Recent Posts
- Hikma v. Vanda: Oral Argument Recap
- Teva v. Lilly should not be read as creating a new 112 rule for method of use claims
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- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Category: Citizen Petitions
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Tyco Healthcare et al. v. Mutual Pharm. et al., No. 2013-1386 (Fed. Cir.) by Aaron F. Barkoff In 2006, Mutual filed an ANDA for a generic version of Restoril (temazepam), including a paragraph IV certification to Tyco's U.S. Patent No. 5,211,954. Tyco filed suit against Mutual under 35 USC 271(e)(2), Mutual responded with antitrust…
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"The MMA generally precludes multiple 30-month stays for those applications to which it applies." That is a statement from the FDA in a draft guidance document entitled "Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement and Modernization Act of 2003," published in October…
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We reported last month that King Pharmaceuticals filed a citizen petition that could delay final approval of numerous ANDAs for generic versions of Altace (ramipril), which were set to earn final approval on June 7. King's citizen petition asked FDA to require ANDA applicants for ramipril to file patent certifications with respect to newly-issued U.S. Patent No.…
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King Pharmaceuticals markets Altace (ramipril), which is indicated for the treatment of high blood pressure. Until last year, when the Federal Circuit invalidated King's compound patent on ramipril, King earned about $700 million annually from U.S. sales of Altace. Although Lupin was the ANDA filer who prevailed against King in the patent litigation, Cobalt Labs,…
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Last Monday, the Federal Circuit affirmed a district court decision in McNeil-PPC v. Perrigo, concerning a generic version of Pepcid Complete. The decision was affirmed without an opinion, under Rule 36. Tuesday, AstraZeneca and Ranbaxy announced a settlement of their patent litigation over generic Nexium (esomeprazole), with Astra granting Ranbaxy exclusive rights to sell a…
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Last Friday, Rep. Anna G. Eshoo (D-CA) announced that she and Rep. Joe Barton (R-TX) introduced H.R. 5629, the "Pathway for Biosimilars Act" (click here for summary; click here for text of bill). BIO immediately applauded the bill, while GPhA immediately denounced it. For more, visit FDA Law Blog; Pharmalot; or the WSJ Health Blog.…
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A reader recently e-mailed me about an interesting citizen petition that Teva filed last August. In the petition, Teva requests that FDA: (1) relist U.S. Patent No. 5,158,952 in the Orange Book for Risperdal (risperidone) tablets; (2) confirm Teva’s right to 180-day exclusivity for risperidone tablets; and (3) refrain from approving any other ANDAs for…
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Teva announced last week that it was granted 180-day exclusivity for its generic Kytril injection product (granisetron HCl, 1 mg/mL in 1 mL vials). Thus, it appears the FDA decided the 180-day exclusivity issue raised in Teva’s citizen petition–namely, whether Teva’s failure to market its generic product within 30 months of ANDA submission caused forfeiture…
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FDA recently posted numerous comments from industry regarding Ramipril 180-day exclusivity issues on its website. The comments come in response to FDA's request last month. A summary of the new comments is in the works. FDA also established a docket for comments on Granisetron HCl 180-day exclusivity issues. This too follows an FDA request made…
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Last Friday, FDA Law Blog wrote about yet another 180-day exclusivity letter from the FDA, this one requesting comment on the "failure to market" forfeiture provisions of the MMA. FDA Law Blog also posted a very nice summary of the FDA Amendments Act, which, among other changes, revises the citizen petition process. GSK sued the…
Orange Book Blog 