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. 4, No. 2

Summer 2014

The Summer 2014 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:

  • Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc. (Fed. Cir.)
  • Allergan, Inc. v. Apotex, Inc. (Fed Cir)
  • Gilead Sciences, Inc. v. Natco Pharma Ltd. (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
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

Because the district court did not take into account the full scope of the claims of the patent-in-suit, and erred in arriving at the date of conception of the other patent-in-suit, findings of non-obviousness as to both were reversed.
Defendants did not meet their burden of showing that all three patents-in-suit are invalid as obvious, and stipulated to infringement of two of three of those patents.
Following the reversal of the district court’s claim constructions concerning two terms—“clinically significant electrolyte shifts” and “a patient”—summary judgment of infringement was vacated and remanded; findings of patent validity were affirmed.
In order to establish obviousness in cases involving new chemical compounds, the accused infringer usually must identify some reason that would have led a chemist to modify a “lead compound.” In this case, such modification was minor and obvious.
A consent judgment between branded and the generic drug manufacturers in the underlying patent litigation is not entitled to Noerr-Pennington immunity from antitrust claims.
Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date
An earlier-expiring patent may qualify as an obviousness-type double patenting reference for a later-expiring patent under certain circumstances.
Finding of obviousness affirmed when it would have been obvious to select a once-monthly oral dosing regimen of ibandronate to treat osteoporosis and to set that dose at 150 mg.
FDA’s decision to treat an original and its reissued patent as having a single bundle of rights for purposes of generic exclusivity was reasonable, therefore Mylan’s motion for preliminary injunction was denied.
Asserted claims found infringed based on presence of antioxidant and free radical generators creating an oxidative environment susceptible to degradation, and not obvious because a lack of motivation to combine prior art references.
The asserted claim was obvious because all of its elements were in the prior art.
Plaintiffs motion to dismiss counterclaims relating to two patents for which they have given a covenant not to sue was denied because covenant does not render counterclaims moot; defendant’s cross motion for judgment on the pleadings with regard the same two patents was denied as moot because plaintiffs were afforded leave to amend their claims.
District court did not have subject matter jurisdiction in a case where NDA holder sued 505(b)(2) applicant, which had not yet received FDA approval, and in the absence of a paragraph IV certification, NDA holder’s case may be dismissed for failure to state a claim upon which relief could be based.
Because the patented combination was more effective than the prior art, the Federal Circuit found that substantial evidence supported a jury finding of validity.
A subset of the 18 patents-in-suit and over 400 asserted claims are found to be infringed and valid on summary judgment.
Summary judgment of non-infringement denied because amended ANDA label may still implicitly instruct physician and patients to practice claimed limitation.
Motion for summary judgment of invalidity based on anticipation denied because there were fact questions that must be resolved by a fact-finder.

Vol. 4, No. 1

Spring 2014

Vol. 4, No. 4

Winter 2014