News that a federal judged had ordered French pharmaceutical giant Sanofi and partner Regeneron (REGN) to stop selling their latest cholesterol treatment Praluent because of patent infringement rocked the drug world this week. The companies plan to immediately appeal that decision.
But this is just one of at least three intense patent scuffles involving pharmaceuticals that could rock biotech and pharma bottom lines in the coming years, including massive firms like Merck (MRK), Gilead (GILD), and Novartis (NVS).
Here’s the trifecta of cases to keep a close eye on in 2017.
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Amgen vs Sanofi/Regeneron
Judge Sue Robinson ruled in Delaware district court on Thursday that Sanofi and Regeneron had infringed on biotech giant Amgen’s (AMGN) patents for a rival cholesterol-busting drug called Repatha. Praluent and Repatha, which are the only approved “PCSK9 inhibiting” therapies on the market, have been shown to dramatically slash “bad” cholesterol levels in patients during clinical trials (to the tune of more than 60%). Both won FDA approval on each other’s heels in 2015.
But at about $14,000-per-year per treatment course, they’re a whole lot more expensive than conventional, generic cholesterol treatments like statins. That’s led to ‘slow initial uptake by doctors, patients, and insurers who want definitive proof that the higher price is justified by improved health outcomes. Still, some analysts have projected that PCSK9 drugs could achieve more than $2 billion in annual sales by 2020.
Amgen and Sanofi/Regeneron have been in a legal dance over these drugs’ patents for years. Amgen notched an important victory in March when a jury ruled that two of its patents for compounds used in the products were valid. The new injunction on Praluent sales raises the stakes considerably, since the judge ordered Sanofi/Regeneron to halt sales for 12 years.
The companies have a month to appeal the decision, and plan to do so.
Merck vs Gilead
Gilead ended an already rough 2016 on a particularly sour note after a federal jury ordered the hepatitis C and HIV drug specialist to pay a stunning $2.5 billion in royalties to Merck.
The dispute centers on Gilead’s flagship hepatitis C cures Sovaldi and Harvoni, which gained notoriety for their stratospheric prices but also dominated the hep C drug market (before running afoul of aggressive insurers and benefits managers demanding better deals). In March, a jury concluded that two of Merck’s own hepatitis C drug patents were valid—a significant development since Gilead used similar molecules in its treatment and could then be on the hook to pay massive royalties.
The jury based their award on a 10% royalty on both of the drugs’ sales since August. (Merck also won a separate $200 million award over Gilead hepatitis C meds in March, but that was actually overturned and under appeal by Merck.)
Gilead is appealing the royalty award and stresses that it can still keep selling Sovaldi and Harvoni in the meantime—a luxury that Sanofi and Regeneron may not have in a month.
CRISPR gene-editing pioneers vs each other
From a pure “potential stakes” standpoint, the epic patent spat between the University of California and the University of Vienna on one side and the Broad Institute of MIT and Harvard University on the other may be the most significant patent battle in experimental biopharma technology.
If you’re a regular reader of our health innovations newsletter Brainstorm Health Daily (and, really, you should be, so sign up here), you know the footprint CRISPR-Cas9 has already left in the life sciences. The (super) early-stage gene-editing platform significantly simplifies the process of slicing and dicing problematic genetic material and is being tested as a treatment option for cancer, sickle cell, and a host of other diseases.
But there’s a big dispute over who technically owns CRISPR patent rights because, while University of California at Berkeley professor Jennifer Doudna and the University of Vienna’s Emannuelle Charpentier were first to announce their discoveries and file patents on them, MIT’s Feng Zhang actually won the patent after going through an expedited process. (For more on the bad legal blood, read my colleague Clifton Leaf.)
Billions of dollars in potential sales are at stake in the fight. The respective academic organization and scientists have struck licensing arrangements with biopharma companies to create CRISPR treatments and haul them across the regulatory finish line. And, unsurprisingly, these firms have huddled into silos with their respective research institutes. Novartis, CRISPR Therapeutics, Intellia Therapeutics, and Caribou Biosciences are all allied with Berkeley/Doudna/Charpentier, while Editas is linked with MIT/Zhang.