Supreme Court Refuses Inter Partes Review

Akorn’s Win On Difluprednate Patent Will Not Be Reopened

Standards of evidence for obviousness used in US inter partes patent reviews will not be reviewed by the US Supreme Court. Nor will the court consider whether the Federal Circuit can confirm inter partes decisions without issuing an opinion.

Supreme_Court
The US Supreme Court has decided not to review inter partes obviousness standards • Source: Shutterstock

The US Supreme Court has refused to review standards for determining obviousness via inter partes patent reviews, as well as procedures for affirming such determinations on appeal. Originators Senju Pharmaceutical and Mitsubishi Chemical had sought clarification in their dispute with Akorn over Durezol difluprednate eye drops.

In a petition for certiorari, Senju and Mitsubishi had asked the Supreme Court to decide if the Patent Trial and Appeal Board within the US Patent and Trademark Office must, in assessing patent validity, “consider

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Legal & IP

After Jazz, Hikma Agrees $50m Settlement For ‘Most’ Xyrem ‘Pay-For-Delay’ Claims

 
• By 

Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”

Viatris Pens Aprepitant Settlement Agreement After Kabi Loses Initial Patent Case

 
• By 

Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.

J&J Denied Injunction Over Private-Label Ustekinumab In US

 
• By 

Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.

UK Forxiga SPCs Wiped Out As Trio Succeed With Plausibility Attack

 
• By 

Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.

More from Generics Bulletin

Trump Order On Domestic Manufacturing Wins Plaudits From Industry

 
• By 

An executive order from US president Donald Trump aimed at incentivizing domestic manufacturing of critical medicines has been welcomed by the US Association for Accessible Medicines.

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By 

The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.

Amgen Biosimilars Continue Surge Ahead Of Imminent Denosumab Competition

 
• By 

Thanks to its efficient development pipeline, sales of Amgen’s biosimilars neared $750m for the first three months of the year, offering some comfort as the firm gears up for the loss of exclusivity for its denosumab franchise.