Debunked: USPTO Findings Should End False Pharma Patent Narratives

One of the more interesting public policy reads of 2024 comes from the U.S. Patent and Trademark Office (USPTO), whose “Drug Patent and Exclusivity Study” effectively debunks the false narratives and bogus statistics that have been levied against pharmaceutical patents with significant effect in recent years.

The inescapable takeaway from the USPTO study is that activists have manipulated data to inflate the effects of patents and other exclusive rights on competition. Relying on the complexity of the underlying subject matter to hide their deception, the Initiative for Medicines Access & Knowledge (I-MAK) and others conceived and perpetuated a false narrative that the patent system is being gamed by biopharmaceutical industry innovators who patent scores of “trivial variations” to existing medicines in order to prevent competition from generic products.

Citing such findings, many policymakers have been critical of pharmaceutical patents and supported legislation that would discourage private sector investment, harming America’s leadership in innovative medicines. Among those misled by I-MAK falsehoods were Members of Congress who cite I-MAK data to justify restricting the patent rights of biotech innovators and weakening the U.S. patent system itself.

You Can’t Deny the Data

The expert analysis from the USPTO exposes factual misrepresentations that have been made about the role of patents, their quantity, and their duration in the life sciences sector. The study came in response to requests from Senator Thom Tillis (R-NC) for a fact-based analysis of claims that vital prescription medicines have eluded competition as a result of patent proliferation and unfair extension of patent terms. The USPTO corrects the record with a clear, empirical analysis.

The USPTO examines all patents granted for each of 25 medicines emblematic of the lifecycle for innovation of new therapies and the subsequent transition to generic competition. The report details a range of scenarios where generic market entry occurs despite unexpired patents. The study explicitly illustrates that patents on improvements to existing products do not extend the life of the claims made by the original patent; they only cover the specific, novel claims that enable the improvement.

The USPTO study is a tacit defense of the patent system and its application to life sciences. It reveals that innovation does not end with discovery of a promising new chemical entity and the original subject matter patent. These are merely the core from which researchers branch out in fruitful directions. This high-level guided tour of the innovation lifecycle shows appropriate use of patents and regulatory exclusivities at each stage of drug development, the limits on their scope, duration and overlap, and why numerous patents cover a single successful drug product. The report explains:

“[M]ultiple patents associated with a single marketed product are … a common practice in many innovative industries, especially for complex products.”

Much of the criticism that has been leveled at biopharmaceutical innovators focuses on this so-called “post-approval” innovation, which takes place after the U.S. Food and Drug Administration has recognized the medicine as safe and effective and approves it, and usually before the patent on the subject matter compound expires. These investments in post-approval innovation often make a medicine safer and more effective for a broader group of patients, enable a medicine’s use in children, or even uncover new conditions for which a given product may have a therapeutic benefit.

The costly and laborious work of building on a basic drug discovery conveys additional rights to the innovator, which the study shows do not materially affect the duration of the innovator’s exclusive rights. According to the report:

“Such improvements, when deemed patentable, are entitled to patent protection, which is limited in scope to the patentable improvement. “Importantly, once the original patent expires, the public may use the technology covered by the expired patent. Patents on the improvements only prevent the public from using the new technology until the new patents expire.”

The statutory term of U.S. patent protection is 20 years, a period of exclusivity intended to give the innovator time to recoup sunk costs of research and development, clinical trials, and regulatory approvals, before facing lower-cost generic competition. The USPTO found that none of the 25 medicines examined in the report—among them the “most prescribed” and “top grossing” prescription medicines of the study period—was afforded more than 3 to 18 years of market exclusivity.

*Included in both I-MAK papers identified by Senator Tillis and the USPTO Study.

**These medicines remain under patent with no current generic competition. The period of marketing exclusivity listed is the maximum available if no generic is launched prior to patent expiration.

Do No Harm

These findings that not one of the 25 high-value innovative medicines studied enjoyed more than 18 total years of exclusivity stand in stark contrast to the accusations of patent manipulation that have been made by activists and relied upon by Congress.

The USPTO study clearly debunks false narratives that resulted in legislative and regulatory proposals harmful to innovation. Patents at all stages of the innovation lifecycle, with terms of exclusivity well within statutory and regulatory bounds, are evidence of the fruitfulness of continuing research investment. Living innovation, enabled by well-functioning patent law and administration, is making more breakthrough medicines available to more patients and children in more therapeutic areas.

Congress, first do no harm.

Join Kilbride and other panelists for a session titled “In-House Counsel Perspective: What Keeps Us Awake at Night?” at IPWatchdog’s Life Sciences Masters program this Tuesday. Register to attend here.