Client Successes

Amgen Launches New Neulasta® (Pegfilgrastim) Wearable Delivery Kit

In 2015, Amgen announced that the Neulasta® (pegfilgrastim) OnPro™ Kit is now available in the United States (U.S.). The Neulasta® OnPro™ Kit includes a specially designed single-use prefilled syringe co-packaged with a new On-Body Injector. With the Neulasta® OnPro™ Kit, the healthcare provider (HCP) initiates administration of Neulasta® with the On-Body Injector on the same day as cytotoxic chemotherapy. Administration is delayed however, and this results in the automatic delivery of the patient's full dose of Neulasta® the day following chemotherapy administration. This advantageously eliminates the need for the patient to return to the HCP to receive the Neulasta® injection, which can be physically and emotionally challenging a mere day following cytotoxic chemotherapy treatment.

Marshall, Gerstein & Borun LLP worked closely with Amgen to navigate a sophisticated and complex field of prior art to build a robust international patent portfolio directed to the novel On-Body Injector included within the Neulasta® OnPro™ Kit.

Infections send 200,000–300,000 cancer patients to the hospital per year. The Neulasta® OnPro™ Kit makes delivery of infection-fighting drugs one less worry for those fighting the disease.

Easing the Use of Patient Care at Home

Amgen launched its Enbrel MiniTM single-dose prefilled cartridge with AutoTouchTM reusable autoinjector in the United States in 2017. The AutoTouch™ reusable autoinjector has an ergonomic design that includes features that were designed with patients in mind, including an ergonomic handle, a needle designed to stay hidden during the injection, a sensor to detect placement on skin, a speed switch with three injection speeds, a progress bar and a speaker.

Amgen turned to the patent attorneys at Marshall Gerstein for development of an extensive patent portfolio to protect this ground-breaking device. The patent strategy for the device evolved in real time along with the device. This process requires a close relationship and open line of communication between the patent attorneys, engineers, and business executives at Amgen. This unique relationship allowed Marshall Gerstein to have a deeper understanding of the technology and how it was being developed and commercialized.

The Marshall Gerstein team possesses a wealth of knowledge relating to medical devices which allowed them to more easily identify which features of a given device can and should be patented. This advantage helps save clients time and money and presents clients with opportunities they may not have seen previously.