API and IP Newsletter
Contents
DMFs filed in December 2020.
General information.
Cascade Chemistry Initiates USD 14 Mio Expansion of cGMP Pharmaceutical Manufacturing Capacity.
Breaking vaccine patents will only make the next pandemic worse: Opinion.
Intellectual Property.
DMFs filed in December 2020
More than 80 DMFs filed in December 2020. Generally, about 45-50 DMFs are filed per month. Out of which 50% are filed by Indian companies. In December, being the last month of the year, more than 80 DMFs were filed. We are covering only a part of those filings in this newsletter and the remaining would be covered in the subsequent ones.
General information
Cascade Chemistry Initiates USD 14 Mio Expansion of cGMP Pharmaceutical Manufacturing Capacity
Eugene, OR-based Cascade Chemistry initiated construction of a USD 14 mio facility to significantly increase its cGMP pharmaceutical manufacturing capacity. (Read more)
Breaking vaccine patents will only make the next pandemic worse: Opinion
The cost of developing a new prescription medicine from initial clinical trials to regulatory approval by the U.S. Food and Drug Administration was between USD 2.6 - 2.9 bio (in 2013 dollars). That translates to USD 2.9 - 3.2 bio in today’s U.S. dollars. And the whole process takes more than a decade.
Suspending pharmaceutical patents would unfairly transfer profits from the investors who funded the R&D to generic companies that have invested nothing, and it would distort the risk-reward calculation that encourages people to invest in pharmaceutical R&D. Capital would flow out of the pharmaceutical business into non-pharmaceutical industries that produce higher or safer returns.
Intellectual Property
Takeda vs Torrent and Indoco
Torrent and Indoco appealed the district court’s final judgment on claims 4 and 12 of U.S. Patent No. 7,807,689, owned by Takeda. District court opined in favor of Takeda and matter was in CAFC.
This was drug Alogliptin benzoate. Claims which were contested, claims 4 and 12.
4. A compound of the formula or pharmaceutically acceptable salts thereof.
12. A compound of the formula wherein the compound is present as a benzoate salt
Without going into too much of details, Torrent and Indoco argued structural obviousness based on compound F162 (structure below) reported in US 7,723,344.
F-162
Among other arguments, Torrent alleged that a skilled person would have found it obvious to replace F162’s pyrimidinone scaffold with uracil (in short, structure in blue circle could be replaced by structure in green circle to achieve desired results), citing Bohm and Kim. Bohm discloses that scaffold replacement techniques were known in the prior art as of the relevant priority date. Kim reports that administering uracil lowers blood glucose in an animal model of diabetes.
CAFC opined, a skilled person would not have been motivated to make the proposed scaffold and isosteric replacements with a reasonable expectation of success. CAFC confirmed validity of claims 4 and 12 of the ’689 patent. There were few other interesting arguments too. The Court decision could be read here.
Disclaimer
Sidvim LifeSciences Private Ltd has taken due care and caution in developing this document. Since the data used for analysis in this document is based on the information available in the public domain, its adequacy or accuracy or completeness cannot be guaranteed. This document is for information only and Sidvim is not responsible for losses that may or may not arise due to any decisions made based on the same. No part of the document shall constitute or be represented as a legal opinion of any kind or nature. No warranties or guarantees, expressed or implied, are included in or intended by the document, except that it has been prepared in accordance with the current generally accepted practices and standards consistent with the level of care and skill exercised under similar circumstances by professional consultants or firms that perform the same or similar services.
