Expert / Expert Witness Cases

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Biaxin® clarithromycin abridged formulation, Abbott Laboratories vs. Minister of Health, (Canada), Apotex, Novopharm, Pharmascience, Ratiopharm, and Sandoz (each separately) Canada No. 2,393,614. For Abbott. Wrote all 5 Expert Reports.

Prevacid® lansoprazole tablets, Abbott Laboratories Ltd. vs. Minister of Health (Canada), Novopharm. Canada Nos. 1,327,010 and 1,338,377. For Abbott.

Prilosec® omeprazole, Astra Zeneca vs. Eon Laboratories, US No. 4,786,505. For Eon. (pH and alkalinity). Wrote Expert Reports for pH and alkalinity.

Plavix® clopidogrel, Sanofi Canada Minister of Health (Canada) vs. Novopharm/Teva, US No. 4,529,596, CA 1,336,777, and CA 1,194,875. For Novopharm/Teva.

Rythmol® propafenone extended release, Reliant US vs. PAR, US No. 5,681,588. For PAR. (Different formulations, no infringement.) Wrote Expert Reports defining differences.

Liquisolid Systems, George Kontonatos vs. Hygrosol, Spiridon Spireas, et.al. US Nos. 5,800,834, 5,968,550, 6,096,337 and 6,423,339 B1. US District Court, for Eastern District of Pennsylvania. For Kontonatos. (Contract Dispute) 2009. Served as the only Expert and Consultant. Wrote the ER and Testified at Deposition and Trial. Client prevailed.

Ceftin® cefuroxime axetil, Glaxo Group Limited and GlaxoSmithKline Canada vs. Minister of Health (Canada), Apotex Inc. Canada, and Canada No. 1,240,313. For Apotex. (Melting-DSC issues) 2010. Wrote ERs.

Sustiva® efavirenz, compressed tablet, Bristol-Myers Squibb Canada Co. et al. vs. Minister of Health (Canada), Mylan Pharmaceuticals ULC et al. Canada No. 2,332,876. For Mylan. (Patent invalidity) 2010. Patent cited novel use of an excipient; however that use was cited in ref text book.

UNIVASC® and UNIRETIC® moexipril and moexipril HCT, Apotex vs. UCB Inc, US No 6,767,556. For Apotex. 2012.

DUEXIS® famotidine and ibuprofen, Horizon Pharma Inc. and Horizon Pharma USA Inc vs. Par Pharmaceutical Inc, US No. 8,067,033 B2 and US No 8,309,127 B2. For Horizon (Claim construction) 2012.

ABILIFY® aripiprazole oral solution, Otsuka Pharm Co. Ltd vs. Apotex Corp and Apotex Inc USA, US No. 6,977,257 B2. For Apotex (Claim Construction Preformulation perspective) 2013.

Champix® varenicline tartrate tablets, Pfizer Canada Inc. and Pfizer Inc. vs. Minister of Health (Canada), Canada Patent No. 2,467,490. Canadian Federal Court. For Actavis Pharma (Claim Construction Formulation) 2014.

Vimovo® esomeprazole-naproxen tablets, AstraZeneca AB, AstraZeneca LP, KBI-E Inc. and Pozen Inc. vs. Dr. Reddy Laboratories Inc. and Ltd., US 8,557,285 B2 and US 6,926,907 B2. For Dr. Reddy (Claim Construction Formulation) 2014.

Truvada® Tenofovir DF and Emtricitabine combination, Gilead Sciences and Emory Univ. vs. Mylan, Mylan Pharmaceuticals Inc., US 6,642,245; 6,703,396, 8,592,397, and 8,716,264. For Mylan (Claim Construction) Wrote Declaration in Support of Defendants’ Answering Claim Construction Brief in Support of their Construction for US Patents Nos. 8,592,395 and 9,716,263. 2015.

Prevacid® lansoprazole orally disintegrating tablet (ODT), Takeda vs. Wockhardt, Wockhardt, AG, Ltd, LLC, US 6,328,994, 7,431,942, and 7,875,292. For Wockhardt (Claim Construction and Expert Witness: particle size) 2015.

Prevacid® lansoprazole orally disintegrating tablet (ODT) Takeda vs. Dexcel Pharma, US No. 6,328,994, US No. 7,431,942, and US No. 7,875,292. For Dexcel (Claim Construction Particle size) 2016.

SENSIPAR® Cinacalcet HCl tablets, Amgen, Amgen v. Aurobindo Pharma LTD, et al (Consolidated), US 9,375,405. For Piramal Health Care LTD, Patent Prosecution History and Claims. Authored Expert Report regarding Patent Prosecution History and Claims. Testified regarding Patent Prosecution History at deposition. Testified regarding Claims at Trial. 2017 - 2018. Client Prevailed.

RIOMET®​ Metformin HCl, Ranbaxy Laboratories LLC, Sun Pharmaceutical Industries Ltd and Ranbaxy Signatures LLC v. Saptalis Laboratories, US No. 6,890,957. For Saptalis Laboratories, Authored Declaration regarding patent inconsistencies, Current 2019.

KAZANO® Alogliptin benzoate and metformin, and other Alogliptin benzoate products. Takeda Pharmaceutical, LTD v. Torrent Pharmaceutical LTD, US Nos. 7,807,688, 8,173.663, 8,288,539, and 8,900,638, Client Torrent Pharmaceuticals LTD/Pillsbury, Winthrop, Shaw, Pitman, Issue is differences in manufacturing processes. Issue withdrawn by plaintiff. 2019.

POMALYST® Pomalidomide, Celgene v Hetero Labs, Hetero Labs LTD Unit-V, Hetero Drugs LTD, Hetero USA Inc, US 10,555,939 B2. For Hetero, attorneys Wiley Law. Provided opinions regarding claim. 2020.

Riboflavin 5'-Phosphate Injection, Berkshire Sterile Manufacturing LLC (CDMO) v.. Glaukos and Avendro Inc. (Client / Sponsor). Issue: Cause and responsibility for the rejection of 3 Regulatory Batches of the injection in 3 Regulatory Batches of prefilled syringes of Riboflavin 5'-Phosphate Injection due to high / unacceptable numbers of cloudy and particulate containing syringes. Reviewed Batch Records and Independent Laboratory Analysis Test Results and opined on the causes of the cloudiness and particulates. For: Glaukos and Avendro. Attorneys: K & L Gates. 2022 - 2023. Negotiated Settlement.​