API and IP Newsletter
Contents
The Role of Modern Digital Solutions in the Pharmaceutical Industry
FDA chief has been confirmed, despite concerns over his pharmaceutical industry ties
FDA approvals in January 2022
We analyze FDA approvals every month. FDA approved Abrocitinib on 14 January 2022. CIBINQO (abrocitinib).
Abrocitinib, sold under the brand name Cibinqo, is a Janus kinase inhibitor medication used for the treatment of atopic dermatitis. Pfizer is expecting USD 3 bn revenue from Cibinqo at peak. Here.
CIBINQO (abrocitinib) tablets contain the free base of abrocitinib. Abrocitinib is a white to pale colored powder with the chemical name: N-((1s,3s)-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide
The solubility of abrocitinib in water is 0.04 mg/mL at 25ºC.
WO2020008391 descrobes the process in example 4 as below.
Glenmark filed patent application for the process and must have started working on API long ago before the FDA approval.
Teva, Aurigene are importing KSM viz Benzyl 3-oxocyclobutylcarbamate and one could expect lot of competition at NCE-1 date.
General information
The Role Of Modern Digital Solutions In The Pharmaceutical Industry
More and more pharmaceutical companies are entrusting their manufacturing and logistics processes to outsourcing companies in order to reduce costs and increase overall efficiency. In oncology, the success rate dropped to a devastating 3.4%. AI/ML technologies can help select several of the most promising compounds out of tens of thousands of candidates for the role of a drug. This selection process is carried out in silico, with no lab tests or human participation, which can accelerate drug discovery from 4-5 years to several months and therefore help drive down the costs
News here.
FDA chief has been confirmed despite concerns over his pharmaceutical industry ties
Dr. Robert Califf will once again head the Food and Drug Administration, narrowly securing his position as the head of the consumer safety agency. The Senate confirmed Califf on Tuesday despite some concerns over his close ties to the pharmaceutical industry and GOP opposition to his stance on access to birth control.
News here.
Intellectual Property
CAFC Affirms District Court decisions that Naloxone Patents are Obvious
Narcan is a branded nasal spray (Naloxone) used to treat patients suffering from an opioid overdose. Narcan’s US sales is about USD 311 million in 2021. Here.
OB listed patents are as below
Teva filed ANDA with P-IV certification to market generic version of the drug. Adapt sued Teva for the infringement.
District Court for the District of New Jersey opined that patents are obvious and ruled in favour of Teva.
Adapt challenged the district court’s decision. Specifically, Adapt challenged several of the district court’s factual findings underlying its obviousness determination as clearly erroneous, namely: (1) its finding that a skilled artisan would have been motivated to combine the prior art references to arrive at the claimed invention; (2) its finding that the prior art, as a whole, does not teach away from the claimed invention; and (3) its findings related to Adapt’s proffered objective indicia of nonobviousness
The district court found that a skilled artisan would have been motivated to improve on the MAD Kit because its shortcomings were well-known.
CAFC agreed to District court’s view. As the district court explained, the FDA in 2012 discussed its interest in improving the MAD Kit, and encouraged the industry to develop an intranasal naloxone product that could be FDA approved. Thus, several years before the priority date of the patents in-suit, the FDA explicitly provided a motivation to formulate an intranasal naloxone product by identifying a need or problem known in the industry at the time of the invention.
A skilled artisan would have been motivated to use sodium chloride, hydrochloric acid, BZK, and EDTA in an intranasal naloxone formulation. The Court relied on Dr. Smyth’s (Teva’s expert) testimony. The district court, therefore, found that a skilled artisan would have been motivated to optimize the formulation for nasal delivery. The CAFC agreed.
According to CAFC, the district court also did not err in finding that the pH of an intranasal formulation is important to avoid nasal irritation, and that the pH determined through routine optimization should be somewhere between 3.5 and 7. One prior art identified a pH of 6.5 and other prior art identified a pH of most preferably less than 5.5 (the outer limit of the claimed range) for an intranasal naloxone formulation. And one more prior reference specifically used hydrochloric acid to adjust the pH of the formulation. Thus, the district court’s finding that a skilled artisan would have been motivated to use sodium chloride as a tonicity agent and hydrochloric acid to adjust the pH of the solution to prevent nasal irritation is not clearly erroneous.
Federal Circuit (CAFC) affirmed a decision of New Jersey District Court, explaining that the district court did not err in finding several Adapt Pharma patents obvious.
Decision here.
