Litigation Highlights

Below are certain highlights of RMMS’s trial and Federal Circuit practice:

  • ABACAVIR SULFATE / LAMIVUDINE / ZIDOVUDINE (TRIZIVIR®): Patent infringement action involving ViiV’s/GlaxoSmithKline’s patent for its triple-combination anti-HIV drug. The case was tried before Judge Andrews (Del.). Our attorneys prevailed at trial on non-infringement grounds.

  • BIMATOPROST (LATISSE®): Patent infringement action involving Allergan’s patents for its eyelash enhancing drug. The case was tried before Judge Eagles (M.D.N.C.). Our attorneys prevailed on appeal before the Federal Circuit, which held that Allergan’s patents were obvious.

  • MOMETASONE (NASONEX®): Patent infringement action involving Merck-Schering’s patent for its allergic rhinitis nasal spray. The case was tried before Judge Sheridan (D.N.J.). Our attorneys prevailed at trial on non-infringement grounds and subsequently prevailed on appeal before the Federal Circuit as well.

  • GATIFLOXACIN (ZYMAXID®/ZYMAR®): Patent infringement action involving Senju and Allergan’s patent for its ophthalmic medication. The case was tried before Judge Robinson (Del.). Our attorneys prevailed at trial on invalidity grounds.

  • BUDESONIDE (PULMICORT®): Patent infringement action involving Astra-Zeneca’s patents for its asthma medication. The case was tried before Judge Bumb (D.N.J.). Our attorneys prevailed at trial on invalidity on one patent and non-infringement on the other. Affirmed on one patent and remanded on another by the Federal Circuit.

  • RAMIPRIL (ALTACE®): Patent infringement action involving Aventis/King’s patent for its anti-hypertension drug. Our attorneys prevailed on appeal before the Federal Circuit, which held the patent invalid.

  • PAROXETINE (PAXIL®): Patent infringement action involving GSK’s patent for its antidepressant drug. The case was tried before Judge Posner, sitting by designation (N.D. Ill.). Our attorneys prevailed at trial and on appeal before the Federal Circuit as well, obtaining a landmark ruling on inherent anticipation and conversion.

RMMS also has considerable experience defeating preliminary injunction/TRO proceedings filed to prevent our clients from commercially launching their products, including:

  • GATIFLOXACIN (ZYMAXID®/ZYMAR®): Patent infringement action involving Senju and Allergan’s patent for its eye medication. The case was tried before Judge Robinson (Del.). Our attorneys prevailed at trial on invalidity grounds, and then defeated injunction motions filed in district court and the Federal Circuit.

  • IBANDRONATE (BONIVA®): Patent infringement action involving Roche’s patents for its bisphosphonate osteoporosis treatment (marketed by Genentech). The proceedings were held before Judge Chesler (D.N.J.). Our attorneys prevailed and defeated the preliminary injunction motion and the ensuing emergency motions for injunctive relief pending appeal filed both before the district court and the Federal Circuit. Our attorneys also prevailed on appeal, obtaining an affirmance of the district court’s order denying the preliminary injunction motion.

  • TIAGABINE (GABATRIL®): Patent infringement action involving Cephalon’s patent for its epilepsy treatment. The emergency TRO and PI proceedings were held before Judge Wolfson (D.N.J.). Our attorneys prevailed and defeated two separate emergency TROs and a separate preliminary injunction.

  • RAMIPRIL (ALTACE®): Patent infringement action involving Aventis/King’s patent for its anti-hypertension drug. The emergency TRO proceedings were held before Judge Davis (D. Md.). Our attorneys defeated an emergency TRO.

  • CLOBETASOL (OLUX®): Patent infringement action involving Stiefel/Connetics’ patent for its steroid dermatology treatment. The preliminary injunction proceeding was heard by Chief Judge Brown (D.N.J.). Our attorneys prevailed and defeated the preliminary injunction motion.

  • SULFUR/SULFACETAMIDE (PLEXION®): Patent infringement action involving Medicis’ patent for its rosacea treatment. The preliminary injunction proceeding was heard by Judge McNamee (D. Ariz.). Our attorneys prevailed and defeated the preliminary injunction motion on both obviousness and inequitable conduct grounds.

