A challenge to a marketing authorisation for a generic drug to treat osteoarthritis in dogs was brought outside the applicable time limits, a High Court judge has ruled.
Mr Justice Garrett Simons said it seemed his preliminary finding means the judicial review challenge must be dismissed but he deferred a final decision on that issue for a week to allow the sides make submissions.
Arthopharm (Europe) Limited sought judicial review against the Health Products Regulatory Authority over a marketing authorisation granted by that body on July 20th 2018 to Chantelle Pharmaceuticals Manufacturing Ltd for a generic product known as Osteopen 100mg/ml Solution for injection for dogs.
Arthopharm, which has been authorised since 1991 to market Carthophen Vet 100mg/ml Solution for Injection, used to treat osteoarthritis and related musculoskeletal disorders in dogs, challenged the Osteopen authorisation on several grounds.
As a result of case management of the proceedings, a number of issues were identified on which preliminary rulings were sought.
In a judgment on Tuesday, Mr Justice Simons ruled the proceedings were brought outside the relevant three month limit for judicial review.
He found the relevant date for calculation of the three month limit was July 23rd 2018, when the decision to grant the marketing authorisation to Chantelle was posted on the HPRA website.
These proceedings, initiated on December 20th 2018, were outside the three month limit, he held.
He also ruled Arthopharm had failed to demonstrate "good and sufficient" reason to extend the time for bringing the proceedings. He rejected arguments otherwise, including that Arthopharm was entitled to await receipt of analysis of a sample of the generic product before taking its case.
While he considered his findings meant the judicial review proceedings should be dismissed "in their entirety", that was subject to arguments concerning whether the Authority had made a "fresh" decision which meant the three month time limit only began to run from March 2019, he said.
He will hear the sides on that issue next week before finalising his decision.
Kim Kardashian has given her fans an glimpse into the sweet bond shared by her her daughter Chicago and niece True, both one.
The Keeping Up With The Kardashians star, 39, took the adorable cousins to American supermarket Target and posted a short video clip and a number of cute snaps of the little ones onto her Instagram account on Monday.
Proving they have a special bond, the cute kids could be seen feeding one another in the supermarket restaurant and nestled together in the trolley as Kim whizzed them about.
Kim captioned the offering: "swipe for major cuteness."
Kim's post comes amid claims that True's mum Khloe Kardashian wants to expand her family, and sources claim the blonde bombshell "would love another baby" with ex-boyfriend Tristan Thompson .
The ex-couple are parents to adorable True, who was born amid a devastating cheating scandal between Khloe and Tristan.
Just weeks before Khloe was about to give birth to True, a video emerged of Tristan kissing another woman in a nightclub, leaving Khloe "heartbroken".
Later, TMZ claimed Tristan took the woman in question back to his hotel and she “eventually left with a Louis Vuitton overnight bag.”
Their relationship hit the rocks when Tristan’s numerous affairs were exposed last year, with Khloe dumping him for good in February 2019 when his fling with sister Kylie’s best friend Jordyn, 21, hit headlines.
But Khloe is reportedly willing to put the past behind her, as she now wants to grow her family with pro basketball player Tristan.
An insider previously told People Magazine: "Khloé would love another baby and to give True a sibling.
"She always wanted to be a mum and it wouldn't be surprising if she got pregnant again."
The source added to People that becoming new parents helped bond the couple amid the drama.
The insider added: "True gave her something incredible to focus her love and energy on, and it helped her and Tristan stay bonded no matter what."