A featured document in the Docket Report recently highlighted an Amended Opinion by Judge Cavanaugh of New Jersey:

“The court granted plaintiff’s motion for summary judgment of indirect infringement based on defendants’ use of a label containing “instructions on how to use the product in a manner that encourages acts of infringement” even though “doctors prescribe the drug for a number of non-infringing uses” and defendants used the label only because it was required by the FDA. “Here, the accused infringers will be labeling the product in a manner which encourages direct infringement by others. . . . This objective evidence is critical in determining whether intent to cause infringement exists, and such evidence is sufficient to establish Defendants’ intent.”

Eli Lilly and Co. developed and markets STRATTERA brand atomoxetine capsules.  received a patent on a method of treatment patent, which issued as U.S. Patent No. 5,658,590, entitled “Treatment of Attention-Deficit/Hyperactivity Disorder.”  The ‘590 Patent contains 16 claims. Claim 1 is the only independent claim
and it reads:

“[a] method of treating attention-deficit/hyperactivity disorder comprising administering to a patient in need of such treatment an effective amount of tomoxetine.”

Claims 2-16 recite more particular methods of treating ADHD.  The ‘590 patent does not claim tomoxetine itself.  All claims of the ‘590 Patent require tomoxetine to be administered to (1) a patient in need of treatment and (2) in a so-called “effective” dose. The  patent specification states that the dose administered to the patient “must be set by the physician in charge of the case.”

Lilly contends that each of the Defendants’ act of filing an ANDA constitutes infringement under 35 U.S.C. з 271(e)(2)(A). Lilly further contends that the Defendants intend to commercialize generic atomoxetine products defined in their ANDAs if they receive FDA approval. Lilly argues that the commercialization of generic atomoxetine before the expiration of the ‘590 Patent would constitute further infringement of the ‘590 Patent under 35 U.S.C. 271(a), (b), and/or (c). Defendants asserted that Lilly’s patent is for the treatment of patients by physicians which is something the Defendants do not do. Defendants further argued that 35 U.S.C. з 271(e)(2)(A) does not create a new or independent infringement test and that they did not and cannot infringe Lilly’s patent.

Subsection 271(e)(2)(A) of the Hatch-Waxman Act “provides an ‘artificial’ act of infringement that creates case-or-controversy jurisdiction to enable the resolution of an infringement dispute before the ANDA applicant has actually made or marketed the proposed product.” Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1365 (Fed. Cir. 2003). This provision of the Act is about ripeness and establishing jurisdiction. It is well settled that “the substantive determination whether actual infringement or inducement will take place is determined by traditional patent infringement analysis, just the same as it is in other infringement suits.” Id. Thus, while filing an ANDA is sufficient to trigger an action under 35 U.S.C. 271(e)(2), this subsection “does not determine the ultimate question whether what will be sold will infringe any relevant patent.” Glaxo, Inc. v. Novopharm, Inc., 110 F.3d 1562, 1569 (Fed. Cir. 1997).

Eli Lilly and Company v. Actavis Elizabeth LLC, 2-07-cv-03770 (NJD December 31, 2009, Amended Opinion (Cavanaugh, J.).

Today’s post is by Guest Barista Amy Towell of  Docket Navigator.

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  2. Just a note to write down: Drug companies will NEVER come out with any drug to actually “cure” anything or stop anything. It is not in their business interests to do so. I think “Dead or taking our drugs” is their motto.