Other noteworthy patent rulings on dispositive motions, Markman and/or on appeal include the following:

  • CEFDINIR (OMNICEF®): Patent infringement action involving Abbott/Astellas’ patent for its antibiotic. The case was before Judge Payne (E.D. Va.). Our attorneys prevailed at the Markman hearing and on summary judgment, obtaining a judgment of non-infringement on the asserted product-by-process claims on the eve of trial. On appeal before the Federal Circuit, our attorneys again prevailed and obtained the landmark and controlling en banc decision on product-by-process claims.

  • GABAPENTIN (NEURONTIN®): Patent infringement action involving Pfizer/Warner-Lambert’s patents for its epilepsy treatment. The first case was before Judge Plunkett (N.D. Ill.), and the second MDL action was before Judge Lifland (D.N.J.). In the Illinois litigation, our attorneys obtained separate summary judgments of non-infringement on both the composition and method-of-use patents. On appeal before the Federal Circuit, we also prevailed and obtained the seminal, and still-controlling, decision on infringement of method-of-use patents under Hatch-Waxman, which is still applied today (as described below). In the New Jersey MDL litigation, we prevailed on both Markman and summary judgment, and obtained a judgment of non-infringement.

  • IBANDRONATE (BONIVA®): Patent infringement action involving the infringement and validity of Roche/Genentech’s monthly dosing patents for its bisphosphonate osteoporosis treatment. After defeating a preliminary injunction motion (and the ensuing emergency motions pending appeal), our attorneys also obtained summary judgment of invalidity of the primary asserted use patents.

  • GUAIFENESIN (MUCINEX®): Patent infringement action involving the infringement and validity of Reckitt’s formulation patent for its OTC cold medicine. The case was before Judge Quist (W.D. Mich.). Our attorneys obtained summary judgment of non-infringement. When that decision was remanded by the Federal Circuit due to disputed fact issues, our attorneys obtained another summary judgment of non-infringement on different grounds.

  • ROSUVASTATIN (CRESTOR®): Patent infringement action involving the infringement and validity of AstraZeneca’s method-of-use patents for its blockbuster statin. The case was before Judge Kugler (D.N.J., sitting by designation in D. Del.). Our attorneys obtained a dismissal of all claims, based on the prior GABAPENTIN (NEURONTIN®) precedent, described above. Our attorneys also obtained an affirmance from the Federal Circuit on appeal.

  • PAROXETINE (PAXIL®): Patent infringement action involving GSK’s patents for its blockbuster antidepressant. The case was before Judge Surrick (E.D. Pa.). Our attorneys obtained summary judgment of invalidity of several asserted product-by-process patents.

RMMS has also prevailed in regulatory actions involving the FDA/HHS, including the following:

  • CARBAMAZEPINE (CARBATROL®): Regulatory action against FDA/HHS involving generic versions of Shire’s epilepsy medication. A competitor filed suit against FDA/HHS under the APA, seeking to delay approval of our client’s application. We intervened to protect our client’s anticipated approval and commercial interests. The preliminary injunction proceeding was heard by Judge Pisano (D.N.J.). After a full hearing, our attorneys defeated the preliminary injunction, thus clearing the way for final approval of our client’s application and product.

  • PIPERACILLIN/TAZOBACTAM (ZOSYN®): Regulatory action against FDA/HHS involving generic versions of Pfizer/Wyeth’s antibiotic. Pfizer/Wyeth filed suit against FDA/HHS under the APA, seeking to prevent the approval of competing products with different labeling and warnings. We intervened to protect our client’s anticipated approval and commercial interests. The TRO proceeding was heard by Judge Huvelle (D.D.C.). Our attorneys defeated the TRO, thus clearing the way for marketing of our client’s product.

  • PAROXETINE (PAXIL®): Regulatory action against FDA/HHS involving competing versions of GSK’s antidepressant. We filed suit against FDA/HHS under the APA and sought a preliminary injunction preventing the approval and commercial launch of competing drugs (challenging FDA’s so-called patent-based “shared exclusivity” policy). The injunction proceeding was heard by Judge Roberts (D.D.C.). Our attorneys obtained a preliminary injunction that preserved our client’s critical exclusivity and prevented the approval and launch of competing products.

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