API and IP Newsletter
Contents
Patent applications filed by Nosch Labs
Few weeks ago, we analysed import-export data of Nosch Labs and tried to estimate their development activities. Here we analyse their patent portfolio.
Observations:
Nosch is experienced in IP filing.
About 7-8 patent family filed in last 8-9 years mainly related to processes.
Most of the applications are either prosecuted only in India or are abandoned.
Nosch filed couple of application of polymorphs and alternate salts, and it shows they have development capabilities of polymorph and salts.
General information
Ready to increase Molnupiravir production: Optimus pharma
Optimus Pharma has fixed the price of its Molnupiravir capsules at ₹630 for a bottle of 10.
Speaking after formally launching the product here on Thursday, D Srinivasa Reddy, Chairman and Managing Director, Optimus Pharma, said his company was ‘ready’ to gear up manufacturing of Molnupiravir. Optimus now has a production capacity of 40 million capsules per month.
News here.
Zacks Industry Outlook Highlights: Dr. Reddy's Laboratories, Teva Pharmaceutical and Amphastar Pharmaceuticals
The generic segment is controlled by a few large generic drugmakers and generic units of large pharma companies. Several smaller companies also develop generic versions of branded drugs. Generic drugs are significantly cheaper than the original drugs.
However, competition in this segment is stiff, which results in thin margins for the manufacturing companies. A few companies in this industry also have some branded drugs in their portfolio, helping them tap a higher-margin market.
News here.
Intellectual Property
Dimethyl fumarate (Tecfidera) decision by CAFC
Mylan had already launched (in August 2020) first generic version of Dimethyl fumarate delayed release capsules 120mg and 240mg for MS treatment in US. Mylan had launched at risk. Mylan launched immediately after FDA approval and based on favourable District Court decision which was handed down in June 2020.
OB listed patents are as below and `514 would have been the most important patent from Biogen point of view.
On 30 November 2021, Federal Circuit affirmed district court and found patent invalid under lack of ‘written description’ support.
The 'written description' requirement implements the principle that a patent must describe the technology that is sought to be patented. As per US law the patent specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.
This write up is confined only to ‘written description’ and not considering inventorship and other issues which were discussed by the Judge in this case.
Granted claim 1 of `514
1. A method of treating a subject in need of treatment for multiple sclerosis comprising orally administering to the subject in need thereof a pharmaceutical composition consisting essentially of (a) a therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof, and (b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof is about 480 mg per day.
The ’514 Patent, features multiple claims that are drawn exclusively to the specific DMF 480 dose, but the specification’s focus on basic research and broad DMF dosage ranges show that the inventors did not possess a therapeutically effective DMF 480 dose at the time of filing `514 in 2007. Dr. Lukashev, the original inventor, offered testimony in which he denied that his research could be extrapolated to a clinical dose of DMF; it was never the focus of his work to inform the clinical dosing of DMF.
That Biogen later established the therapeutic efficacy of DMF 480 is of no import to the written-description analysis. What matters for purposes of the inquiry in this case is whether, at the time of filing the disclosure well before the Phase III study even commenced a skilled artisan could deduce simply from reading the specification that DMF 480 would be a therapeutically effective treatment for MS.
The CAFC stated ’514 patent contains only one paragraph related to treating diseases which mentions “about 480 mg/day.” It only identifies about 480 mg/day at the bottom end of the spectrum of a DMF 480–720 mg/day range.
The Court said, this only DMF-dosage paragraph is not linked to treatment of any specific disease but recites: “Effective doses will also vary, as recognized by those skilled in the art, dependent on route of administration, excipient usage, and the possibility of co-usage with other therapeutic treatments including use of other therapeutic agents”.
So, Court opined, this paragraph cautions that effective doses will vary, and concluded that the original 2007 disclosure, which focused exclusively on screening compounds for activation of the Nrf2 biological pathway, did not disclose a method to administer a therapeutically effective dose of DMF480 for the treatment of MS.
Decision here
