GENERICally Speaking Hatch Waxman Bulletin

The Hatch-Waxman Litigation practice group at Robins Kaplan LLP is pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the generics business.

Vol. 3, No. 4

Winter 2013

The Winter 2013 issue of the GENERICally Speaking email campaign provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation.

Relevant court decisions highlighted in this issue:

  • AstraZeneca AB v. Hanmi USA, Inc., Fed. Cir.
  • Galderma Labs., L.P. v. Tolmar, Inc., Fed. Cir.
  • Fresenius USA, Inc. v. Baxter International, Inc., Fed. Cir.

Read more about these and other important court decisions, New ANDA Cases, ANDA Litigation Settlements, ANDA Approvals, and Generic Launches.

Oren D. Langer


Managing Partner, New York Office

In the context of a hypothetical negotiation, the court found that AstraZeneca would be entitled to 50% of Apotex’s profits resulting from its infringing at-risk launch of generic omeprazole from November 2003 until October 2007.
Affirming construction of the term “alkaline salt” and judgment of non-infringement based on that construction.
The district court’s non-infringement holding was remanded in view of a different claim construction; its holding that the asserted claims were invalid as obvious was affirmed.
Finding that defendants’ allegations meet the “but-for materiality” and “intent to deceive” prerequisites of an inequitable conduct claim, the court granted the instant motion to amend.
Plaintiffs cannot use the doctrine of equivalents to reach beyond what is claimed and described in the patents-in-suit, therefore summary judgment of non-infringement was appropriate.
Finding the asserted patents-in-suit infringed and not invalid.
The Federal Circuit’s decision in Seagate did not create any pleading requirement above and beyond that established under Fed. R. Civ. P. 8, nor did it create a per se rule that a plaintiff could never succeed on a willful infringement claim if it was denied a preliminary injunction.
After the Federal Circuit’s finding of infringement and validity, a subsequent Federal Circuit affirmance of the PTO’s rejection of the same claims trumps the Federal Circuit’s first ruling.
Because the prior art combination disclosed each and every element of the asserted patents, and the district court’s findings concerning secondary considerations were erroneous, the district court’s finding of non-obviousness was reversed on appeal.
Patents-in-suit claiming compositions, methods of preparation, and methods of treatment concerning azalide antibiotics were not obvious.
Motion to dismiss under Rule 12(b)(6) is appropriate if proposed ANDA product labeling does not include an indication that is covered by the patented method.
On summary judgment, asserted claims held invalid for lack of written description; summary judgment of non-infringement granted.
Section 305 requires that the patent applicant subjectively believes that he or she is submitting prior art to the USPTO and that such belief is objectively reasonable.
When a claim element in a product-by-process patent requires “efficient mixing” and the ANDA product is formulated by “inefficient mixing,” the ANDA product cannot infringe as a matter of law. Filing of an ANDA, in the absence of any other activities on the part of the Defendant, could not support a finding of willful infringement.
ANDA product did not infringe asserted claims because it used abacavir in a salt form, not abacavir in its free base or pure form; invention is not obvious because there was very little about anti-HIV therapy that could be described as predictable at the time of the invention.
Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date

Vol. 3, No. 1

Spring 2013

Vol. 3, No. 2

Summer 2013

Vol. 3, No. 3

Fall 2013