Amgen Attacks Academics’ False Claims About Biologic Patents

“Amgen’s takeaway is simple yet profound: The current system is working, and innovation is benefiting actual patients.”

The ongoing policy debate about pharmaceutical and biologic patents has been coopted by those who don’t like patents—including those who have a financial incentive not to like patents. These paid mercenaries concoct and then disseminate fraudulent “reports”, which have become the lifeblood for patent critics. Even when the inaccuracies and lies are clearly identified, the cacophony of patent haters drowns out the truth thanks to a complicit, ideologically aligned popular press that continues to cite and rely on fabricated “findings” that couldn’t stand up to the scrutiny of your average fifth grader.

Although not the only example by a longshot, the easiest, most clear example of fiction masquerading as truth comes to us courtesy of the Initiative for Medicines, Access & Knowledge (I-MAK), which the Council for Innovation Promotion (C4IP) has recently launched a campaign to expose. As recently as July 2023, I-MAK’s website proclaimed there was “no generic alternative to Pfizer’s drug Lyrica® approved by the Food and Drug Administration (FDA) or available on the market.”

I-MAK’s Many False Claims

I-MAK’s claim about Lyrica® is false. The FDA approved multiple generics of Lyrica®  in July 2019, which coincided with the patent expiration of the Lyrica® compound patent in June 2019. And those generics were on the market well before I-MAK made this incorrect statement. What makes this example particularly egregious is I-MAK continued to pedal this phony claim long after it had been exposed as untrue. And Lyrica® is not the only drug for which I-MAK has made similarly false claims. I-MAK claimed patents on Revlimid® would prevent generic competition until at least 2028 despite Teva launching the first generic in 2022. I-MAK claimed patents on Gleevec® would delay generic competition until at least 2029 despite Sun Pharma launching a generic in 2016.

I-MAK has also made false and misleading claims about the number of patents that cover brand name drugs. For example, I-MAK has claimed that the Novartis drug Gleevec® is covered by 73 patents, when in fact the number of patents actually covering Gleevec is 6. I-MAK admits the source of their deception in the footnotes saying they are including expired patents, pending applications and four-dozen abandoned patent applications to arrive at the number 73.

The public deserves better. Simply put, relying on fraudulent “reports” and made-up “data” is no way for public policy to be set or influenced. Deception and fabrication is not the way to set or frame an important discussion about the role patent play in the healthcare innovation ecosystem. We need—and deserve—an honest discussion about the merits of patenting in the biopharma space, particularly now with the Trump Administration poised to do something about the fact that drug prices in the United States are so much higher than in the rest of the world.

Amgen Addresses the Critics

Against the backdrop of charlatans with hollow rationales and contrived grievances, Amgen has recently jumped into the ongoing public policy debates about biologic manufacturing patents and whether such patents unfairly delay the entry of biosimilars—a similar yet still bogus refrain.

In a recent letter to the editor published in Nature Biotechnology, Amgen responded to an academic paper published by the same journal in March titled The Puzzle of Biologics Manufacturing Platform Patents. Drawing on its real-world experience with the portfolios of patents identified by the academic authors, Amgen argues that policymakers deserve the facts, not speculation, writing:

“Contrary to their hypothetical, academic positions, Amgen’s real-world experience with the patent portfolios reviewed by the authors shows there is no puzzle to be solved and no reason to promulgate legislation to address non-existent problems. The authors’ repeated false propositions badly misinform policymakers.”

As a manufacturer of both biologics and biosimilars, Amgen is uniquely positioned to respond to the contrived grievances and false claims made by academics who are known to dislike patents generally, and who have a longstanding grudge against the biopharma industry. And bringing facts to the argument, Amgen counters the academics’ claims that biosimilars have been slow to emerge in the United States. In fact, Amgen cites the growing numbers of biosimilars with FDA approval—now more than 70—and how multiple biosimilars on several products have just recently been launched. Development timelines and significant capital requirements—not manufacturing patents—largely explain launch timing for biosimilars. But when you are a hammer, the world looks like a nail! So, rather than consider the real-world business realities of actually running a biopharma company, these one-trick academics who don’t like patents and blame them for everything not surprisingly conclude that patents are the root cause of the ills they invent. Simply stated, patents are not the problem.

Amgen also takes aim at the supposed lack of notice to biosimilars of the relevant innovator patents, explaining that existing tools mitigate any claimed lack of notice. For example, the Biologics Price Competition and Innovation Act’s (BPCIA’s) information?exchange mechanism (the so?called “patent dance”) identifies relevant patents and the FDA’s Purple Book publishes certain patent lists identified during those exchanges, including manufacturing patents. Moreover, as Amgen explains:

“[B]iosimilar manufacturers are sophisticated companies (as it can cost over $100 million to develop a biosimilar) who know how to conduct patent searches…. With the biosimilar’s manufacturing process in mind, a skilled patent searcher could easily sift through the innovator’s patents and find relevant manufacturing patents within a matter of days.”

Amgen also emphasizes that manufacturing-related patents protect valuable process technology. Unlike small?molecule synthesis, biologics are produced by living cells engineered to express the desired protein.  The process is complex and requires introducing DNA into host cells adapted for growth in culture, proceeds through host cell expansion and production phases, and ends with multi?step purification tailored to the biologic’s characteristics and requirements. Each step can require inventive effort to achieve reliable quality and yield and can be the subject of patent filings, including filings on cell lines, cell culture media, processing techniques, and purification steps.  While many steps are similar for producing any protein, each protein has different characteristics and may require customized processes.

