Congress Must Not Rewrite Patent Rules Without Evidence

Tomorrow, June 17, the Senate HELP Committee will vote on a raft of bills aimed at making medical care more affordable. That’s a worthy goal. But in the case of the Medication Affordability and Patent Integrity Act, lawmakers are setting themselves—and patients and the rest of us—up for failure.

The legislation seeks to prevent drug companies from gaming the patent system by holding these firms to new disclosure and certification requirements.

How the bill is supposed to save patients money is far from obvious. What is more, there are already laws against the kind of abuse the legislation targets. And there is little to suggest those rules aren’t working.

But by introducing more uncertainty and administrative costs into the patent system, lawmakers will compromise the basic protections that make medical progress both possible and profitable—resulting in fewer new breakthroughs and treatments.

Changes to the Law Require Evidence of a Problem

At the heart of the bill is a suspicion that drug companies are sharing information with the Food and Drug Administration (FDA) that never reaches patent examiners at the U.S. Patent and Trademark Office (USPTO)—and that they are doing so in order to secure patents they don’t, in fact, deserve.

The bill’s new disclosure requirements are designed to crack down on such alleged misconduct by ensuring that the FDA and USPTO are working from the same set of facts.

Of course, the reform only makes sense if there is evidence that existing safeguards aren’t already preventing this kind of behavior. By all accounts, there isn’t any.

Patent applicants already operate under a duty of candor, good faith, and disclosure before the USPTO. A company that intentionally withholds material information from patent examiners can lose the ability to enforce the patent.

If the current rules aren’t working, Congress should be able to point to clear evidence of this failure before creating a new layer of compliance obligations.

Unintended Consequences

The bill assumes more information submitted to the FDA also being sent to USPTO is an obvious good. But the two agencies serve vastly different purposes. Determining whether a medicine is safe and effective, as the FDA does, requires different information than evaluating whether an invention is new, useful, and nonobvious, which is the USPTO’s purview.

More paperwork is the last thing America’s patent system needs. There are currently hundreds of thousands of patent applications awaiting USPTO review. Requiring examiners to sort through additional regulatory submissions will only add to that workload, which is more likely to slow the review process than improve it.

The bill also raises serious confidentiality concerns for pharmaceutical developers. When seeking approval for a new drug, companies have to submit large amounts of sensitive, proprietary documents to the FDA with the expectation that confidential business information and trade secrets will remain protected.

Patent filings, by contrast, are generally published 18 months after submission. That creates a very different set of expectations around confidentiality than those that govern many FDA submissions. A reform that moves more FDA-related material into the patent process creates significant risks regarding and raises many serious questions about the handling and protection of sensitive information.

At the same time, more disclosures and certifications would mean more compliance work, legal review, and litigation for pharmaceutical firms, forcing companies to divert resources away from groundbreaking research in order to accommodate these new bureaucratic demands.

In the end, the legal landscape surrounding drug innovation would become far less predictable and confidentiality far from certain. Disputes over what information should have been disclosed and whether companies met their obligations could linger for years. And even long-standing patents might become newly vulnerable to challenge.

The Bill Would Bring New Burdens Without Solving Problems

In an industry where developing a new treatment can take years and require billions of dollars in investment—with no guarantee of success—a less reliable patent system is no small problem.

Patents give inventors and investors confidence that, if a discovery succeeds, it will not be immediately copied by competitors. In doing so, they make it worthwhile for companies to bet big on experimental new medicines.

Also, patents aren’t just essential to medical science. Our nation’s technological leadership and global competitiveness depend on strong, consistent IP protections. Any measures that make these property rights less secure, predictable, and enforceable should be highly scrutinized.

Congress must do its part to lower healthcare costs. But the Medication Affordability and Patent Integrity Act won’t advance that goal. However, it will create needless paperwork, invite costly litigation, and add new burdens to an already-strained patent system—all while stifling medical innovation.

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Author: BlueJay18