Pharmaceuticals

July 5, 2018

Indiana Patent Litigation: U.S. District Court Rules in Favor of Eli Lilly in Alitma Patent Infringement Case

Indianapolis, Indiana – Attorneys for Plaintiff, Eli Lilly and Company of Indianapolis, Indiana filed suit in the Southern District of Indiana alleging that Defendants, Dr. Reddy’s Laboratories, LTD. of Hyderabad, Telagana, India, and Dr. Reddy’s Laboratories, Inc,. a New Jersey corporation, infringed its rights in U.S. Patent No. 7,772,209 (“the ‘209 Patent”).

The ‘209 Patent at issue here is a method patent for administering pemetrexed disodium, a chemotherapy drug, with vitamins, the combination of which is marketed as ALITMA® by Lilly. This invention helps to solve the toxicity issue in chemotherapy patients being treated with pemetrexed. The particular regimen of vitamin and folic acid are important for the pretreatment of these patients. As of December 2015, Dr. Reddy’s informed Lilly that it had submitted a FDA New Drug Application for a product that would be marketed as a competing product to ALITMA®.

The first issue the Court had to decide was whether Lilly was barred from asserting the doctrine of equivalents under prosecution history estoppel. The Court held that Lilly had not surrendered the equivalent in question because their decision to use the choice pemetrexed salt was tangential to the reasons for the amendment. The choice to narrow was simply to overcome a rejection in view of a prior art article about a different antifolate, methotrexate.

April 5, 2018

Indiana Patent Litigation: Texas Pharmaceutical Company Sues Indiana-Based Roche

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Attorneys for Plaintiff, Blue Sky Networks, LLC of Plano, Texas filed suit in the Southern District of Indiana alleging that Defendant, Roche Diabetes Care, Inc., of Indianapolis, Indiana infringed its rights in United States Patent Nos. 6,484,027, (“the ‘027 Patent”), 6,865,372, (“the ‘372 Patent”), 8,265,691, (“the ‘691 Patent”), 8,346,169, (“the ‘169 Patent”), and 8,792,828 (“the ‘828 Patent”). Plaintiff is seeking judgment, damages, and attorneys’ fees.

According to the complaint, “The Asserted Patents are directed to wireless mobile devices, such as handsets, peripherals, and computing devices, that operate via wireless short-range direct communication with other wireless devices. Such devices may also be enabled for simultaneous operation on a wireless network…and wireless short-range direct communication with other wireless devices.”

November 21, 2017

Indiana Patent Litigation: Eli Lilly and Teva Pharmaceuticals Clash Again over Alimta

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Attorneys for Plaintiff, Eli Lilly and Company of Indianapolis, Indiana, filed suit in the Southern District of Indiana alleging that Defendants, Actavis LLC of Parsippany, New Jersey; Teva Pharmaceuticals USA of North Wales, Pennsylvania; and Teva Pharmaceutical Industries, Ltd. of Petach Tikva, Israel infringed its rights in United States Patent No. 7,772,209 (“the ’209 patent”) for “Antifolate Combination Therapies”. Plaintiff is seeking injunctive relief, declaratory judgment, and damages including costs and attorneys’ fees.

Eli Lilly and Teva have been involved in numerous patent infringement lawsuits against each other in the past. In April, Eli Lilly sued Teva on a claim of patent infringement of the same drug involved in this case, Alimta. This new complaint is based on a filing by Defendant with the FDA “seeking approval to manufacture and sell its Pemetrexed Injection Concentrate.”

October 25, 2017

The USPTO Denies Petition filed by Neptune Generics, LLC in Challenge to Indiana-based Eli Lilly’s Patent

By Overhauser Law Offices, LLC

Petitioner, Neptune Generics, LLC had filed a petition with the United States Patent and Trademark Offices against Eli Lilly & Company of Indianapolis, Indiana, challenging the validity of patent no. 7,772,209, Antifolate combination therapies, which has been issued by the USPTO. This patent covers intellectual property embodied in Alimta®, a drug therapy used for the treatment of various types of cancer.

