ICYMI: New Report Outlines How AbbVie Abuses Patent System To Stave Off Competition for Critical Cancer Drug

WASHINGTON, DC: In case you missed it, STAT today highlighted a new analysis that shows AbbVie could have its patents on cancer drug Imbruvica extended through 2036, forcing consumers to spend an additional $41 billion for the cancer treatment drug.  As I-MAK details in a new report, this move would prevent cheaper generic alternatives from entering the market for almost another 10 more years.  In the past, AbbVie has also used its patents to thwart competition for Humira, a rheumatoid arthritis medication.  

If you’re reporting on AbbVie’s abuse of the patent system to block competition, please consider the following statement by Matthew Lane, Executive Director of the Coalition Against Patent Abuse:

  • “U.S. drug prices are nearly four times higher than average prices compared to similar countries in large part because Big Pharma has been abusing and gaming the patent system for far too long.  Efforts like this to extend a decades-long monopoly on specific drugs, while blocking or stalling generic competition, have substantially increased the cost of prescription medication for millions of Americans.  This is an eye-opening new report from I-MAK that we hope the media and policymakers in Washington will read carefully.”

Key excerpts:

  • “Since the first patent application was filed in 2006, the drug has been the subject of a blizzard of applications that has yielded no less than 88 patents. In fact, more than half of the 165 applications were filed after Food and Drug Administration approval in 2013, and most of those cover different indications or formulations, not the active ingredient in the drug itself.”
  • “The combined effect means that, even though the main patent on medication expires in 2026, lower-cost generic competition will not appear for nearly 10 more years. In all, patent exclusivity on Imbruvica, which has a $174,000 list price, will run at least 29 years, according to the analysis by Inittiative for Medicines, Access, and Knowledge, or I-MAK, a nonprofit that studies drug patents.”
  • “For many years, the focus has been on so-called pay-to-delay deals that are used to settle patent litigation. Under such arrangements, a brand-name drug company may offer cash or something else of value to a generic rival in exchange for delaying the launch of a lower-cost generic version of its medicine. This gives a brand-name drug maker more time to ring the register. Drug makers contend such deals are not only legal, but actually allow lower-cost generic drugs to reach consumers faster than if patent litigation drags on for years. The U.S. Supreme Court ruled some deals deserve anti-trust scrutiny.”
  • “Humira sales in the U.S. rose 8.6% last year to nearly $14.9 billion. And I-MAK contended that Imbruvica is on the same trajectory.”

Below is a link and full text of the article:

AbbVie Uses Dozens Of Patents To Ward Off Competition For A Pricey Cancer Medicine
STAT News
Ed Silverman
July 15, 2020
https://www.statnews.com/pharmalot/2020/07/15/abbvie-imbruvica-patents-drug-prices/

The pricey Imbruvica cancer treatment that became available seven years ago could have its monopoly extended through 2036 thanks to dozens of patents and, as a result, consumers may be forced to spend an extra $41 billion for the medicine by then, according to a new analysis.

Since the first patent application was filed in 2006, the drug has been the subject of a blizzard of applications that has yielded no less than 88 patents. In fact, more than half of the 165 applications were filed after Food and Drug Administration approval in 2013, and most of those cover different indications or formulations, not the active ingredient in the drug itself.

The combined effect means that, even though the main patent on medication expires in 2026, lower-cost generic competition will not appear for nearly 10 more years. In all, patent exclusivity on Imbruvica, which has a $174,000 list price, will run at least 29 years, according to the analysis by Initiative for Medicines, Access, and Knowledge, or I-MAK, a nonprofit that studies drug patents.

Consequently, the slow but steady stream of patent filings for Imbruvica — some of which represent only incremental changes — illustrates a loophole in the U.S. patent system that can dent American pocketbooks, according to the nonprofit. And Imbruvica raises questions about whether patent standards should be retooled to better reward true innovation.

At the same time, however, the tactic can yield big profits for drug makers. In this case, Imbruvica is sold by AbbVie (ABBV), which acquired the drug as part of a larger deal in 2015. AbbVie has also used dozens of patents to block competition for its Humira rheumatoid arthritis medicine. The company has come to typify this approach to warding off lower-cost generic competitors, but critics say the company does so at the expense of patients.

“This is AbbVie’s playbook,” said Tahir Amin, the executive director at I-MAK. “It’s in line with their behavior with Humira, where most of the patents were filed after the first approval. Once the drug is approved, they try to extend patent life as much as possible. And as they get new indications — and there are now six — they keep filing more patents.

“But it goes against the idea that drug companies say there will be no investments in innovation without patents as incentives. In this instance, most of the applications were filed after FDA approval [in 2013]

and most of those patents were filed by AbbVie, even though the company bought the drug two years later. There’s probably more innovation in the legal drafting of the patents than the drug research.”

We asked AbbVie for comment and will update you accordingly.

The analysis emerges amid growing debate over the extent to which the patent system is exploited by the pharmaceutical industry. Increasingly, drug makers have been criticized for various maneuvers that delay generic competition, an issue that has become more controversial as more Americans complain they are having difficulty paying for their medicines.

For many years, the focus has been on so-called pay-to-delay deals that are used to settle patent litigation. Under such arrangements, a brand-name drug company may offer cash or something else of value to a generic rival in exchange for delaying the launch of a lower-cost generic version of its medicine. This gives a brand-name drug maker more time to ring the register.

Drug makers contend such deals are not only legal, but actually allow lower-cost generic drugs to reach consumers faster than if patent litigation drags on for years. The U.S. Supreme Court ruled some deals deserve anti-trust scrutiny. Last month, however, a federal court judge ruled AbbVie did not unfairly thwart competition by striking deals with other companies that resolved Humira patent lawsuits.

More recently, there has been increasing scrutiny of patent filings — and those of AbbVie, in particular. The company filed so many patents for Humira that its tactic became known as a patent thicket. And the strategy worked. Over the past two years, several would-be rivals settled patent litigation and, as a result, lower-cost versions of Humira will not be available in the U.S. until 2023.

AbbVie has clearly benefited. Humira sales in the U.S. rose 8.6% last year to nearly $14.9 billion. And I-MAK contended that Imbruvica is on the same trajectory. In explaining his reasoning, Amin also pointed to marketing exclusivities that were granted for Imbruvica by the FDA, some of which overlap or parallel the patents granted for the drug.

“This creates a fortress of exclusivity,” Amin maintained. “Eventually, when FDA [marketing] exclusivity runs out, they still have the patent exclusivity, which they keep building out with more and more [patent] applications for indications and formulations. And no generic company can penetrate this. But the system allows it, which means more people may go without a needed medicine.”

But solving the problem may not be so easy, according to Michael Carrier, a Rutgers University School of Law professor who specializes in anticompetitive practices and intellectual property.

“It’s unclear exactly how to fix this. Should the Patent Office raise the standards for patentability? Should this be an antitrust violation? I’d say that there are many examples like this. But a detailed showing of the types of patents -and their timing – is useful in thinking about the frequently discussed issue of the relationship between patents and innovation.”