (2) Environmental Safety, (3) Manufacturing Methods and Controls, (4) Public Safety, (5) Residue Chemistry and Regulatory Methods, and (6) Target Animal Safety. Center for Veterinary Medicine Document Submission Information - An Update, 14 (Apr. 1995, as modified Nov. 1995) (CVM Phased Review Policy). FDA reviews the technical sections on a concurrent as-received basis. In addition, "[w]ith prior agreement, the sponsor may request review of less than one of the [technical sections] listed above." Id. at 14. Thus, sponsors may submit technical sections as they are completed or, by agreement, they may submit "useful pieces of technical sections." Id. at 13. When FDA completes its review of a technical section, it sends the sponsor a "complete letter" for that section. Once the sponsor compiles all of its complete letters, it may submit an administrative NADA. The administrative NADA incorporates by reference all of the complete letters and contains additional administrative information. In phased review, FDA marks the beginning of the approval phase as the date that the sponsor submits the administrative NADA.

FDA described phased review as a more "streamlined" process than traditional review.

When a sponsor opts for phased review, it may switch over to traditional review by filing a NADA. As explained by FDA, "[m]ost sponsors find it useful to use the more fluid INAD structure during early development and, as more of the data is acceptable to CVM [Center for Veterinary Medicine], an NADA is filed." Id. at 2. The NADA may incorporate by reference any complete letters that the sponsor has already received. Id.

Once FDA receives a NADA (either traditional or administrative), it evaluates the application and determines whether to approve the drug. Filing an administrative NADA will generally result in a much shorter approval period because FDA has already completed review of the technical sections.

Wyeth sought FDA approval for a parasite treatment for cattle (4,916,154), a review process that lasted eight years. Upon that, the FDA granted an extension. Not enough, cried Wyeth.

Wyeth asked FDA to revise its determination of the regulatory review period. Wyeth reiterated its position that it had initially submitted its NADA on August 8, 1995, when it submitted its first technical section (Residue Chemistry). Wyeth reasoned that at that point, FDA had sufficient information to commence its review.

FDA denied Wyeth's request. It set forth its position that "the approval phase for purposes of patent term extension begins when the marketing application is complete, including all technical sections and the CVM complete letters." J.A. 232... FDA therefore concluded that the approval phase in phased review begins with the submission of an administrative NADA.

Wyeth took the FDA to district court and lost.

Government being government, rules are at times clear as mud.

The district court concluded that the date an application is initially submitted for purposes of 35 U.S.C. § 156(g) is ambiguous.

To which the CAFC agreed.

Whereupon the FDA gets to set its own metric, as "a court must defer to an agency's reasonable interpretation of a statute and must not substitute its own judgment for that of the agency even if the court might have preferred another interpretation and even if the agency's interpretation is not the only reasonable one." Wheatland Tube Co. v. United States, 495 F.3d 1355, 1360-61 (Fed. Cir. 2007).

FDA - okay. Affirmed.

Ortho-McNeil Pharmaceutical  & Daiichi Sankyo v. Lupin Pharmaceuticals (CAFC 2009-1362) precedential

'407 is exclusively licensed to Ortho-McNeil Pharmaceutical (owned by Daiichi Sankyo).

Besides upholding the patent term extension, the "district court enjoined Lupin from infringement during the extended term of the patent."

We affirm the district court's ruling that the '407 patent on levofloxacin was properly granted the statutory term extension, for the enantiomer is a different drug product from the racemate ofloxacin, and was subject to regulatory approval before it could be commercially marketed and used.

Affirmed.