antibody extension patent term
- Grant of Interim Extension of the Term of U.S. Patent No. 5,693,323; Recombinant Humanized Monoclonal Antibody (IgG1
314 F.3d 1313 (Fed. Cir. 2003), 01-1191, Amgen Inc. v. Hoechst Marion Roussel, Inc.
...("Amgen") is the owner of numerous patents directed to the production of erythropoietin ...7, line 42. Similar attempts using antibody techniques failed because of difficulty in ... claims 1, 2, and 9 (with the disputed claim terms here and below underscored):. 1. A ... 22 We note that by logical extension...
- 21 CFR 514.8 - Supplements and other changes to an approved application
Expired patents, trade secrets, and stymied competition.
... benefits of the patent system for a limited term but then using trade secrecy to block competition ... form of erythropoietin, some monoclonal antibody, or some other therapeutic protein--but not the ... but closely related form of monopoly extension happens when a firm maintains a monopoly on other ...
In Mayo, Federal Circuit Seeks to Head Off Disputes Over When Claims Are “Deemed Allowable” by Counting Continued Examination Time Until Notice of Allowance
Earlier this week, the Federal Circuit declined to further extend the patent term of an antibody patent held by the Mayo Foundation. In Mayo Foundation v. Iancu, the court held that the time spent on a request for continued examination (“RCE”) following a declaration of interference did not count toward the three-year application pendency period for purposes of patent term extension.
... Circuit declined to further extend the patent term of an antibody patent held by the Mayo ... period for purposes of patent term extension. As discussed below, the Mayo decision could have ...
PATENT-INELIGIBILITY AS COUNTERACTION.
... is a doctrinal phenomenon that this Article terms technology-specific regulatory inefficacy. (11) A ... footprint in the material world of extension is now commonplace. Intangibility lies at the .... (159.) The historical antibody patents that were actually issued in the 1980s ...
764 F.3d 1366 (Fed. Cir. 2014), 2013-1545, Abbvie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Trust
...Patent Nos. 7,846,442 (the '442 patent) and 6,270,766 ...-modifying antirheumatic drug and an antibody. . Kennedy secured two patents ... Kennedy's proposed construc-tions of the terms " co-administering," as it is used in the '766 ...) does not receive an undue patent term extension. See Berg , 140 F.3d at 1432, 1435; Goodman ...
549 U.S. 118 (2007), 05-608, Medimmune, Inc. v. Genentech, Inc.
... After the parties entered into a patent license agreement covering, inter alia, ... a clear threat to enforce the patent, terminate the license agreement, and bring a patent ... "Licensed Products" as a specified antibody, "the manufacture, use or sale of which . . . ...extension of Steffel, supra, to apply to voluntarily ...
ARGX-110 AND ARGX-111 RECEIVE ACCELERATED GRANT.
arGEN-X N.V. has received a grant of key patents in the United States relating to its two lead ... relating to ARGX-110, a novel SIMPLE Antibody product targeting human CD70. The issued patent ... for up to an additional five years of Patent Term Extension for marketing delays caused by ...
Much ado about genes: untangling the evolving law of subject matter eligibility.
... or phenotype, will not be protected by patents that can meaningfully exclude a competitor from ... useful and valuable but, a reasonable extension of the argument outlined in this example suggests that an antibody cloned from a human patient would not enjoy ... the USPTO definition of the critical term "significantly different" as essentially circular ...
Reports and guidance documents; availability, etc.:
Guidance documents; annual list,
... Drug User Fee Act of 1992; Notice of extension of application deadline--11/19/2004 Guidance for ...: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug ...: Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of ... about the Drug Price Competition and Patent Term Restoration Act (Posted 3/2/1998) Letter to ...
880 F.3d 1315 (Fed. Cir. 2018), 2017-1257, In re Janssen Biotech, Inc.
... from the United States Patent and Trademark Office, Patent. Trial and ... to prevent the extension of the term of a patent by. prohibiting the ... composition containing an antibody. On February 4, 1994,. rather than filing a ...
Genentech, Inc. v. Iancu, 032620 FEDFED, 2019-1263
... PROPERTYAND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, Intervenor. GENENTECH, ... the Board construed the claim terms "an amount effective. to extend the time to ... anti-ErbB2 antibody and a taxoid, in the absence of an. ..., it is never set forth what the extension of. time to disease progress is relative ...
