Pharmaceuticals

January 23, 2017

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

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.

December 29, 2016

Indiana Patent Litigation: Lilly Defends Alimta Patent in Federal Court

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Eli Lilly and Company of Indianapolis, Indiana filed a lawsuit in the Southern District of Indiana alleging patent infringement.

Defendant is Hospira, Inc. of Lake Forest, Illinois. It has been accused of infringing U.S. Patent No. 7,772,209 (the “‘209 patent”) by the filing of a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture and sell a pharmaceutical product, “Pemetrexed for Injection,” in various concentrations. In its filing with the FDA, Hospira contended that the claims of Lilly’s patent are “invalid, unenforceable, and/or not infringed by the manufacture, use, offer for sale, or sale of Hospira’s NDA Products.”

Lilly contends that this product will compete with Alimta®, which also consists of the pharmaceutical chemical pemetrexed disodium. Alimta is used as a chemotherapy agent to treat certain types of cancer.

November 30, 2016

Indiana Patent Litigation: Alcon Alleges Infringement of Eye Drug by Generic Drugmaker

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Alcon Research, Ltd. of Fort Worth, Texas and Alcon Pharmaceuticals Ltd. of Fribourg, Switzerland filed an intellectual property lawsuit in the Southern District of Indiana. They assert infringement of two patents covering Pataday®, an ophthalmic pharmaceutical. Pataday is covered by U.S. Patent Nos. 6,995,186 (the “‘186 patent”) and 7,402,609 (the “‘609 patent”).

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Defendant Akorn, Inc., a generic drugmaker based in Lake Forest, Illinois, filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration seeking approval to manufacture and sell a generic version of Plaintiffs’ drug prior to the expiration of the two patents-in-suit. Plaintiffs contend that the submission of this ANDA is an act of patent infringement.

In this Indiana complaint, patent lawyers for Alcon ask the court to adjudicate the following:

November 23, 2016

Indiana Patent Litigation: Lilly Sues Generic Drugmaker for Third Time Regarding ALIMTA

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Patent attorneys for Plaintiff Eli Lilly and Company filed a lawsuit in the Southern District of Indiana alleging infringement. Defendant is Fresenius Kabi USA, LLC of Lake Zurich, Illinois.

Lilly, an Indianapolis-based company, is a developer and seller of pharmaceutical drugs. One of its drugs, ALIMTA®, is marketed as a chemotherapy agent used for the treatment of various types of cancer.

Fresenius, formerly known as APP Pharmaceuticals, LLC, manufactures and sells generic drugs. Earlier this year, Fresenius amended its Abbreviated New Drug Application (“ANDA”), which was previously filed to seek U.S. Food and Drug Administration (“FDA”) approval to manufacture three different concentrations of ALIMTA. Through its recent amendment, Fresenius now asks for approval to manufacture and sell a fourth generic version of ALIMTA. Lilly filed this litigation in response.

October 31, 2016

Indiana Patent Litigation: Lilly Sues Alleging Infringement of Testosterone Product

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Patent lawyers for Plaintiffs Eli Lilly and Company of Indianapolis, Indiana, its subsidiary Eli Lilly Export S.A. of Geneva, Switzerland and Acrux DDS Pty Ltd of West Melbourne, Australia filed a lawsuit alleging patent infringement. This federal lawsuit, commenced in the Southern District of Indiana, lists two Defendants, Cipla Limited of Mumbai, India and its wholly owned subsidiary Cipla USA, Inc. of Miami, Florida.

The parties in this litigation are engaged in the development and sale of pharmaceuticals. At issue is Plaintiffs’ transdermal testosterone solution, which is marketed under the trade name “Axiron®.” Lilly holds New Drug Application No. 022504 for this drug, which was approved by the U.S. Food and Drug Administration (“FDA”).

Defendants submitted an Abbreviated New Drug Application (“ANDA”) to the FDA seeking approval to market a generic version of Lilly’s Axiron product. In this ANDA, Defendants certified to the FDA that they believed that the patents-in-suit were invalid, unenforceable and/or would not be infringed by the commercial manufacture, use or sale of the generic version of Axiron described in the ANDA.

According to Plaintiffs, the filing of this ANDA by Defendants constitutes patent infringement. Plaintiffs also contend that other threatened activities, such as commercial manufacture, importation and sale of a generic version of Axiron, would also infringe Plaintiffs’ patents.

