TBLA performs independent research and analyses. We have advised equity analysts (buy-side and sell-side) and institutional investors on the following United States litigation, patent, and regulatory matters. This is a representative list only, and does not include projects that clients wish to remain confidential.


Vascepa® (icosapent ethyl)

  • Patent validity and enforceability analysis of U.S. Patent Nos. 8,793,727, 8,324,195, 8,318,715 and 8,293,728 and all related pending patent applications for Amarin's cardiovascular drug Vascepa®.
  • Review and analysis of two Phase 3 clinical trials conducted under Special Protocol Assessment (SPA) agreements with FDA.
  • Regulatory analysis of all factors considered by FDA to determine likelihood of FDA's New Chemical Entity (NCE) status designation.
  • Regulatory analysis of all factors considered by USPTO and FDA for Patent Term Extension (PTE) applicability.
  • Analysis of GSK's Orange Book listed patents for Lovaza® (U.S. Patent Nos. 7,732,488, 5,656,667 and 5,502,077). Considered various litigation strategies relating to patent validity, non-infringement, and design-around issues for Vascepa®.

Revlimid® (lenalidomide)

  • Patent validity and enforceability analysis of twenty-three FDA Orange Book listed patents, and numerous pending U.S. patent applications and non-Orange Book listed patents for Celgene’s blood cancer drug Revlimid®.
  • Considered various litigation and patent prosecution strategies relating to patentability, non-infringement, and design-around issues for polymorphic variants of Revlimid®.
  • See Celgene Corp. v. Natco Pharma Ltd., Case No. 2:10-cv-05197 (D.N.J.).

Lovenox® (enoxaparin sodium)

  • Regulatory analysis of FDA approval of Sandoz/Momenta’s ANDA for a generic version of Sanofi-Aventis’s anticoagulant drug Lovenox®, including scientific and legal review of multiple FDA Citizen Petitions.
  • Patent validity and enforceability analysis of U.S. Patent Nos. 5,389,618 and RE38,743.
  • See Aventis Pharma SA, et al. v. Sandoz Inc., Case No. 2:06-cv-04858 (C.D. Cal.).
  • See also Aventis Pharma SA, et al. v. Amphastar Pharmaceuticals, Inc., et al., Case No. 5:03-cv-00887 (C.D. Cal.).
  • See TBLA’s commentary in TBLA’s Publications and Articles section, Summer 2010, “United States FDA Approval Of Generic Lovenox®: A First Glimpse At Follow-On Biologic Sameness”

Angiomax® (bivalirudin)

  • Analysis of the USPTO granting of multiple interim patent term extensions (PTE) under 35 U.S.C. §156 for U.S. Patent No. 5,196,404, which covers The Medicine Company's anticoagulant drug Angiomax®.
  • See The Medicines Co. v. Kappos, Case No. 1:10-cv-00286 (E.D. Va.).

Taxotere® (docetaxel)

  • Patent validity and enforceability analysis of U.S. Patent Nos. 5,714,512 and 5,750,561 following Hospira Inc. filing a Paragraph IV certified NDA (under § 505(b)(2) of the FDCA) to manufacture a generic version of Aventis’s anticancer drug Taxotere®.
  • See Aventis Pharma SA et al. v. Hospira Inc. and Apotex Inc., Case No. 1:07-cv-00721 (D. Del.).

BRACAnalysis® (breast cancer diagnostic tests)

  • Patent validity and enforceability analysis of seven United States patents relating to Myriad Genetics's test for detecting BRCA1 and BRCA2 gene mutations, including consideration of patentable subject matter and violation of 35 U.S.C. §101.
  • See Association for Molecular Pathology et al. v. U.S. Patent and Trademark Office et al., Case No. 1:09-cv-04515 (S.D.N.Y.).

Qsymia® (phentermine/topiramate)

  • Patent validity and enforceability analysis of U.S. Patent Nos. 7,056,890, 7,553,818, 7,674,776 and 7,659,256 and related pending patent applications for Vivus Inc.’s anti-obesity drug Qsymia®.

Lunesta® (eszopiclone)

  • Patent validity and enforceability analysis of U.S. Patent Nos. 7,381,724, 6,864,257, 6,444,673 and 6,319,926 following Teva Pharmaceutical filing a Paragraph IV certified ANDA to manufacture a generic version of Sepracor’s anti-insomnia drug Lunesta®.
  • See Sepracor Inc. v. Teva Pharmaceuticals USA, Inc., et al., Case No. 2:09-cv-01302 (D.N.J.).

Cubicin® (daptomycin)

  • Patent validity and enforceability analysis of U.S. Patent Nos. 6,852,689, 6,468,967 and RE39,071 following Teva Pharmaceutical filing a Paragraph IV certified ANDA to manufacture a generic version of Cubist’s cyclic lipopeptide antibiotic Cubicin®.
  • See Cubist Pharmaceuticals Inc. v. Teva Parenteral Medicines Inc. et al., Case No. 1:09-cv-00189 (D. Del.).

Vytorin® (ezetimibe/simvastatin)

  • Patent validity and enforceability analysis of U.S. Patent Nos. 5,846,966 and RE 37,721 following Mylan Labs filing a Paragraph IV certified ANDA for a generic version of Merck/Schering-Plough’s hyperlipidemia drug Vytorin®.
  • See Schering Corp. et al. v. Mylan Pharmaceuticals Inc. et al., Case No. 2:09-cv-06383 (D.N.J.).

Effexor XR® (venlafaxine hydrochloride)

  • Patent validity and enforceability analysis of U.S. Patent Nos. 6,419,958, 6,403,120 and 6,274,171 following Lupin Pharmaceuticals filing a Paragraph IV certified ANDA to manufacture a generic version of Wyeth’s antidepressant Effexor XR®.
  • See Wyeth v. Lupin Ltd. et al., Case No. 1:07-cv-00632 (D. Md.).

Temodar® (temozolomide)

  • Patent validity and enforceability analysis of U.S. Patent No. 5,260,291 following Barr/Teva Pharmaceutical filing a Paragraph IV certified ANDA to manufacture a generic version of Merck/Schering-Plough’s brain tumor drug Temodar®.
  • See Cancer Research Technology Ltd. et al. v. Barr Laboratories Inc. et al., Case No. 1:07-cv-00457 (D. Del.).

Zetia® (ezetimibe)

  • Patent validity and enforceability analysis of U.S. Patent No. RE37,721 following Glenmark Pharmaceuticals filing a Paragraph IV certified ANDA to manufacture a generic version of Merck/Schering-Plough’s anticholesterol drug Zetia®.
  • See Schering Corp. et al. v. Glenmark Pharmaceuticals, Inc. USA et al., Case No. 2:07-cv-01334 (D.N.J.).