Client Successes

Eliminating Spillover via an Inter Partes Victory

Eliminating Spillover

The Firm secured a complete victory for SSW Holding Company, Inc., in an inter partes review proceeding challenging the validity of an SSW patent, making its client one of just a handful to emerge from the newly established inter partes review process with every challenged patent claim fully intact.

Inter partes review (IPR) is a streamlined process for challenging patents created through the Leahy-Smith America Invents Act of 2011 and, to date, has proven favorable to those challenging patents. Of the 78 decisions issued in IPR proceedings through June of 2014, the Patent Trial and Appeal Board cancelled or invalidated nearly 80 percent of the patent claims before it. In only 14 percent of such cases did the board find in favor of the patent owner with respect to all of the patent claims under consideration, as it did in Schott Gemtron Corp. v. SSW Holding Company, Inc. The Patent Trial and Appeal Board’s decision rejected arguments that SSW’s patent—which covers spill-containing refrigerator shelving technology used by major appliance manufacturers—was “obvious” and therefore invalid. Oral argument in the case took place on June 23, 2014.

Amgen Launches New Neulasta® (Pegfilgrastim) Wearable Delivery Kit

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

Blue and pink chemistry structures

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.

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