Patient Advocates Argue Exercising Bayh-Dole "March-In" Rights Reasonable to Ensure Ongoing Supply of an Insulin Novo Nordisk Intends to Discontinue

Back in 2016 (when President Obama was still in office), the trade group known as the Pharmaceutical Research and Manufacturers of America (better known by the acronym PhRMA) claimed in an organization-published white paper (see https://web.archive.org/web/20161022175500/https://phrma.org/sites/default/files/pdf/bayh-dole-act-white-paper-summary.pdf for an archived copy of that paper from PhRMA; note that it has since been removed from PhRMA's website, hence I found a copy on the Internet Archive) the PhRMA championed the Bayh-Dole Act of 1980. 

Understand that what PhRMA really wants to prevent a particular provision of the Bayh-Dole Act from ever operating in order to address prescription drug prices. That provision is known as "march-in" rights. To do this, the PhRMA trade organization made a variety of baseless assertions about Bayh-Dole that could not be supported with any data or involved data that had absolutely nothing to do with Bayh-Dole. In fact, its entire opposition to Bayh-Dole "march-in" provisions is having the government use those provisions over drug prices. 

But what about reasons other than price? PhRMA would prefer to not acknowledge the possibility of such a thing happening. But the industry has discontinued products before, and that is currently happening in the insulin space. Specifically, refer to my recent blog post about the November 8, 2023 announcement from Novo Nordisk so it could instead redeploy internal manufacturing capacity to making drugs for the indication of obesity without Type 2 diabetes because it cannot keep up with demand.

A well-written summary of the PhRMA debate over using "march-in" rights under Bayh-Dole can be found at https://researchenterprise.org/2016/09/29/phrma-loves-bayh-dole-but-cant-say-why/ (just note that it's link to the PhRMA white paper noted above is now dead; I accessed a copy on the Internet Archive) which essentially refuted every asserted claim made by PhRMA in its 2016 white paper. At issue is whether prescription drugs which are created based on inventions made (at least in part) with public funding enable drug companies to receive the benefit of federal research funding and then can do pretty much what they want with the results. That's essentially what the pharmaceutical industry argues and believes it is entitled to. 

For its part, the Biden Administration in 2023 did propose a roadmap that would potentially allow the federal government to grant licenses to third-parties (such as generic and biosimilar manufacturers) for products which were developed (at least partially) using federal funds if the original patent holder does not make them available to the public on what are deemed "reasonable terms." The basic idea was that "reasonable terms" could potentially be interpreted as price for the first time ever even though the outline never mentioned price.

But in the case of the product withdrawal and discontinuation of Levemir (again, see my coverage of that announcement at https://blog.sstrumello.com/2023/11/novo-nordisk-to-discontinue-levemir-in.html and also https://blog.sstrumello.com/2024/01/the-business-case-for-biosimilar.html for more), that in the case of Levemir (insulin detemir), no one is even suggesting that the government exercise of Bayh-Dole "march-in" rights should be used to address price. Instead, patients are seeking continued availability for a still-efficacious insulin which the manufacturer announced that intends to stop making and selling. In my mind, discontinuing a product sounds like "reasonable terms" for the government to exercise "march-in" rights in order to ensure that the molecule (developed in part with U.S. taxpayer money) remains available to the patients who need it from biosimilar manufacturers instead of Novo Nordisk which announced it won't even make it after December 2024.

Novo Nordisk expects patients to simply switch to is newest, patent-protected basal insulin branded as Tresiba or alternatively to Sanofi's patent-expired Lantus or a growing number of biosimilars of that particular product (right now, copies are already made and sold by Biocon and Lilly, but in 2024, Sandoz, Amphastar Pharmaceuticals, Lannett Company, and CivicaScript have biosimilars pending FDA approval decisions on Lantus biosimilars (a third company known as Meitheal Pharmaceuticals has one expected a few years from now). 

