Some Observations on Drug Patents – A Response to Arie Michelsohn

Dr. Michelsohn’s recent post on this blog takes issue with pharmaceutical patenting practices and urges us to police drug patents more vigorously, perhaps “with a fury,” to ensure that drugmakers receive patent protection only for true innovation. Dr. Michelsohn is particularly concerned about secondary, or follow-on patents, which, he fears, too often claim trivial improvements and wouldn’t be granted if only the USPTO applied the same standards for novelty and nonobviousness that it applies in other technologies.

Nothing in my own experience leads me to believe that the PTO applies a lower anticipation or obviousness standard to pharmaceuticals, and I expect this would be news to my colleagues in the industry too. I do, however, often get questions from policymakers, journalists, and others who have been misinformed and led to believe that pharmaceutical companies are re-patenting old drugs to keep prices high, and that our industry is spending “too much” effort on trivial modifications to old medicines rather than creating new ones. Be assured – there is no such thing as “re-patenting,” and our industry is spending plenty on true innovation – but Dr. Michelsohn is certainly raising a fashionable complaint. Public debate by and large seems to have accepted that any given smartphone model is covered by hundreds of patents, but when a complex pharmaceutical product is covered by more than one patent there’s immediate scrutiny and concern.

One peculiar aspect of working in medicinal chemistry, biological manufacturing, and related areas is that a small change to existing technology can make a big difference. There are patents on molecules where only a couple of atoms are different from prior art compounds, but the resulting molecule is well-tolerated where the prior art molecule is toxic. Or modified formulations where the change of buffer means that the drug has an extended shelf-life at room temperature where the original formulation was unstable and required refrigeration. Such patent claims can look like they’re very close to the prior art, and critics find it tempting to point to those small changes and call them trivial.

Also, peculiar to the pharmaceutical and biotech industries, patentees who want to incorporate such improvements into their existing drugs typically must back up their claims with experimental and clinical studies to meet the requirements of the Food and Drug Administration. In other industries, I suspect, making a small change to an existing product can often be accomplished at correspondingly small cost. But in the biopharma space, implementing a “small” improvement can easily require years of studies and dozens of millions of dollars. This means that drugmakers are likely to make only those product changes that produce a real clinical difference (there are no “nice to have” features in our products). It also means that there is maybe a greater incentive to seek narrow improvement patents that wouldn’t be sought in other industries. It doesn’t mean there’s necessarily anything less inventive about such patents.

Developing a pioneering medicine, from conception to first FDA approval, typically requires close to a decade of basic and applied research and a financial investment exceeding two billion dollars. But innovation does not and cannot just stop once a new drug is launched. Biopharmaceutical companies generally follow up on their initial investment with additional research to improve the clinical usefulness, safety, and effectiveness of new drugs. This makes eminent sense. Whether or not such improvements represent “real” innovation depends on one’s point of view. Critics may deem such advances too trivial to support even narrow patent protection. But what seems trivial to some patent professionals may not be trivial to patients and physicians, who may prefer an improved once-daily drug formulation over the original 3x/day version, or pharmacies who see real benefit in stocking pharmaceuticals with extended shelf-lives compared to predecessor formulations that too often expire before they are dispensed. And patients living with rare diseases may benefit from new treatment options, even if that means using an existing drug in a new way.

Whatever one’s point of view, it is hard to dispute that improvements to pharmaceutical products require sustained investment that, if resulting in additional clinical benefits, should deserve a certain measure of additional reward. To those who view the patents covering such benefits as trivial, I recommend: don’t practice them. There is nothing stopping anyone from developing competing products that don’t embody “trivial” improvements. But I suspect, as Dr. Michelsohn seems to concede by urging “opening-up those trivial modification drug patents for all,” that would-be copyists often view the features protected by such patents as important benefits, and greatly desire to include them in their copy products.

Be that as it may, if pharmaceutical product improvements were really trivial and clinically meaningless, as some critics argue, we wouldn’t be having this debate. Nobody would care. The much more likely explanation for persistent demands to put such improvements into the public domain long before their patent protection expires is that these innovations are important, life-improving, and sometimes life-saving. Let’s at least acknowledge that.

The opinions expressed herein are the author’s, and should not be attributed to BIO or any of its members.

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