Hatch-Waxman Act
Hatch-Waxman Act, also formally known as The Drug Price Competition and Patent Restoration Act of 1984, was an effort to resolve two major issues:
- regulatory delays in marketing of pharmaceutical products faced by innovator (also called pioneer or research) drug companies; and
- difficulties generic drug companies had at that time in marketing generic versions of pioneer products following expiration of pertinent patent(s).
In practical terms, this Act does three things:
- it provides for the extension of the term of one existing patent for innovator drugs;
- it makes provisions for the marketing of generic versions of patented drugs on the day after patent expiration; and
- it provides opportunities to challenge the validity of patents issued to innovator drug companies.
Of interest, Paragraph IV of the Hatch-Waxman Act provides a mechanism for the litigation of pharmaceutical patent infringement disputes. Many of these cases have been settled with “reverse payments” by the brand to the generic in return for delayed generic entry.
We are a professional, ethical and experienced team of lawyers representing people just like you: individuals, consumers and small business owners.
Members of our attorney team are recognized nationally as class action and complex litigation specialists in defective pharmaceuticals and medical devices, toxic chemicals, price-fixing, and antitrust violations. Our record speaks for itself.
We are a professional, ethical and experienced team of lawyers representing people just like you: individuals, consumers and small business owners.
Members of our attorney team are recognized nationally as class action and complex litigation specialists in defective pharmaceuticals and medical devices, toxic chemicals, price-fixing, and antitrust violations. Our record speaks for itself.
If you think you might have a case, you are encouraged to contact the law firm of Audet & Partners, LLP at 800.965.1461 to speak to an attorney. The call is free, and there is no obligation. You may also email us. Act now, as delays can harm your case.
