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21 April 2022AmericasAlex Baldwin

Alkermes and Janssen enter arbitration over nanocrystal tech

Irish biopharmaceutical company Alkermes has entered arbitration proceedings over two license agreements with Johnson & Johnson (J&J) subsidiary Janssen Pharmaceuticals.

The proceedings look to settle a dispute over agreements in which Alkemers provided access to its “small particle pharmaceutical compound technology” nanocrystal.

The compound was crucial for the development of several Janssen treatments, including its antipsychotic Invega Sustenna (Paliperidone Palmitate), Invega Hafyera (Paliperidone Palmitate), and antiretroviral medication Cabenuva (Cabotegravir/rilpivirine)

Alkermes said that it partially terminated the agreements with Janssen in the US in February 2022.

In a press release published on Tuesday, April 19, Alkermes says that the arbitration proceedings will decide whether Janssen has an obligation to continue paying royalties on sales in the US of the products it developed using the technology.

Alkermes claims that, so far, Janssen has refused to pay the royalties required by the agreement since the partial agreement termination.

“Alkermes strongly disagrees with Janssen's position and contends that it continues to owe royalties. Alkermes remains committed to enforcing its contractual rights and addressing any unauthorized use of its intellectual property,” the company stated.

As a result, Alkermes triggered the dispute resolution provision of the agreement, sparking confidential arbitration proceedings that will take place between a panel of three arbitrators.

Alkermes stated that it “does not intend to comment or provide additional information regarding the arbitration until an order on the merits or other material order is issued in the arbitration or the arbitration is otherwise concluded.”

Invega Sustenna is a blockbuster drug. J&J’s portfolio of schizophrenia injections—Invega Sustenna/Xeplion/Invega Trinza/Trevicta—made $4 billion in sales in 2021.

In February, Janssen filed a lawsuit against India’s Intas Pharmaceuticals seeking to block the drugmaker from launching its generic Invega Sustenna. It alleges that the generic infringes on one of its patens which is set to expire in 2031.

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More on this story

Americas
31 July 2019   Biopharmaceutical company Alkermes has entered into a settlement and licence agreement with generic maker Amneal Pharmaceuticals to resolve an inter partes review.
Americas
26 April 2019   Petitioners will continue to be able to launch litigation simultaneously before both the district court and the Patent Trial and Appeal Board, effectively having two bites at the apple, according to John Kirkland, director of IP at biopharmaceutical company Alkermes.

More on this story

Americas
31 July 2019   Biopharmaceutical company Alkermes has entered into a settlement and licence agreement with generic maker Amneal Pharmaceuticals to resolve an inter partes review.
Americas
26 April 2019   Petitioners will continue to be able to launch litigation simultaneously before both the district court and the Patent Trial and Appeal Board, effectively having two bites at the apple, according to John Kirkland, director of IP at biopharmaceutical company Alkermes.