Plaintiffs list three disputed patents in this lawsuit: U.S. Patent Nos. 8,435,944; 8,993,520 and 9,180,194. These patents have been issued by the U.S. Patent and Trademark Office. Indiana attorneys for Plaintiffs ask the court for relief with respect to the following claims of patent infringement:

• Count I: Direct Infringement of U.S. Patent No. 8,435,944
• Count II: Inducement To Infringe U.S. Patent No. 8,435,944
• Count III: Contributory Infringement of U.S. Patent No. 8,435,944
• Count IV: Direct Infringement of U.S. Patent No. 8,993,520
• Count V: Inducement To Infringe U.S. Patent No. 8,993,520
• Count VI: Contributory Infringement of U.S. Patent No. 8,993,520
• Count IV [sic]: Direct Infringement of U.S. Patent No. 9,180,194
• Count V [sic]: Inducement To Infringe U.S. Patent No. 9,180,194

• Count VI [sic]: Contributory Infringement of U.S. Patent No. 9,180,194

The complaint also lists three counts seeking declaratory judgment.

Plaintiffs aver that this case is “exceptional” and ask the court for an award of their costs, including attorneys’ fees, pursuant to 35 U.S.C. §§ 285 and 271(e)(4).

July 8, 2016

Indiana Patent Litigation: Lilly Alleges Infringement, Sues Generic Drugmakers

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Patent lawyers for Plaintiffs Eli Lilly and Company of Indianapolis, Indiana, Eli Lilly Export S.A. of Geneva, Switzerland and Acrux DDS Pty Ltd. of West Melbourne, Australia initiated patent infringement litigation in the Southern District of Indiana.

Defendants are Apotex Corp. of Weston, Florida and Apotex Inc. of Ontario, Canada. Both companies manufacture, market and distribute generic pharmaceutical products. This lawsuit was initiated in response to an Abbreviated New Drug Application submitted to the U.S. Food and Drug Administration for approval to market a generic version of Lilly’s Axiron®, a prescription testosterone product used to treat males for conditions associated with a deficiency or absence of endogenous testosterone.

Defendants are accused of infringing Plaintiffs’ intellectual property rights in seven patents: U.S. Patent Nos. 8,419,307; 8,177,449; 8,435,944; 8,807,861; 8,993,520; 9,180,194 and 9,289,586.

In a 28-count complaint, filed by Indiana patent attorneys for Plaintiffs, 21 counts of patent infringement are listed, including a count of direct infringement, a count of inducement to infringe and a count of contributory infringement for each of the seven patents-in-suit. The remaining seven counts seek declaratory judgment of infringement of each of the seven patents.

In addition to relief for the wrongdoings alleged in the 28 counts, Plaintiffs seek reimbursement of the costs and attorneys’ fees associated with this lawsuit.

March 17, 2016

Indiana Patent Litigation: Lilly Sues Alleging Infringement of Patented Osteoporosis Drug

By Overhauser Law Offices, LLC

Indianapolis, Indiana – An Indiana patent lawyer for Plaintiff Eli Lilly and Company of Indianapolis, Indiana (“Lilly”) filed a patent infringement lawsuit in the Southern District of Indiana. The allegations of infringement have been directed at Defendants Teva Pharmaceuticals USA, Inc. of North Wales, Pennsylvania and its parent company Teva Pharmaceutical Industries Ltd. of Israel.

This lawsuit was instituted in response to Abbreviated New Drug Application (“ANDA”) No. 208569, which was filed with the U.S. Food and Drug Administration by Teva USA. The ANDA seeks approval to market a generic version of Forteo®, a prescription drug offered by Lilly to treat osteoporosis.

At issue in this litigation are Lilly’s U.S. Patent Nos. 6,770,623; 7,144,861; 7,550,434; 6,977,077; 7,163,684; and 7,351,414. All have been issued by the U.S. Patent and Trademark Office. Lilly contends that the filing of the ANDA constitutes direct infringement, inducement to infringe and contributory infringement of these patents under U.S. patent law.

Lilly seeks equitable relief, costs and attorney’s fees.

March 1, 2016

Indiana Patent Litigation: Lilly Sues India Manufacturer of Generic Drugs for Infringement

By Overhauser Law Offices, LLC

Indianapolis, Indiana – An Indiana patent attorney for Plaintiff Eli Lilly & Company (“Lilly”) of Indianapolis, Indiana filed a lawsuit in the Southern District of Indiana alleging that Biocon Limited of Bangalore, India will infringe its patented chemotherapy drug, which Lilly offers under the brand name ALIMTA.