Lead Petitioner Neptune Generics, LLC is a Chicago, Illinois-based pharmaceutical company that focuses on increasing access to affordable medications. Defendant Eli Lilly is a multinational pharmaceutical company based in Indianapolis. Other petitioners joined in the case are Apotex, Inc, Teva Pharmaceuticals USA, Fresenius Kabi USA, and Wockhardt Bio AG.

April 12, 2017

Indiana Patent Litigation: Lilly Again in Federal Court to Defend Alimta Patent

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Eli Lilly and Company of Indianapolis, Indiana filed a federal lawsuit in the Southern District of Indiana alleging patent infringement. Defendants are Actavis LLC of Parsippany, New Jersey; Teva Pharmaceuticals USA, Inc. of North Wales, Pennsylvania; and Teva Pharmaceutical Industries, Ltd. of Petach Tikva, Israel.

At issue is a patent for Antifolate Combination Therapies, Patent No. 7,772,209 (“the ‘209 patent”) which has been issued by the U.S. Patent and Trademark Office. This patent covers intellectual property embodied in Alimta®, a drug therapy used for the treatment of various types of cancer.

In a complaint filed by an Indiana patent litigator, Lilly states that Defendants filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to manufacture and sell generic equivalents of ALIMTA® prior to the expiration of the ‘209 patent. It asserts that this filing constitutes and/or will constitute infringement of the ‘209 patent, active inducement of infringement of the ‘209 patent, and contribution to the infringement by others of the ‘209 patent.

Lilly seeks, inter alia, injunctive relief, costs and attorneys’ fees.

April 3, 2017

Indiana Patent Litigation: Lilly Alleges Patent Infringement, Sues Generic Manufacturer

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Eli Lilly and Company of Indianapolis, Indiana filed a patent infringement lawsuit in the Southern District of Indiana asserting infringement of U.S. Patent No. 7,772,209 (‘209 Patent). Defendant is Amneal Pharmaceuticals LLC of Bridgewater, New Jersey.

Lilly states that Amneal filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to manufacture and sell two “Pemetrexed for Injection” products prior to the expiration of the ‘209 patent. Lilly contends that the ‘209 patent, which was issued by the U.S. Patent and Trademark Office, protects the Pemetrexed products.

In this patent litigation, filed by attorneys for Lilly, a single count is listed, “Infringement of U.S. Patent No. 7,772,209.” Lilly seeks relief from the Indiana court including a judgment of infringement, injunctive relief, costs and attorneys’ fees.

Practice Tip: Lilly has had some success protecting its ‘209 patent, which relates to the cancer drug Alimta®, against generic manufacturers. See, e.g., U.S. Court of Appeals Rules In Lilly’s Favor on Alimta Vitamin Regimen Patent.

March 22, 2017

Patent Law: Federal Circuit Rules on Two Eli Lilly Patent Cases

By Overhauser Law Offices, LLC

Washington, D.C. — The Federal Circuit ruled on two patent infringement decisions, Los Angeles Biomedical Research Institute v. Eli Lilly & Co. and Eli Lilly & Co. v. Los Angeles Biomedical Research Institute, that involve Indianapolis-based Eli Lilly and Company.

These companion cases pertain to a pharmaceutical patent, U.S. Patent No. 8,133,903 (“the ’903 patent”), owned by Los Angeles Biomedical. Also at issue is one prior art reference, International Patent Application No. WO 01/80860, published Nov. 1, 2001, common to both lawsuits.

Los Angeles Biomedical Research Institute v. Eli Lilly & Co. arose as an inter partes review of a decision by the Patent Trial and Appeal Board holding all claims of the ‘903 patent to be obvious. The Federal Circuit reviewed claims in a provisional application relating to a study involving rats in combination with a method in an uncited reference to convert those results to apply to humans. It held that the rat study and uncited conversion method did not support the claimed dosage for humans. It further concluded that claims directed to an underlying condition should not be construed broadly to treat symptoms of that condition, holding that the Board had not adopted the broadest reasonable interpretation of the claims but instead had adopted an overbroad interpretation. The panel remanding, stating:

The question remains whether a person of skill in the art would have had a reason to combine [the three cited references relating to the medical condition] and would have had a reasonable expectation of success from doing so. Because the Board’s obviousness analysis was based on an erroneous construction of the claim language and an overly broad interpretation of [one of the references], and because the Board did not address the record evidence summarized above, we remand for the Board to make new findings as to whether there was an apparent reason to combine the prior art references and whether that combination would have rendered [the treatment] obvious.

