Ian Scott

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Summary

Ian has over 25 years’ experience in IP law, concentrating his practice on pharmaceutical drug patent litigation under the Hatch-Waxman Act. His experience covers all aspects of the litigation process – including drug and formulation development and selection, preparation of regulatory filings, fact and expert witness phases, trial and appeal, as well as negotiation of settlements.

Ian has extensive experience in the preparation of legal opinions in connection with planning for litigation, including opinions regarding patentability, invalidity, freedom-to-operate and priority of invention of U.S. patents and publications.

Ian is a registered patent attorney, and provides counseling for clients in connection with the protection of their intellectual property rights and avoidance of third-party rights. He is experienced in all areas of the preparation, prosecution, and exploitation of patent applications, including licensing of intellectual property rights and due diligence analyses. Ian counsels clients in a broad array of technical fields, including pharmaceuticals and pharmaceutical formulations, chemistry and chemical processes, industrial gases and related applications, medical devices, small molecules, polymers, polymer blends and dispersions, UV absorbers, and cosmetics.

Prior to practicing law, Ian worked as an industrial chemist for a decade, becoming a senior chemist at E.M. Industries, an affiliate of Merck KGaA, Darmstadt. He carried out and oversaw applied research and development in the areas of specialty pigments and sunscreen active materials, and the formulation of related personal care products. He also carried out research and development in the area of solution phase deposition processes. In addition, Ian participated in the commercialization and marketing of specialty pigment, sunscreen active and chemical raw material products.

Ian is a frequent speaker on issues related to pharmaceutical litigation, and has been recognized as a leading attorney in the field of Hatch-Waxman litigation.

Ian is licensed to practice law in New Jersey and New York, as well as before the U.S. Patent and Trademark Office and U.S. Court of Appeals for the Federal Circuit only.

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Education

Pace University School of Law (1996)
St. John's University (1994)
M.S. – Chemistry
University College Swansea, University of Wales (1988)
with honors
B.SC. – Chemistry

Admissions

Federal - United States Patent and Trademark Office
Federal - U.S. Court of Appeals, Federal Circuit
Federal - New York Southern District Court
Federal - New York Eastern District Court
Federal - New Jersey District Court
State - New Jersey
State - New York

