API and IP Newsletter
Contents
Generic Drugs Program Activities Report - FY 2022 Monthly Performance
Analysis of ANDA and DMF filings
More details here
This is bit dated information at FDA website, though FDA site mentions it is updated till 02 March 2023! This table represent financial year. As many of the readers would know in the United States, the federal government's fiscal year ends on 30 September.
We will update as soon as FDA site is updated. But one can see the directional trend under various headings in the table.
Let us understand some of the terminologies in this table and consequences for the sponsors of ANDA, such as “Refuse to Receive (RTR) – Originals”.
This is an important concept. Please note, if the FDA determines an ANDA as RTR, they will notify the sponsor, who may then:
(i) Withdraw the ANDA under 21 CFR 314.99; or
(ii) Correct the deficiencies and resubmit the ANDA; or
(iii) Take no action, in which case FDA may consider the ANDA withdrawn after 1 year.
Then one can notice GDUFA I and GDUFA II in the table. What is the difference between the GDUFA I and GDUFA II?
There is refund possibility under GDUFA II.
Under GDUFA I, sponsors had no incentive to withdraw and correct an application, even if they become aware of a fatal flaw in the application. With GDUFA II, if for any reason a sponsor decides to withdrawal an ANDA application before it has been received for filing by the Office of Generic Drugs, they are entitled to a 75% refund of the application fee for the fiscal year in which the application was submitted.
Then understand submission types.
More details here
What is First Cycle Approvals?
This should be the aim of the regulatory scientist in any company’s regulatory department.
It means a drug is approved on the first cycle. A complete response letter is not sent as no deficiencies are identified.
General information
SPC Lifesciences Files Draft Papers With SEBI For IPO
Pharmaceutical ingredients maker SPC Lifesciences Ltd has filed preliminary papers with the capital market regulator Sebi to raise funds through an initial public offering. The Initial Public Offering (IPO) consists of fresh issuance of equity shares worth Rs 300 crore and an Offer For Sale (OFS) of 89.39 lakh equity shares by promoter -- Snehal Rajivbhai Patel -- according to the draft red herring prospectus.
News here.
MacFarlan Smith to close Annan API manufacturing facility
Pharmaceutical company MacFarlan Smith has proposed the closure of its facility near Annan, UK, after its parent company Veranova concluded its manufacturing capacity exceeds market demands.
Referred to as Annan by its owner, the site in Southwest Scotland manufactures intermediate and finished product active pharmaceutical ingredients (APIs).
It hosts a multipurpose API pilot plant, which includes reactors up to 1,600 L, and a large-scale GMP manufacturing facility that includes two manufacturing trains. The large-scale facility has total reactor capacity of 65,000 L and is capable of batch sizes up to 800 kg. Good manufacturing practice, or GMP, is the minimum standard that medicine manufacturers must meet in their production processes.
News here
Intellectual Property
Abbott Vs Nestle: T 0703/18 (Infant formulas containing DHA and lutein
This proceeding is for EP 1945045. This was issued to Abbott Laboratories.
This decision concerns the appeal filed by Société des Produits Nestlé S.A. (Nestle) against the opposition division's decision to reject the opposition.
Nestle requested that the patent be revoked due to lack of inventive step, among other things.
The documents relevant to this decision are:
D16: US 2003/0228392 A1
D18: V. C. Jewell et al., "A comparison of lutein and zeaxanthin concentrations in formula and human milk samples from Northern Ireland mothers", European Journal of Clinical Nutrition, 58, 2004, 90-97
The only claim relevant to the decision is claim 1 of the patent as granted (main request). It reads:
"A ready-to-feed liquid infant formula comprising fat, protein, carbohydrate, vitamin, and minerals, including docosahexaenoic acid and at least 75 µg/liter of lutein, wherein the weight ratio of lutein (µg) to docosahexaenoic acid (mg) is from 1:2 to 10:1 and the formula is free of egg phospholipids."
Nestle argued that claim 1 lacked inventive step over D16 (US 2003/0228392 A1) as closest prior art. The distinguishing feature was the concentration of lutein. The problem solved was to provide an infant formula suitable for new-born infants. The solution would have been obvious in view of the disclosure of D18.
Abbott on the other hand, argued that claim 1 involved an inventive step. D16 was the closest prior art. The claimed subject-matter differed from example 1 of D16 by a higher concentration of lutein (at least 75 µg/liter in claim 1 and in example 1). Abbott further stated, the invention was a "problem invention" and resided in recognising that bioavailability of lutein from infant formula was low. None of the prior art documents addressed this problem. The solution would not have been obvious to the skilled person.
D18 teaches that the concentration of lutein found in human milk, and especially in milk of mothers of new-born infants, is considerably higher than that disclosed by example 1 of D16.
In view of this, the solution that the skilled person would have provided is to increase the concentration of lutein. This has the inevitable side effect that the bioavailability of lutein is increased. Increasing the amount of lutein in an infant formula is a straightforward exercise.
D16 suggests the addition of a commercially available ingredient.
Nestle argued that the skilled person would have chosen a concentration of 75 µg/liter or higher. The board said, it had no reason to doubt that this is a value that the skilled person would consider. This value is within the range suggested in claim 2 of D16.
The Board concluded, irrespective of whether the amount of lutein selected is 75 µg/liter, 109 µg/liter (as discussed in D18) or even as high as 230 µg/liter (the highest amount suggested in D16), with any of these concentrations the weight ratio of lutein (µg) to docosahexaenoic acid (mg) called for in claim 1 would be fulfilled.
Therefore, the Board opined claim 1 as granted lacks inventive step. And patent was revoked.
Decision here.
