Posts Tagged: "ANDA"

Actavis plc (NYSE: ACT) announced yesterday that it has entered into an agreement with Valeant Pharmaceuticals International (NYSE: VRX) to settle all outstanding patent litigation related to Actavis’ generic version of Acanya®… Actavis believes it was the first applicant to file an ANDA for the generic version of Acanya® Gel and, should its ANDA be approved, should be entitled to 180 days of generic market exclusivity.

What follows below is a review of some of the pharma news stories that caught my attention during the month of April 2014. Supreme Court Denies Teva’s Request for an Injunction Relating to Generic Copaxone® — Actavis Announces Celebrex® Patent Challenge Settlement — Actavis Net Revenue Increases 40% to $2.66 Billion in First Quarter 2014.

Mylan Inc. (NASDAQ: MYL) recently prevailed in the United States District Court for the Northern District of West Virginia in a patent dispute involving Perforomist® (formoterol fumarate) Inhalation Solution, which has as the active ingredient a bronchodialating compound. The district court confirmed the validity of all patents asserted by Mylan. At issue were U.S. Patent Nos. 6,667,344; 6,814,953; 7,348,362; and 7,462,645, which cover Perforomist through June 2021.

Mouse Model of Parkinson’s Disease Shows Improved Brain Function — DARPA Awards $25 Million To Develop Messenger RNA Therapeutics™ — Actavis Files ANDA for Generic Suboxone® Sublingual Film — AzaSite® Patents Upheld in Patent Infringement Lawsuit Against Sandoz — Surgeons Successfully Remove “Inoperable” Metastatic Breast Cancer — Actavis Files ANDA on Acanya® Gel, Gets Sued by Dow, Valeant — NYSE Inquires About Unusual Market Activity for Ampio Pharmaceuticals — Cannabis Biotech Hires Patent Attorney to Protect Medical Marijuana Innovation — Merck’s Hepatitis C Drug Gets Breakthrough Therapy Designation — Therapeutic Vaccine for Hepatitis C Enters Phase I — Urine Test for Cancer Monitoring — Popular Prenatal Vitamin Patent Upheld in District Court — Clinical Trials on Brain Technology to Assist ALS Patients — Teva Gets Favorable Ruling on COPAXONE in the Netherlands — BVGH Recruits Dr. Linda Venczel as New Program Director — Actavis’s settles with FTC over $8.5 Billion acquisition of Warner Chilcott

“Reverse payment” cases are an outgrowth of a key feature I noted in my first article on the basics of Paragraph IV Certifications: the filing of an Abbreviated New Drug Application (ANDA) by the generic drug maker with a Paragraph IV Certification is treated as a technical act of patent infringement.[2] After receiving notice of the Paragraph IV Certification, the patent owner/NDA holder has 45 days to bring suit, otherwise the FDA can move forward on approving the ANDA.[3] Conversely, if the patent owner/NDA holder does bring an infringement suit within the prescribed 45 day period, the FDA cannot approve that ANDA for 30 months, unless the patent(s) that are the subject of the Paragraph IV Certification are earlier deemed invalid or not infringed in that suit.[4]

In a moment of extreme weakness, I agreed to Gene’s request to doing a primer on Paragraph IV Certifications under the Drug Price Competition and Patent Term Restoration Act, commonly referred to as Hatch-Waxman. I don’t know if you would call me an expert, but I’ve studied many, many cases involving Paragraph IV Certifications under Hatch-Waxman. The courts have found Hatch-Waxman to be a hydra-like monster with a labyrinth of sections that are frequently confusing (or worse yet, conflicting). Paragraph IV Certifications are a particular trouble spot in Hatch-Waxman. So if you’re up to diving into the “belly of this beast,” let’s examine the characteristics of this most infamous of the Hatch-Waxman monsters. To understand Paragraph IV Certifications, you must first address what an Abbreviated New Drug Application (ANDA) is. ANDAs are how generic drug manufactures expedite the approval of their generic drugs.

Last week the Federal Circuit decided the case of Santarus, Inc. v. Par Pharmaceutical, Inc., which dealt with whether a drug covered by an Abbreviated New Drug Application (ANDA) infringed the patents owned by that patent owner relative to the proton pump inhibitors (PPI) product omeprazole. The big issue in the case is what might at first glance seem to be a rather innocuous statement relative to the support necessary in a patent specification for a negative claim limitation. But after reading the Newman dissent (which joins in the other aspects of the Court’s decision) it starts to become clear that this could be a much larger issue of significant consequence.

While the Supreme Court may have expanded the reach of the Hatch-Waxman “safe harbor,” the Medtronic and Merck cases only involved pre-marketing FDA approval activity. But the recent split Federal Circuit panel decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. has now (alarmingly in my view) further widened the applicability of this “safe harbor” beyond such pre-marketing FDA approval activity. In Momenta Pharmaceuticals, Judge Moore (writing for the majority joined by Judge Dyk) ruled that this “safe harbor” could also apply to post-FDA approval activity, even if that activity was at least arguably commercial in nature.

Last week, on Friday, June 15, 2012, Merck (NYSE: MRK) announced the U.S. District Court for the District of New Jersey (Judge Peter G. Sheridan) ruled against the company on the issue of patent infringement in its suit against Apotex Inc. According to Merck, global sales of Nasonex® in 2010 topped $1.2 billion. See Merck News. A variety of Internet sources place the Nasonex® market share of the inhaled steroid market at 47%. Therefore, this patent loss some 6 years before the Nasonex® patent expires is a big deal.

Some may recall my “dissertation” on the case of Amgen Inc. v. F. Hoffman-La Roche Ltd. See CAFC: A Divisional By Any Other Name Is Not a Divisional .  In Amgen, the Federal Circuit made it clear that you had better characterize an application as a “divisional” if you wanted the benefit of the “safe harbor” provided by 35 U.S.C…

Teva Pharmaceutical Industries Ltd. issued a press release last week discussing the abbreviated new drug application (ANDA) containing a Paragraph IV certification for COPAXONE® (glatiramer acetate injection), filed by Mylan Pharmaceuticals Inc. Teva announced that it has filed a lawsuit against Mylan Pharmaceuticals, Inc., Mylan Inc. and Natco Pharma Ltd. for patent infringement in the U.S. District Court for the…

The Patent Docs are reporting that on February 3, 2009, Senator Herb Kohl (D-WI) introduced legislation into the Senate titled the Preserve Access to Affordable Generics Act, which would prohibit brand name drug companies from compensating generic drug makers for delaying the entry of generic drugs into the market.  This bill is in response to a lawsuit initiated by the FTC…