Understanding Pharma Patents

Understanding Pharma Patents REALITY CHECK - The protective powers of a patent are far less powerful than you would imagine. In order to secure rights to a particular compound, drug companies apply for patent protection far in advance of FDA approval. By the time the drug has entered the market, the 20 years offered by UPTSO has dwindled to 6, leaving little time to recover development costs. Often times the only way to do so is by invoking the Hatch-Waxman Act to extend patent terms and retain market exclusivity. Patent's Timeline The lag in time between patent approval and new drug approval resuts in a minimal amount of time where the drug is both approved and under patent protection. Below clearly defines the mismatch between the patent life-cycle and the process for approving a new drug. Years Patent FDA Animal Toxicity Studies Initiated Discovery of New Chemical Element Drug Approval Process Initiated Filed Patent Application IND Filed Received Patent 8 Phase I, II, III Clinical Trials Approval 10 Product Filed NDA Launched 12 Application Received NDA Approval Filed Patent Term Extension 16 Phase IV Post-Marketing Trials (if any) 18 Patent Extension Granted (Hatch- Waxman Act) Patent Expired Generics Approved by FDA 25 Mapping Blockbusters' Timeline By examining the timelines of 10 major US blockbuster drugs going off patent betwen now and 2015, its clear that patent protection is far shorter than 20 years. The 4 Stages of Patent Protection Hatch-Waxman No Patent Development On-Market Market Protection Exclusivity 14 Years Plavix -0-0-0=O 14 Years, Singulair O-0-0-0-O- 14 Years Seroquel -0-0-0 13 Years Lipitor -0-0-0 13 Years Actos =0=0=0-0=0 12 Years Aciphex 10 Years Lexapro Abilify Years Nexium Years Cymbalta Years The End of a Blockbuster Era From 2011 to 2015, the United States alone will see blockbuster drugs with a combined revenue of $47.4 billion go off patent. 2010 Sales in US $ Billion Abbott Astrazeneca $3.5 $5.6 Cephalon Eisai Forest Labs GD Searle $1.5 $1.1 Lilly $2.5 $2.8 Merck $3.8 Novartis $1.4 Otsuka Pfizer $5.3 Sanofi $5.0 Takeda %242.9 Teikoku Drugs ZoomRx Sources: www.uspto.gov - www.fda.gov- www.imshealth.com Companies Lipitor 2011 Zyprexa Diovan uopoag Lexapro A wapopri 2012 XIAeld Provigil janbosəs Singulair Tricor Aciphex 2013 Cymbalta Celebrex 2014 Nasonex unixƏN Abilify ST015