API and IP Newsletter
Contents
Merck's oral COVID-19 drug sees India's Everest Organics hit start on production
University of Cincinnati researchers develop new treatment for common knee injury
FDA activities in last three quarters
We analyse FDA approvals (for small molecules), ANDA approvals and DMFs filed by Indian companies and publish our view point each week.
FDA publishes data about actions each month. One can find summary on FDA website. Here.
General observations:
About 700 new ANDAs submitted in last 9 months and about 600 ANDAs are approved by FDA during same period
About 20% of ANDA approvals are tentative approvals. Most of them must wait till patent expiration dates, or till the agreed launch date with innovator.
The real value for generic company lies in seeking approval for first time generics. One must notice less than 15% of the approvals (barring couple of exceptional months) are for first time generics.
About 50-60 DMFs (Type -II) filed each month and about 35-40 DMFs are assessed by FDA. In other words, this could mean, about 30-40% of filed DMFs don’t generate revenue for their organisations. They could be classified as Non Preforming Assets in famous (or infamous) term used in recent days.
General information
Merck's oral COVID-19 drug sees India's Everest Organics hit start on production
Indian generic drug maker Everest Organics started manufacturing active pharmaceutical ingredients for Merck’s oral COVID-19 treatment.
News of the production rollout comes in tandem with Merck filing for emergency use authorization from the FDA for the antiviral, molnupiravir, which would be the first newly developed oral treatment to stave off COVID-19.
News here.
University of Cincinnati researchers develop new treatment for common knee injury
Each year in the U.S., more than 500,000 people sustain tears in their meniscus, a piece of cartilage in the knee that cushions and stabilizes the joint. The tears often require invasive surgeries that frequently do not achieve the desired outcome.
Researchers at the University of Cincinnati are developing therapies that use a regenerative approach to meniscal tears that could benefit soldiers, athletes and weekend warriors by making those surgeries more reliable.
News here.
Intellectual Property
Vasopressin: CAFC affirmed the District of Delaware’s decision that Eagle’s vasopressin product does not infringe
Eagle is first to file an Abbreviated New Drug Application (ANDA) for Vasopressin, which had total U.S. sales of $786 million in 2020.
OB listed patents are as below.
In May 2018, Par sued Eagle for infringement of several patents. Mainly the claims 1, 4, 5, and 7 of the #209 patent and claims 1, 5, and 8 of the #785 patent were asserted.
The trial was held in July 2021.
A broad claim 1 of the #209 patent is as below:
A method of increasing blood pressure in a human in need thereof, the method comprising administering to the human a unit dosage form, wherein the unit dosage form comprises from about 0.01 mg/mL to about 0.07 mg/mL of vasopressin or a pharmaceutically acceptable salt thereof, wherein: the unit dosage form has a pH of 3. 7-3.9;…………
During the stability study of batches, for one of the batches (SVA-001), Eagle recorded a pH level of 3.69 (which rounds to 3.7) at the 24-month mark-i.e., at the very end of a shelf life.
In response to the single out-of-specification pH test result for one batch,
Eagle "optimized" its manufacturing process "to assure tighter control of pH. To achieve this optimization, Eagle adjusted its manufacturing process.
Eagle added a new pH stabilization step after the pH adjustment step to ensure pH uniformity.
Further, Eagle narrowed the in-process pH specifications for the pH measurements taken immediately before and after a filtration step from 2.5-4.5 (for the pre-optimization batches) to 3.42-3.54 (for the post-optimization batches).
Thus, Eagle's optimized manufacturing process achieved its goal of assuring a tighter control over pH.
On the other hand, Par has not demonstrated by a preponderance of the evidence that vasopressin manufactured according to Eagle's optimized process will have a pH that does not meet the stability pH specification.
So, Court found that Eagle does not infringe claims 1, 4, 5, and 7 of the #209 patent and claims 1, 5, and 8 of the #785 patent. This is the gist of the case; more details could be found here.
Par appealed.
On appeal, Par alleges the district court’s finding is clearly erroneous because “actual, real-world evidence” shows that the pH of products released at the upper end of the pH range identified in Eagle’s release specification will inevitably drift up into infringing territory.
CAFC opined, the district court’s finding that there was no upward pH drift in Eagle’s post-release pH data was not clear error. The court thoroughly considered the post-release pH data Par cited, along with Eagle’s expert testimony assessing that data, and found that, while the pH measurements fluctuated over time, there was no discernible trend—and certainly not an inevitable upward trend—in the fluctuations.
CAFC affirmed the District of Delaware’s decision that Eagle’s vasopressin product does not infringe on any of the patents asserted by Par Pharmaceutical.
Eagle had already commenced marketing its product in January 2022 based on the District Court’s decision.
CAFC decision is here
