Alan Clement is the Chair of the Intellectual Property Department of Locke Lord LLP and is a partner in the New York Office. He has significant experience in all fields of intellectual property, including litigation, patent and trademark prosecution, licensing and counseling.
For more than the past 20 years, Alan Clement has been intimately involved in a number of multi-patent complex Hatch-Waxman pharmaceutical patent infringement litigations, including acting as lead trial counsel on numerous matters. From written discovery to fact depositions, to expert reports and depositions, to motion practice and to lead counsel at trial (including cross examination of key expert witnesses of brand companies), he has been involved in all aspects of these actions. Some of his specific Hatch-Waxman experience includes:
- Rhone Poulenc v. Andrx (Dilacor): Counsel in litigation relating to sustained release diltiazem Geomatrix patents, resulting in a settlement for Andrx.
- Hoechst-Marion-Roussel v. Andrx (Cardizem CD): Counsel in litigation relating to stair-step sustained release diltiazem patents, resulting in a settlement for Andrx.
- Biovail v. Andrx (Tiazac): Trial counsel in litigation relating to a surface active agent sustained release diltiazem patent, securing a verdict of noninfringement at trial (verdict was upheld on appeal) (decisions reported at 158 F.Supp.2d 1318 (S.D. Fla. 2000) and 239 F.3d 1297 (Fed. Cir. 2001)).
- Glaxo v. Andrx (Wellbutrin SR): Secured a judgment of noninfringement from the trial court on summary judgment regarding sustained release hydrogel matrix and dissolution bupropion patents. This summary judgment decision later was overturned by the appeal court, however, the case later settled and did not proceed to trial (decisions reported at 190 F.Supp.2d 1354 (S.D. Fla. 2002) and 344 F.3d 1226 (Fed. Cir. 2003)).
- Pfizer v. Andrx (Glucotrol XL): Counsel in litigation regarding four osmotic push-pull sustained release glipizide patents through the summary judgment stage and obtained a settlement on behalf of Andrx.
- Bristol-Myers v. Andrx (Monopril): Trial counsel in litigation relating to fosinopril formulation patent and secured a verdict of noninfringement. Bristol-Myers did not appeal the decision of the trial court (decision reported at 343 F.Supp.2d 1124 (S.D. Fla. 2004)).
- Astra v. Andrx (Toprol XL): Counsel in litigation regarding salt selection sustained release metoprolol technology two patent action through the summary judgment stage, securing summary judgment of invalidity for double patenting and summary judgment of unenforceability for inequitable conduct. The double patenting invalidity ruling was upheld on appeal (decisions reported at 2006 WL 120343 (E.D. Mo. 2006) and 494 F.3d 1011 (Fed. Cir. 2007)).
- Abbott v. Andrx (Biaxin XL): Counsel in litigation relating to three extended release clarithromycin pharmacokinetic and side effect patents to trial stage including through preliminary injunction phase including appeal, fact and expert discovery and preparation of pretrial stipulation; settled case prior to trial (decision reported at 473 F.3d 1196 (Fed. Cir. 2007)).
- McNeil v. Andrx (Concerta): Counsel in litigation regarding sustained release methylphenidate dissolution and pharmacokinetic two patent case up to trial. Court found invalidity and noninfringement, invalidity ruling was upheld on appeal (decisions reported at 607 F.Supp.2d 614 (D.Del. 2007) and 603 F.3d 935 (Fed. Cir. 2010)).
- Eli Lilly v. Apotex (Strattera): Lead trial counsel in method of treating ADHD with atomoxetine patent obtaining invalidity ruling from District Court (decision reported at 676 F.Supp.2d 352 (D.N.J. 2009)). Case was reversed on appeal.
- Senju v. Apotex (Zymar): Trial counsel in obtaining invalidity ruling on gatifloxacin eye drop solution patents from District Court (decisions reported at 717 F.Supp. 2d 404 (D. Del. 2010) and 836 F.Supp.2d 196 (D.Del. 2011). Invalidity ruling was upheld on appeal.
- Senju v. Apotex (Zymar): Counsel in litigation regarding gatifloxacin eye drop solution reexamination patent case, obtaining summary judgment of invalidity based on res judicata (decision reported at 2012 WL 4062325 (D.Del. 2012)). Decision currently on appeal.
- Acorda v. Apotex (Zanaflex Capsules): Lead trial counsel in obtaining noninfringement
and invalidity rulings on patent regarding food effect of tizanidine capsule formulation from District Court (decision reported at 2011 WL 4074116 (D.N.J. 2011); both noninfringement and invalidity rulings were upheld on appeal.
