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`New Patents Could Sustain Allergan Restasis Franchise Until
`2024
`Jan.14.14 | About: Allergan plc (AGN)
`In its most recent quarterly results, Allergan (NYSE:AGN) stated that its Restasis product
`had $239.3M in net sales for the three months ended September 30, 2013, and $662.4M
`in net sales for the nine months ended September 30, 2013. Allergan gave guidance that
`it expected Restasis to have net sales for the full year of 2013 of $900-920M. This is
`roughly 15% of Allergan's total expected annual product sales. Thus, Restasis appears to
`be a very important product to Allergan.
`
`Restasis is a drug that was approved by the FDA in December 2002. Its active ingredient
`is cyclosporine (0.05% strength) and it is an ophthalmic emulsion. Allergan stated in its
`most recent 10-Q that "The U.S. Patent covering Restasis will expire in May 2014."
`Indeed, the FDA's Orange Book listing of patents for Restasis currently contains only one
`patent, U.S. Pat. 5,474,979 ("the '979 patent"), which expires on May 17, 2014. Fear of
`generic competition for Restasis sent Allergan's shares down more than 10% last summer
`when the FDA issued guidance for how generic forms of Restasis could be developed.
`
`This morning, the U.S. Patent and Trademark Office issued a new patent to Allergan for
`"Methods of Providing Therapeutic Effects Using Cyclosporin Components." This is the
`second patent the Patent Office issued in as many weeks from the same family of
`applications that date back to September 2003. There will be a third patent from the family
`issued next week and at least two more issued in the near future. Specifically, on
`December 31, 2013, the PTO issued U.S. Pat. No. 8,618,064 ("the '064 patent"), and
`today the PTO issued U.S. Pat. No. 8,629,111 ("the '111 patent"). Any patents issued from
`this family, including the '064 and '111 patents, will have a term that extends to at least
`2024, a decade longer than the only current Orange Book patent for Restasis that expires
`in a few months.
`
`While the '064 patent claims, "A method of treating or preventing corneal graft rejection ...
`," which may not effectively protect Restasis from generic competition, the brand new '111
`patent issued this morning broadly claims, "A topical ophthalmic emulsion for treating an
`eye of a human comprising cyclosporin A in an amount of about 0.05% by weight ... ."
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`https://seekingalpha.com/article/1945551-new-patents-could-sustain-allergan-restasis-franchise-until-2024
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`MYLAN - EXHIBIT 1083
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, & -01132
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`Thus, it seems to be a broad patent that Allergan can list in the Orange Book and assert
`against any potential generic challenger to Restasis. Indeed, Allergan filed an 8-K with the
`SEC this morning stating, "The Company has submitted the '111 Patent for listing in the
`United States Food and Drug Administration (the "FDA") publication Approved Drug
`Products With Therapeutic Equivalence Evaluations, commonly known as the Orange
`Book. The '111 Patent will expire in August 2024."
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`https://seekingalpha.com/article/1945551-new-patents-could-sustain-allergan-restasis-franchise-until-2024
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