February 24, 2017

Indiana Patent Litigation: Trial Court Grants Stay in Axiron Lawsuit

By Overhauser Law Offices, LLC

Indianapolis, Indiana – The matter of Eli Lilly and Company, et al. v. Apotex Inc., et al. has been stayed pending a ruling by the U.S. Court of Appeals for the Federal Circuit.

This Indiana lawsuit was initiated by Lilly, an Indianapolis pharmaceutical company, in conjunction with other Plaintiffs. Patent attorneys for Plaintiffs filed a lawsuit asserting patent infringement after Defendants filed an Abbreviated New Drug Application seeking approval to market a generic version of the drug Axiron® before various patents related to the drug expired. Among Plaintiffs’ contentions were claims of patent infringement of seven patents pertaining to Axiron.

In this motion, patent lawyers for Plaintiffs have asked the court to stay its proceedings pending a ruling in a similar case, Eli Lilly and Company, et al. v. Perrigo Company, et al. The Perrigo case was filed in the Southern District of Indiana in 2013. After a trial, the court issued findings including that one claim in one of the Axiron patents was invalid, while two claims pertaining to another Axiron patent were valid. That ruling was appealed to the Federal Circuit; that appeal remains pending.

February 23, 2017

Indiana Patent Litigation: Lilly Sues TWi Pharmaceuticals for Patent Infringement

By Overhauser Law Offices, LLC

Indianapolis, Indiana – A patent lawyer for Eli Lilly and Company of Indianapolis, Indiana, Eli Lilly Export S.A. of Geneva, Switzerland and Acrux DDS, Pty Ltd. of West Melbourne, Australia filed an intellectual property lawsuit in the Southern District of Indiana.

Two Defendants are listed, TWi Pharmaceuticals, Inc. of Paramus, New Jersey and TWi Pharmaceuticals USA, Inc. of Taipei, Taiwan. In a 28-count complaint, Defendants are accused of infringing seven patents by filing an Abbreviated New Drug Application with the U.S. Food and Drug Administration for approval of a generic version of the pharmaceutical product Axiron® before the expiration of the patents under which the drug is protected. The patents at issue in this litigation are U.S. Patent Nos. 8,435,944; 8,993,520; 9,180,194; 8,419,307; 8,177,449; 8,807,861 and 9,289,586.

The counts against Defendants include “direct patent infringement,” “inducement to infringe” and “contributory infringement” as well as counts requesting declaratory judgment. Lilly et al. are seeking declaratory relief, injunctive relief, costs and attorney fees.

January 23, 2017

U.S. Court of Appeals Rules In Lilly’s Favor on Alimta Vitamin Regimen Patent

By Overhauser Law Offices, LLC

Indianapolis, Indiana – The U.S. Court of Appeals for the Federal Circuit has upheld the district court’s decision and ruled in favor of Eli Lilly regarding validity and infringement of the vitamin regimen patent U.S. Patent No. 7,772,209 for Alimta® (pemetrexed for injection).

In the case of Eli Lilly and Company v. Teva Parenteral Medicines, Inc., et al., the court affirmed the earlier district court’s rulings that the vitamin regimen patent is valid and would be infringed by the generic challengers’ proposed products. If the patent is ultimately upheld through all remaining challenges, Alimta would maintain U.S. exclusivity until May 2022, preventing marketing of generic products for as long as the patent remains in force. The Alimta compound patent remains in force through January 24, 2017.

In March 2014, the U.S. Court for the Southern District of Indiana upheld the validity of the vitamin regimen patent. In August 2015, the same court ruled in Lilly’s favor regarding infringement of the vitamin regimen patent.