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Paragon BioTeck receives affirmation of R-phenylephrine hydrochloride formulation in patent case

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Paragon BioTeck announced the United States Patent and Trademark Office affirmed claims made by the company in the patent for its R-phenylephrine hydrochloride formulation, which is used to attain dilation of the pupil for ocular examinations.

The ruling was handed down by the office after Altaire Pharmaceuticals sought in 2015 to invalidate Paragon’s patent that claims a method of maintaining purity of the formulation. The ruling affirmed that the petition by Altaire was without merit. This is only the fourth written decision by the Patent Trial and Appeals Board, according to a Paragon press release.

“While our belief in the strength of our patent was never in doubt, this is a tremendous win for Paragon BioTeck. This continues to reaffirm our belief and company mission behind the science and products we develop,” Patrick Witham, president and CEO of Paragon, said in the release.

The patent ruling affirmed the science behind the R-phenylephrine hydrochloride formulation. Phenylephrine hydrochloride ophthalmic solution, USP 2.5% and 10%, is an alpha-1 adrenergic receptor agonist that dilates the pupil due to its vasoconstrictor and mydriatic action, according to the release.