Lilly, Pfizer, et al. back Sanofi and Regeneron in PCSK9 patent appeal. AbbVie doesn't

Big Pharma is enthralled with the Amgen vs. Sanofi patent fight, and for good reason: Its outcome could affect their in-development meds—and farther up the pipeline, their decisions to advance candidates at all.

The reason: Amgen, which makes the cholesterol-fighting Repatha, is asserting an antibody patent that, if upheld, could give the California biotech the power to push Sanofi and Regeneron’s rival PCSK9 drug off the market. And it’s a type of patent that has the potential to allow Amgen—and other drugmakers in other fields—to stake out a claim to an entire class of therapies, or so Sanofi’s legal team said in a recent phone conference with reporters.

And that’s why drugmakers have been weighing in with amicus curiae briefs at the U.S. Appeals Court for the Federal Circuit, which hears all patent appeals—Pfizer, Eli Lilly and Ipsen among them. Those three urge the appeals panel to rule in Sanofi and Regeneron’s favor; they don’t like the idea of antibody patents that cover the way antibodies work, rather than the specific structure of specific antibodies.

The lone outlier, at least so far? AbbVie.

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AbbVie’s brief contends that antibodies are expensive to develop, and without strong patent protections that limit competition, wouldn’t be worth the expense. Patent protection may mean drugs cost more in the short run, but that’s the price of developing new and complex biologic treatments, the brief states.

“Because weak patent protection will have a severe impact on the availability of new biologics like Repatha and Praluent, the public’s interest in vigorous enforcement of the patent laws is especially strong here,” AbbVie’s lawyers wrote in the brief.

AbbVie also supports the lower court’s decision to grant Amgen’s injunction against Praluent’s presence on the market. If that injunction stands, then Sanofi and Regeneron will have to pull the drug—or, if Amgen’s amenable, strike a royalty deal.

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If a royalty deal was what Amgen wanted, however, then it might not have sought an injunction in the first place, and in a previous patent fight, over a Roche rival to its blockbuster anemia drugs, Amgen held firm, only agreeing to a future launch date that came before its patent expired.

And that’s the sort of outcome Lilly, Pfizer and Ipsen object to, according to their amicus briefs. Upholding Amgen’s patent as the lower court did, they say, will upturn drug pipelines across the industry.

“Such patents, to the detriment of patients and payers, chill and tax development of unique antibody drug products that act on the same antigen,” Lilly’s brief states, in a sentence that echoes the other drugmakers’ friend-of-the-court statements.

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Examples of “overbroad patents” that could have nixed competition in previous drug classes, Lilly says: Cholesterol-fighting statins (which happens to be one cited by Sanofi in its press call). If some drugmaker, perhaps Merck with its first-to-market Mevacor, had successfully quashed rivals in that class, there would likely be no Crestor, the AstraZeneca drug that came to be known as the most powerful in that field, recommended for use if others didn’t work.

Selective serotonin uptake inhibitors for depression, like first-to-market Prozac or its follow-ups Zoloft, Paxil, Lexapro and now Viibryd. SGLT2-inhibiting diabetes drugs, like Lilly’s own Jardiance, second-to-market and the first diabetes drug ever to show it could cut heart risks in a cardiovascular outcomes trial.

Pfizer and Ipsen, which filed a joint brief, noted that legal commentators were already theorizing how drugmakers might take advantage of the ruling if Amgen were to prevail. Carefully crafting a patent application could allow for broader coverage and “sizably expand the scope of protection around important commercial products,” one commentator write, as quoted by the brief.

Conclusion: The appeals court shouldn’t uphold “the validity of overly broad, functional antibody claims,” Pfizer and Ipsen assert. “The district court’s judgment should be reversed.”

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Sanofi and Regeneron just filed their latest response in the case. It’s on an expedited schedule for hearing this year, probably in the fall. Praluent can stay on the market till the appeal is decided, under a ruling by the Circuit Court.

Meanwhile, the two sides will be fighting over another antibody patent: One of Amgen’s that covers an immune system pathway used by Sanofi and Regeneron’s brand-new atopic dermatitis drug Dupixent. The partners filed first, seeking a ruling that their drug doesn’t infringe on Amgen’s patent. Amgen says it’s prepared to defend its patent in court.

“[T]here is plausible argument that Dupixent ... infringes Amgen's patent,” Bernstein analyst Ronny Gal said in a note after that lawsuit was filed. Should the district court go Amgen’s way again, the company “may be in a position to delay the Dupixent launch or claim royalties off the product.”

And there could be an overarching strategy here, given the same parties on either side of similar lawsuits, Gal suggested: Amgen “may also look to trade this patent against the Praluent litigation.” 

Editor's note: This story was corrected to show that the correct brand name for the first statin drug was Mevacor, not Zocor as previously stated.