Inter Partes Review: an extreme way to kill Patents.

Inter partes review is a trial proceeding conducted at the Board to review the patentability of one or more claims in a patent only on a ground that could be raised under §§ 102 or 103, and only on the basis of prior art consisting of patents or printed publications

Generic companies are using Inter Partes Review as a key weapon against Innovator’s OB listed patents while a patent litigation on those patents is pending in a Federal district court.

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Apotex is one of the companies which keep on targeting the Innovator’s OB listed patents by initiating IPR proceedings. And Apotex succeeded in Alcon’s Vigamox (Moxifloxacin HCl), wherein Apotex filed both paragraph IV certification and IPR against the OB listed patents of Vigamox. Further, PTAB considered the very same prior art references as the district court considered, but came to the opposite conclusion, which results in the settlement of Alcon with Apotex.

Recently Apotex filed an Inter Partes Review against the OB listed patents of Restasis® (Cyclosporine Ophthalmic Emulsion) which is approved to Allergan. Allergan listed the following patents in Orange Book for Restasis.

i) US 8,629,111 B2 (Aug 27, 2024): claims MOT an eye using topical ophthalmic emulsion which comprises 0.05% cyclosporin A, 1.25% castor oil together with various excipients.

ii) US 8,633,162 B2 (Aug 27, 2024): claims MOT an eye using an ophthalmic emulsion comprising 0.05% cyclosporin A and 1.25% castor oil together with various excipients.

iii) US 8,642,556 B2 (Aug 27, 2024): claims MOT an eye using first topical ophthalmic emulsion which comprises cyclosporin A in an amount of about 0.05% by weight, polysorbate 80, acrylate/C10-30 alkyl acrylate cross-polymer, water, and castor oil in an amount of about 1.25% by weight.

iv) US 8,648,048 B2 (Aug 27, 2024): claims a method of increasing tear production in the eye using an emulsion comprises cyclosporin A in an amount of about 0.05% by weight, polysorbate 80, acrylate/C10-30 alkyl acrylate cross-polymer, water, and castor oil in an amount of about 1.25% by weight.

v) US 8,685,930 B2 (Aug 27, 2024): claims MOT an eye of a human having keratoconjunctivitis sicca using topical ophthalmic emulsion which comprises cyclosporin A in an amount of about 0.05% by weight, polysorbate 80, acrylate/C10-30 alkyl acrylate cross-polymer, water, and castor oil in an amount of about 1.25% by weight.

Apotex challenged the above patents on the following grounds:

a) Claims are not novel over the disclosure of US 5,474,979;

b) Claims are obvious over the disclosures of US 5,474,979, US 5,981,607 & US 5,578,586;

wherein Apotex argued that US ‘979  teaches  the formulations of cyclosporin A in castor oil emulsions which are used in the treatment of an eye: one emulsion contains 0.05% cyclosporin A with 0.625% castor oil; and another emulsion contains 0.10% cyclosporin A with 1.25% castor oil, which is sufficient to motivate a person skilled in the art to derive the present invention with a reasonable expectation.

Further US ‘979 also teaches the use of cyclosporin A in treating immune mediated karatocunjunctivitis sicca (KCS or dry eye disease); and

US ‘607 patent teaches topical ophthalmic castor oil emulsions for the treatment of dry eye.

On July 15, 2015 Allergan confirmed that the company has received a notice letter dated July 10, 2015 (the “Notice Letter”) from Akorn Pharmaceuticals stating that theU.S. Food and Drug Administration (FDA) has received Akorn’s Abbreviated New Drug Application (ANDA) containing a “Paragraph IV” patent certification seeking approval to market a generic version of Allergan’sRestasis® (cyclosporine ophthalmic emulsion) 0.05% product.  In addition, Allergan has received communication suggesting that additional ANDAs for generic versions of Restasis® may have been received by the FDA.

The Notice Letter received from Akorn states that the “Paragraph IV” patent certification was made with respect to certain U.S. patents covering the formulation and method of use of the Restasis® product, which are listed in the Orange Book.

For more information, visit Allergan’s website at www.allergan.com.

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