Patent Law

House Bill OK?s 12-Year Data Exclusivity for Biotech Drugs

By Stephen Albainy-Jenei

Congress is busy doing what it does best. That is, taking a massive, overly-convoluted piece of legislation and making it more complex with amendments. And so it is with the ?America?s Affordable Health Choices Act of 2009? bill (H.R. 3200, 1018 pages and counting).

After adding in hundreds of amendments that never seem thoughtfully considered as to how they all fit together, the House of Representatives? Energy and Commerce Committee voted 47-11 in favor of allowing 12 years of data exclusivity for biotech drugs. The change on data exclusivity follows the similar amendments by the Senate Health, Education, Labor and Pensions Committee.

Data exclusivity for biotech drugs is separate from patent protection and is the amount of time before other drug makers could receive market approval for generic versions of the drugs or drugs that are improvements that need to rely on the data of the original drug (see an overview at Patent Docs).

Biotechnology Industry Organization President and CEO Jim Greenwood issued a press release saying:

The strong bipartisan support in the Energy and Commerce Committee for a fair and balanced pathway for the approval of biosimilars is a decisive win for the patients of today and tomorrow. The approved amendment, introduced by Representatives Anna Eshoo (D, CA), Jay Inslee (D, WA) and Joe Barton (R, TX), strikes the appropriate balance among ensuring patient safety, expanding competition, reducing costs and providing necessary and fair incentives that will provide for continued biomedical innovation.

The Generic Pharmaceutical Association (GPhA) released a statement from GPhA President and CEO Kathleen Jaeger stating:

We are sincerely disappointed that some members of the House Energy and Commerce Committee have decided to put brand pharmaceutical profits before patient needs. The amendment passed tosses patient needs out the window.

Rep. Anna Eshoo (D-CA), sponsored the amendment that would provide a pathway for approval of generic biologics (biosimilars or follow-on biologics).  In total, the amendment to H.R. 3200 could provide for up to 12.5 years of exclusivity through an initial 12-year exclusivity period that may be extended with 6 months of pediatric exclusivity.

Meanwhile, Rep. Bobby Rush (D-IL) got an amendment approved, in a voice vote, which would ban ?pay-for-delay? settlements between branded and generic drugmakers that are used to keep generic competitors out of the market. This got a high-five from Jon Leibowitz, chairman of the Federal Trade Commission (FTC), who is set against these deals.

The bill would amend Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) by adding at the end the following:

“(A) conduct prohibited.?It shall be unlawful for any person to directly or indirectly be a party to any agreement resolving or settling a patent infringement claim in which?
“(i) an ANDA filer receives anything of value; and
“(ii) the ANDA filer agrees to limit or forego research, development, manufacturing, marketing, or sales, for any period of time, of the drug that is to be manufactured under the AND A involved and is the subject of the patent infringement claim.”

Look for more tweaks when Congress gets back from its vacation.

Related posts:

1. Senate Committee: 12 Years of Data Exclusivity is Cool “To amend the public health service act to establish a...
2. Economist Argues That 7 Years Ought to be Enough for Biologic Data Exclusivity As Congress is considering possible legislation to create an abbreviated...
3. Administration’s First Volley on Biosimilars: 7 Years of Exclusivity is Long Enough The Obama Administration sent out a warning shot that seven...

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Full post as published by Patent Baristas on August 03, 2009 (boomark / email).