Two years ago, Federal Circuit Judge Kimberly Moore found it relatively easy to side with Apple Inc. when it sought to enjoin Samsung from marketing a few smartphone features. After all, she wrote at the time, “Apple does not seek to enjoin the sale of lifesaving drugs.”
Next week, that much thornier issue arrives at the U.S. Court of Appeals for the Federal Circuit. Sanofi, Regeneron Pharmaceuticals Inc. and Kirkland & Ellis partner Paul Clement will warn the D.C.-based appellate court that it’s putting patient lives at risk if it upholds a ban on its cholesterol-fighting biologic drug Praluent.
U.S. District Judge Sue Robinson of Delaware ordered Praluent off the market in January after a jury upheld the validity of Amgen Inc.’s patents on a competing biologic, Repatha. While describing it as a close call, Robinson found that the injunction wasn’t in the public interest. She nevertheless ruled that consideration was outweighed by the damage Sanofi and its development partner Regeneron were doing to Amgen’s $2 billion investment in Repatha.
Clement argues in his brief to the Federal Circuit that the public interest “overwhelmingly” militates against an injunction and that Robinson’s finding should have ended the matter under Supreme Court case law. “An injunction that the issuing court itself views as contrary to the public interest should be the null set,” he writes.
But Moore also made clear in another decision last year that there’s no hard-and-fast rule against enjoining the sale of lifesaving products. “Congress has expressly indicated that injunctions may be granted in cases involving lifesaving goods, such as pharmaceutical drugs,” she wrote.
It’s not yet known whether Moore will sit on the panel when the Federal Circuit convenes for Amgen v. Sanofi the morning of June 6. But the three judges assigned to the case will face a host of knotty issues pitched by two premier advocates of the Federal Circuit bar.
Amgen’s attorney, King & Spalding partner Daryl Joseffer, will argue the case is hardly a matter of life and death. The U.S. Food and Drug Administration has approved Repatha as a substitute for Praluent, he says in Amgen’s brief. The only public health issues in the case are being manufactured outside the trial record by Sanofi’s amici curiae, he argues.
Sanofi and Regeneron went to market on full notice of Amgen’s patent claims—even spending $67 million to expedite FDA review after Amgen filed its lawsuit, Joseffer writes. They are “admitted infringers who placed a bet that Amgen’s patents would be found invalid and lost.”
Amgen is the latest Federal Circuit case to test the contours of the U.S. Supreme Court’s 2006 decision on patent injunctions, eBay v. MercExchange. Joseffer is joining a trial team from McDermott Will & Emery and Young Conaway Stargatt & Taylor that obtained the injunction, which the Federal Circuit has stayed pending appeal. Clement is accompanied by a team from Steptoe & Johnson.
Beyond the injunction, the Federal Circuit will have to decide whether Amgen’s two patents are too broad to meet the Patent Act’s written description requirement. Instead of claiming the specific Repatha amino acid sequence, Amgen is claiming a group of antibodies that are capable of binding to a precise location on a protein called PCSK9. That prevents PCSK9 from elevating a person’s LDL cholesterol level.
Echoing a debate in the software field, Sanofi complains that Amgen is claiming a result rather than describing the process of achieving it. “The crux of Amgen’s case is that disclosing binding sites on an antigen necessarily describes all antibodies that bind there,” Clement writes. That’s “no more defensible than the proposition that describing the location of a parking spot describes all vehicles that fit into it.”
Amgen responds that the true innovation was developing the protocols and screening methods that identified the “sweet spot” on PCSK9 and the antibodies that will bind to it. That includes Repatha and 23 other amino acid sequences Amgen identified. At that point, it became “a matter of routine” for others to develop additional antibodies trained on the same target, Amgen says.
The case has split the pharmaceutical industry. Eli Lilly and Co. and Pfizer Inc. argue as amici curiae that Amgen’s patents are invalid, while AbbVie Inc. is urging the court to affirm the injunction. “A rule that precludes district courts from enjoining the sale of pharmaceutical products (other than generics and biosimilars, presumably) cannot be squared with eBay,” Latham & Watkins partner Melissa Sherry writes for AbbVie Inc.
The Supreme Court issued eBay amid complaints that injunctions were becoming too automatic following judgments of patent infringement. Justice Clarence Thomas’ opinion stressed that patent injunctions should be based on traditional equitable principles, not on categorical rules.
Specifically, a patent owner must meet the traditional test of showing irreparable injury, the inadequacy of monetary damages, that the balance of hardships tips in its favor, and “that the public interest would not be disserved by a permanent injunction.”
Robinson found that Amgen satisfied the first two factors and that the balance of hardships was neutral. On public interest, she said she found herself “between a rock and a hard place” between enforcing Amgen’s patent rights and taking “an independently developed, helpful drug off the market.” She concluded that “the public interest of having a choice of drugs should prevail.”
Amgen said Robinson properly “balanced the four injunction factors” and found on the whole that they pointed to an injunction. But Clement points out for Sanofi that eBay doesn’t say anything about balancing the four factors against each other. Rather, the case says the patent owner must demonstrate that each of the four factors is met, he argues.
“The most basic principles of equity (in addition to eBay) underscore that an equitable remedy that disserves the public interest may not be granted,” Clement writes. That’s why branded pharmaceutical companies don’t typically seek injunctions against each other, he asserts, pointing to Merck & Co.’s royalties-only case against Gilead Sciences over hepatitis medications as an example.
Sanofi also is getting amicus support from six physicians and two patients, including an 84-year-old grandmother with hypercholesteremia. Their attorneys at Boies Schiller Flexner call Praluent a “lifesaving therapy” and caution about potential side effects from switching to Repatha.
Amgen has vigorously contested their submission, saying it flies in the face of FDA findings and is a transparent attempt to admit fact testimony after the trial record has closed, without cross-examination. Amgen contends that one of the amici physicians has accepted $35,000 in funding from Sanofi and another has been found by a federal jury to have defamed Amgen’s medical expert in the patent case.
Judge Jimmie Reyna, serving on the Federal Circuit’s motions panel, accepted the brief in March but said it will be up to the merits panel to decide whether to consider it.
On validity, Amgen’s Joseffer argues that the company’s patents provide a “comprehensive road map” that teaches persons skilled in the art how to produce the full scope of the claimed antibodies. He maintains that Robinson properly instructed the jury that Amgen could claim the antibodies by fully disclosing “a newly characterized antigen.” The Patent Trial and Appeal Board has applied the same test to antibody claims, Joseffer argues.
Eli Lilly and Pfizer are “partisans, not true amici,” Joseffer adds. Eli Lilly fails to disclose that it has a PCSK9 antibody therapy in clinical trials, he says, and Pfizer acknowledges that its working on a potentially competing product.
The idea that pharmaceutical companies don’t often seek injunctions is “wishful thinking,” Joseffer writes. He points to two suits brought by Sanofi divisions, though both appear to be aimed at generics.
In any event, Joseffer and Amgen argue it would be unprecedented to compel a pharmaceutical innovator to license a patented drug. “Injunctions have been routinely granted in pharmaceutical cases,” he writes, “in order to protect the investment needed to research new lifesaving treatments.”