TPP Deal Calls for Five to Eight Years of Biologics Exclusivity

U.S. companies taking new biologicals to 11 Pacific Rim nations would get no more than eight years of marketing exclusivity — four less than what they enjoy in the U.S. — under a trade deal agreed to by all 12 countries.

The 12-year exclusivity period in the U.S. would not be impacted.

The U.S. Trade Representative’s office said Oct. 5 that the trade ministers had reached an agreement on the Trans Pacific Partnership, following more than five years of negotiations. Details of the agreement weren’t formally disclosed.

But a source tells Generic Line that the deal provides for a two-track option for patent protection for biologics — either of which is significantly shorter than the 12 years of exclusivity that biologics makers currently enjoy in the U.S.

Under the first option, drugmakers would get at least eight years of exclusivity. The second option provides five years of data protection. If those aren’t sufficient to protect exclusivity, then a country’s government would need to take regulatory measures to achieve that goal.

Length of exclusivity was a major sticking point during the negotiations, as no other country besides the U.S. provides more than eight years of data protection for biologicals, and some provide none.

PhRMA President and CEO John Castellani says the group is disappointed that negotiators failed to secure 12 years of data protection.

The 12-year term was not a random number, he says, but the result of a long debate in Congress, which determined that time period captured the appropriate balance between stimulating research and allowing timely access to biosimilars.

The conclusion of negotiations now starts a legal scrub to make sure the text is interpreted the same in all 12 countries. After that, President Barack Obama will sign a letter of intent to sign the TPP, starting a 90-day clock — 60 days of public review and then 30 days for the president’s actual signing. Once this occurs, Congress has agreed to fast-track the final ratification process with a straight up and down vote on the deal.

The pact is formally adopted when all 12 TPP nations have ratified it.

Sen. Orrin Hatch (R-Utah), who has supported 12 years exclusivity for brand name biologic drugs, said the deal “appears to fall woefully short.”

Hatch said he will examine the agreement to ensure trade negotiators followed the law. He has said repeatedly that we will vote against ratifying the TPP if it doesn’t sufficiently protect U.S. manufacturers’ interests. — Jonathon Shacat




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