Federal Circuit Agrees Purdue’s OxyContin Anti-Tampering Patent Is Obvious
On April 4, 2019, the U.S. Court of Appeals for the Federal Circuit affirmed a November 2017 decision of the Patent Trial and Appeal Board (PTAB) invalidating a Purdue Pharma LP patent covering a way to make its OxyContin painkiller resistant to abuse. According to Purdue, the patent covered the use of a hot-melt extrusion process which yielded a “core matrix” of magnesium stearate, oxycodone, and polyethylene oxide; this matrix “swells when the tablet is tampered with, creating a gunky mass that is difficult to snort or inject.” But the PTAB had ruled, and the Federal Circuit has agreed, that three pieces of prior art, when considered together, show that this invention was obvious.
US Senate Looks to Tame Its “Bring Your Own Device” Cyber Risk
Following a rash of ransomware attacks and other cybersecurity incidents, the U.S. Senate is attempting to mitigate the dangers posed by members and staff who choose to conduct official government business on their personal computing devices. Senators Ron Wyden (D-OR) and Tom Cotton (R-AK) introduced the Senate Cybersecurity Protection Act on March 27, 2019, which would provide for the Sergeant at Arms to offer prophylactic and remedial cybersecurity services for the personal devices and accounts of Senate personnel. Using personal devices for official business is frowned upon, but the bill recognizes that the practice is unlikely to go away given the convenience and efficiency it affords. Instead, the Act is an attempt to deal with the reality on the ground and ensure the availability of resources that can reduce the substantial cybersecurity risks that attach to the use of personal computing devices.
Hulu Patent Bid Opens Door for New Prior Art Precedent
The Precedential Opinion Panel (POP) of the Patent and Trademark Office (PTO) said on April 3, 2019 that it would reconsider the PTAB’s denial of Hulu LLC’s request for an administrative review of a patent owned by Sound View Innovations, LLC. Hulu argues that the method, which involves data processing, is unpatentable as it was rendered obvious in part due to information contained in textbook. The issue is whether the textbook can be considered prior art. Any document used in an inter partes review (IPR) must qualify as prior art; part of that qualification means establishing that the art existed before the application being considered. This element of qualification can be difficult when it comes to non-patent literature, especially when it is pulled from the internet, because it can be hard to prove when the literature became available. That the POP is reviewing this case could be a sign that the PTO is looking for an opportunity to provide more detailed guidance about how to qualify non-patent literature as prior art.
CVS Must Face Antitrust Suit Over Compliance Software
On April 3, 2019, Judge Beth Bloom of the U.S. District Court for the Southern District of Florida allowed Sentry Data Systems, Inc., to move forward with its claims that CVS Pharmacy Inc. unlawfully forced hospitals to adopt compliance software developed by one of its subsidiaries, Wellpartner Inc. The software, which helps hospitals comply with the federal 340B program, created a “self-auditing” regime for inventory, reimbursements, and other records. Although Sentry has not established that CVS has a large enough national market share to face liability nationwide, Judge Bloom ruled that the suit could move forward on the basis of CVS’s dominant position in 22 local markets.
FDA Developing New Rules for Artificial Intelligence in Medicine
On April 2, 2019, the FDA announced that it was designing a regulatory regime for the use of artificial intelligence in medicine. The outgoing commissioner, Scott Gottlieb, released a white paper acknowledging the need for greater oversight and outlining the broad strokes of his preferred approach. The FDA has already approved devices that use “locked algorithms”—meaning that nothing about how the device functions is changed except by the manufacturer at periodic intervals. But there is, as of yet, no regime for regulating more powerful machine learning algorithms that learn and evolve on their own, often in ways that their manufacturers may not anticipate or understand. On the one hand, these tools have the potential to drastically improve the quality of medical care. But the FDA is concerned about the possibility of unintended consequences, and is committed to a tailored review of any such device.