Pharmaceuticals and medical devices are subject to such a review period, and new drug products in particular often involve a lengthy application and testing process. which the Secretary of Health and Human Services intends to recommend controls under the
form prior to administration of the product to the patient, not the resultant form the
This list is for informational purposes only and is not intended to have legal effect. § 156及び37 C.F.R. . . 1585 (codified at 21 U.S.C. formally complete and whether the patent is eligible for extension. The Patent and Exclusivity Addendum of the "Orange Book" the We would like to know what you found helpful about this page.We may have questions about your feedback, please provide your email address.The USPTO is currently improving our content to better serve you. The court also noted several other limitations based on the language of Section 156: first, "[r]egardless of the time so lost, if a patent was issued and testing began before the 1984 enactment of the Hatch-Waxman Act, the total extension period may not exceed two years . approved drug. Animal Inspection Service of the Department of Agriculture. product." See Furthermore, a "drug product" is the active ingredient of a particular
Try the beta replacement for EFS-Web, Private PAIR and Public PAIRCheck patent application status with public PAIR and private PAIRPay maintenance fees and learn more about filing fees and other paymentsFile a trademark application and other documents online through TEAS.Check trademark application status and view all documents associated with an application/registration.Find out how to protect intellectual property in other countries.Find upcoming programs related to IP policy and international affairsPlease note that nearly all patent term extension applications are available on Additional information concerning patent expiration dates of human drug products can be obtained from the Food and Drug Administration, Center for Drug Evaluation and Research. Federal Food, Drug and Cosmetics Act and the Public Health Service Act) including any
In this case, Biogen received a patent term extension for its Patent US7619001 associated with using the drug Tecfidera (MS treatment). amended by the Improving Regulatory Transparency for New Medical Therapies Act (Pub. The statute is unfortunately complex and poorly written. On the other side of the issue, the way a body transforms the pro-drug into the active drug occurs in nature. Drug and Cosmetic Act. The term "claims a product" is not synonymous with "infringed by a
other than as enacted by Last Modified:
prior to commercial marketing or use. . . . § 156 – Meant to compensate for delays in … (I’m not a pharma guy)’cause if DoE is never argued . See Where a product contains multiple active ingredients, if any one active
Whether or not infringement occurs obvious requires (at the minimum) a valid patent whose term has not yet expired. §154(b) and Patent Term Extension (PTE) under 35 U.S.C. Patent term restoration is available for certain patents related to drug products (as defined in 35 U.S.C. It comes down to the scope of the claims, because in most cases, the transformation (the part that could potentially fall under the law of nature) is not included in the claim language.The ‘actual transformation not in the claims’ is not the only aspect, as Paul, think of it this way: when a PTE is granted, does that extend the term of ALL of the claims of the patent, each claim across its entire scope? approval is the first approval of the drug or product for use in food producing animals. patent term provided the patent claims that ingredient. U.S. Patent Term Extension 6 “Product” Requirements under §156(a) §156 (a)(5)(A) requires that the regulatory review period must be for the first commercial marketing/use of the product New NDA does not always qualify for PTE – Fisons v. Quigg, 876 F.2d 99 (Fed. Can you describe the problem?We may have questions about your feedback, please provide your email address.We may have questions about your feedback, please provide your email address.Search recorded assignment and record ownership changesSearch recorded assignment and record ownership changesHave a comment about the web page you were viewing?United States Patent and Trademark Office - An Agency of the Department of CommerceThe USPTO is currently improving our content to better serve you. In the present case, the generic manufacturer used a slightly different active ingredient, but the generic product was bioequivalent to the innovator/patentee’s product. The RRP is simply the time from the date on which the IND or IDE became effective until the date on which the NDA, biologic license application (BLA) or pre-marketing authorization (PMA) was approved.