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Attorney: Expect PTO Director To Use ‘Discretion’ In New Patent Appeal Authority

 
• By Elizabeth Orr

The US Supreme Court found that the role of administrative judges in patent review was unconstitutional but could be fixed by giving the PTO’s director more oversight, reinforcing the staying power of the patent appeals process.

US Supreme Court building at dusk, Washington

Industry efforts to do away with the Patent Trial and Appeals Board (PTAB) process were thwarted on 21 June when a divided Supreme Court issued rulings in high-profile patent case US v. Arthrex that leave the process largely in place, but order the Patent and Trademark Office (PTO) to give the office’s director greater oversight of rulings.

The justices split 5-4 on whether the process, established under the 2012 America Invents Act, was constitutional, and 7-2 on whether giving the director more authority would fix the issues

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FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By Elizabeth Orr

States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.