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Biotech outfit with eye on cholesterol drug patents grilled at Supreme Court

Amgen is fighting to enforce patents deemed overbroad for a drug designed to lower the risk of heart attack and stroke.

WASHINGTON (CN) — Working to aid the high court's digestion of a patent case behind the drugs that purport to lower "bad" LDL cholesterol, a lawyer for Amgen asked the justices Monday if they could think about the technology in the same way they see other history-making enterprises.

“When you say an invention like the James Watt steam engine, you don't say, ‘which variant which embodiment of the steam engine have you claimed?’ It's the steam engine — that principle, the invention,” attorney Jeffrey Lamken said. “As this court's cases describe it, there can be lots and lots of different variations on an invention.”

Amgen initiated the litigation at hand in 2014, claiming that Sanofi, a rival French drugmaker, and its partner Regeneron were marketing drug called Praluent whose makeup infringed its patents for monoclonal antibodies that are key to the Amgen drug Repatha.

Amgen identified 26 antibodies that bind to the protein PCSK9 — which inhibits the extraction of cholesterol from the bloodstream — in its patent by amino-acid sequence, but Lamken noted that thousands if not up to millions of other sequences would produce the same result when binding to the gene and could be produced by following the patent’s “step-by-step roadmap” through a process of trial and error. 

“There may be millions of ways to make the James Watt steam engine, but you're not invalidated simply because it would take a long time to make all of those different variants of the steam engine,” Lamken continued, claiming Amgen’s patent is for all antibodies that would bind to PCSK9, including those used in Repatha.

If Lamken was trying to simplify the issues, Justice Clarence Thomas nevertheless voiced confusion at the lawyer's explanation.

“It seems as though you’re actually trying to patent the use of steam pressure, which you could use for almost anything. And that makes it very difficult because then you're looking at: what can it be used for?” Thomas noted, drawing out the analogy.

Although a federal jury in Delaware sided with Amgen, agreeing that its patent would apply to the competitor’s drug, the presiding judge overturned their verdict, ruling in favor of Sanofi — a decision that the Federal Circuit later upheld. 

Earlier this year, Amgen appealed to the high court for reconsideration of whether its two Repatha patents are valid based on a section of the Patent Act relating to the written description of the patent. Sanofi argued that the patent misses the law’s enablement requirement if the public “cannot predictably produce specific undisclosed embodiments of the claimed invention” without significant trial and error.

Sanofi referred to the suit in its high court response brief as a "blatant attempt" to rid the market for the anti-cholesterol drug of competitors. The company's lawyer, Paul Clement, hammered that point home for the company Monday.

A former U.S. solicitor general, Clement told the justices that Amgen is at odds with its own expert testimony by asserting that “millions and millions of antibodies” claimed under the patents will all serve the same purpose.

“If you change one thing in the antibody sequence, you have to retest it. You have to go through that whole experimental process again to confirm that it binds in the right place,” Clement said of the drug.

He noted that while Samuel Morse invented the telegraph, this didn’t also make him the inventor of the fax machine, even though both inventions could be perceived to be on the same evolutionary tree.

Lamken made the case that a ruling in Amgen’s favor would “enhance innovation.”

“Look, the patent means that others aren't going to go in to look for things that are separately patentable. It pushes them away from sort of copycat antibodies that operate on identical principles in identical ways with identical results,” Lamken said. “If you truly want different therapies, you protect this sort of patent. And this tells people, ‘well, if you're going to do this sort of thing, it has to be better and separately patentable as a result.’ Or it pushes them to completely different non-antibody procedure treatments,” Lamken said.


The Sanofi lawyer continued on Monday, noting Nobel Prize winner Gregory Winter, who received the accolade for his contributions in this field, maintained in a friend-of-the-court brief that you can’t look at the function of an antibody and rely on that to tell you about its structure.

“They're pointing to something that exists in nature, and they're saying, ‘we claim everything that works to bind there and block,” Clement said of the Thousand Oaks, California-based company.

Justice Ketanji Brown Jackson also seemed to wonder about the breadth of the patent Amgen was asking for Monday, questioning the company’s attorney as to why Amgen didn’t find and patent all of the amino acid sequences.

“The patent law has never required you to list all of your embodiments in there,” Lamken replied.

Justice Neil Gorsuch meanwhile asked Lamken about how much work another company would have to do to find a similar antibody, using Amgen’s patent.

“Would you agree that the broader the patent, the more you have to do to show what a skilled artisan will have to undertake to accomplish?” Gorsuch asked.

Lamken said no. 

“But if you're judging reasonableness, how much experimentation do you have to put into it? And part of the allegation in your case is that this is simply trial and error. And so how long does it take?” Chief Justice John Roberts also pressed the attorney.

Lamken explained that the process was simple, involving taking some 3,000 antibodies that “humanized” lab mice produce, “put it in a machine and wait for it, to the cost of $30.” 

“This is just what antibody scientists do. It's not undue experimentation,” Lamken said.

Justice Sonia Sotomayor asked Clement about this process.

“It sounded to me that your adversary was saying that most of this work is done by computers — that you inject the mice, that the antigens appear, and the computer then sorts them out to see which have the sweet spot or not. That's what I understood him to say. And if that's true, I don't know why that's undue experimentation, or why it's costly or why it's time consuming,” Sotomayor said.

She asked if there was anything the Sanofi attorney wanted to clarify that he and Amgen disagreed about.

“Mr. Lamken thinks it's very helpful to his case that somebody who runs the experiments necessary in the roadmap is going to produce an antibody within the range every time. And I think that can't be right. It can't be particularly interesting because that rewards breadth. And what skilled artisans want is not to randomly generate something within the broad range that's claimed, but they want to be able to pick a specific embodiment, not a hypothetical one, but a specific one,” Clement said.

Justice Jackson also pushed back on Clement .

“There are some fields where there is a degree of unpredictability or randomness. And I guess I'm just a little worried that your view on this would mean that we would not be able to have patterns where some experimentation was required,” Jackson said.

Colleen Sindak, assistant to the solicitor general, also spoke before the court Monday on behalf of the Department of Justice Monday, siding with Sanofi.

The Supreme Court added the case to its docket in November.

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