Posts Tagged: "FDA"

Nothing clarified the stakes in orphan drug development like hearing Ron Bartek describe how after 16 years a promising treatment for his son’s disease finally emerged with TRND’s help. The therapy demonstrated enough potential that it was licensed by a small company which took it through Phase I and II trials. Both showed very promising results. Ron choked up describing how he felt after such a long struggle to help his child and finally seeing a real glimpse of hope. Everyone in the room shared the lump in his throat. A day like that reminds you why tech transfer and intellectual property are so important. When used correctly they improve and protect lives all around the world.

The Supreme Court reversed a decision from the Ninth Circuit that held that within the realm of labeling for food and beverages, a Lanham Act claim asserting that the label is deceptive and misleading is precluded by the Federal Food, Drug, and Cosmetic Act (FDCA). This case arose relating to the belief of POM that claims made by the Coca-Cola Company were misleading with respect to a juice blend sold by Coca-Cola’s Minute Maid division. The juice sold by Coca-Cola prominently displays the words “pomegranate blueberry,” but in truth the product contains only .3% pomegranate juice and only .2% blueberry juice.

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.

The Court will hear oral argument as follows: on February 26, in two cases on granting (Octane Fitness) and reviewing (Highmark) attorneys’ fee awards; on March 31, in a case (Alice Corp.) on patent eligibility of system and computer-implemented method claims; on April 21, in a case (POM Wonderful) on claims under Section 43 of the Lanham Act challenging labels regulated by the Food and Drug Administration; on April 22, in a case (Aereo) on whether a provider of broadcast television programming over the Internet violates a copyright owner’s public performance right; on April 28, in a case (Nautilus) on the proper standard for finding indefiniteness invalidity for patents; and on April 30, in a case (Limelight) on joint liability for method claim infringement where all of the claimed steps are performed but not by a single entity.

Kava Plant May Prevent Cigarette Smoke-induced Lung Cancer *** Conditional Approval for Treatment of T-cell Lymphoma in Dogs *** All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C Genotype 1 *** Favorable Markman Ruling for Dopomed in GRALISE® Patent Litigation *** More FDA Woes for Ranbaxy *** Inovio Develops DNA-based Immune Booster to Enhance T-cell Responses *** Fish & Richardson Wins Hatch-Waxman Litigation for Allergan *** FDA approves Mekinist with Tafinlar for Advanced Melanoma

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

1. Reed Tech takes over USPTO Contract from Google. 2. Pharma Patent Settlements Saved $25.5 Billion for US Health System. 3. Coffee Analysis Smart Phone App for that Perfect Brew. 4.FDA Approves Brain Wave Test to Assess ADHD in Children. 5. CAFC Copaxone® Patent Ruling Allows May 2014 Generic Launch. 6. A Permanent Injunction in a Patent Infringement Case! 7. Post-Grant Proceedings Treatise Publishes.

The FDA is following through on plans to issue a proposed rule to revise regulations to allow generic drugmakers to update labeling. The rule would update current regulations that prevent generic drugmakers from doing so, even if they become aware of a potential risk not mentioned in labeling. By contrast, brand-name drugamkers can update warnings and precautions on labeling before obtaining FDA approval. Additionally, Merck won an important court ruling for the entire pharmaceutical industry. A federal court decided that, under certain circumstances, drugmakers may defend themselves against product liability lawsuits by citing preemption.