Why Current Legislative Efforts to Prevent Patent Thickets Are a Start — But Not Enough

In February, the United States Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing to investigate why the U.S. pays the highest drug prices in the world. I was asked to testify about the central role patent abuse plays in driving up prices. During the hearing, Senator Cassidy (R-LA) asked me if the Affordable Prescriptions for Patients Act introduced by Senators Cornyn (R-TX) and Blumenthal (D-CT) would effectively address patent thickets. I said “no”. That may have surprised some folks.

For those who aren’t familiar, the Affordable Prescriptions for Patients Act is a bipartisan bill that passed through the Senate Judiciary and may be included in a year-end package. Its goal is to “prevent bad actors in the pharmaceutical industry from deliberately abusing the patent system” by prohibiting product hopping and imposing some limits on the number of biologic patents of a particular type that can be asserted in patent litigation. The bill seeks to prevent patent thickets by setting a limitation that drugmakers may assert no more than a total of 20 of the following types of patents in the biologic patent dance litigation process:

• The biologic product, its method of use, or a method or product used to manufacture the biological product
• That have a filing date of more than 4 years after the first approval of the branded drug
• That include a claim to a manufacturing process that is not being used by the branded drugmaker.

I’ll get into details shortly, but let’s be clear upfront: imposing limits on how many patents can be enforced in litigation is helpful, but this bill alone will not prevent bad actors from deliberately abusing the patent system.

We will not prevent patent thickets until we raise the bar for what should be considered an invention deserved of being granted a patent.

In essence, the bill places a cap of 20 on the types of patents mentioned above. Importantly, this does not mean the bill will limit drugmakers to asserting at most 20 patents in all instances. Whether the cap will be enough to limit the total number of asserted patents to 20 will depend on how each particular patent thicket looks. So while the bill takes a step in the right direction by imposing some limits, there are still unaddressed issues that remain:

First, while the bill’s patent cap should help curb some of drugmakers’ patent thickets in litigation, it won’t prevent drugmakers from building thickets in the first place. Litigation isn’t the only place where drugmakers leverage patent thickets. If we only place some limits on the number of patents a drugmaker can assert in litigation, we’re still leaving the door open for them to use thickets to hamper or dissuade competitors in other ways. Generic and biosimilar competitors have to navigate every application and patent a branded drugmaker is granted. Branded drugmakers know this, so they file a high volume of patent applications, many of which they may not intend to use in litigation. The purpose of this strategy is to create an unpredictable environment that slows down competitors and forces them to expend extra resources in order to track and assess their thicket as it grows. This hidden aspect of patent thickets is something that practitioners are well aware of, but that the industry avoids talking about and wants to keep hidden from policymakers. What drugmakers don’t want policymakers and the public to know is how all of their patent applications and granted patents can impact competition even before we get to the litigation phase. Patent abuse runs much, much deeper. This is why I keep repeating that we must work upstream by directly addressing the root causes of patent thickets to begin with. As Peter Maybarduk of Public Citizen stated during his testimony, “the fish rots from the head.”

Secondly, while the bill does put some limit on the number of patents filed more than four years after the first FDA approval, it still allows branded drugmakers ample room to stagger patent filings over time to extend total patent protection on a drug. Merck filed at least 49 patent applications in the first four years after FDA approval on Keytruda. The vast majority of these patents are method of treatment patents that should be considered unpatentable for obviousness, but which could still be asserted as part of the 20 patent limit.

Lastly, the bill allows branded drugmakers to assert manufacturing process patents that are not used to make a drug. This is problematic for reasons related to my first point. Drug companies can patent as many routes to make a drug as possible, even if they won’t use a particular route, just to delay and extract a settlement and royalties from a competitor. An example of this anti-competitive behavior is where Johnson & Johnson (J&J), facing the entry of biosimilar competition on Stelara in 2023, asserted at the last minute four manufacturing process patents it had acquired for $6.5 billion from Momenta Pharmaceuticals. J&J was able to delay the entry of Amgen’s biosimilar version until 2025 by asserting these patents, even though they were granted years after the FDA’s approval of Stelara and J&J doesn’t use them to manufacture the drug. These patent games put J&J back on track for a $57 billion revenue forecast in 2025. The worst part is this practice is not new. It is the reason why I-MAK called for a “use it or lose it” system in our latest policy blueprint on how to address patent thickets. Basically, if a drugmaker does not use a manufacturing patent to make a drug within the 12-year FDA marketing exclusivity period, it is open to being canceled by a competitor. This type of policy would prevent the kind of patent games played by J&J, that are currently considered “legal”, and get to the root of the problem.

The Affordable Prescriptions for Patients Act aims to prevent bad actors in the pharmaceutical industry from abusing the patent system. Establishing some limits on the number of patents drugmakers can assert in litigation is a small, helpful step toward managing patent thickets. To be sure, Congress should pass this bill. However, we must recognize that this bill alone will not put an end to such practices once and for all. Ultimately, we will not prevent patent thickets until we raise the bar for what should be considered an invention deserved of being granted a patent. If we can do this, we will restore integrity to the patent system and help propel genuine breakthrough inventions rather than the current business model of incentivizing “innovative” tweaks that maximize corporate profits and CEO salaries at the expense of patients.

To prevent patent thickets, we have to do more than trim around the hedges. We have to stop patent thickets from taking root.

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Tahir Amin is the Co-Founder and CEO of the Initiative for Medicines, Access & Knowledge (I-MAK), a team of lawyers, scientists, and health experts challenging systemic injustice and advocating for health equity in drug development and access.

To learn how policymakers can put an end to patent thickets, read “Address Patent Thickets, Improve Competition, and Lower Prescription Drug Prices: A Blueprint for Reform”