A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in performance. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.
Warner Chilcott was a company in the pharmaceutical industry based in Rockaway, New Jersey. It was primarily focused on women's healthcare and dermatology. On October 1, 2013, the company was acquired by Actavis.
In patent law, the research exemption or safe harbor exemption is an exemption to the rights conferred by patents, which is especially relevant to drugs. According to this exemption, despite the patent rights, performing research and tests for preparing regulatory approval, for instance by the FDA in the United States, does not constitute infringement for a limited term before the end of patent term. This exemption allows generic manufacturers to prepare generic drugs in advance of the patent expiration.
Mylan N.V. was a global generic and specialty pharmaceuticals company. In November 2020, Mylan merged with Upjohn, Pfizer's off-patent medicine division, to form Viatris. Previously, the company was domiciled in the Netherlands, with principal executive offices in Hatfield, Hertfordshire, UK and a "Global Center" in Canonsburg, Pennsylvania, US.
Test data exclusivity refers to protection of clinical trial data required to be submitted to a regulatory agency to prove safety and efficacy of a new drug, and prevention of generic drug manufacturers from relying on this data in their own applications. It provides a form of market exclusivity outside that provided by patent rights.
Kaye Scholer was a law firm founded in 1917 by Benjamin Kaye and Jacob Scholer. The firm had more than 450 attorneys in nine offices located in the cities of Chicago, Frankfurt, London, Los Angeles, New York City (headquarters), Shanghai, Palo Alto, Washington, D.C., and West Palm Beach.
The Drug Price Competition and Patent Term Restoration Act, informally known as the Hatch-Waxman Act, is a 1984 United States federal law that established the modern system of generic drug regulation in the United States. The Act's two main goals are to facilitate entry of generic drugs into the market and to compensate the original drug developers for regulatory delays by the Food and Drug Administration. It is generally believed that the Act accomplished both goals: encouraging development of new medications and accelerating market entry of generics.
Teva Pharmaceutical Industries Ltd. is an Israeli multinational pharmaceutical company with headquarters in Tel Aviv, Israel. It specializes primarily in generic drugs, but other business interests include active pharmaceutical ingredients and, to a lesser extent, proprietary pharmaceuticals. Teva Pharmaceuticals was the largest generic drug manufacturer, when it was surpassed briefly by US-based Pfizer. Teva regained its market leader position once Pfizer spun off its generic drug division in a merger with Mylan, forming the new company Viatris at the end of 2020. Overall, Teva is the 18th largest pharmaceutical company in the world.
Actavis Generics is a global pharmaceutical company focused on acquiring, developing, manufacturing and marketing branded pharmaceuticals, generic and over-the-counter medicines, and biologic products. Actavis has a commercial presence across approximately 100 countries. The company has global headquarters in Dublin, Ireland and administrative headquarters in Parsippany-Troy Hills, New Jersey, United States.
Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858, was a court case in the United States related to the manufacturing of generic pharmaceuticals.
Evergreening is any of various legal, business, and technological strategies by which producers extend the lifetime of their patents that are about to expire in order to retain revenues from them. Often the practice includes taking out new patents, or by buying out or frustrating competitors, for longer periods of time than would normally be permissible under the law. Robin Feldman, a law professor at UC Law SF and a leading researcher in intellectual property and patents, defines evergreening as "artificially extending the life of a patent or other exclusivity by obtaining additional protections to extend the monopoly period."
Reverse payment patent settlements, also known as "pay-for-delay" agreements, are a type of agreement that has been used to settle pharmaceutical patent infringement litigation, in which the company that has brought the suit agrees to pay the company it sued. That is, the patent holder pays the alleged infringer to stop its alleged infringing activity for some period of time and to stop disputing the validity of the patent. These agreements are distinct from most patent settlements, which usually involve the alleged infringer paying the patent holder.
AbbVie Inc. is an American pharmaceutical company headquartered in North Chicago, Illinois. It is ranked 6th on the list of largest biomedical companies by revenue. The company's primary product is Humira (adalimumab), administered via injection. It is approved to treat autoimmune diseases including rheumatoid arthritis, Crohn's disease, plaque psoriasis, and ulcerative colitis.
FTC v. Actavis, Inc., 570 U.S. 136 (2013), was a United States Supreme Court decision in which the Court held that the FTC could make an antitrust challenge under the rule of reason against a so-called pay-for-delay agreement, also referred to as a reverse payment patent settlement. Such an agreement is one in which a drug patentee pays another company, ordinarily a generic drug manufacturer, to stay out of the market, thus avoiding generic competition and a challenge to patent validity. The FTC sought to establish a rule that such agreements were presumptively illegal, but the Court ruled only that the FTC could bring a case under more general antitrust principles permitting a defendant to assert justifications for its actions under the rule of reason.
The Patent Trial and Appeal Board (PTAB) is an administrative law body of the United States Patent and Trademark Office (USPTO) which decides issues of patentability. It was formed on September 16, 2012, as one part of the America Invents Act. Prior to its formation, the main judicial body in the USPTO was the Board of Patent Appeals and Interferences (BPAI).
Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), is a decision by the Supreme Court of the United States holding that generic drug manufactures cannot be held liable under state law for not adequately labeling medication when federal law prohibits them from changing the label from the original brand name drug.
An inter partes review (IPR) is a procedure for challenging the validity of a United States patent before the United States Patent and Trademark Office.
Allergan plc is an American, Irish-domiciled pharmaceutical company that acquires, develops, manufactures and markets brand name drugs and medical devices in the areas of medical aesthetics, eye care, central nervous system, and gastroenterology. The company is the maker of Botox.
Oil States Energy Services, LLC v. Greene's Energy Group, LLC, 584 U.S. ___ (2018), was a United States Supreme Court case in which the Court held that the inter partes review process granted by Congress to the United States Patent and Trademark Office for challenging the validity of patents, rather than a jury trial, is constitutional and did not violate either Article III of the Constitution nor the Seventh Amendment.