Notable Matters

Represented Qilu Pharmaceutical Co., Ltd, Qilu Pharmaceutical (Hainan) Co., Ltd and Qilu Pharma Inc. in a patent infringement action regarding Qilu’s ANDAs to make a generic version of APONVIE and CINVANTI^® (aprepitant emulsions).
Represented Qilu Pharmaceutical Co., Ltd and Qilu Pharma Inc. in a patent infringement action regarding Qilu’s ANDA to make a generic version of RYTARY^® (carbidopa and levodopa).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of EPIDOLEX^® (cannabidiol).
Represented Qilu Pharmaceutical Co., Ltd and Qilu Pharma Inc. in a patent infringement action regarding Qilu’s ANDA to make a generic version of INVEGA SUSTENNA^® (paliperidone palmitate).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of MAVENCLAD^® (cladribine).
Represented Qilu Pharmaceutical Co., Ltd and Qilu Pharma Inc. in a patent infringement action regarding Qilu’s ANDA to make a generic version of YUPELRI^® (revefenacin).
Represented Qilu Pharmaceutical Co., Ltd and Qilu Pharma Inc. in a patent infringement action regarding Qilu’s ANDA to make a generic version of XTANDI^® (enzalutamide).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of GENVOYA^® (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide fumarate).
Represented Qilu Pharmaceutical Co., Ltd and Qilu Pharma Inc. in a patent infringement action regarding Qilu’s ANDA to make a generic version of VASCEPA^® (icosapent ethyl).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of SYMTUZA^® (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDAs to make a generic versions of VEMLIDY^® (tenofovir alafenamide fumarate), DESCOVY^® (tenofovir alafenamide fumarate), and ODEFSEY^® (tenofovir alafenamide fumarate).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of IBRANCE^® (palbociclib).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of TRINTELLIX^® (vortioxetine).
Represented Qilu Pharmaceutical Co., Ltd and Qilu Pharma Inc. in a patent infringement action regarding Qilu’s ANDA to make a generic version of IBRANCE^® (palbociclib).
Represented Qilu Pharmaceutical Co., Ltd and Qilu Pharma Inc. in a patent infringement action regarding Qilu’s ANDA to make a generic version of GILOTRIF^® (afatinib dimaleate).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of STIVARGA^® (regorafenib).
Represented Qingdao Baheal Pharmaceutical Co., Ltd. in a patent infringement action regarding Baheal’s ANDA to make a generic version of FORTAMET^® (metformin hydrochloride).
Represented Sagent Pharmaceuticals, Inc. in a patent infringement action regarding Sagent’s ANDA to make a generic version of KYPROLIS^® (carfilzomib).
Represented Strides Pharma Global PTE Limited and Strides Pharma, Inc. in a patent infringement action regarding Strides’ ANDA to make a generic version of SENSIPAR^® (cinacalcet).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of ASTEPRO^® (eliglustat).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of CERDELGA^® (azelastine).
Represented Micro Labs USA Inc.. in a patent infringement action regarding Micro Labs’ ANDA to make a generic version of XIIDRA (lifitegrast).
Represented Micro Labs USA Inc.. in a patent infringement action regarding Micro Labs’ ANDA to make a generic version of XARELTO (rivarovaban).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of STIVARGA (regorafenib).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of FANAPT (iloperidone).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of TEFLARO (ceftaroline).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of BRIVIACT (brivaracetam).
Represented Apotex Inc. in the widely-followed CELEBREX (celecoxib) ANDA matter against Pfizer. The Eastern District of Virginia granted Apotex’s motion for summary judgment holding that Pfizer’s reissued patent-in-suit had been improperly granted under Section 251 of the Patent Act.
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of ULORIC (febuxostat).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of VIMPAT (lacosamide).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of SAVELLA (milnacipran).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of ANGIOMAX (bivalirudin).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of KEPPRA XR (levetiracetam).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of LYSTEDA (tranexamic acid).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of PRISTIQ® (desvenlafaxine).
Represented Sandoz Inc. in a patent infringement action regarding Sandoz’s ANDA to make a generic version of Shire’s ADHD product INTUNIV® (guanfacine hydrochloride).
Represented Sandoz Inc. in patent infringement action regarding Sandoz’s ANDA to make a generic version of Helsinn’s anti-nausea product ALOXI® (palonosetron hydrochloride injection).
Represented Sandoz Inc. in a patent infringement action regarding Sandoz’s ANDA to make a generic version of Roche’s VALCYTE® (valganciclovir hydrochloride).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of AVODART® (dutasteride).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of ACULAR LS® (0.4% ketorolac tromethamine).
Represented Sandoz Inc. in a patent infringement action regarding Sandoz’s ANDA to make a generic version of Abbott’s cholesterol product NIASPAN® (niacin).
Represented Sandoz Inc. in a patent infringement action regarding Sandoz’s ANDA to make a generic version of Abbott’s ZEMPLAR® (paricalcitol).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of Sanofi-Aventis’ anti-cancer product TAXOTERE®, the active ingredient of which is docetaxel. Following a two-week trial, obtained an order for Apotex striking down the patents-in-issue as invalid as obvious and unenforceable due to Sanofi-Aventis’ inequitable conduct in procuring the patents. Successfully argued on appeal with the Federal Circuit affirming trial court decision (April 2012). Of import is that inequitable conduct defense remains viable in ANDA litigations because of this ruling.
Represented Apotex in a patent infringement action regarding Apotex’s ANDA to make a generic version of Pfizer’s migraine product RELPAX®, the active ingredient of which is eletriptan hydrobromide.
Represented Sandoz Inc. in a patent infringement action regarding Eon/Sandoz’s abbreviated new drug application (ANDA) to make a generic version of Pfizer’s anti-seizure product NEURONTIN®, the active ingredient of which is gabapentin.
Represented Sandoz Inc. in a patent infringement action regarding Sandoz’s ANDA to make a generic version of Allergan’s glaucoma drops COMBIGAN® (brimonidine tartrate/timolol maleate.)
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of Wyeth’s anti-depressant product EFFEXOR XR® (venlafaxine hydrochloride).
Represented Sandoz Inc. in a patent infringement action regarding Sandoz’s ANDA to make a generic version of Endo’s pain product OPANA® ER (oxymorphone hydrochloride).
Represented Sandoz in a patent infringement action regarding Sandoz’s ANDA to make a generic version of Pfizer’s antimuscarinic tablet DETROL and DETROL LA®, the active ingredient of which is tolterodine tartrate.
Represented Sandoz Inc. in a patent infringement action regarding Sandoz’s ANDA to make a generic version of Merck’s anti-nausea product EMEND® (aprepitant).
Represented Apotex Inc. in a patent infringement action regarding Apotex’s ANDA to make a generic version of Procter’s osteoporosis product ACTONEL® (risedronate).
Represented Sandoz Inc. in a patent infringement action regarding Sandoz’s ANDA to make a generic version of Medicis’ acne product SOLODYN® (minocycline hydrochloride).
Represented Schwarz Pharma in a patent infringement action regarding Schwarz Pharma’s ANDA to make a generic version of Braintree Labs’ constipation product Miralax®, the active ingredient of which is polyethylene glycol. During discovery, Braintree dismissed its infringement complaint, waiving the remaining portion of the 30 month stay on FDA approval of Schwarz Pharma’s product.

Speeches and Publications

Co-Presenter, “Overview of Recent US Caselaw of Note to the Pharmaceutical Industry,” IP Forefront Pharma Forum (IFPF), Sept. 19, 2025.