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, GENERICally Speaking: A Hatch-Waxman Litigation Bulletin.
Taking on an ANDA patent litigation requires significant corporate resources, time, and money. Staying on top of industry news and outcomes, following trends in the judiciary and the steps others are taking, and keeping informed of recently-enacted rules and legislation are critical.
This bulletin provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation. We hope you find it helpful.
Relevant Court Decisions
- AstraZeneca AB v. Hanmi USA, Inc., Fed. Cir.
Affirming construction of the term “alkaline salt” and judgment of non-infringement based on that construction.
- Galderma Labs., L.P. v. Tolmar, Inc., Fed. Cir.
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.
- Fresenius USA, Inc. v. Baxter International, Inc., Fed. Cir.
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.
- AstraZeneca LP v. Breath Ltd., Fed Cir.
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.
- ViiV Healthcare UK Ltd. v. Lupin Ltd.
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.
- Prometheus Labs. Inc. v. Roxane Labs., Inc.
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.
- The Medicines Co. v. Mylan, Inc.
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.
- Auxilium Pharms, Inc. v. Upsher-Smith Labs., Inc.
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.
- AstraZeneca AB v. Apotex Corp.
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 1603 until October 1607.
- Noven Pharms., Inc. v. Watson Labs., Inc.
On summary judgment, asserted claims held invalid for lack of written description; summary judgment of non-infringement granted.
- Cadence Pharms., Inc. v. Exela Pharms. Sciences, LLC
Finding the asserted patents-in-suit infringed and not invalid.
- Novartis Pharms. Corp. v. Wockhardt USA LLC
Motion to dismiss under Rule 13(b)(6) is appropriate if proposed ANDA product labeling does not include an indication that is covered by the patented method.
- Cephalon, Inc. v. Sun Pharms., Ltd.
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.
- Insite Vision Inc. v. Sandoz Inc.
Patents-in-suit claiming compositions, methods of preparation, and methods of treatment concerning azalide antibiotics were not obvious.
- Auxilium Pharms., Inc. v. FCB I LLC
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.
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