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29 March 2019Americas

Fed Circuit backs Endo in Alice suit over oxymorphone patent

The US Court of Appeals for the Federal Circuit yesterday, March 28, overturned a district court decision and handed a victory to pharmaceutical companies Endo and Mallinckrodt.

In a precedential decision, the Federal Circuit concluded that the US District Court for the District of Delaware had incorrectly found that the claims at issue in US patent number 8,808,737 were directed to a natural law.

The Endo-owned ‘737 patent covers a method of using oxymorphone to treat pain in patients with impaired kidney function.

Endo and Mallinckrodt had previously accused generic maker Teva and its subsidiaries Actavis and Barr Laboratories of infringing claims 1 to 6.

Actavis moved to dismiss the suit, arguing that the patent claims were ineligible under section 101, a motion that the magistrate judge recommended granting.

Under step one of Alice/Mayo, the judge reasoned that the claims were directed to the natural law that the “bioavailability of oxymorphone is increased in people with severe renal impairment”.

The judge then considered the second step of Alice/Mayo, analysing whether the patent claims added enough to qualify as a patentable method that applies the law of nature.

He concluded that “[t]he administering step merely instructs physicians to dispense oxymorphone for the treatment of pain in a well-know[n] manner, while utilising the natural law to manage the dosage”.

The district court adopted the judge’s recommendation, finding the patent claims ineligible and dismissing Endo’s claims.

Endo appealed against the decision to the Federal Circuit, which yesterday reversed the district court’s ruling.

Applying step one of Alice/Mayo, the court concluded that the asserted claims were not directed to patent-ineligible subject matter.

“On the contrary, the claims are directed to a patent-eligible method of using oxymorphone or a pharmaceutically acceptable salt thereof to treat pain in a renally impaired patient,” said Circuit Judge Kara Stoll on behalf of the court.

Stoll added that the ‘737 claims differ from those in Mayo in material respects.

Although in Mayo the representative claim recited administering a thiopurine drug to a patient, the claim as a whole was not directed to the application of a drug to treat a particular disease, explained Stoll.

By contrast, the administering step in the ‘737 patent is the step that describes giving a specific dose of the drug based on the results of kidney function testing.

“Because the ’737 patent claims are not directed to patent-ineligible subject matter, we reverse the district court’s decision,” concluded the court.

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11 July 2019   There has been a significant drop in the number of patents invalidated due to so-called Alice challenges since Federal Circuit rulings in Berkheimer v HP, and Aatrix Software v Green Shades Software, according to a new report.
Medtech
2 November 2021   The US Court of Appeals for the Federal Circuit has ruled that yet another CardioNet heart monitor patent is invalid for not citing an inventive concept under the Alice test.