Published On: May 22nd, 2019Categories: Featured Litigation Cases

We recently started a new series on the MaxVal Blog, “Featured Patents and Applications of the Week,” which our readers have positively responded to. We are now rolling out an additional weekly column, “Featured Litigation Cases of the Week,” which will provide insights into recently issued litigation cases around the world.

In this post, we take a look at Novartis vs Mylan Pharmaceuticals and Dr. Greens, Inc. vs Spectrum Laboratories, LLC.

Permanent injunction on Mylan Pharmaceuticals Inc. by Novartis

Mitsubishi Tanabe Pharma Corporation, the owner of US Patent 5,604,229 and its exclusive licensee Novartis, proved yet again that their ‘229 patent is valid and enforceable.

On April 22, 2016, Novartis and Mitsubishi lodged a patent infringement suit (1:16-cv-00289) against Mylan Pharmaceuticals in the district of Delaware, stating that Mylan’s ANDA product has the same method and active ingredient of Novartis’s product, GILENYA®.

In 2010, the FDA approved GILENYA® for adults with relapsing forms of multiple sclerosis and later in 2018, it approved the expansion of the use of the oral multiple sclerosis therapy GILENYA® (fingolimod, Novartis AG) to include the treatment of children and adolescents 10 years of age or older with relapsing multiple sclerosis.

Mylan Pharmaceuticals Inc. sent a notice to litigants on April 6, 2016, stating that they have submitted an application to the FDA, for commercial manufacturing of fingolimod 0.5 mg capsules (Abbreviated New Drug Application No. 208005), a generic version of Novartis’s GILENYA®, prior to the expiration of the ’229 patent. The notice also disclosed that Mylan had filed a certification asserting the ’229 patent is invalid.

Novartis had already won a case against Actavis Inc, Ezra Ventures LLC, HEC Pharm Co. Ltd., and Apotex Inc. in 2017, proving its ‘229 patent to be valid, enforceable, and infringed.

Based on these facts, Chief Judge Leonard P. Stark declared a final, non-appealable judgment on May 2, 2019, in favor of Novartis and issued a permanent injunction on Mylan Pharmaceuticals Inc.

Declaratory suit against Spectrum Laboratories, LLC by Dr. Greens, Inc.

Dr. Greens, Inc., known for selling synthetic urine, has been the sole and exclusive distributor for Spectrum Laboratories, LLC since 1999. Dr. Greens has purchased synthetic urine under the brand name “Quick Fix” since 2001 and marketed it to various end-users. By the end of 2001, James Matthew Stephens, (major shareholder of Spectrum) terminated the distributor license of Dr. Greens, but they continued to purchase and sell “Quick Fix” as a replacement of Spectrum’s synthetic urine with a minor mark up in price until 2009.

In late 2003, Dr. Greens invented a new synthetic urine product and sold it under the brand name “Agent X.” In the meantime, on January 8, 2004, Stephens filed a patent application for “Synthetic Urine and Method of manufacturing same,” and it was granted on March 20, 2007 by the USPTO (US 7,192,776).

Stephens sent a cease and desist letter dated September 8, 2009 to Dr. Greens, insisting that the product contains biocides which infringe his patent ‘776. At the same time, Spectrum Laboratories enjoyed a substantial increase in sales of synthetic urine from recipients by sending a legal action notification letter to Dr. Greens’ customers.

Later, Dr. Greens filed a declaratory suit (3:11-cv-00638) against Spectrum Laboratories, to prove whether or not ‘776 patent is valid and if “Agent X” infringes it. A chemical test was done on “Agent X,” and the results proved that it contains biocides mentioned in the claims 1 – 4 of the ‘776 patent.

After 10 days of trial, the jury awarded a damage amount of $865,173 in favor of Spectrum Laboratories. Afterwards, the firm filed a notice of motion requesting enhanced damages of three times the original damage amount of $865,173 specified in the jury verdict.

Judge John A. Houston entered a judgment on March 29, 2019, in favor of Spectrum Laboratories and awarded damages of $2,595,519 plus prejudgment interest of $326,728. Unhappy with the judgment, Dr. Greens has filed an appeal against Spectrum Laboratories (2019-1830) in the Federal Court of Appeals on May 2, 2019.

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