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Supreme Court hears arguments in drug patent cases

Rulings could impact how physicians are able to provide certain lab tests and prescribe certain drug uses.

By — Posted Dec. 19, 2011

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U.S. Supreme Court justices in December heard oral arguments in two high-profile patent cases that could have widespread effects on patients who need certain drugs.

In Mayo Collaborative Services v. Prometheus Laboratories Inc., the high court is weighing whether a test that measures patients' metabolite levels to determine drug dosages should be patentable. Prometheus sued Mayo in 2004, claiming that Mayo infringed on its test patents after Mayo developed a similar metabolite test. Mayo says Prometheus' patents are invalid because the correlations between metabolite levels and drug efficacy are derived from a natural body process, which cannot be patented. Lower courts have issued conflicting rulings in the case.

In Caraco Pharmaceutical Laboratories Ltd. v. Novo Nordisk A/S, justices are examining whether a generic drug manufacturer may sue a brand-name drug company over the scope of its patent. Novo Nordisk has a patent on the diabetes drug repaglinide, which is approved by the Food and Drug Administration for three separate uses related to the disease. Novo Nordisk's patent covers only one of the three uses, but the summary of the "patent scope" that the company submitted to the FDA covers all three uses.

A federal court ruled that the generic drug company would be violating the scope of Novo's patent by selling the drug for the other two uses. Caraco wants Novo to correct its patent description. The Supreme Court is examining whether a generic drug manufacturer has standing to sue a brand-name firm over drug patent information filed with the FDA.

Decisions in both cases are expected in 2012.

Are tests of body processes patentable?

During Dec. 7 arguments in the Prometheus case, Stephen Shapiro, Mayo's attorney, argued that preventing Mayo and others from using tests similar to Prometheus' is detrimental to patients and threatens doctors.

"The problem with the Prometheus patent is its broad preemption of a physical phenomenon, which prevents others like Mayo Clinic from offering a better metabolite test with more accurate numbers. This is a huge practical problem for patients," he said. "If you are aware of [a patient's] range when you're drawing blood, that's an infringement right then and there, if you're aware or warned by their number. So any doctor in the United States that draws blood and is aware of this range of theirs is preempting, and the practical result is we haven't been able to offer this competing test now for seven years."

But while Prometheus' patents build on a known process, they describe a specific method for improving the treatment of diseases through a series of concrete and transformative steps, said Richard P. Bress, attorney for Prometheus.

"In our case, what existed before in the prior art, so to speak, was people knew that you could administer thiopurines for these particular diseases. ... They were used together before we did them, but why were they used? They were used by people who were trying to come up with what we came up with ... in order to try to find a new treatment method, a new way of calibrating the right dose for each individual patient based on their metabolism, and help seriously ill patients," he said during the arguments. "The idea that we are not novel because people took some of the same steps along the way to invention that we actually succeeded in is wrong."

Justice Sonia Sotomayor questioned whether Prometheus' patents were as broad as Mayo was making them out to be. Other companies "can offer the test. It just can't recommend the dosage to the doctor," she noted. "The tests can happen. The doctor gets a number. What the doctor does with that number is a different issue."

The Litigation Center of the American Medical Association and the State Medical Societies, the Assn. for Molecular Pathology and others have raised concerns that the Prometheus patents harm the practice of medicine. Any physician measuring metabolite levels who finds an adjusted drug dosage necessary based on body correlations becomes a patent infringer, said a joint court brief filed by the AMA Litigation Center and other medical associations in support of Mayo.

Can patents preclude all generic uses?

During Dec. 5 oral arguments in the Novo Nordisk case, James Hurst, attorney for Caraco, said preventing his firm from suing over Novo's patents harms generic drug manufacturers' freedom and goes against federal law allowing generics to enter the drug market legitimately.

"Since 1984, whenever a drug has multiple FDA-approved uses, there has been a statutory path for generic drugs to reach the market if there are specific uses not covered by a patent. Here, there is no dispute that Novo's patent does not claim the use of repaglinide when used alone, and that is 'an approved method' of using the drug," he said. "My client, Caraco, is attempting to get on the market for admittedly noninfringing uses, which occupy about 70% of the marketplace out there."

But Mark Perry, attorney for Novo, argued that the case's focus should be on the FDA's administrative process to approve patents and their scopes. "What really is at issue here" is a challenge to the FDA's administration of patents, he said. The FDA has said it does not have the authority to correct summaries of patient scopes. It should be Congress' responsibility, and not the courts', to change the current administrative process on patents, he said.

"Our position is we have complied in every respect at every moment with every bit of FDA's regulations. And again, that's what the evidence in this record shows," he said.

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ADDITIONAL INFORMATION

Cases at a glance

Should a diagnostic test that measures patients' metabolite levels to determine drug dosages be patentable?

Mayo Collaborative Services says the patents held by Prometheus Laboratories Inc. are invalid because the correlations between metabolite levels and drug efficacy are derived from a natural body process, which cannot be patented. Prometheus says the patents describe a specific method for improving the treatment of certain diseases through a series of concrete and transformative steps, and should be allowed. The U.S. Supreme Court heard arguments Dec. 7.

Impact: Doctors say that if the patents are upheld, more companies will obtain exclusive rights over the use of scientific data critical to providing sound medical care. Physicians also are concerned that if they measure metabolite levels and find an adjusted drug dosage necessary based on a patient's body correlations, they will become patent infringers.

Mayo Collaborative Services v. Prometheus Laboratories Inc., U.S. Supreme Court

Can a generic drug manufacturer sue a brand-name drug company over the company's patent?

Caraco Pharmaceutical Laboratories says the scope of Novo Nordisk's patent on a diabetes drug is overly broad. Novo's patent covers only one of the three uses for the drug approved by the Food and Drug Administration. A federal court ruled that the generic drug company would be violating the scope of Novo's patent in trying to sell the drug, despite Novo not marketing the drug for the purposes for which the generic seeks its use. Novo says the issue should be resolved administratively and not by the courts. The U.S. Supreme Court heard arguments Dec. 5.

Impact: A ruling for the brand-name firm could affect the freedom of generic companies to join the drug market sooner and sell drugs for uses not covered by brand-name manufacturers' patents. Observers also say such a ruling could impact nationwide drug shortages as more generic drug companies are delayed from selling versions of brand-name drugs.

Caraco Pharmaceutical Laboratories Ltd. v. Novo Nordisk A/S, U.S. Supreme Court

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External links

Mayo Collaborative Services v. Prometheus Laboratories Inc., U.S. Supreme Court (link)

Caraco Pharmaceutical Laboratories Ltd. v. Novo Nordisk A/S, U.S. Supreme Court (link)

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