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26 April 2022GenericsMuireann Bolger

BioMarin, MSD sue Aurobindo over rare disease drug

BioMarin Pharmaceutical and MSD (known as 'Merck & Co' in the US), have sued Aurobindo Pharmaceuticals for patent infringement in a dispute over the drug Kuvan (Sapropterin hydrochloride), used to treat a rare genetic disorder.

The companies filed the complaint at the US District Court for the District of New Jersey on April 22.

The litigation arises from Aurobindo’s filing of a purported Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to commercially manufacture and market a generic version of the 100 mg tablets before the expiration of the patents that protect it.

The patents-in-suit are US patent numbers: 7,566,462, 7,566,714, 7,612,073, 7,727, 987, 8003,126 , 8,067,416, RE43,797, 8,318,745, and 9,433,624.

According to the lawsuit, BioMarin and MSD received a letter from Aurobindo, dated March 8, 2022, stating that the patents-in-suit are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, or sale of Aurobindo’s generic product.

Consequently, Aurobindo had decided to pursue approval of its proposed generic product prior to the expiration of the patents-in-suit.

According to the complaint, Aurobindo’s purported ANDA contains information showing that Aurobindo’s generic product is bioequivalent to the patented Kuvan product; with the same active ingredient, route of administration and strength as the patented product.

It also has the same, or substantially the same, dosage form and proposed labelling as the patented drug with the same indication and usage, said the complaint.

The companies are seeking a judgment ordering that the effective date of any approval of ANDA number 216797 shall not be any earlier than the expiration date of the patents-in-suit, including any extensions.

But they have also added that if Aurobindo commercialises the generic product within the US, or imports it before the expiration of the patents-in-suit, they are requesting monetary relief together with interest and attorneys’ fees along with costs and expenses.

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