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

Top 20 breaking World Pharma News of 2017

We are proud to announce the top 20 most popular breaking World Pharma News from 2017. Have a wonderful 2018 new(s) year filled with health, happiness, and spectacular su...

Novartis advances head-to-head superiority trials …

Novartis announced today the initiation of SURPASS, a head-to-head clinical trial of Cosentyx® (secukinumab) versus proposed biosimilar adalimumab** in ankylosing spondyl...

Roche and Ignyta reach definitive merger agreement

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Ignyta, Inc. (NASDAQ: RXDX) today announced they have entered into a definitive merger agreement for Roche to fully acquire Ignyta ...

Antidepressant may help combat the course of multi…

The antidepressant clomipramine may also alleviate symptoms of multiple sclerosis (MS), specifically in its progressive form, i.e. when it occurs without relapses or remi...

Diabetes drug 'significantly reverses memory loss…

A drug developed for diabetes could be used to treat Alzheimer's after scientists found it "significantly reversed memory loss" in mice through a triple method of action...

FDA updates the label of Tasigna to reflect that c…

The U.S. Food and Drug Administration today updated the product label for the cancer drug Tasigna (nilotonib) to include information for providers about how to discontinu...

Zika remains a research and public health challeng…

Since 2016, when Zika was declared by the World Health Organization as a public health emergency of international concern, the virus has become established in more than 8...

Try exercise to improve memory, thinking

For patients with mild cognitive impairment, don't be surprised if your health care provider prescribes exercise rather than medication. A new guideline for medical pract...

Dirt-dwelling microbe produces potential anti-mela…

A type of soil-dwelling bacterium produces molecules that induce death in melanoma cells, research at Oregon State University shows. The molecule is a secondary metabolit...

Sandoz regulatory submission for proposed biosimil…

Sandoz, a Novartis division and the global leader in biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics Licen...

Novartis Kisqali® received FDA Breakthrough Therap…

Novartis today announced Kisqali® (ribociclib) received US Food and Drug Administration (FDA) Breakthrough Therapy designation for initial endocrine-based treatment of pr...

FDA approves first treatment for breast cancer wit…

The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast can...

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]