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Pharmaceutical Litigation

Whether you are contemplating filing a lawsuit or have just been sued, selecting the right counsel is critical.  It is particularly important in an  IP-related case because of the inherent complexity of the subject matter.  And, we know that in today’s competitive marketplace, it is imperative to knock down the obstacles that keep your products from gaining entry as quickly as possible.

What sets Sterne Kessler apart is its integrated trial team, which brings together a deep bench of experienced litigators, technical experts, and attorneys and agents with specialized patent law knowledge to provide you with a fully synchronized approach to your case.  Sterne Kessler professionals hold nearly 50 Ph.D.’s and 30 Master’s degrees in substantive technical fields like Organic Chemistry, Medicinal Chemistry, Biochemistry and Molecular and Cell Biology.   Our ANDA expertise includes over 50 Paragraph IV filings and over 500 opinions.

In pharmaceutical litigation matters, we provide early and ongoing analysis of the relevant patents, prior art, and products involved.  And, we formulate strong positions on invalidity, non-infringement and claim construction at the outset of the litigation, ensuring that our tactics advance the defined set of goals. 

Sterne Kessler represents both brand and generic pharmaceutical companies involved in experimental and prescription drugs and biologics.

Our team has litigated dozens of pharmaceutical cases including:

  • Takeda Pharmaceuticals Co. v. Torrent Pharmaceuticals Ltd., et al. (SDNY) (currently representing Torrent Pharmaceuticals in Abbreviated New Drug Application (ANDA) case involving pioglitazone (ACTOS®))
  • AstraZeneca Pharmaceuticals LP v. Intas Pharmaceutical Ltd., (D. NJ) (currently representing Intas Pharmaceuticals and Accord Healthcare in ANDA case involving quetiapine fumarate (SEROQUEL®))
  • GlaxoSmithKline v. Glenmark Generics, Inc. (D. Del) (currently representing Glenmark Generics, Inc. in ANDA case involving atovaquone / proguanil (MALARONE®))
  • Teva v. Glenmark Pharmaceuticals, Inc. (D. NJ) (lead counsel for Glenmark in patent case involving carvedilol)
  • Teva v. Matrix Laboratories (D. NJ) (lead counsel for Matrix Laboratories in patent case involving sertraline)
  • Nutrition 21, Inc. et al. v. General Nutrition Company (E.D. Tex) (lead counsel for Nutrition 21 in patent case involving chromium picolinate)
  • Administrators of Tulane University v. Debio Holding SA, et al. (USDC ED La) (lead counsel for Debio Holding)

We have acted as co-counsel in Hatch Waxman cases involving:

  • Cholesterol drugs
  • Blood pressure drugs
  • Sleep aides
  • Chemotherapeutics
  • Urinary agents
  • ADHD drugs
  • Approved biologics
  • Respiratory disorder and asthma drugs
  • Dermatological drugs
  • Analgesics
  • Antihistamines
  • Mental disorder drugs
  • Treatments in the form of patches, creams, suspensions, topicals, orals, injectables, rings, suppositories and ODTs, to name a few

Specific examples include:

  • Merck & Co. v. Barr Laboratories, Inc. (FOSAMAX®)
  • Schering AG and Berlex, Inc. v. Barr Laboratories, Inc. (YASMIN®)
  • Pfizer v. Eli Lilly (Cialis®)
  • Chiron v. Eli Lilly (HCV Therapeutic)
  • Glaxo Smith Kline v. Apotex et al. (Paxil®)
  • Cancer Research Technology Ltd. and Schering Corp. v. Barr Laboratories, Inc. and Barr Pharmaceuticals, Inc. (TEMODAR®)
  • Minnesota Mining and Manufacturing, Riker Laboratories, Inc. and Alphapharm PTY. LTD. v. Barr Laboratories, Inc. (TAMBOCOR®)

(1) Success Stories

  • Alembic Pharmaceuticals Limited

    Cleared the Way for Generic Drug

    Successfully represented Alembic in defeating a motion for a preliminary injunction and temporary restraining order brought by Otsuka Pharmaceuticals. We overcame multiple grounds including claim construction, direct infringement, induced infringement, invalidity, immediate and irreparable harm, balance of hardships, and the public interest factors. The decision is significant, clearing the way for Alembic to launch a generic version of Otsuka's multi-billion dollar blockbuster drug Abilify®.

(4) Sterne Kessler Welcomes Litigators John Christopher Rozendaal & Michael Joffre to the Firm

Sterne Kessler Welcomes Litigators John Christopher Rozendaal & Michael Joffre to the Firm
A Case Study:

Sterne Kessler Welcomes Litigators John Christopher Rozendaal & Michael Joffre to the Firm

Sterne Kessler is pleased to announce that John Christopher (J.C.) Rozendaal and Michael Joffre have joined the firm as directors.

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