The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k). The Notice indicates that anyone with pending 510(k) submissions for devices that are now exempt “should withdraw their submissions.”
Hospira (owned by Pfizer) filed five IPR petitions against Genentech patents that Genentech asserted were directed to Herpceptin® (trastuzumab). The PTAB has now instituted IPRs in three of the five petitions and denied the other two.
On July 20, 2017, the Food and Drug Administration announced the clearance of “the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU)” to Aspect Imaging Ltd.
The STRONGER (Support Technology & Research for Our Nation’s Growth and Economic Resilience) Patents Act of 2017 was recently introduced in the Senate by a bipartisan group led by Senator…
On July 28, 2017, the PTAB issued a final written decision holding all claims unpatentable in an IPR after the Fed. Cir. vacated and remanded the PTAB’s previous final written decision. On remand, the PTAB reached the same patentability conclusion as it had previously, despite the Fed. Cir. reversing a critical component of the PTAB’s final written decision.
A recent survey conducted by ZingBox, a Silicon Valley internet security startup, found that more than 90% of healthcare IT networks have Internet of Things (IoT) devices. The survey further found that more than 70% of IT departments believe that current security systems for laptops and servers can also protect connected medical devices.
U.S. Customs and Border Protection (“CBP”), the primary federal agency responsible for securing America’s borders, is also charged with the protection of intellectual property rights and guarding against the infringement of U.S. copyrights and trademarks.
The University of Florida obtained patents covering new varieties of blueberry plants that can be grown in warmer climates. The University of Florida licensed these plants to companies, including Hartmann’s Plant Company in 2000. In 2004, Hartmann notified the University of Florida that it was terminating the licenses.
On July 25, 2017, a federal court in Wisconsin ordered Apple to pay a whopping $506 million for infringement of a patent on computer processor chip technology held by the Wisconsin Alumni Research Foundation (WARF), the licensing arm of the University of Wisconsin.
This case arose out of an ANDA litigation between Millennium and a number of generic-drug companies who sought FDA approval of the generic counterparts of Velcade®, an oncology drug prescribed for multiple myeloma and mantle cell lymphoma. Millennium had sued the generic-drug companies over U.S. Patent 6,713,446 which claims the mannitol ester of bortezomib generated by lyophilizing bortezomib with mannitol. According to the district court, Millennium had conceded that the claimed mannitol ester was a natural result of lyophilizing bortezomib in the presence of mannitol.
