Drug Litigation Newsroom

Recent Congressional Action On Generics Legislation

Both the Senate and the House have added generic drug access provisions to their versions of the Medicare bill, which have passed both chambers and are currently in conference. We are pleased that both versions of this legislation include key ideas embodied in FDA's regulation to improve access to generic drugs, and do not include certain other problematic provisions contained in legislation (S. 812) that passed the Senate last year. Summary of the Generic Drug Amendment to the Senate Medicare Bill (S. 1) The Senate bill amends the existing statutory 30-month stay in the following ways: requires the ANDA applicant to provide notice to the patent owner and NDA holder within 20 days after the applicant is notified that FDA has filed its ANDA when the applicant has submitted a certification that can trigger a lawsuit and resulting 30-month stay;
limits the patents eligible for the 30-month stay to those submitted to the Agency prior to submission of the ANDA, disallowing later-submitted patents from triggering additional 30-month stays; permits approval of an ANDA if, before any 30-month stay expires, a district court finds the patent invalid or not infringed, or if a district court judgment finding the patent infringed is overturned on appeal, upon judgment of the court of appeals. The Senate bill also allows an ANDA applicant to file a declaratory judgment action against a patent owner or the NDA holder if no patent infringement suit is brought within 45 days after the applicant provides notice of the certification challenging the patent. The provision seeks to make the failure to file such a suit an actual controversy under the declaratory judgment statute. If a suit is filed, the applicant may assert a counterclaim for an order to require deletion of patent information that the NDA holder should not have submitted for listing in the Orange Book. The Senate bill amends the existing statutory 180-day exclusivity provision as follows:applies exclusivity on a product basis, rather than patent-by-patent basis; allows all ANDA applicants that challenge patents on the first day that ANDAs challenging patents are submitted for a particular listed drug to qualify for exclusivity; triggers 180-day exclusivity only with commercial marketing; provides for forfeiture of an applicant's eligibility for exclusivity if it does not market the drug within a particular period of time or after courts resolve the status of the challenged patents, if the applicant withdraws its ANDA, if the patent challenges are withdrawn, if the applicant fails to obtain tentative approval within 30 months, if the applicant enters into an anticompetitive agreement, or if all qualifying patents expire. The bill defines bioavailabilty and bioequivalence for non-systemic drugs (those not absorbed into the bloodstream).Lastly, the Senate bill states that a court may refuse to award treble damages in a patent litigation action if the NDA holder fails to submit a patent to FDA for listing in the Orange Book that claims a drug or a method of using a drug.

Differences between Senate and House Generic Drug Legislation

The House version of the generic drug legislation is very similar to the Senate version described above. The bills differ in the following areas:   Approval of a different listed drug - The House bill prohibits ANDA applicants from amending or supplementing an application to seek approval of a generic drug referencing a listed drug different from the listed drug identified in the original application. That prohibition does not apply to different strengths. The Senate bill lacks this language.
Civil action for patent certainty - The Senate bill allows the ANDA applicant to bring a civil action for a declaratory judgment that the patent is invalid or will not be infringed if the patent owner or NDA holder does not bring suit within 45 days after notice is received. The House bill is slightly different.  Access to confidential ANDA information - The House bill allows a declaratory judgment action to be brought if the 45 days expires and the notice was accompanied by a document providing a right of confidential access to the ANDA applicant's application for the purposes of determining whether a lawsuit should be brought. The provision sets forth the contents of the document, including restrictions on access to the application and the uses of information obtained through the process. The Senate bill does not contain the confidential access provision.
Failure to bring patent infringement action - The Senate bill makes the failure to bring a patent infringement action within 45 days of notice an actual case or controversy sufficient to confer subject matter jurisdiction on the Federal courts. The House bill does not contain this provision. Treble damages - The Senate bill provides that in determining remedies for infringement of a patent that claims a drug or a method of using a drug, the court shall consider whether information on the patent was required to be submitted under section 505(b), and if such information was required to be submitted but was not, the court may refuse to award treble damages. The House bill lacks this provision. Filing of certain agreements with FTC - Both bills contain requirements that certain agreements between generic drug manufacturers and innovators regarding the marketing of a generic drug be filed with the FTC. The House bill requires that certain agreements between generic manufacturers also be filed with FTC, while the Senate bill does not. Relationship Between the Legislation and the Final Rule The legislation, included as part of the Medicare bills in the House and Senate, does not address all of the provisions in the final rule. If such legislation were to pass, based on our review, we believe that only the 30-month stay provision of the final rule would be impacted.

CONCLUSION

Greater access to generic drugs will reduce health care costs because the price of generic drugs is typically much lower than the brand-name drug. Reducing expensive lawsuits over drug patents and making the approval process more efficient will also help to lower national health care costs by reducing the cost of bringing safe and effective generic drugs to market. Thanks to the President's leadership, we are making real progress to build on his initiatives on speeding access to generic drugs by finalizing a generic drug rule that will save consumers $35 billion over 10 years by increasing access and availability to generic drugs. FDA continues to implement the Hatch-Waxman Amendments exclusivity provisions in the best manner possible given the text and history of the legislation, and the numerous court challenges. In doing so, FDA has tried to maintain a balance between innovation in new drug development and expediting the approval of lower-cost generic drugs, as Congress sought to do in enacting this statute. We are confident that the President's initiative and the Agency's regulatory changes will go far towards achieving these goals, and improving health care outcomes as a result.