Guardians at the gate: patent protection of therapeutic monoclonal antibodies through product life cycle management--Part 3.
Product life cycle management, which necessarily utilizes a multi-disciplinary approach, is an essential tool for companies that develop or market therapeutic monoclonal antibodies (mAbs). Too little attention to such a plan, or use of the wrong resources, could substantially curtail a product's life span. The most difficult part of the therapeutic antibody business is the development of high-quality, safe and effective products. Great care should thus be taken to ensure that products with these characteristics are positioned in a marketplace that is competition-free for as long as possible. In an era of mAbs with billion dollar markets, the loss of even a single day of sales could cost companies millions of dollars in lost revenue.
McCabe
Kevin W
KW
Sterne, Kessler, Goldstein & Fox; P.L.L.C., Washington, DC, USA. kmccabe@skgf.com <kmccabe@skgf.com>
Calvo
Paul A
PA
D000911:Antibodies, Monoclonal / Q000191:economics* / Q000627:therapeutic use; D055808:Drug Discovery / Q000331:legislation & jurisprudence; D004465:Economic Competition / Q000331:legislation & jurisprudence; D006801:Humans; D007167:Immunotherapy; D018973:Intellectual Property; D007880:Legislation, Drug; D040541:Marketing / Q000331:legislation & jurisprudence; D010330:Patents as Topic; D020399:Practice Management
D000911:Antibodies, Monoclonal