At issue in this patent litigation is U.S. Patent No. 7,772,209 (the “‘209 patent”). In February, Biocon notified Lilly that it had submitted an Abbreviated New Drug Application (“ANDA”) to the FDA. Lilly believes that the product that is the subject of the ANDA will be marketed as a generic version of ALIMTA and that such conduct will infringe the ‘209 patent.

This federal patent infringement lawsuit, filed by an Indiana lawyer on behalf of Lilly, lists a single count: Infringement of U.S. Patent No. 7,772,209.

Lilly states that it will suffer irreparable injury unless Defendant is “enjoined from infringing the ‘209 patent, actively inducing infringement of the ‘209 patent, and contributing to the infringement by others of the ‘209 patent.” It seeks a declaratory judgment, equitable relief, damages, costs and attorneys’ fees.

February 9, 2016

Indiana Patent Litigation: Eli Lilly Asks Indiana Federal Court to Adjudicate Dispute Regarding Patented Pharmaceutical

By Overhauser Law Offices, LLC

Indianapolis, Indiana – Indiana patent attorneys for Plaintiff Eli Lilly and Company of Indianapolis, Indiana (“Lilly”) filed an intellectual property lawsuit in the Southern District of Indiana asserting infringement of U.S. Patent No. 7,772,209 (“the ‘209 patent”), which was filed with the U.S. Patent and Trademark Office.

This patent infringement lawsuit asserts unlawful behavior by two Defendants. Specifically, the complaint states that Dr. Reddy’s Laboratories, Inc. of Princeton, New Jersey is acting on behalf of Dr. Reddy’s Laboratories, Ltd. of Hyderabad, India in seeking approval to manufacture and sell a generic version of Lilly’s ALIMTA®, a chemotherapy agent used for the treatment of various types of cancer. Lilly further contends that the two Defendants are agents and/or alter-egos of one another.

Lilly states that unless Defendants are “enjoined from infringing the ‘209 patent, actively inducing infringement of the ‘209 patent, and contributing to the infringement by others of the ‘209 patent, Lilly will suffer irreparable injury.”

This lawsuit, filed by Indiana patent lawyers for Lilly, lists a single count: Infringement of U.S. Patent No. 7,772,209. Lilly seeks a declaratory judgment, equitable relief, damages, costs and attorneys’ fees.

December 4, 2015

Federal Circuit Patent Law: Quality Control Testing Is Not Patent Infringement; Does Not “Make” a Product as Contemplated Under § 271(g)

By Overhauser Law Offices, LLC

Washington, D.C. – The United States Court of Appeals for the Federal Circuit heard a patent infringement lawsuit styled Momenta Pharms., Inc. v. Teva Pharms. USA Inc. on the issue of whether Defendants’ quality control procedures infringed the patent-in-suit. This appeal included a companion case, Momenta Pharms., Inc. v. Amphastar et al. Both cases were heard at the trial court level in the United States District Court for the District of Massachusetts by Judge Nathaniel M. Gorton.

Momenta was the first to market enoxaparin, an anticoagulant drug, in generic form. Momenta also owns U.S. Patent No. 7,575,886 (“the ‘886 patent”), which includes claimed methods designed to ensure that every batch of enoxaparin was of sufficient quality. Momenta asserted the ‘886 patent against other manufacturers, including Teva and Amphastar, which also wanted to bring a generic version of enoxaparin to market. It contended that Defendants’ quality-control measures infringed the ‘886 patent.

In this litigation, the United States District Court for the District of Massachusetts determined that patent infringement had not taken place, listing two separate grounds. First, the asserted claims were directed towards analyzing enoxaparin for the purpose of quality control, not manufacture of the drug, which did not amount to patent infringement. Second, the district court found that use of the analytical methods of the ‘886 patent were protected under the safe harbor provisions of 35 U.S.C § 271(e)(1). Momenta appealed.

Circuit Judges Dyk, Moore and Wallach of the Federal Circuit ruled on this appeal in November. Writing for the court, Judge Wallach affirmed the trial court’s ruling that Defendants Teva and Amphastar had not infringed the ‘886 patent, holding that infringement under 35 U.S.C. § 271(g) occurs when “making” a product and that quality-control testing, thus, did not constitute patent infringement.

The Federal Circuit vacated the district court’s judgment that the activities were also protected under the “safe harbor” provisions within § 271(e)(1) and remanded this issue to the district court for further inquiry.