Durbin Gives Pharma Fleece Award to Drug Companies Abusing Patent System

WASHINGTON – U.S. Senator Dick Durbin (D-IL) today on the Senate floor, as part of his new “Pharma Fleece Awards” series of floor speeches highlighting egregious cases of pharmaceutical industry greed, slammed Celgene, Pfizer, and Sanofi for amassing a large number of excessive secondary patents to block generic competition. Many high-cost, brand-name drugs are shielded from competitiondue to manipulation of the patent system by “evergreening” or filing numerous additional patents to their product in an attempt to forestall generic competition. Durbin highlighted his new bipartisan legislation with Senator Bill Cassidy, M.D. (R-LA), the REMEDY Act, to crack down on this monopoly abuse and lower prescription drug costs for patients.

“Often, Big Pharma charges as much as they can get away with—because they manipulate the patent system to avoid competition….In what other industries does the price of a consumer product increase, year-after-year, after being introduced on the market? Maybe collector artwork or baseball cards? But it certainly should not happen for life or death prescription drugs,” said Durbin. “In fact, the top-twelve best selling drugs in America each have an average of 71 patents…and 74 percent of all new drug patents are for drugs that are already on the market. They are gaming the system.”

Sanofi’s insulin product, Lantus, has received 45 additional patents after it was approved by the Food and Drug Administration (FDA) in 2000, which has provided a 37-year monopoly period during which time the price of Lantus has increased more than 600 percent. Celgene’s cancer drug, Revlimid, has been awarded 96 patents—many of which were awarded after FDA approval. As a result, Revlimid effectively enjoys 40 years of protection from generic competition. Pfizer’s nerve pain drug, Lyrica, entered the market in 2004 and has received 68 patents—including filing more than two-dozen after FDA approval.

Last month, Durbin and Cassidy introduced a bipartisan bill to tackle the pharmaceutical industry’s practice of gaming the patent system to extend monopolies on lifesaving drugs. The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act, would lower prescription drug prices and promote competition by removing barriers to FDA approval for lower-cost generic drugs.

The REMEDY Act amends FDA statute to remove incentives for drug manufacturers to file excessive patents, and would lift barriers that delay generic market entry. Today, lower-cost generic drug applicants are often blocked by a maze of secondary patents on a drug, such as for a pill coating or manufacturing technique, which stifles competition despite having limited impact on the safety or efficacy of a drug. But under this policy, once the drug’s primary substance patent and all exclusivities expire, generic manufacturers would be allowed to enter the market more easily. The REMEDY Act also increases transparency and removes hurdles for generic drug companies by ensuring that when a patent is invalidated by a ruling at the U.S. Patent and Trademark Office, and upheld on appeal, the FDA’s listing of relevant drug patents would be updated.

The bipartisan REMEDY Act is endorsed by the Campaign for Sustainable Rx Pricing.

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