Jury upholds Amgen's patents on Repatha® (evolocumab)

AmgenAmgen (NASDAQ:AMGN) announced that a Delaware jury delivered a verdict in Amgen's favor upholding the validity of two Amgen patents related to PCSK9 antibodies. These patents describe and claim antibodies, like Amgen's innovative Repatha® (evolocumab) product, that bind to a specific region on PCSK9 and reduce LDL-C levels in the body. This verdict follows a previous trial in March 2016 where Sanofi and Regeneron admitted infringement of Amgen's patents and where a prior jury also upheld the validity of Amgen's patents. The prior jury decision was partially reversed on appeal and the case was remanded to the district court for a new trial on two validity issues. In today's verdict, the jury found that the Amgen patents meet the legal requirements of written description and enablement.

"Today's decision protects intellectual property which is essential to innovators who are bringing forward new medicines for patients with serious diseases. Amgen scientists discovered and developed Repatha, which can play a key role in the fight against cardiovascular disease," said Robert A. Bradway, chairman and chief executive officer at Amgen. "We are thankful that the jury weighed the evidence carefully and recognized the validity of Amgen's patents."

Today's decision follows recent decisions in the European Patent Office and the Japanese Patent Office which also rejected challenges to the validity of Amgen's PCSK9 antibody patents brought by Sanofi, Regeneron and other potential competitors. Amgen is seeking to enforce these patents in the national courts in Europe and Japan against Sanofi and Regeneron.

About Repatha® (evolocumab)

Repatha® (evolocumab) is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.

Repatha is approved in more than 60 countries, including the U.S., Japan, Canada and in all 28 countries that are members of the European Union. Applications in other countries are pending.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Most Popular Now

Scientists uncover SARS-CoV-2-specific T cell immu…

The study by scientists from Duke-NUS Medical School, in close collaboration with the National University of Singapore (NUS) Yong Loo Lin School of Medicine, Singapore Ge...

Common FDA-approved drug may effectively neutraliz…

A common drug, already approved by the Food and Drug Administration (FDA), may also be a powerful tool in fighting COVID-19, according to research published this week in ...

Drug linked to 45% lower risk of dying among COVID…

Critically ill COVID-19 patients who received a single dose of a drug that calms an overreacting immune system were 45% less likely to die overall, and more likely to be ...

GSK and CureVac announce strategic mRNA technology…

GlaxoSmithKline plc (LSE/NYSE: GSK) and CureVac announced the signing of a strategic collaboration agreement for the research, development, manufacturing and commercialis...

Pfizer and BioNTech granted FDA Fast Track designa…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX, "BioNTech") announced that two of the companies' four investigational vaccine candidates from their BNT162 mRNA-bas...

Sanofi and Regeneron provide update on Kevzara® (s…

Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Phase 3 trial of Kevzara® (sarilumab) 400 mg in COVID-19 patients requiring mechanical v...

Neutralizing antibodies isolated from COVID-19 pat…

Researchers at Columbia University Irving Medical Center have isolated antibodies from several COVID-19 patients that, to date, are among the most potent in neutralizing ...

Novartis launches first-of-its-kind not-for-profit…

Novartis announced a new initiative to help patients in low-income and lower-middle-income countries (LIC; LMIC) access affordable medicines to treat the major symptoms o...

COVID-19 vaccine AZD1222 showed robust immune resp…

Interim results from the ongoing Phase I/II COV001 trial, led by Oxford University, showed AZD1222 was tolerated and generated robust immune responses against the SARS-Co...

Another mRNA-based vaccine candidate protects anim…

An experimental messenger RNA (mRNA)-based vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) elicits protective immune responses in mice and no...

Pfizer and BioNTech announce an agreement with U.S…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced the execution of an agreement with the U.S. Department of Health and Human Services and the Department of...

Pfizer and BioNTech announce agreement with the Un…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced an agreement with the United Kingdom to supply 30 million doses of their BNT162 mRNA-based vaccine candid...