API and IP Newsletter
Contents
Merck Wins Patent Ruling on Viatris’ Copies of Diabetes Drugs
Central committee to look into regulation of pharma marketing practices
FDA approvals in September 2022- Gadopiclenol
Elucirem™ (Gadopiclenol), a new macrocyclic gadolinium-based contrast agent (GBCA) for use in contrast-enhanced magnetic resonance imaging (MRI) approved by FDA.
This contrast agent with high relaxivity indicated for use in adults and children aged 2 years and older.
The product is used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).
WO2020030618A1 discloses process of manufacturing of Gadopiclenol in example 2.
WO2007042506A1 could be considered as composition of matter patent for Gadopiclenol.
Many companies importing raw materials required for Gadopiclenol. However, similar RMs will be required for all Gd based contrast agents, and it will be very difficult to estimate which companies are working on Gadopiclenol based on imports.
Cipla, Aurobindo, BlueJet etc are very actively importing RMs required for gadolinium-based contrast agent (GBCA).
General information
Merck Wins Patent Ruling on Viatris’ Copies of Diabetes Drugs
Merck & Co. won a West Virginia federal judge’s ruling that generic versions of Januvia and Janumet proposed by Mylan Pharmaceuticals Inc. infringe two patents related to an active ingredient in the diabetes treatments, whose US sales provided $1.77 billion of Merck’s 2021 revenue.
Judge Irene M. Keeley also rejected the Viatris Inc. subsidiary’s arguments for cancelling one of the patents, according to a judgment issued Wednesday in the US District Court for the Northern District of West Virginia. Keeley issued her ruling under seal, and no redacted version is yet available.
News here.
Central committee to look into regulation of pharma marketing practices
A five-member committee chaired by NITI Aayog is to submit recommendation in 90 days
With the relationship between pharmaceutical companies and healthcare professionals coming in for intense scrutiny, the Centre has set up a high-level committee to examine the need for a legally enforceable mechanism to regulate pharmaceutical marketing practices.
News here.
Intellectual Property
Treprostinil decision by Delaware court
OB listed patents for Treprostinil (Tyvaso®) are as below
UTC is the holder of New Drug Application ("NDA") No. 022387 for Tyvaso®, an inhaled solution formulation of treprostinil approved for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
The ' 066 patent discloses an improved process for preparing treprostinil. Two independent claims are as below.
1. A pharmaceutical composition comprising treprostinil or a pharmaceutically acceptable salt thereof, said composition prepared by a process comprising providing a starting batch of treprostinil having one or more impurities resulting from prior alkylation and hydrolysis steps, forming a salt of treprostinil by combining the starting batch and a base, isolating the treprostinil salt, and preparing a pharmaceutical composition comprising treprostinil or a pharmaceutically acceptable salt thereof from the isolated treprostinil salt, whereby a level of one or more impurities found in the starting batch of treprostinil is lower in the pharmaceutical composition, and wherein said alkylation is alkylation of benzindene triol.
8. A process of preparing a pharmaceutical product comprising treprostinil or a pharmaceutically acceptable salt thereof, comprising alkylating a triol intermediate
The '793 patent discloses a method of administering treprostinil by inhalation.
Liquidia submitted NDA No. 213005 under§ 505(b)(2) seeking FDA approval for the manufacture, use, and sale of its proposed product LIQ861 (Yutrepia™).
LIQ861 is a dry powder formulation of treprostinil sodium.
The FDA tentatively approved LIQ861 for the treatment of pulmonary arterial hypertension.
Liquidia's NDA contains Paragraph IV certifications alleging that both the '066 and '793 patents are invalid and/or will not be infringed by the manufacture, use, or sale of its proposed product.
UTC received notice of Liquidia' s Paragraph IV certifications and initiated the present lawsuit.
Key prior art cited: A 2004 Journal of Organic Chemistry article by Moriarty et al., in relevant part titled "Synthesis of UT-15 (Treprostinil)" ("Moriarty"), teaches the synthesis of 99. 7% pure treprostinil free acid, via alkylation and hydrolysis.
The claim language requires that the impurities result from the "prior alkylation and hydrolysis steps."
The Court said, Liquidia had shown by clear and convincing evidence that the claimed treprostinil product is functionally and structurally the same as the UT-15 treprostinil disclosed in Moriarty. Thus, the Court found that claims of the '066 patent are invalid as anticipated.
However, for `793 patent the Court opined, UTC could prove by a preponderance of the evidence that Liquidia will induce infringement of claims 1, 4, 6, 7, and 8 of the '793 patent. The `793 patent will expire in May 2027.
Decision here.
