One of the most interesting public policy reads in 2024 comes from the US Patent and Trademark Office (USPTO), whose “Drug patent and exclusivity study” effectively debunks false narratives and false statistics that have been levied against pharmaceutical patents with significant effect in recent years.

The inevitable takeaway from the USPTO study is that activists manipulated the 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 and Knowledge (I-MAK) and others have crafted and perpetuated a false narrative that the patent system is gamed by biopharma innovators who patent scores of “trivial variations” in existing drugs to prevent generic competition.

Citing such findings, many policymakers have criticized pharmaceutical patents and supported legislation that would discourage private sector investment, harming America’s leadership in innovative drugs. Among those misled by I-MAK fakes have been members of Congress who cite I-MAK data to justify curtailing the patent rights of biotech innovators and weakening the US patent system itself.

You cannot deny the data

The USPTO’s expert review reveals factual misrepresentations that have been made about the role, quantity and duration of patents in the life sciences sector. The study came in response to calls by Sen. Thom Tillis (R-NC) for a fact-based analysis of claims that essential prescription drugs have evaded competition as a result of patent proliferation and unfair patent term extensions. The USPTO corrects the record with a clear, empirical analysis.

The USPTO reviews all patents granted for each of the 25 flagship drugs in the life cycle for the innovation of new therapies and subsequent transition to generic competition. The report details a number 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 cover only the specific, new claims that enable improvement.

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

“Many patents associated with a single marketed product are . . . a common practice in many innovative industries, particularly for complex products.”

Much of the criticism that has been leveled at biopharmaceutical innovators focuses on this so-called “post-approval” innovation, which occurs after the US Food and Drug Administration has recognized the drug as safe and effective and approves it, and usually , before the patent on the compound expires. These investments in post-approval innovation often make a drug safer and more effective for a wider group of patients, allow a drug to be used in children, or even discover new conditions for which a particular product may have therapeutic benefit.

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

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

The statutory term of US patent protection is 20 years, a period of exclusivity intended to give the innovator time to recoup the outstanding costs of research and development, clinical trials and regulatory approvals before facing lower-cost generic competition. The USPTO found that none of the 25 drugs examined in the report—among them the “most prescribed” and “most cost-effective” prescription drugs during the study period—received market exclusivity of more than 3 to 18 years old.

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

**These drugs remain off patent with no current generic competition. The period of marketing exclusivity listed is the maximum available if no generic drug is launched before the patent expires.

It does no harm

These findings that none of the 25 high-value breakthrough drugs studied enjoyed more than 18 years of total exclusivity stand in stark contrast to allegations of patent manipulation that have been made by activists and relied upon to Congress .

The USPTO study clearly debunks the false narratives that have led to innovation-damaging legislative and regulatory proposals. Patents at all stages of the innovation life cycle, with exclusivity terms within legal and regulatory limits, are proof of the fruitfulness of continued investment in research. Live innovation, facilitated by well-functioning patent law and administration, makes more innovative medicines available to more patients and children in more therapeutic areas.

Congress, first do no harm.

Join Kilbride and other panelists in a session titled “The In-House Counsel’s Perspective: What Keeps Us Up at Night?” at IPWatchdog’s Masters in Life Sciences program on Tuesday. Register to participate here.