COPD, or chronic obstructive pulmonary disease, is a progressive disease that makes it hard to breathe. “Progressive” indicates that the disease gets worse over time. COPD can cause coughing that produces large amounts of mucus, wheezing, shortness of breath, chest tightness, and other symptoms. Cigarette smoking is the leading cause of COPD. Most people who have COPD smoke or used to smoke. Long-term exposure to other lung irritants—such as air pollution, chemical fumes, or dust—also may contribute to COPD.

DALIRESP® (roflumilast) is indicated as a treatment to reduce the risk of Chronic Obstructive Pulmonary Disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Takeda and AstraZeneca sued a case in New Jersey federal court against an Indian generic drug manufacturer for infringing their product Daliresp for the chronic obstructive pulmonary disease drug by filing an ANDA with FDA.

AstraZeneca said, Hetero Labs Ltd. has filed an ANDA seeking U.S. Food and Drug Administration approval to market 500-microgram tablets of roflumilast, the generic version of Daliresp. Although Hetero labs Ltd. has argued that its application won’t infringe the patent, which expires on Jan. 27, 2020, and AstraZeneca has disagreed the comment and stated that the patent is invalid or unenforceable.

The major dispute is Hetero’s ANDA product has the same active ingredient, same method of administration, the same form of dosage, the same strength as Daliresp and is bioequivalent to Daliresp, the complaint said.

The branded drug is used to reduce the risk of worsening COPD symptoms in patients with severe COPD associated with chronic bronchitis.

Takeda owns U.S. Patent No. 5,712,298 and AstraZeneca have the exclusive licensee in the U.S. They are seeking a judgment that the patent isn’t invalid, are enforceable and are infringed by Hetero’s ANDA. They also want an order barring the generic company from doing anything with the generic version of Daliresp until after the patent expires, including any extensions or additional periods of exclusivity to which they are, or become, entitled, and that the effective date of any ANDA approval won’t be earlier than the expiration date.

AstraZeneca holds the patent, which it acquired an year before when it forked over $600 million to buy Actavis PLC’s branded respiratory business in the U.S. and Canada. The transaction also netted the rights to Tudorza Pressair, another COPD treatment.

The purchase built directly on AstraZeneca’s $2.1 billion 2014 acquisition of the rights to several respiratory treatments developed by Spain’s Almirall SA, the company said. That deal exposed respiratory ailments as a key focus for the British company as it sought more market power.

The two companies began suing over generic roflumilast and the related lawsuits, including the one filed, have been consolidated in New Jersey federal court.

One of the more recent suits was filed in December against Apotex Inc., alleging similar claims to those Takeda and AstraZeneca made in Friday’s complaint.

Apotex has offered the two companies the option of accessing confidential parts of its ANDA, but they say Apotex’s conditions are “unreasonable.”

For example, the companies would have to agree to only give access to outside counsel, which Takeda and AstraZeneca say would prevent them from seeking the opinion of objective experts or discussing the relevant findings — restrictions beyond what a protective order would do, the companies said.

Hetero could not be reached for comment. Takeda and AstraZeneca together hit Hetero labs Ltd.

key words: Hetero labs Ltd, Takeda, AstraZeneca, roflumilast, Daliresp, COPD.