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10 December 2018Americas

Double victory for Novartis at Federal Circuit

The US Court of Appeals for the Federal Circuit has reversed one decision and affirmed another in two cases involving Novartis, with both judgments delivering victory to the Swiss pharmaceutical company.

The Federal Circuit delivered the precedential decisions on Friday, December 7.

One dispute arose in 2014, when Novartis accused generic manufacturers Par Pharmaceutical and West-ward Pharmaceuticals, plus medical research firm Breckenridge Pharmaceutical, of patent infringement.

The three companies were seeking to make generic versions of Novartis’s chemotherapy drugs Zortress and Afinitor (everolimus), covered by patent number 5,665,772.

They conceded that their proposed products infringe the patents, but claimed that the ‘772 patent was invalid for “obviousness-type double patenting” (OTDP).

Under the OTDP doctrine, patent owners are prevented from obtaining multiple patents on the same invention, meaning that they cannot extend the patent term on that invention by re-filing patents.

Novartis’s 772 patent was filed before, but was due to expire after, another of its patents, which was directed to the treatment of and compositions comprising everolimus (6,440,990).

The date complications of the patents occurred due to an “intervening change in law” that altered the statutory regime of patent terms (The Uruguay Round Agreements Act 1994), the Federal Circuit said.

The US District Court for the District of Delaware agreed with the three companies, and invalidated the earlier-filed ‘772 patent based on OTDP.

Novartis had risked the shortening of the ‘772 patent’s term by later filing an “obvious variant of its invention claimed in its first issued patent”, the court ruled.

However, on Friday, the Federal Circuit upheld Novartis’s appeal.

“We disagree that the ‘990 patent is an invalidating reference,” the court said, as to find that OTDP applies would annul Novartis’s right to enjoy one full patent term on its invention.

Reversing the district court’s decision, the Federal Circuit held that a change in patent term law should not “truncate” the term statutorily-assigned to the earlier ‘772 patent.

In Novartis’s other case heard on Friday, the Federal Circuit affirmed a lower court’s decision—again, delivering victory to Novartis.

This dispute started when generic manufacturer Ezra Ventures sought to produce a generic version of Gilenya (fingolimod), Novartis’s branded multiple sclerosis drug.

Novartis accused Ezra of infringing patent number 5,604,229, which claims a large group of compounds including fingolimod, in a complaint filed at the US District Court for the District of Delaware.

Like the ‘772 patent in the other dispute, the ‘229 patent was filed before the statutory change to patent terms. It was due to expire in 2014, but Novartis secured an extension of five years.

Novartis did not apply for an extension of another patent, number 6,004,565, which covers a method of administrating fingolimod. This patent—which was filed after the statutory change—expired in 2017.

Ezra claimed that the ‘229 patent should be invalidated, and the extension of its term is “impermissible” as it also extends the life of the ‘565 patent.

In 2017, the district court disagreed and found that Congress had intended extensions such as this to be permissible.

The ‘229 patent is valid, unexpired, and enforceable, the court said. It imposed an injunction on Ezra’s generic product, which lasts until the ‘229 patent expires in 2019.

Ezra appealed against the ruling, but on Friday, the Federal Circuit upheld the district court’s decision.

The ‘565 patent is not a double patenting reference to the ‘229 patent, and the ‘229 patent is valid until the end of its extension, the court said

The Federal Circuit confirmed that Novartis had met the requirements for a patent term extension, and that OTDP does not invalidate a validly obtained extension.

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