Exela is in a different position. Unlike Apotex, Exela
appeals the district court’s finding that the product pro-
posed in its ANDA infringes Allergan’s patent rights.
The issue turned on pH:
Allergan asserted only the ’834 patent against Exela.
Claims 7 and 16 of that patent recite a 0.15% brimonidine
solution including SCD as a preservative adjusted to a pH of
7.0 or greater. The only issue in this case is whether the
product described in Exela’s ANDA infringes that pH limita-
tion. Both Exela and Allergan agree that the highest pH at
which Exela requests permission to manufacture and sell its
proposed product is 6.7.
There was some conjecture:
The district court reasoned
that Exela would take this 0.5 unit drop in pH into account
when manufacturing its brimonidine formulation. To
produce a product that will maintain a pH greater than 6.5,
the district court concluded that Exela would necessarily
manufacture its product at an infringing pH of 7.0 or above.
Some legal references:
The infringement action is a hypothetical case
that asks the factfinder to determine whether the drug that
will be sold upon approval of the ANDA will infringe the
asserted patent. Bayer AG v. Elan Pharm. Research Corp.,
212 F.3d 1241, 1249 (Fed. Cir. 2000). In Abbott Laborato-
ries v. TorPharm, Inc., we explained that “[b]ecause drug
manufacturers are bound by strict statutory provisions to
sell only those products that comport with the ANDA’s
description of the drug, an ANDA specification defining a
proposed generic drug in a manner that directly addresses
the issue of infringement will control the infringement
inquiry.” 300 F.3d 1367, 1373 (Fed. Cir. 2002).
Excela won: We cannot assume that Exela will not act in full
compliance with its representations to the FDA