Senate Republican Says Drug Patent Legislation Needed (Corrected)

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By Bronwyn Mixter

Sen. Susan Collins (R-Maine) is working on legislation that would lower drug costs by keeping large drug companies from gaming the patent system.

Collins, chair of the Special Committee on Aging, told Bloomberg Law Feb. 7 she plans to draft a bill to restrict so-called “evergreening” —the practice of extending protection for a product by taking out a new patent based on a different indication or new formulation. She said this after a committee hearing on the cost of rheumatoid arthritis drugs.

Collins’ remarks come after President Donald Trump said fixing high drug prices will be one of his top priorities in his Jan. 30 State of the Union address. The introduction of generic versions of drugs and biologics help lower their prices.

While Collins is drafting legislation, her panel doesn’t have authority over patent law. That’s the responsibility of the Senate Judiciary Committee. Representatives of that committee didn’t respond to a request for comment on evergreening legislation.

Evergreening

Collins said the drug company AbbVie, for example, has more than 100 patents on the rheumatoid arthritis drug Humira (adalimumab). She noted that many of the patents were added as the expiration date of the drug’s main patent approached in 2016.

Collins said biosimilar versions of Humira were approved by the Food and Drug Administration in 2016, but AbbVie used patent litigation to hold up market entry. Biosimilars are less expensive versions of complex, FDA-approved biologic drugs. A 2010 law created a FDA pathway for approving biosimilars, but few have hit the market so far.

The biosimilars for Humira are Amgen Inc.'s Amjevita and Boehringer Ingelheim’s Cyltezo.

Biosimilar competition for Humira is needed as the price of the drug has risen from about $19,000 per year in 2012 to more than $38,000 per year today, Collins said.

Humira generated sales of $16 billion in 2016, and sales are expected to approach $21 billion by 2020, AbbVie said in October when it announced third-quarter 2017 financial results.

Additional Legislation, Hearings

As well as evergreening legislation, Collins said, she also supports the Creates Act ( S. 974), which would prevent brand drugmakers from using risk evaluation and mitigation strategies (REMS) as an excuse for withholding product samples that generic and biosimilar companies need to perform bioequivalence studies. The FDA sometimes imposes a REMS to ensure that a product’s benefits outweigh its risks--which can involve restricting who prescribes and who has access to the medication.

Collins also told Bloomberg Law her committee will hold additional hearings, as well as a hearing in April, on the increasing prices of the diabetes treatment insulin as part of her investigation into the cost of drugs.

Representatives of branded pharmaceutical lobbying groups didn’t respond to a request for comment from Bloomberg Law about Collins’ plan.

(Corrects that Sen. Collins, not committee, is working on the legislation.)

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bloomberglaw.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bloomberglaw.com

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