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Keeping Your Company’s Federal Contracting Options Safe in the Face of Pending BIOSECURE Act Legislation
…of the historical background that spurred Congressional action here, including national security risks highlighted by U.S. Departments of Defense (DoD) and Commerce actions against several specific Chinese biotechnology companies. An…
OPQ’s 2022 Report Shows the Global Task of Ensuring Quality
…dramatic effect on import alerts. FDA issued 28 quality-related import alerts in 2022, and most of those 28 alerts were for hand sanitizers that contained impurities or had other defects….
Mining the Bowels of the Orange Book: What Do the Data Reveal?
…drug patent settlement agreements (here), user fees (here), orphan drugs (here), or just general FDA regulation (here). We find it all rather interesting. After all, data can provide an informative…
Orange Book Patent Delisting Counterclaim Raised in 505(b)(2) Application Patent Infringement Litigation; Decision Could Provide Guidance on Drug Delivery System Patent Listability
…(bb) an approved method of using the drug. The MMA also added almost identical counterclaim provisions at FDC Act §505(j)(5)(C)(ii)(I) applicable to ANDA sponsors. Both counterclaim provisions refer to FDC…
Counting to 60 – A Task that is Perhaps More Difficult than One Might Think; AstraZeneca Cries Foul Over PTE Application Timeliness Calculation Method
…date after product approval. AstraZeneca cites several examples of PTEs allegedly granted since 1986 in which the PTE application for the subject patent was submitted to the PTO based on…
PTO’s ANGIOMAX PTE Denial is Vacated and the Case Goes Back to PTO – What Happens in the Interim?
…notice of NDA approval of the drug product if that transmittal occurs after normal business hours. In the case of the PTE application for the ‘404 patent covering ANGIOMAX, that…
Teva Sues FDA Over Generic RESTASIS 180-Day Exclusivity; Lawsuit Challenges FDA’s New “First Applicant” Interpretation
…applicant” to mean: an applicant that, on the first day on which a substantially complete application containing a [Paragraph IV certification] is submitted for approval of a drug, submits a…
A Noteworthy Event for the Drug and Device Industries
…in the drug/biological product approval process SEE the importance of cGMPs to the post-approval regulatory process NAVIGATE the protocols of adverse events monitoring, pharmacovigilance, and Risk Evaluation and Minimization Strategies…
The “Dog Ate My Homework Act” Resurfaces
…things, the PTO cited Unimed, Inc. v. Quigg, 888 F2d 826; 12 USPQ2d 1644 (Fed. Cir. 1989), in which the Federal Circuit addressed the timeliness of a PTE application submission…
The Medicines Company Initiates an 11th Hour Push for ANGIOMAX Patent Term Extension; Petitions PTO to Adopt a Rule of Construction for Determining NDA Approval Date
…review period occurred for commercial marketing or use” (i.e., within 60-days of the date of NDA approval). In April 2007, the PTO denied the PTE request. Among other things, the…
A Noteworthy Fraud and Abuse Compliance Event for the Medical Device Industry
…legal parameters of DTC marketing, including “new media” TRACK state legislative initiatives and HARMONIZE inconsistent state obligations Additional details and registration information are available at www.AmericanConference.com/MedicalDevices or by calling 888-224-2480….
The Medicines Company Continues Lobbying Push for ANGIOMAX Patent Term Extension Legislative Fix; Latest Iteration of the “Dog Ate My Homework Act” Maintains $65 Million Late Fee
…approval). In April 2007, the U.S. Patent and Trademark Office (“PTO”) denied the PTE request. Among other things, the PTO cited Unimed, Inc. v. Quigg, 888 F2d 826; 12 USPQ2d…
ACI’s 42nd FDA Boot Camp – New York City Edition
…practical real-world examples that will help you to excel in your everyday practices. Join the “Who’s Who” of the FDA Bar and don’t miss your opportunity to join their ranks!…
Convergence: Recent Court Actions and Pressure From FDA May Mean the Sun is Finally Setting on the Premature Paragraph IV Notice Strategy
…(later amended) Allergan, Inc. (“Allergan”) filed alleging premature notice concerning generic RESTASIS (cyclosporine ophthalmic emulsion) 0.05%. Allergan was seeking, among other things, a “Declaratory Judgment of False Paragraph IV Notification”…
HP&M’s John Fleder, Dara Katcher Levy, and James Valentine to Speak at DIA’s Marketing Pharmaceuticals 2016
…they be engaged? How to remain compliant in a global environment Scientific exchange Social media: using new and emerging technologies compliantly Global advertising and promotion processes and standards Hyman, Phelps…