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Your search for “patent exclusivity” returned the following results.
…on whether Teva forfeited 180-day exclusivity eligibility because the only exclusivity-qualifying patent – U.S. Patent No. 5,608,075 – “expired” in March 2009 after Merck ceased paying certain patent maintenance fees. …
…to adjudicate patentability of issued patents. (The IPR procedures replaced the old inter partes re-examination procedures.) IPR petitions are filed with the PTO’s Patent Trial and Appeal Board (“PTAB”), which…
Market exclusivities—patent or otherwise—are a critical part of the Hatch-Waxman compromise, intended to encourage continued innovation in spite of the introduction of generic competition. Even a month of market exclusivity…
…In addition, in June 2007, FTC Commissioner Pamela Jones Harbour stated during a speech that “it would be incorrect to assume that Hatch-Waxman [patent and exclusivity benefits] can simply be…
…granted by the U.S. Patent and Trademark Office (“PTO”) with respect to U.S. Patent No. 5,053,407 (“the ‘407 patent”) covering Ortho McNeil-Janssen Pharmaceutical, Inc.’s (“Ortho’s”) LEVAQUIN (levofloxacin) is valid. Levofloxacin…
By Kurt R. Karst – Earlier this year we posted on two pending lawsuits brought by potential biosimilar applicants challenging the the so-called “patent dance” patent resolution provisions added to…
…by the patent brings a patent infringement action against the applicant, the applicant may assert a counterclaim seeking an order requiring the holder to correct or delete the patent information…
…“patent strength” standard and instead applies a “patent relitigation” standard, under which “it determines the amount of but-for competition by engaging in an ex-post judicial determination of the patent issues…
…its unanimous decisions in two cases that should solidify as to when a patent covering a drug product is eligible for a Patent Term Extension (“PTE”). In each case – Photocure…
…by refusing to grant orphan drug exclusivity for GRALISE. Instead of recognizing orphan drug exclusivity for GRALISE, FDA “placed additional hurdles between Gralise and orphan-drug exclusivity by attempting to impose…
…be considered a new chemical entity entitled to 5 years of exclusivity. Thus, for purposes of determining whether a particular drug product is eligible for 5-year NCE exclusivity, FDA’s Exclusivity…
…says that the Agency decided to “punt” on whether or not exclusivity would be available to Zydus: With respect to 180-day generic drug exclusivity, we note that Zydus was the…
…the development of antibiotics – and especially the “push” mechanism described in the report as “[t]radable vouchers to extend patent life or market exclusivity of another drug.” This is longhand…
Earlier this month, FDA published much-needed draft guidance on 180-day exclusivity, titled “180-Day Exclusivity: Questions and Answers.” We perused the document and promptly posted on it the next day, noting,…
…forfeit 180-day exclusivity under FDC Act § 505(j)(5)(D)(i)(VI) because the only exclusivity-qualifying patent – U.S. Patent No. 5,608,075 (“the ‘075 patent”), which was previously identified in the Orange Book as…