580 F.3d 1340 (Fed. Cir. 2009), 2009-1020, Amgen Inc. v. F. Hoffman-LA Roche Ltd.
.... This is a patent case. Amgen Inc. (" Amgen" ) is the owner of . ... the cell, the final amino acid, or the C-terminal amino acid, of the 166 amino acid sequence is ... the potential windfall [a] patent term extension could provide to a patentee, this court applies a ... fluids) in a similar way (using an antibody), to obtain very similar, if not identical ...
Repurposing - finding new uses for old (and patented) drugs: bridging the "Valley of Death," to translate academic research into new medicines.
... offered to the NIH have significant patent terms remaining-typically more than ten years. (33) ... original CoM patent-holder a de facto extension beyond the twenty-year term, which the generic ... embryos, first using a monoclonal antibody (LM609) he developed himself and later using a ...
- 114 CMR 40.06 - Fees
927 F.2d 1565 (Fed. Cir. 1991), 89-1541, Scripps Clinic & Research Foundation v. Genentech, Inc.
...The patent in suit, United States Reissue Patent No. 32,011 ... clones that in turn produce a specific antibody. As described in the R'011 patent, the hybridoma ... it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to ..." doctrine is to prevent unwarranted extension of the claims beyond a fair scope of the ...
811 F.3d 466 (Fed. Cir. 2016), 2015-1265, Pfizer, Inc. v. Lee
... PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, Defendant-Appellee . ... properly calculated the length of a patent term adjustment (" PTA" ) for U.S. Patent No. ... automatically for all authorized extensions of time during the pendency of the '894 ... requirement, but failed to divide the antibody claims " based on whether the antibody . . . ...
Determination of Regulatory Review Period for Purposes of Patent Extension; KEYTRUDA
...I. Background. The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and ...KEYTRUDA is a programmed death receptor-1 (PD-1)-. blocking antibody indicated for the treatment of:. Patients with unresectable or ...
Immunex Corporation v. Sandoz Inc., 070120 FEDFED, 2020-1037
... . . Patent. owner Hoffmann-La Roche Inc. ("Roche"), ...antibody. Antibodies are proteins deployed by the. ... Under. the terms of the Accord & Satisfaction, Immunex has a. ... extension of the right to exclude through claims in a ...
Karyopharm Reports First Quarter 2019 Financial Results and Highlights Recent Company Progress.
... Application (NDA) and the subsequent extension of the Prescription Drug User Fee Act (PDUFA) ... B-cell generation, double-stranded DNA antibody levels, and persistence of self-reactive antibody ...'s ability to obtain, maintain and enforce patent and other intellectual property protection for ...$. 83,506. $. 118,021. Short-term investments. 180,918. 210,178. Prepaid expenses ...
331 F.3d 860 (Fed. Cir. 2003), 02-1052, Integra Lifesciences I, Ltd. v. Merck KGaA
...Patent Nos. 4,988,621 ('621 patent), 4,792,525 ('525 ... or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic ...Moreover, such an extension would not confine the scope of § 271(e)(1) to ... a license for a pre-clinical stage antibody in 1990. The ImClone license included an up-front ...
...He has experience in patent protection, including analog and digital ... He has taught a class at UC San Diego Extension on Patent Protection, . WHAT HE SAYS "Pushing ... work readiness training for the long-term unemployed, veterans and youth preparing to enter ...He is the founder of his firm's Antibody Patent Group and leads the San Diego office ...
Government-Owned Inventions; Availability for Licensing
...Foreign patent applications are filed on selected inventions to ... Tumor Delivery and Penetration of Antibody-Toxin Anti-Cancer Conjugates. Description of ... memory T cells represent an important extension of these studies. Adoptive immunotherapy is ... T cells into a vaccine regimen for longer term immune responses or to treat malignancies that ...
The Daily Biotech Pulse: Applied DNA Begins Validating COVID-19 Test, Cara's Positive Readout, Novan Explores Strategic Alternatives.
... Hospital to validate and implement its patent-pending nucleic acid diagnostic test to detect ...Novartis Releases Positive Long-Term Data For Multiple Sclerosis Drug. Novartis AG ... from the five-year EXPAND open-label extension trial to assess the long-term efficacy and safety ... has accepted a sNDA for its anti-PD-1 antibody tislelizumab in combination with two chemotherapy ...