Novo Nordisk has retired no fewer than six insulin varieties over my lifetime (actually more if one considers both porcine and bovine-sourced insulins sourced from pancreas glands derived as a byproduct of meat production). For example, the entire porcine and bovine Lente series consisting of Semilente, Lente and Ultralente [at the time, bovine Ultralente was considered the most effective long-acting basal insulin for most patients, while the shorter-acting porcine varieties tended to be favored for their effectiveness by many others; remember that porcine insulin is actually much closer in genetic structure to human insulin than are Novolog and Lantus, which introduce two amino acids which do not exist in insulin found in nature in order to have a desired impact on absorption, distribution, metabolism, and excretion, aka "ADME" properties], and then again when the company discontinued the newer Novolin biosynthetic "human' insulin variety of Semilente, Lente and Ultralente a few years later, and patients who used those products were left with no alternative than to use something else. 

At the time, Novo Nordisk intended for patients to switch to its $#!tty mid-range insulin variety known as insulin isophane/Neutral Protamine Haegdorn referred to by the acronym "NPH" but branded as Novolin N, but many patients switched to Sanofi's Lantus or an insulin pump using prandial only insulin programmed to be delivered in tiny amounts all the time as a basal rate. 

In other words, the patent and intellectual property rights for Levemir (insulin detemir injection) which Novo Nordisk views as its exclusive property could, under the Bayh-Dole "march-in" provisions be used to encourage other manufacturers to make insulin detemir instead. That is essentially what patient activists are seeking: to create an "open license" for any remaining patents on Levemir (most of the original Levemir patents expired in 2021) to ensure biosimilar manufacturers realize the potential and won't be sued for patent infringement by Novo Nordisk.

As I noted in my previous blog post entitled "The Business Case for a Biosimilar Company to Bring a Copy of Levemir to Market" https://blog.sstrumello.com/2024/01/the-business-case-for-biosimilar.html last month, PhRMA remains committed to ensure that Bayh-Dole "march-in" rights are never ever exercised under any circumstance. But for the reasons I've already acknowledged, there really is no substance behind the effort. It's just what the pharmaceutical industry feels entitled to: government welfare for the pharmaceutical industry.

No offense to PhRMA President Steve Ubl, but a) march-in rights have never been exercised in 44 years, and b) prior to Bayh-Dole, government research never sat on the shelf; the pharmaceutical industry routinely mined it for new drug ideas). However, it is not abuse when the government reclaims rights which it paid for in the first place when a company forfeits its rights by discontinuing a product.

A scrappy patient advocacy organization known as Alliance to Protect Insulin Choice (APIC) has been on a nonstop lobbying campaign in Washington, DC meeting with dozens of federal lawmakers. They have a Facebook group located at https://www.facebook.com/groups/3901021673560624 (which, if you're a patent upset over Novo Nordisk's latest product retirement might be a place to find like-minded people). Their website can be found at https://alliancetoprotectinsulinchoice.org/.

The real question is whether exercising Bayh-Dole "march-in" provisions in order to provide patients who use that insulin with an ongoing supply in the form of biosimilars is a reasonable use to use the rights enshrined in a 44 year-old law.

PhRMA claims the drug industry does NOT consider a product withdrawal to be a "reasonable" use for the government to exercise "march-in" rights under Bayh-Dole (and that no reason is ever considered "reasonable" use), and that the patents and intellectual property rights given to Novo Nordisk by U.S. taxpayers under Bayh-Dole should continue to belong to Novo Nordisk exclusively. But PhRMA also believes and argues that Bayh-Dole "march-in" provisions should never, ever be exercised. 

The thing is that the Secretary of the U.S. Department of Health and Human Services may not be given the luxury of siding with PhRMA. The reason is because anyone or any entity with a vested interest in the matter is permitted to petition the HHS Secretary, and by law, the HHS Secretary is legally obliged to both consider the petition itself, and render a decision on the petition. 

But will the federal government agree when patient activists file a petition with the Secretary of the U.S. Department of Health and Human Services which argues that ensuring continued availability for a drug might be a "reasonable" use to exercise those rights? We may soon find out!