On Sep. 18, 2024, Federal Circuit vacated District court’s judgment and remanded the case in which district court determined, sua sponte that claims of U.S. Patent 10,842,780 are invalid under 35 U.S.C. § 101.
In Astellas Pharma, Inc. v. Sandoz Inc., Astellas Pharma appealed a decision by the U.S. District Court for the District of Delaware. The court ruled that claims 5, 20, and 25 of Astellas’s U.S. Patent No. 10,842,780 (related to …
1. CHEWTADZY (Tadalafil), Chewable tablet
Approval: Jun. 28, 2024
Applicant: B Better LLC
Indication: Erectile Dysfunction & Benign Prostatic Hyperplasia
PREA: Waived, because necessary studies are impossible or highly impracticable
Value addition: Alternate (Chewable) dosage form
2. PEMETREXED (Pemetrexed), Injection
Approval: Jun. 25, 2024
Applicant: Apotex
Indication: NSCLC & Pleural mesothelioma
PREA: Exempted, none of the PREA criteria apply to the application
Value addition: Different salt
3. TEPYLUTE (Thiotepa), Injection
Approval: Jun. 25, …
On Jun 10, 2024, New Jersey court denied Teva’s motion and granted Amneal’s motion for delisting of patent from Orange Book.
I. BACKGROUND
This case arises out of a patent infringement dispute under the Hatch-Waxman Act between Teva and Amneal. Teva holds approved NDA No. 021457 for ProAir® HFA (albuterol sulfate) Inhalation Aerosol (“ProAir® HFA”), and owns certain patents listed in the Orange Book as covering this product: U.S. Patent Nos. 8,132,712 (the “’712 …
On Jun 13, 2024, Delaware district court denied Tolmar’s motion for reconsideration.
Janssen Pharmaceuticals sued Tolmar, Inc. for patent infringement under the Hatch-Waxman Act. The case revolved around U.S. Patent No. 9,439,906 (“the ’906 patent”), which Janssen held. This patent is listed in OB for product, Invega Sustenna. Following a four-day bench trial, the court ruled in favor of Janssen, declaring the asserted claims of the ‘906 patent nonobvious over the prior art. The …
While many 505(b)(2) products have entered the market, success stories are varied.
On May 24, 2024, UK Court of Appeal affirmed High Court’s decision of invalidity of once-daily method of use rivaroxaban patent.
Background: This case involves the revocation of European Patent (UK) No. 1 845 961 (the “Patent”), owned by Bayer and covering the use of rivaroxaban (marketed as Xarelto) for treating thromboembolic disorders through once-daily administration. The Patent was challenged by generic medicine suppliers who sought to market generic versions of rivaroxaban. On …
Here are below some recent 505b2 approvals with value additions and different approaches to address unmet need of patients.
1. XROMI (Hydroxyurea), Oral solution
Approval: Apr 04, 2024
Applicant: Nova Labs
Indication: sickle cell anemia with recurrent moderate to severe painful crises in pediatric patients aged 6 months of age to less than 2 years
PREA: Exempted because of orphan drug designation
Value addition: First oral liquid formulation for pediatric patients
2. RETEVMO …
Wondering what value additions 505b2 bring and how companies solve the unmet need. Look at below recent approvals of Q1 2024 to know more:
1. EOHILIA (Budesonide), Oral solution
Approval: Feb 09, 2024
Applicant: Takeda
Indication: For eosinophilic esophagitis (EoE)
Value addition: First and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE).
2. LEGUBETI (Acetylcysteine lysine), For oral solution
Approval: Feb 13, 2024
Applicant: Galephar Pharma
Indication: …
On Apr. 11, 2024, Federal Circuit affirmed District court’s determination regarding obviousness, effective approval date of ANDA and motion to modify the final judgement.
Salix Pharmaceuticals contested a final judgment from the District of Delaware, which invalidated several of its patents (US 8,309,569; 10,765,667; 7,612,199; 7,902,206) as obvious. The patents in question pertained to the treatment of various conditions using rifaximin, a widely used antibiotic. Salix’s appeal focused on the invalidation of specific patent …
On Mar. 22, 2024, Delaware district court rejected plaintiff’s infringement theory as speculative without evidence.
In the case of Galderma v. Lupin, Galderma holds patents for a doxycycline capsule called Oracea, used for inflammatory lesions of rosacea. Oracea’s patented formulation consists of an immediate-release portion containing about 30 mg of doxycycline and a delayed-release portion containing about 10 mg of doxycycline, coated to release at a higher pH level in the small intestine. Galderma …
