Overview
A law firm needs to protect its wins and reverse its losses on appeal. We have done that in the past and expect to do that in the future.
FLH offers reliable and cost-effective solutions for our clients’ appellate needs. By developing creative arguments and relying on our experienced team of professionals with highly persuasive writing and oral-advocacy skills, FLH puts forth a winning effort towards achieving a winning result.
Appellate work starts long before filing a notice of appeal. As appellate advocates and advisors, the Appellate Practice Group is involved in many facets of litigation, including:
- Researching complex issues
- Consulting with trial counsel to address discovery and other pretrial issues
- Preparing trial-court briefs on substantive, procedural, and evidentiary issues, including briefs for discovery motions, motions in limine, dispositive motions, and post-trial motions
- Preparing proposed jury instructions
- Working with trial counsel to preserve issues for appeal
- Preparing appellate-court briefs and cert. petitions
- Holding moot courts
- Presenting oral arguments
FLH’s experience in the appellate area is long-standing, especially in cases before the Court of Appeals for the Federal Circuit (CAFC) and the Second Circuit. We possess special expertise in patent, trademark, and trade secret appeals. Our Appellate Practice Group provides clients the representation and advice required to succeed in their appeals, whether seeking a reversal or upholding a successful result in the trial court.
FLH’s Managing Partner, Ed Haug, serves on the Board of Directors for the Federal Circuit Bar Association, a national organization for members of the CAFC bar. As such, he brings to the firm an intimate knowledge of the CAFC, the appellate bar, and its workings.
Our standing among the bench and bar permits us to pursue our clients’ objectives on appeal with credibility.
Recognized for our excellent track record, FLH remains a dedicated partner and trusted advisor, committed to serving our clients with integrity, innovation, vision, and success.
Recent Successes
Hoffman-La Roche Inc. v. Apotex Inc. et. al.
October 11, 2012 - Federal Circuit Affirms District court's Decision Denying a Preliminary Injunction Against Firms Clients, Mylan Inc. and Mylan Pharmaceuticals Inc. (collectively, “Mylan”)
In March 2012, the district court (Chesler, J.), after considering the briefing and conducting a hearing with witnesses, denied Roche’s motion to enjoin Mylan from launching its generic version of Boniva®, Roche’s once-monthly osteoporosis drug. The disputed claims in the two patents at issue were directed to oral dosing regimens of ibandronate-sodium tablets. The district court held that Roche failed to show that at trial it would likely succeed on the merits of its infringement claim.
In affirming the district court, the Federal Circuit noted that Roche’s appeal involved two aspects of the obviousness analysis. First, Roche argued that the district court erred by applying an “obvious to try” standard because the prior art taught multiple possible dosing regimens that yielded unpredictable results. Second, Roche argued that the district court erred by failing to consider Roche’s evidence of unexpected results for the claimed inventions.
As to the first argument, the Federal Circuit noted that the district court carefully evaluated each prior-art reference and the testimony of Roche’s expert. The appellate panel concluded that the district court did not clearly err by finding that these references disclosed every claim limitation and that, while uncertainties remained, the field was trending towards intermittent dosing based on the total-dosing concept (which the patents at issue discussed). As to the second argument, the Federal Circuit observed that the district court expressly found that Roche had failed to detail its secondary considerations position in briefing or substantively point out the pertinent evidence. Consequently, the Federal Circuit held that finding to likewise not be clearly erroneous. Accordingly, the Federal Circuit declined to rule that the district court abused its discretion, and Mylan’s successful opposition of Roche’s preliminary injunction was left undisturbed.
Dey Pharma, LP v. Sunovion Pharm., Inc.
April 16, 2012 — Federal Circuit Affirms District Court’s Judgment of Noninfringement in Favor of Firm Clients, Dey Pharma, LP and Dey, Inc.
In 2008, Dey brought suit against Sunovion seeking a declaratory judgment that its generic levalbuterol product did not infringe U.S. Patent No. 6,451,289, one of six patents listed by Sunovion in the FDA’s Orange Book. In response, Sunovion provided Dey with a covenant not to sue and moved to dismiss the action asserting that Dey lacked subject-matter jurisdiction. The district court denied Sunovion’s motion to dismiss reasoning that the ’289 patent remained a barrier to generic entry because Dey could not obtain FDA approval without a judgment of noninfringement or invalidity with respect to each Orange Book listed patent. The district court subsequently entered a final judgment of noninfringement.
On appeal Sunovion argued that the district court lacked jurisdiction because of certain events that had transpired since the filing of the lawsuit. Specifically, Sunovion noted that: (1) it had entered into a settlement agreement with Breath Ltd., the first ANDA filer for generic levalbuterol, which allowed Breath to launch generic levalbuterol in August 2012; and (2) Dey, as a practical matter, could not obtain a judgment of noninfringement or invalidity with respect to Sunovion’s other Orange Book patents before August 2012. In other words, Sunovion asserted that the court should not allow the current declaratory-judgment action to proceed because Dey’s other lawsuit—challenging Sunovion’s other Orange Book patents—could not be completed before the date of Breath’s potential generic entry.
The Federal Circuit rejected this argument noting that Breath could choose to delay triggering its statutory 180-day exclusivity period thereby delaying generic entry for Dey and other generic companies. In affirming the district court’s decision, the Federal Circuit held that the court would retain subject-matter jurisdiction until Breath sold generic levalbuterol.
The appellate team included Ed Haug, Elizabeth Leff, Steve Amundson, and Sam Desai.
Duramed Pharm., Inc. v. Paddock Labs., Inc.
July 21, 2011 — A unanimous Federal Circuit panel affirmed a finding of summary judgment of noninfringement for FLH client Paddock Laboratories, Inc. against Duramed Pharmaceuticals, Inc. (now known as Teva Women’s Health).
Paddock sought to market a generic version of Duramed’s Cenestin® tablets. Based on Paddock’s paragraph IV certification, Duramed initiated the lawsuit under the Hatch-Waxman Act in March 2009, alleging infringement of U.S. Patent No. 5,908,638 (“the ’638 patent”).
Duramed agreed that the ’638 patent was not literally infringed but asserted infringement under the doctrine of equivalents. Paddock argued that Duramed’s narrowing amendment during prosecution of the ’638 patent gave rise to prosecution history estoppel, which prevented Duramed from asserting the doctrine of equivalents.
In particular, Duramed argued that Paddock’s alleged equivalent—a PVA moisture barrier coating—was unforeseeable at the time of the narrowing amendment and therefore prosecution history should not apply. In June 2010, the district court found that Paddock’s moisture barrier coating was foreseeable at the time of the narrowing amendment and granted summary judgment of noninfringement. The Federal Circuit affirmed. Both the district court and the Federal Circuit relied on a PCT publication that was available before Duramed’s narrowing amendment, which disclosed the exact moisture barrier coating used by Paddock.
The appellate team included Ed Haug, David Zwally, and Andrew Roper.