IP tutorialHUB

1) When ANDA filer need to send notice Letter (PIV) to brand company?  After submitting ANDA to FDA, An ANDA applicant must notify both patent owner and NDA holder by sending notice Letter, In notice Letter applicant need describe invalidation or non-infringement arguments.  Timeline: After filing ANDA, FDA will give acknowledgment that the ANDA has been received and is ready for substantive review.  After receiving FDA acknowledgment letter applicant has 20 days time to send notice Letter. 2) To whome all ANDA applicant need to send notice Letter?   ANDA need to send both patent owner and NDA holder, if product having multiple NDA holders and patent owners then ANDA applicant has to send notice Letter to all of them. 3) When 30 months stay trigger and which date need to consider? 30 months stay trigger from the date of receiving notice Letter to NDA holder and patent owner.  4) If product having multiple NDA holder and patent owners in different locations and...

Patent term adjustment: Patent term adjustment (PTA), which is intended to adjust the patent term to compensate for delays occurred from the USPTO during the prosecution & examination of patent application.  Patent term adjustment (PTA) applicable for utility and plant patents, not for reissue, design patent applications. History: After the Uruguay Round Agreement Act (1994) and to realize patent harmonization, the term of the patent was adjusted from 17 years from the date of grant/issuance to 20 years from the date of filing of the national patent application, with effect from June 8th, 1995, subsequently including the prosecution time within the ambit of the patent term. This sets the onus on the PTO to conclude patent prosecution within 3 years from the filing date of application failing which would decrease the actual term expectancy of the patent, and exclusive monopoly worked out therewith. In this manner, PTA is a guaranteed tool to get a term extension of the patent fo...

Exclusivity and their types:   Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. It prevents the submission or effective approval of ANDAs or applications described in Section 505(b)(2) of the Act, and was designed to promote a balance between new drug innovation and generic drug competition.   Types of exclusiveties: NDA exclusiveties Orphan Drug Exclusivity (ODE) – 7 years New Chemical Entity Exclusivity (NCE) – 5 years Generating Antibiotic Incentives Now (GAIN) Exclusivity– 5 years added to certain exclusivities New Clinical Investigation Exclusivity – 3 years Pediatric Exclusivity (PED) – 6 months added to existing Patents/Exclusivity ANDA exclusivities: Patent Challenge (PC) – 180 days (this exclusivity is for ANDAs only) Competitive Generic Therapy (CGT) - 180 days (this exclusivity is for ANDAs only)