API and IP Newsletter
Contents
Unexpected Results In Hatch Waxman Litigation: A Review Of Legal Decisions From 2023
Revolutionizing Drug Discovery: Scientists Develop World’s First Single-Atom Editing Technology
Recent FDA approvals
We follow FDA approvals.
The FDA approved Acoramidis, the Brand name ATTRUBY, on 23 November 2024 to treat transthyretin amyloid cardiomyopathy (ATTR-CM). MA holder is BridgeBio Pharma, Inc.
The European Medicines Agency (EMA) has accepted BridgeBio's marketing application for acoramidis, and approval is expected in 2025. BridgeBio has granted Bayer the exclusive rights to commercialise acoramidis for ATTR-CM in Europe. As per the terms of the deal, BridgeBio will receive $310 million in upfront and near-term payments for rights to the drug in Europe. BridgeBio will also be eligible for future milestone payments and at least a “low thirties” percent royalty on European sales.
News here
Some industry watchers believe acoramidis is a potential blockbuster. Consensus estimates indicate that the drug could generate approximately $2 billion in peak annual sales
News here
ATTRUBY contains 356 mg of acoramidis equivalent to 400 mg of acoramidis HCl. Acoramidis HCl is a transthyretin stabilizer. The chemical name of acoramidis HCl is 3-[3-(3,5-dimethyl1H-pyrazol-4-yl)propoxy]-4-fluorobenzoic acid hydrochloride. The structural formula is:
Acoramidis HCl is a white to tan solid. The solubility of acoramidis is 12 micrograms per milliliter (µg/mL) from pH 1.2 to 6.8 in aqueous media.
ATTRUBY is supplied as a white, film-coated oval tablet containing 356 mg of acoramidis. On one side, it is printed with the BridgeBio company logo followed by “ACOR” in black ink.
The inactive ingredients are croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film coating and printing ink contain black iron oxide, glyceryl monocaprylocaprate, hypromellose, polyvinyl alcohol, propylene glycol, talc, titanium dioxide, and vinyl alcohol graft copolymer.
This compound has been disclosed in WO 2014/100227.
Acoramidis and its preparation are disclosed in WO 2014/100227.
The various crystalline forms of acoramidis hydrochloride are disclosed in the patent family WO 2018/151815, including several anhydrous forms designated as Type A, Type B, and Type E, a hydrate form designated as Type I, and two solvated forms designated as Form H (methanol solvate) and Form J (dimethylacetamide solvate). These forms resulted from an extended solid form screening program.
Examples 7 and 8 in WO2018151815A1 describe the manufacturing process of acoramidis.
Teva imports small quantities of API, which could be used to characterise and develop API.
Sandoz has filed a patent application for polymorphs; thus, these generic companies must have already begun working on the product.
The essential compound required for synthesising acoramidis is 3-(3,5-dimethyl-1H-pyrazol-4-yl) propane-1-ol. Some CROs in India have exported these compounds, and hence, Indian sources for intermediate 3-(3,5-dimethyl-1H-pyrazol-4-yl) propane-1-ol could be available.
General information
Unexpected Results In Hatch Waxman Litigation: A Review Of Legal Decisions From 2023
Patent owners generally look to secondary indicia to bolster their nonobvious defenses when prior art and/or knowledge of a person of ordinary skill in the art ("POSA") seem to make the obviousness decision a close call.
News here
Revolutionizing Drug Discovery: Scientists Develop World’s First Single-Atom Editing Technology
KAIST researchers have developed a groundbreaking single-atom editing technology using light-powered “molecular scissors” to convert oxygen atoms into nitrogen in drug compounds, simplifying drug development and boosting efficacy.
News here
Intellectual Property
BOROLINE: G.D Pharmaceuticals vs Cento Products
Facts
G.D Pharmaceuticals has been manufacturing, marketing, selling, and exporting a variety of medical and cosmetic preparations since 1929 and has coined the word BOROLINE concerning antiseptic medicinal ointments, creams, etc.
The word BOROLINE was registered on 19 April 1943.
G.D. Pharmaceuticals’ brand BOROLINE, alongside a distinctive getup, packaging, and colour scheme, has been used uninterruptedly, bona fide, exclusively, and continuously for 90 years.
In December 2018, G.D. Pharmaceuticals was alerted through its market sources about the presence of the brand BOROBEAUTY, which was similar to the G.D. Pharmaceuticals product BOROLINE. M/S Cento Products was marketing the BOROBEAUTY product.
G.D. Pharmaceuticals sued M/S Cento Products in the Delhi High Court, seeking a permanent injunction against Cento Products that restrains infringement of trademark and copyright.
For this write-up, both above images were copied from the Internet. The original photos on the internet can be found here and here.
The defendant, Cento Products, did not really put forth any counterarguments.
A learned counsel appearing for the defendant, Cento Products had handed over a copy of the photograph of a new trade dress proposed to be used by Cento Products to submit that Cento Products would give up the green colour trade dress altogether and would adopt a new trade dress in blue.
He further submitted that Cento Products does not intend to use the prefix “BORO‟ and will change the name of its product to something distinct from G.D. Pharmaceuticals’ product “BOROLINE”.
A decree of permanent injunction is issued in favour of G.D. Pharmaceuticals and against the defendant Cento Products, thereby restraining Cento Products, its partners, proprietors, servants, agents, and all others in active concert or participation with them from manufacturing, selling, offering for sale, advertising, directly or indirectly dealing in products bearing the mark/ name “BOROBEAUTY”.
Cento Products was directed to change its trade dress and trademark, which shall be totally distinct and different from G.D. Pharmaceuticals’ well-known trademark and trade dress. Cento Products shall not use the trade dress of dark green color, which is used by G.D. Pharmaceuticals. Further, the defendant Cento Products shall adopt a new trade name that does not include the prefix “BORO‟ and is not similar to the trademark of the plaintiff G.D. Pharmaceuticals, “BOROLINE.”
Considering the suit's long pendency, the court directs that the defendant (Cento Products ) pay the plaintiff (G.D. Pharmaceutical) a cost of ₹ 2,00,000/-.
The learned counsel appearing for the defendant (Cento Products) submitted that he is a small-time businessman and may be granted eight weeks’ time to pay the debt.
Accordingly, the defendant is directed to pay the cost of ₹ 2,00,000 to the plaintiff within eight weeks.
Decision here
