Appeals Court Affirms Patent Infringement Rulings Against Roche's peg-EPO Product

AmgenAmgen (Nasdaq: AMGN) has announced that the Court of Appeals for the Federal Circuit affirmed the Massachusetts District Court's decision that Roche's peg-EPO product, Mircera, infringes four Amgen patents ('868, '698, '933 and '422) relating to recombinant erythropoietin (EPO) and processes for making it. Regarding a fifth patent ('349), the Federal Circuit reversed the holding of non-infringement by the District Court and remanded that issue for a new trial allowing Amgen to show that Roche's product infringes that patent as well. The Federal Circuit also affirmed the validity of Amgen's patents except for a single issue of obviousness-type double patenting which only impacts Amgen's later expiring patents ('933, '422 and '349). The Federal Circuit remanded this issue to the District Court for further analysis.

"We are pleased with today's decision," said David Scott, Amgen's senior vice president and general counsel. "The successful enforcement of intellectual property rights enables Amgen to continue to invest in truly innovative new medicines."

Today's decision affirms the infringement and validity on all grounds for Amgen's process patents ('868 and '698), affirms the infringement on Amgen's product patents ('933 and '422), affirms all but one validity issue which will be further reviewed by the district court on the '933, '422 and '349 patents, and allows Amgen a new trial to show infringement of the '349 patent.

The Federal Circuit left undisturbed the permanent injunction that prohibits Roche from selling its pegylated EPO product, Mircera in the United States.

Scott added, "Biotechnology innovation is complex, expensive and extremely risky. Companies and investors need appropriate intellectual property protection to justify the risk and to realize an appropriate return on investment."

About Amgen
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.

Most Popular Now

Primary endpoint met in COMET-TAIL Phase III trial…

GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Vir) (Nasdaq: VIR) announced headline data from the randomised, multi-centre, open-label COMET-TAIL Phase...

Merck and Ridgeback's molnupiravir, an oral COVID-…

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced that the United Kingdom Medicines and Healthcare products Re...

Johnson & Johnson COVID-19 vaccine named one o…

The editors of Time announced that the Johnson & Johnson COVID-19 vaccine has been selected as one of Time's Best Inventions of 2021. The vaccine, for which Johnson & ...

New target for COVID-19 vaccines identified

Next generation vaccines for COVID-19 should aim to induce an immune response against 'replication proteins', essential for the very earliest stages of the viral cycle, c...

Safety concerns raised for neuroblastoma candidate…

St. Jude Children's Research Hospital scientists looking for drugs to improve survival of children with high-risk neuroblastoma found a promising candidate in CX-5461. Th...

Two billion doses of AstraZeneca’s COVID-19 vaccin…

AstraZeneca and its partners have released for supply two billion doses of their COVID-19 vaccine to more than 170 countries across every continent on the planet in the l...

Pfizer's novel COVID-19 oral antiviral treatment c…

Pfizer Inc. (NYSE: PFE) today announced its investigational novel COVID-19 oral antiviral candidate,PAXLOVID™, significantly reduced hospitalization and death, based on a...

'Dancing molecules' successfully repair severe spi…

Northwestern University researchers have developed a new injectable therapy that harnesses “dancing molecules” to reverse paralysis and repair tissue after severe spinal ...

Repurposing a familiar drug for COVID-19

For the past year and a half, the COVID-19 pandemic has continued to engulf the globe, fueled in part by novel variants and the uneven distribution of vaccines. Every day...

Researchers reveal a strategy for next-generation …

A study led by the Garvan Institute of Medical Research has revealed a guide to developing COVID-19 vaccines that both prevent the coronavirus from infecting human cells ...

A target for potential cancer drugs may, in fact, …

In recent years, much scientific effort and funding has focused on developing drugs that target an enzyme with the unwieldy name of Src homology 2-containing protein tyro...

A commonly found parasite could treat certain type…

Scientists have discovered that a deadly parasite, known to cause ill health in pregnant women and immunocompromised patients, could potentially be used to treat various ...