A federal district court has ruled against Allergan in patent litigation for one of its top-selling drugs, Restasis (cyclosporine ophthalmic emulsion), a drug to treat dry eyes, and separately, Allergan has reached a settlement with InnoPharma, a subsidiary of Pfizer, for an authorized generic of Restasis. The drug had 2016 global sales of $1.4 billion.

Allergan has been involved in patent litigation for Restasis with several generic-drug companies, and the US District Court for the Eastern District of Texas has ruled the four asserted patents covering Restasis are invalid based on obviousness. The patents relate to methods of providing therapeutic effects using cyclosporin components (US Patent Nos. 8,629,111; 8,648,048; 8,685,930 and 9,248,191). The patents in question are listed in the Orange Book, which publishes all US Food and Drug Administration-approved drug products with therapeutic equivalence, and are set to expire on August 27, 2024.

Allergan said it will appeal the court’s ruling. “We are disappointed by the federal district court’s decision on the Restasis patents,” said Robert D. Bailey, chief legal officer, Allergan, in a company statement. “We are carefully reviewing the decision and are considering all options. Allergan remains committed to vigorously defending the intellectual property of our products, which allows us to continue to invest in developing and bringing forward new medicines for millions of patients.”

Allergan issued a question-and-answer document to further answer questions on the ruling, including the potential timing for a launch of generic versions of the drug. The company said that a late 2018/early 2019 generic launch is reasonable under the following assumptions: (1) there is a US Food and Drug Administration (FDA) approved generic product by that time; (2) the appeal process takes approximately 12 months, which is a typical time horizon; and (3) a court grants an injunction pending appeal. The company said it is possible that a generic entrant may enter earlier if: (1) there is FDA approval for a generic product, (2) such approved generic product is launched “at-risk”; and/or (3) there is an earlier adverse final court decision.

In assessing the potential financial impact of generic-drug entries, Allergan said in the question-and-answer document: “While opinions on the subject may vary, anticipating a generic launch in early 2018, while conservative, could be an appropriate assumption,” the company said. Allergan said it will provide a general framework on the potential annual impact from generic competition on Restasis in its third-quarter earnings call.

Allergan said in the question-and-answer document that it is currently not aware of any FDA-approved generic products for Restasis, and said “as far as we know, FDA has not made a determination as to whether any of the generics is a ‘first applicant’ entitled to exclusivity.” The company said it does not believe that the FDA has issued sufficient regulatory guidance to provide a clear pathway to approval for a proposed generic version of this product.

Mylan, which was one of the companies involved in the patent litigation with Allergan, commented on the federal district court’s ruling. “We look forward to continuing to work with the FDA to expeditiously bring our more affordable, generic Restasis product to patients,” said Mylan CEO Heather Bresch in a company statement.

The federal district court ruling that invalidated Allergan’s patents followed an earlier effort by Allergan to protect its patent position through an agreement made in September 2017 under which Allergan had transferred all Orange Book-listed patents for Restasis to the Saint Regis Mohawk Tribe, a recognized sovereign tribal government, and which Allergan then licensed the patents. The tribe filed a motion to dismiss an ongoing inter partes review (IPR) of the Restasis patents based on its sovereign immunity from IPR challenges. At the time of the agreement, Allergan said that the agreement with the tribe had no impact on the pending abbreviated new drug application patent litigation regarding the Restasis patent-family case being considered in the Texas federal district court.

The Saint Regis Mohawk Tribe subsequently wrote a letter to the US Senate Judiciary Committee to clarify what it termed as certain claims and misperceptions made in recent media coverage and in a September 27, 2017 letter from Senator Maggie Hassan (D-NH), Senator Bob Casey (D-PA), Senator Sherrod Brown (D-OH), and Senator Richard Blumenthal (D-CT) requesting that the Senate Judiciary Committee investigate the tribe’s purchase of the Orange-Book patents for Restasis.

In a statement, Mylan offered the view that the decision of the federal district court to invalidate the Allergan patents also extends to the agreement made between Allergan and the Saint Regis Mohawk Tribe. “The Court’s decision also will be binding against the Saint Regis Mohawk Tribe, which the Court added to the lawsuit,” Mylan said. “In ultimately allowing the Tribe to join the lawsuit, the Court expressed its concerns that ‘sovereign immunity should not be treated as a monetizable commodity that can be purchased by private entities as part of a scheme to evade their legal responsibilities.” Allergan did not specifically address this point in the statements it publicly released.

Separately, Allergan reached a settlement with InnoPharma, a subsidiary of Pfizer, for an authorized generic of Restasis. As a result, all InnoPharma Hatch-Waxman litigation regarding Restasis patents will be dismissed. Under the settlement, Allergan will grant InnoPharma licenses to market a generic version of Restasis in the US beginning on February 24, 2024, or earlier under certain circumstances. Additionally, under certain circumstances, Allergan will supply and authorize InnoPharma to launch an authorized generic version of Restasis on August 28, 2024.

Source: Allergan (patent litigation loss) , Allergan (settlement), Allergan (tribal deal), Mylan, and St. Regis Mohawk Tribe