On June 21, 2023, Xbrane announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Xbrane’s supplemental Biologics License Application (sBLA) for a LUCENTIS® (ranibizumab) biosimilar...more
On March 30, 2022, Fresenius Kabi announced that the European Commission approved STIMUFEND, a pegfilgrastim biosimilar referencing NEULASTA, for patients with non-myeloid cancer who are receiving myelosuppressive...more
In post-grant proceedings since 2018, the PTAB has applied the same claim construction standard as used in district court; a recent Memorandum confirms the PTAB will likewise apply the same standard that district courts use...more
In IBSA Institut Biochimique v. Teva Pharmaceuticals USA, Inc. a valuable lesson was learned about relying on a translation of a non-English patent application. The IBSA Institut Biochimique (IBSAIB) hired an Italian patent...more
The Federal Circuit has spent the past few years applying the Supreme Court's most recent precedent, Nautilus, Inc. v. Biosig Instruments, Inc., on the indefiniteness standards in the patent statute. 35 U.S.C. § 112(b). The...more
PATENT CASE OF THE WEEK - HZNP Medicines LLC v. Actavis Laboratories UT, Inc., Appeal Nos. 2017-2149, et al. (Fed. Cir. Oct. 10, 2019) - In a lengthy decision following a bench trial, the Court addressed a matter of...more
The legal meaning of the transition language “consisting essentially of” is well-established in Federal Circuit case law and is generally construed to mean that the composition or formulation (a) necessarily includes the...more
Under the U.S. Patent laws, claims must particularly point out and distinctly claim what the inventor understands her invention to be. Up until three years ago, the inquiry for determining indefiniteness was to ask whether...more
In a recently issued claim construction order, Chief Administrative Law Judge Bullock held that terms included in all asserted claims are indefinite. He accordingly found the asserted claims invalid, stayed the Investigation,...more
On August 25, 2017, the Patent Trial and Appeal Board issued a precedential opinion in Ex Parte McAward, reaffirming the Patent Office’s use of a lower pre-issuance threshold for indefiniteness distinct from the Supreme...more
...In a recent (and rare) precedential decision, the Board reaffirmed that the Supreme Court’s decision in Nautilus does not change “the USPTO’s long-standing approach to indefiniteness” in the context of pre-issuance...more
Applying the Supreme Court of the United States’ new indefiniteness standard from Nautilus v. Biosig, the U.S. District Court for the District of New Jersey held three claim terms in a patent on a stabilized, opthalmic...more
Clarifying the application of the indefiniteness standard set forth in the Supreme Court’s Nautilus case, a divided U.S. Court of Appeals for the Federal Circuit denied a combined petition for rehearing and rehearing en banc...more
In Dow Chemical Co. v. Nova Chemicals Corp., 803 F.3d 620 (Fed. Cir. 2015), the Federal Circuit directly acknowledged that the Supreme Court’s recent ruling in Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120...more
After reflecting upon the events of the past twelve months, Patent Docs presents its ninth annual list of top patent stories. For 2015, we identified twenty stories that were covered on Patent Docs last year that we believe...more
In early 2015, the U.S. Supreme Court changed the standard of review for patent claim construction with its decision in Teva Pharmaceuticals USA v. Sandoz Inc., 135 S. Ct. 831 (2015) (Teva I). Previously, the U.S. Court of...more
Federal Circuit Remands Record Damages Award For New Trial On Extraterritorial Sales - In Carnegie Mellon University v. Marvell Technology Group, Ltd., Appeal No. 2014-1492, the Federal Circuit reversed a damages award...more
Addressing the post-Nautilus indefiniteness standard, the U.S. Court of Appeals for the Federal Circuit reversed a jury’s finding that the claims-at-issue are not indefinite and similarly reversed an associated order granting...more
In Dow Chemical Co. v. Nova Chemicals Corp., the Federal Circuit held claims reciting a limitation that could be calculated in several ways indefinite where the patent claims, specification, and prosecution history failed to...more
Dow Chemical Company (“Dow”) lost a ruling that competitor NOVA Chemical Corporation and NOVA Chemicals Inc. (collectively “NOVA”) infringed claims of two Dow patents when the Federal Circuit applied the U.S. Supreme Court’s...more
It has been a little more than a year since the Supreme Court rendered its decision in Nautilus, lowering the standard for finding patent claim terms indefinite. Many commentators at that time predicted the decision would...more
The More Things Change (Lighting Ballast Control LLC v. Philips Electronics North America), the More They Stay the Same (Teva Pharmaceuticals USA, Inc. v. Sandoz Inc.) - On June 18, 2015, the Federal Circuit handed down...more
In an opinion addressing the standard for indefiniteness in view of the Supreme Court of the United States’ 2014 “reasonable certainty” test, the U.S. Court of Appeals for the Federal Circuit maintained its reversal of the...more
FEDERAL CIRCUIT CASES - Subjective Term Not Indefinite when Intrinsic Record Provides Reasonably Certain Scope - On remand from the Supreme Court, on April 27, 2015, the Federal Circuit reassessed whether...more
Applying the Supreme Court’s new “reasonable certainty” standard for patent definiteness in Biosig Instruments, Inc. v. Nautilus, Inc. (2015) (Nautilus III), the Federal Circuit again held that Biosig’s patent for a heart...more