- Endo v. Roxane (Opana ER): Lead counsel for Roxane in three litigations in NJ, NY and Delaware regarding sustained release, pharmacokinetic, renal failure and impurity oxymorphone patents, currently on appeal.
- Jazz v. Roxane (Xyrem): Lead counsel in case currently in litigation involving fifteen (15) patents on sodium oxybate solution, method of making, method of treatment, drug-drug interaction, pharmaceutical kit and exclusive computerized distribution system; resulting in settlement.
- Meda v. Sun (Astelin): Counsel in litigation regarding azelastine nasal formulation patent, leading to settlement for client regarding azelastine formulation.
- Shire v. Roxane (Vyvanse): Lead counsel in case regarding eighteen (18) lisdexamphetamine prodrug, x-ray crystallography, pharmacokinetics, methods of preventing abuse and formulation patents.
- Senju v. Apotex (Zymaxid): Counsel in litigation regarding follow on gatifloxacin eye drop solution reexamination patent.
- Merck v. Roxane (Noxafil Suspension): Lead counsel in litigation regarding three posaconazole patents on chemical composition, polymorph and formulation; case settled.
- Takeda v. Roxane (Uloric): Lead counsel in litigation regarding febuxostat patents covering polymorph and particle size resulting in settlement.
- Amarin v. West-ward (Vascepa): Lead counsel in litigation regarding fifteen (15) patents covering methods of treatment with icosapent; litigation currently pending.
- Gilead Sciences, Inc. v. Sunshine Lake Pharma Co. (Vemlidy): Lead counsel for Sunshine Lake in currently pending multi-defendant, multi-patent litigation involving tenofovir alafenamide anti-viral medication.
- In re Entresto (Sacubitril/Valsartan) Patent Litigation: Lead counsel for Novugen Pharma in currently pending multi-district patent litigation regarding sacubitril/valsartan heart medication.
- In re Jublia: Lead counsel for Alembic Pharmaceuticals in currently pending multi-defendant multi-patent litigation involving efinaconazole toenail medication.
Other Intellectual Property Litigation Experience:
- Pado v. SG Trademark Holding Co. (handheld percussion massager): Counsel in currently pending patent, trademark and copyright infringement litigation.
- NineStars Group v. Factory Direct Wholesalers (induction activated containers): Lead counsel in securing summary judgment of invalidity on asserted patents.
- Sears v. MLI Associates (Deicing chemicals): Lead trial counsel in securing jury trial verdict of noninfringement regarding two deicing formulation patents.
- In re Gartside (Hydrocarbon cracking quench technology): Lead counsel in interference proceeding through appeal to Court of Appeals for the Federal Circuit (decision reported at 203 F.3d 1305 (Fed. Cir. 2000).
- Spectrum v. Sterilite (Crate technology): Lead counsel for patentee in patent infringement proceeding through appeal to Court of Appeals for Federal Circuit regarding crate stacking patent (decision reported at 164 F.3d 1372 (Fed. Cir. 1998)).
- Seaco v. MLI Associates (Deicing chemicals): Lead counsel in patent interference proceeding through appeal to District Court (decision reported at 652 F.Supp.2d 244 (N.D.N.Y. 2009)).
- The Original Creatine Patent Company v. Optimum Nutrition: Handled patent infringement action involving creatine formulation nutraceutical patent; secured settlement for client.
- Forsythe v. The Body Shop (Colorings trademark): Lead counsel in trademark action securing settlement for the client.
- Innovative USA v. Sterling (Book technology): Lead counsel in patent infringement action regarding magnetic book patent, secured settlement for client.
- Versa Valve v. Bifold (Valve technology): Counsel in trade dress infringement action on oil platform blow-off valve design and secured settlement for client.
- Innovative USA v. Innovative Education (Trademark): Lead counsel in securing settlement for client in trademark infringement action.
- Innovative USA v. Firefly (Book technology): Lead counsel in securing settlement in patent infringement action.
Other Areas of Intellectual Property
Alan's experience with patent and trademark prosecution and opinion work has encompassed petrochemicals, hydrocarbon cracking processes, pharmaceuticals, lubricants, deicing chemicals, polymer technology, silicone chemistry, cosmetics and children's books, both in the United States and abroad. This includes experience in chemical patent interferences. Additionally, he has experience in trademark and trade dress litigation.
Registered Patent Agent.
- Partner, Locke Lord LLP
- Partner, Hedman & Costigan, P.C. (1994-2007)
- Associate and law clerk, Hedman & Costigan, P.C. (1988-1994)
- Process Engineer, Precision Valve Corporation (1984-1988)
Professional Affiliations and Recognitions
- Recognized, 2020 Edition of IAM Patent 1000