Proactive Brand Protection Strategies For Pharma Innovators
Partner Laura Vogel and associate Bella Satra's article "Proactive Brand Protection Strategies For Pharma Innovators" has been published by Law360. The full article can be located below.
"Chinese philosopher, general and military strategist Sun Tzu once said “[k]nowing the enemy enables you to take the offensive, knowing yourself enables you to stand on the defensive.” Given the enormous resources it takes for the brand name pharmaceutical manufacturer to successfully bring a drug to market, coupled with the incentives for generic manufacturers to methodically and strategically plot entry into that same market, Sun Tzu’s words ring increasingly true for innovator drug companies.
Brand name drug manufacturers are painfully aware that at some point after U.S. Food and Drug Administration approval of most products they will likely face generic challengers by virtue of the Hatch-Waxman Act. For each product challenged, the brand product manufacturer may have to fend off generic entry via complex patent litigation, often against multiple defendants in multiple jurisdictions, coupled with simultaneous validity challenges in inter partes review proceedings before the U.S. Patent and Trademark Office. Expenses associated with these cases quickly add up and are further escalated by regulatory and FDA procedural issues that may arise. But the loss of revenue from a blockbuster drug due to unanticipated early generic entry can be a devastating and irreversible blow to the innovator company that planned to recoup the investment associated with bringing a brand pharmaceutical product to market for the first time. Consequently, many companies aggressively litigate to defend their products despite the high costs of doing so."
Read the full article here.
- NYS Appellate Court Holds That Whether Provision in Construction Contract Required Additional Insured Coverage Presented Question of Fact
- The 2019-2020 NYS Budget Requires Financial Reporting for Electric Generators
- US Department of Labor Proposes Rule to Update and Clarify “Regular Rate” Requirements
- Unexecuted Indemnification Agreement Not Retroactive Once Executed