In addition, innovators may develop next?generation products. For example, changes can be made to the structure of the product to improve the effectiveness of the treatment and patient experience. These types of structural changes to the molecule result in a new molecular entity, that typically require a new set of clinical trials, a new Biologics License Application filing, and new patent filings. Such patents are new composition of matter patents, not technically follow-on patents, that generate a new patent term of protection for the improved product.

Amgen’s own research exemplifies this development. Amgen developed new molecules for each of its first two products, Epogen® and Neupogen®, to provide better dosing options for patients. Epogen® (erythropoietin) was a breakthrough therapy developed to treat anemia in kidney patients undergoing dialysis, but it had to be administered three times a week, coincident with the patients’ dialysis treatments. Amgen’s scientists made changes to the amino acid sequence of erythropoietin to significantly increase the molecule’s half-life (how long the drug lasts in the body). Amgen launched this new molecule as Aranesp® 12 years after launching Epogen®, which now allows patients to receive dosing either once a week, or once every three weeks.

Similarly, Amgen worked to improve its Neupogen® (filgrastim) product, which is given to cancer patients undergoing chemotherapy to reduce the risk of infection caused by neutropenia (a low white blood cell count). Neupogen®was a lifesaver for chemotherapy patients, but its dosing schedule presented some challenges for patients because it had to be administered daily at the clinic, including an injection 24 hours after chemotherapy. Feeling sick from the chemotherapy, many patients did not feel up to returning to the clinic the next day. To provide a better patient experience, Amgen scientists invented a pegylated version of filgrastim to extend its half-life. That molecule is now sold as Neulasta®and allows patients to receive treatment once every 2-3 weeks to align with chemotherapy cycles.

Can anyone without a predetermined agenda look at the invention of Aranesp®and Neulasta®and see them as anything other than extraordinarily significant advances that deserve protection? In fact, Aranesp®and Neulasta® are precisely the type of innovations that the patent system is supposed to encourage and reward. Certainly, those patients who need these drugs understand the extraordinary value in being able to receive them once every 2-3 weeks rather than 3-7 times each week. Only those who really don’t care about patients and outcomes could look at Aranesp®and Neulasta®and conclude they are not worthy. And, of course, it shouldn’t need to be said, but given how patent haters engage in deception, the fact that Aranesp®and Neulasta®are patented does not mean that the patents for Epogen® and Neupogen®are being extended. That isn’t how it works. Epogen® and Neupogen®fall into the public domain for generics to make and sell once those patents expire.

And there are other important follow-on innovations, including those that involve drug delivery devices.  For example, Amgen helped to invent the OnPro® on-body injector, a wearable device allowing patients to receive Neulasta®at home 24 hours after chemotherapy, eliminating extra doctor visits. While an on-body injector may seem like a simple innovation on its face, many scientists questioned whether it was even possible to have patients wear a device containing unrefrigerated Neulasta®for 24 hours on their bodies, raising the temperature of the medicine and causing extra agitation to the molecule. But thanks to the hard work and innovative thinking of the inventors, the device is highly effective and has led to improved patient compliance and fewer hospitalizations—up from 58% compliance to an eyepopping 94% compliance, fewer hospitalizations (down 50%), and higher patient satisfaction.

The System is Working

Finally, Amgen confronts the academic authors’ position that biologic manufacturing patents filed after the initial FDA approval for the product are likely invalid due to prior commercial use of the claimed process and that legislation is needed to provide patent examiners with access to innovators’ FDA filings to prevent abuse of the system. While it is true that biologics are the product of the process used to make them and manufacturing process choices can affect product attributes (such as isoforms or glycosylation), it is the product specification that is “locked” by FDA approval. Manufacturing process improvements, however, commonly continue after the product has been approved by the FDA and launched commercially. Technology advances and new techniques and production methods are constantly being developed. Patent filings disclosing these new techniques and methods are not invalid because a different process was used to secure FDA approval. The academic authors wrongly believe that manufacturers cannot use these later developments because of the difficulty in changing the process originally approved by the FDA. But the FDA imposes no such barrier and, in fact, has a specific process for submission and approval of post-approval manufacturing changes. Biologic manufacturing patents protecting these innovations are not invalid for prior use, nor is there a sea of FDA submissions containing evidence of prior use. As Amgen explains:

“[The academics] present no evidence of any such patent being held invalid for prior commercial use. Amgen has litigated nearly all the patent portfolios identified by the authors, both on our own products (as the innovator) and against our competitors (as a biosimilar), and we did not find any manufacturing patents invalid owing to prior commercial use of the process. If the problems postulated by the authors existed, Amgen would have seen them, and we have not.”

On this basis, Amgen rightly cautions against proposals like the Interagency Patent Coordination and Improvement Act of 2023 (IPCIA), which would compel unnecessary disclosure of confidential manufacturing information from the FDA to the U.S. Patent and Trademark Office (USPTO). This would weaken innovation incentives, and it would to nothing to enhance patent quality. Amgen explains why no changes are needed:

“In our industry, patent applicants understand the need to be consistent in positions before the FDA and USPTO because competitors will later scrutinize filings to identify inconsistencies that could render a patent invalid or unenforceable. The potential for such scrutiny in future litigation and the threat of inequitable conduct provides sufficient incentive for patent applicants to be forthcoming with both the FDA and USPTO. This explains why Amgen’s real-world experience confirms that existing rules are sufficient and no changes are needed.”

With all of this in mind, Amgen’s takeaway is simple yet profound: The current system is working, and innovation is benefiting actual patients. While the patent system could always be improved, policy decisions based on myths and deception cannot be tolerated. Important issues require serious people having informed conversations, which is something that must be driven by real-world experience and without any predetermined bias.

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