Generic Drugmakers Win Several Rounds of Patent Fights

(CN) – Sandoz Inc., manufacturers of a generic medication, won yet another legal victory this week over pharmaceutical giant Amgen in their ongoing, multipronged patent dispute.

U.S. District Judge Richard Seeborg agreed with Sandoz that its manufacturing process to create a drug instrumental in helping patients fight cancer is distinct enough from Amgen’s to avoid patent infringement.

Amgen sued Sandoz in 2014, citing infringement on a host of its patents. Some of the cases went all the way to the U.S. Supreme Court.

The case before Seeborg in the Northern District of California centered on a three-step process whereby Amgen builds proteins that are meant to simulate white blood cells vital to the human immune system’s ability to ward off disease.

Amgen created a drug called Neupogen, which is a filgrastim – a drug that simulates a protein that occurs naturally in the human body and which is critical in the production of white blood cells. Amgen also created another, longer-lasting version of the drug called a pegfilgrastim, marketing and selling it under the name Neulasta.

During the drug manufacturing process, researchers sometimes encounter proteins that don’t take the three-dimensional shape necessary for effectiveness. In these instances, Amgen scientists undertake a three-step process, using chemical solutions and other methods to give the proteins the necessary dimensions to work well.

Amgen says Sandoz ripped off this process when it brought its biosimilar version of filgrastim, Zarxio, to market in 2015.

Biosimilars refer to an emerging area of patent law that covers biomedical products like the one generated by Amgen. Federal law allows biosimilars once the original patent for the “innovator product” expires.

The entire patent fight can be boiled down to competing interests between research pharmaceutical companies like Amgen, which seek to enforce intellectual property protection for their products and generic pharmaceutical manufacturers like Sandoz, which typically attempt to curtail regulatory protections.

In this particular case, as well as in the overall patent fight, Sandoz has emerged the victor, winning the right to bring a biosimilar version of filgrastim to market. Consumer advocates hail the victory as an important one for cancer patients who rely on low-cost medications in their battle against the disease.

But industry advocates note that companies will be less likely to invest in research and development if the market undercuts their products.

In the case dismissed by Seeborg, the judge found that despite Amgen’s claims that Sandoz mimicked its manufacturing process, the generic drug manufacturer instead developed its own process.

Seeborg said the Sandoz process lacks specific sub-steps that Amgen uses and the generic company uses different chemical solutions along the way.

“Either one of these grounds independently supports a finding that Sandoz’s process does not literally infringe,” Seeborg wrote in his 11-page opinion issued Tuesday.

Seeborg’s ruling comes on the heels of another significant victory for Sandoz at the Federal Circuit Court of Appeals, the appellate court that handles many of the country’s significant patent disputes.

On Monday, the court ruled companies could not use state law to force generic drugmakers to disclose patent information under the federal patent law that guides biomedical manufacture — the Biologics Price Competition and Innovation Act.

This decision came after the U.S. Supreme Court remanded the Amgen v. Sandoz case back to the court, having decided that drug developers could not use federal injunctions to force disclosure. The Supreme Court also said generic drug manufacturers did not have to provide notice to research companies prior to getting FDA approval.

 

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