Implementation of Title XI of the MMA
Written by Garth Boehm February 08, 2015
As we have seen before, most major changes to the Food, Drug, & Cosmetics Act (FD&C) occur every 5 years when the User Fee legislation has to be renewed to enable continued collection of User Fees by FDA. One of those 5 yearly renewals was in 2003. Those of you who have followed amendments to the FD&C Act will be aware that Congress loves to give catchy titles to what is often rather boring legislation. This particular set of amendments is called the “Medicare Modernization Act” or MMA for short. The actual title of the legislation is “Medicare Prescription Drug, Improvement, and Modernization Act of 2003”.
As with all these 5 yearly User Fee renewal bills, this one had a large number of amendments to the FD&C Act in addition to those renewing User Fees. One of these was Title XI which addressed patent certification and related matters for ANDAs and 505(b)(2)s (Paper NDAs). Although the basic framework of patent listing in the Orange Book and the system of certification, challenge, associated notification procedures, and the 30-month stay had all been established in the original Hatch-Waxman Act of 1984, over time there had developed almost endless loopholes that enabled brand companies to extend exclusive marketing and even to make deals with generic first filers. One of the biggest problems of all was that there was no time limit on when the first generic filer’s market exclusivity began and no way to approve second and subsequent generic filers ANDAs until the market exclusivity was over. This allowed for the hold up of generic marketing almost indefinitely. Another big problem was that the actual wording of the Hatch-Waxman Act stated that ANDA approval and marketing exclusivity was triggered by “a court decision” meaning a federal court decision on a patent infringement case brought as a result of the para IV filing. It was crystal clear that Hatch-Waxman meant to say a final court decision, meaning the decision of the appeal court, not the original federal district trial court, but as many federal judges told FDA over the years, the Act does not say Final court decision. Because the Act doesn't say “final” it cannot mean “final”, that is why the law is said to be “deaf, dumb, and blind”, it means what it says, not what it intended to say. In addition to these problems, there were a myriad of other issues that led to ANDA approval delays, and quite frankly some very blatant abuses of the intention of Hatch-Waxman. The MMA amendments set out to “fix” all these problems and so supposedly make the patent certification systems function as originally intended by Hatch-Waxman.
Well MMA was passed in 2003 and for those of you without a calendar handy, it is now 2015, about 11.5 years since FDA was directed to amend the regulations governing that patent certification system. So what has been happening in the 11.5 year interim? FDA has been, as they like to say, governing off the legislation, which is another way of saying we are making it up as we go. Fairness to all parties requires that FDA clearly state in the regulation what the law is so that all parties involved in spending very substantial amounts of money and time know exactly what to expect for each situation. However FDA has always found the whole patent certification system hard to codify, the original CFR regulations took well over a decade to produce, and here we are again.
So the Federal Register Notice (see here) simply titled “Abbreviated New Drug Applications and 505(b)(2) Applications” perhaps an overly broad title, is intended to address the MMA's direction to FDA to codify the new rules aimed at “fixing” the abuses (and some errors) of the Hatch-Waxman Act of 1984. Obviously it will take some time to read, digest, and distill what this FR Notice is saying, so for those of you with an interest in para IV filings, either ANDAs or 505(b)(2)s, keep an eye out for summaries of this proposal which I am sure will be forthcoming form prominent Food & Drug Law firms.
Finally, did the MMA “fix” all the problems? Well, as you might expect when you mix thousands of lawyers with billions of dollars in possible profits, no it didn't. It's like tax law, when you close one loophole, another opens!
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)
Mandatory Reading:
Regulatory Affairs (Reg)
Intellectual Property (IP)
Quality Assurance (QA)
Legal Department
Work Suggestions:
Reg: Ensure the company's drug applications comply with the new drug application procedures and bioequivalence standards.
IP: Monitor patent term extensions and the impact on the company's patent strategy.
QA: Verify that manufacturing processes meet the identity, strength, quality, and purity requirements.
Legal Department: Advise on patent infringement issues and the legal implications of abbreviated new drug applications.
Scope of Application: The Drug Price Competition and Patent Term Restoration Act of 1984 applies to chemical drugs, including new molecular entities and generic drugs, in the United States. It is intended for regulatory bodies, pharmaceutical companies, and legal entities involved in drug development and approval processes.
Key Points Summary:
Abbreviated New Drug Applications (ANDAs): The Act allows for the streamlined approval of generic drugs by submitting abbreviated applications showing bioequivalence to the listed drug, without repeating costly and time-consuming clinical trials.
Patent Term Restoration: Offers a mechanism to extend the effective patent life of a drug to partially compensate for the time lost during the regulatory review process, up to a maximum of five years.
Data Exclusivity: Provides a period of data exclusivity, during which the FDA cannot approve ANDAs for other companies that rely on the innovator's safety and efficacy data.
Patent Certification: Requires ANDA applicants to certify about the listed drug's patents or periods of exclusivity, which can trigger a patent infringement lawsuit.
Regulatory Review Period: Defines the regulatory review period for calculating patent term extensions and sets rules for due diligence during the application process.
Conclusion: The Drug Price Competition and Patent Term Restoration Act of 1984 is a landmark legislation that balances the need for accessible, affordable medications with the incentive for innovation. It has significantly impacted the pharmaceutical industry by fostering competition and ensuring that both innovator and generic drug companies have clear pathways to market. The above points are not exhaustive; for comprehensive understanding, the full text of the Act should be consulted.
