This article summarizes information taken from the following sources: FDA’s Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (Dec. 2013) & information set forth in the following link:
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Indian Tribal Sovereign Immunity Asserted in an IPR
The America Invents Act (“AIA”) provides for post grant challenges of U.S. patents in the Patent Trial and Appeal Board (“PTAB”) of the U.S. Patent and Trademark Office. One type of AIA proceeding, Inter Partes Review (“IPR”), came into effect
Regeneron v. Merus: Federal Circuit Upholds Adverse Inference of Specific Intent to Deceive the USPTO
Inequitable conduct arises when a material reference was intentionally withheld by the patent applicant in order to deceive or mislead the examiner into granting a patent. Both materiality and intent must be proven by clear and convincing evidence.[1] In
Sandoz v. Amgen: The Latest in Biosimilar “Dances”
Finding against the Federal Circuit once again on a patent case, the Supreme Court issued a unanimous decision in Sandoz v. Amgen relating to the interpretation of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) in its first
Venue in ANDA Litigation: Will TC Heartland Be a Sea Change or Just a Drop in the Bucket?
Less than two months after oral argument, the Supreme Court issued a unanimous decision on Monday, May 22, 2017, in TC Heartland LLC v. Kraft Foods Group Brands LLC, uprooting long-standing Federal Circuit precedent regarding proper venue for patent
Legislative Overview: First Quarter 2017
One goal of BioLoquitur is to provide commentary and analysis on important developments in U.S. law affecting the pharmaceutical and biologics industry. It can be easy to forget that legal developments are not limited to the latest court decisions or
Draft FDA Guidance On Demonstrating Interchangeable Biosimilar Proteins
The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) amended Section 351(k) of the Public Health Service Act (42 U.S.C. § 262(k)) in providing ways to obtain licenses for certain biological products via abbreviated applications from the Food and Drug
Early Stage Biotech IP Strategy: Untangling the Chain of Title
The value of an early stage biotech company is driven primarily by the quality and scope of its intellectual property. As such, these companies’ primary goal is to stake out and consolidate a defensible claim in their technology space.
In
P3: A New Post-Prosecution Pilot Program Designed to Assist Applicants and Prosecutors During the Patent Application Process
The U.S. Patent and Trademark Office (USPTO) recently unveiled a new pilot program designed to assist patent applicants and practitioners during patent prosecution. The Post-Prosecution Pilot program, otherwise known as P3, arises under the Enforced Patent Quality Initiative and incorporates
Biosimilar Applicants Must Provide Notice of Commercial Marketing
In a recent case involving Apotex’s proposed biosimilar product to Amgen’s Neulasta® (pegfilgrastim). Amgen sought a preliminary injunction to enforce the Biologic Price Competition and Innovation Act (BPCIA) provision that requires an applicant to give notice 180 days before marketing