USPTO Findings Should Put an End to False Pharmaceutical Patent Stories

Support IPWatchdog with individual sponsorship: Click here

“(The USPTO) findings that none of the 25 high-quality innovative drugs examined have enjoyed more than 18 years of exclusivity stand in stark contrast to the patent manipulation allegations leveled by activists and relied upon by Congress.”

One of the more interesting public policy publications of 2024 comes from the US Patent and Trademark Office (USPTO), whose “Drug patent and exclusivity studyeffective debunks the false stories and false statistics levied against pharmaceutical patents with significant effect in recent years.

The inescapable conclusion from the USPTO investigation is that activists have manipulated data to increase the effects of patents and other exclusive rights on competition. Relying on the complexity of the underlying subject matter to conceal their deception, the Initiative for Medicines Access & Knowledge (I-MAK) and others created and perpetuated a false narrative that the patent system is gamed by biopharmaceutical industry innovators who patent dozens of patents . trivial variations” on existing medicines 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’s falsehoods were members of Congress who cited I-MAK data to justify limiting the patent rights of biotech innovators and weakening the U.S. patent system itself.

You cannot deny the data

The USPTO’s expert analysis exposes factual misrepresentations made about the role of patents, their quantity, and their duration in the life sciences industry. The study came in response to requests from Senator Thom Tillis (R-NC) for an evidence-based analysis of claims that critical prescription drugs have eluded competition due to the proliferation of patents and the unfair extension of patent terms. The USPTO corrects the record with a clear, empirical analysis.

The USPTO examines all patents issued for each of the 25 drugs that are emblematic of the life cycle of innovation of new therapies and the subsequent transition to generic competition. The report describes a range of scenarios in which generic market entry occurs despite unexpired patents. The research explicitly illustrates that patents on improvements to existing products do not extend the life of the claims of the original patent; they only address the specific, new claims that make the improvement possible.

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

“(M)everal patents associated with a single product on the market are… a common practice in many innovative industries, especially for complex products.”

Much of the criticism of biopharmaceutical innovators focuses on this so-called “post-approval” innovation, which occurs after the U.S. Food and Drug Administration recognizes and approves the drug as safe and effective, and usually before the U.S. Food and Drug Administration ( FDA) has recognized and approved the drug as safe and effective. patent on the subject of compound expires. These post-approval investments in innovation often make a drug safer and more effective for a broader group of patients, enable a drug’s use in children, or even identify new conditions for which a particular product may have a therapeutic benefit.

The costly and labor-intensive work of building on a foundational drug discovery gives the innovator additional rights, which the research shows do not materially impact the duration of the innovator’s exclusive rights. According to the report:

“Such improvements, if deemed 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 the improvements only prevent the public from using the software new technology up to and including new patents expire.”

The statutory term of U.S. patent protection is twenty years, a period of exclusivity intended to give the innovator time to recoup the sunk costs of research and development, clinical trials, and regulatory approvals before facing cheaper generic competition. The USPTO found that none of the 25 drugs examined in the report – including the “most prescribed” and “highest grossing” prescription drugs of the study period – were granted more than 3 to 18 years of market exclusivity.

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

**These medicines remain patented and there is currently no generic competition. The stated period of marketing exclusivity is the maximum period available if no generic drug is introduced to the market before patent expiration.

Do no harm

These findings that none of the 25 high-value innovative drugs examined enjoyed a total of more than 18 years of exclusivity are in stark contrast to the patent manipulation allegations leveled by activists and relied upon by Congress.

The USPTO investigation clearly debunks false narratives that have resulted in legislative and regulatory proposals that harm innovation. Patents at all stages of the innovation life cycle, with exclusivity terms well within legal and regulatory limits, are evidence of the fruitfulness of continued research investments. Living innovation, made possible by well-functioning patent law and well-functioning governance, makes more groundbreaking 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 “Corporate Lawyer’s Perspective: What Keeps Us Up at Night?” next Tuesday during IPWatchdog’s Life Sciences Masters program. Register here to attend.

Patrick Kilbride

Patrick Kilbride is a public policy expert specializing in economics, geopolitics and innovation. Previously, he served as Senior Vice President of the Global Innovation Policy Center (GIPC), Executive Vice President, Association of American (…see more)