Replies to post #146792 on Biotech Values

[biomaven0]

>MNTA v. Amphastar

Thanks for posting that link.

My prediction is that this latest ruling will be overturned. It's clearly a significant over-reach that essentially negates all drug-related process patents.

Peter

[mouton29]

In MNTA's brief, their lawyers make this argument:

Amphastar cannot, and does not, dispute
that the conduct at issue in this case is part of a manufacturing quality control
process that it applies to each commercial batch of generic enoxaparin that is sold
after FDA approval. Amph. Br. 8, 43-44, 49. By definition, these tests are not
conducted for the purpose of submitting information to the FDA in order to obtain
FDA approval to sell Amphastar’s generic enoxaparin. Rather, they are conducted
in order to satisfy the FDA’s requirements that each batch of enoxaparin that is\
sold commercially after FDA approval is actually the same as the brand name
drug.

The majority decison in the Federal Circuit calls the last sentence of this a concession:

In this case, Momenta concedes that Amphastar’s
tests “are conducted in order to satisfy the FDA’s requirements that each batch of enoxaparin that is sold commercially after FDA approval is actually the same as the
brand name drug.” Appellee’s Br. at 40-41 (emphasis
added); see also J.A. 56 (allegation that the “FDA requires” the accused testing). Under a proper construction
of 35 U.S.C. § 271(e)(1), the fact that Amphastar’s testing
is carried out to “satisfy the FDA’s requirements” means
it falls within the scope of the safe harbor, even though
the activity is carried out after approval.

The dissent observes:

To facilitate a post-approval, continuous, commercial
use, the court discounts the word “solely.” Indeed,
throughout its opinion, the court cites the language of the
statute yet omits the word “solely.” See Majority Op. 13,
14, 15, 16, 20, 21. If one properly reads “solely” as the
statute says, the result must be that Amphastar’s activity
is not within the statute. Its infringing activity is not
solely for developing and submitting information to the
FDA. Instead, Amphastar uses this method for the purpose of manufacturing a product to sell on the market in
commerce.

In a footnote, the majority responds:

We are puzzled by the dissent’s claim that the use
of the words “solely” and “submitted” require us to limit
the statute to pre-approval activities. This is not the
plain meaning of those words. For example, if the FDA
required post-approval testing with subsequent submission of those test results, those test results were clearly
generated “solely” for an FDA submission and equally
clearly were “submitted” to the agency. “Solely” and
“submitted” in no manner limit § 271(e)(1) to “preapproval testing.”

But the majority ignores the word "solely", i.e., if the testing is for the dual purposes of quality control -- making sure the drug is in fact similar and does not kill patients -- and satisfying the FDA requirements -- is it "solely" for the purposes of submitting information to the FDA?