Today, more than 86 percent of U.S. prescriptions are being dispensed as generic medicines. These medicines have saved consumers and third-party payers more than $1 trillion over the past decade, fulfilling the promise of the legislation sponsored by Senator Orrin Hatch and Representative Henry Waxman, and signed into law by President Reagan in 1984.

With access to affordable generics now a reality, and with generic drug product safety and effectiveness affirmed by both patients and their prescribing physicians, what are some of the remaining issues of interest to the industry and its corporate counsel?

Strategic Options Through Inter Partes Review

The passage of the Leahy-Smith America Invents Act in 2011 effected major changes to U.S. patent law, including creating new procedures for non-patentees to challenge a patent's validity at the U.S. Patent and Trademark Office. Previously the most common option for such a challenge was federal district court litigation.

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