Replies to post #157847 on Biotech Values

[mouton29]

Re: MNTA - Solicitor General

This blogger at the regulatory firm, Hyman Phelps thinks the SG would oppose a grant of cert (although he offers no opinion on whether cert will in fact be granted or the outcome if granted):

According to the U.S., although the Federal Circuit “erred in stating that section 271(e)(1)’s safe harbor encompasses only activities undertaken to obtain the FDA’s pre-marketing approval of generic products . . . there is no longer any practical need for theis Court’s intervention in light of the Federal Circuit’s subsequent decision in Momenta.” Moreover, states the U.S., if “postapproval studies involve the use of patented inventions solely for uses reasonably related to the development and submission of information to the FDA, the plain language of Section 271(e)(1) precludes any claim for patent infringement.” (Thus, if the U.S. Solicitor General is asked to file a brief in the Amphastar/Sandoz appeal, it is not difficult to discern what that brief will say.)

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/02/us-supreme-court-asked-to-review-hatch-waxman-safe-harbor-lovenox-method-patent-case.html

He is an FDA regulatory lawyer, not an IP lawyer, but then, I am a tax lawyer. In any event, pedigree aside, I don't find the second quote in the preceding paragraph as indicative of the SG position as he does. Firstly, the quote is part of the SG's argument that the Classen preapproval limit is wrong, so all this is saying is that in appropriate circumstances, 271(e)(1) protects post approval activity. Here is the entire paragraph from the brief:

The court of appeals erred in stating that Section 271(e)(1)'s safe harbor encompasses only activities undertaken to obtain the FDA's pre-marketing approval of generic products. Congress not only contemplated that drug manufacturers would conduct post-approval scientific studies and clinical trials, but specifically authorized the FDA to require such studies in a variety of circumstances. If such post-approval studies involve the use of patented inventions solely for uses reasonably related to the development and submission of information to the FDA, the plain language of Section 271(e)(1) precludes any claim for patent infringement.

Second, the sentence in question has two key qualifications, the use has to be "solely" for the specified uses of development and "submission" of information. The SG spends a fair amount of space discussing both of those limits.

As to the "submitted" requirement, the SG says in a footnote:

The Momenta court additionally held that, for purposes of Section 271(e)(1), information may be deemed "submitted" to FDA if it is preserved in records that FDA regulations require a drug manufacturer to make available for inspection by FDA on request. See 686 F.3d at 1357. We express no view on the correctness of that conclusion or of the court of appeals' ultimate disposition of Momenta.

On the "solely" requirement, the SG says the following:

Section 271(e)(1) states that "t shall not be an act of infringement to make, use, offer to sell, or sell * * * a pa-tented invention * * * solely for uses reasonably related to the development and submission of information" under federal laws regulating drugs. 35 U.S.C. 271(e)(1). The word "solely" indicates that, in applying the safe harbor, the court should focus on the particular "use[]" that is alleged to be an "act of infringement." A particular "use[]" may be "reasonably related to the development and submission of information," and therefore may fall within the safe harbor, even if it serves other purposes as well. Thus, a researcher's use of a patented invention in conducting an experiment reasonably related to the development and submission of information to the FDA is protected by Section 271(e)(1), even if that experiment also advances other commercial objectives, such as product development. See Abtox, Inc. v. Exitron Corp., 122 F.3d 1019, 1030 (Fed. Cir. 1997). By contrast, if a defendant makes multiple "uses" of a patented invention (e.g., by selling a patented drug commercially while simultaneously administering it to research subjects during a controlled study), one "use[]" may provide a basis for infringement liability even though the other falls within the safe harbor. See p. 18, infra.

In the pre-approval context, determining whether a defendant's use of a patented invention in drug-development research was "solely for uses reasonably related to the development and submission of information" [**30] to the FDA will normally be a straightforward inquiry. In the post-approval context, that inquiry [*18] may be substantially more difficult because the drug maker simultaneously may be engaged in the ordinary commercial manufacture and sale of the product in question. In such circumstances, a more nuanced analysis is required. A drug maker's use of a patented invention in routine commercial activity is not immune from infringement liability merely because, for example, the company may periodically report adverse reactions to the FDA. See 21 C.F.R. 314.80 and 600.80. That is because the ordinary commercial exploitation of a patented invention is not "reasonably related to the development and submission of information" for the FDA, even if such exploitation sometimes generates information useful to the FDA. That conclusion is reinforced by the ordinary meaning of the statutory term "development," which implies more than merely the collection of information incidental to commercial transactions.

In some cases, however, post-approval research activities will fall squarely within the ambit of Section 271(e)(1). If the FDA has approved a drug for acne, for example, and its manufacturer separately conducts a clinical trial of the same drug as a treatment for melanoma, the clinical trial (but not the routine sales of the drug for acne treatment) will be protected under the plain terms of the statute. Likewise, if the FDA directs a manufacturer to conduct a clinical trial of a blood pressure drug to determine whether a different dosing regimen would mitigate dangerous side effects of which the agency recently became aware, see 21 U.S.C. 355(o)(3)(A) (Supp. V 2011), that research will be protected from infringement claims by Section 271(e)(1).