API and IP Newsletter
Contents
Import data analysis of Neuland Laboratories Limited
We study import export databases and try to analysis development portfolio any the companies, this month we chose to analyse portfolio of Neuland Laboratories and some of our observations are tabulated below.
General information
Flow Chemistry Centre of Excellence coming up in Hyderabad
This initiative is aimed towards ensuring greater incorporation of flow chemistry techniques during pharma research and development and greater adoption of continuous synthesis for manufacturing of active pharma ingredients.
News here.
Initiator Pharma receives CTA approval for IPTN2021 program P- I study to assess pain reducing effects
Initiator Pharma A/S, a clinical-stage pharma company, announced today that it has received approval of a Clinical Trials Application for its planned Phase I study in the IPTN2021 program with the drug substance IP2015 in healthy subjects challenged with pain inducing ingredient (capsaicin).
Initiator Pharma’s Clinical Trial Application (CTA) for its planned Phase I study in healthy male subjects has been approved by the Medicines & Healthcare products Regulatory Agency, MHRA, UK as well as the local Ethics Committee. Subject inclusion and dosing is expected to commence in January 2022. The study will be carried out in collaboration with MAC Clinical Research, UK, as a single site study.
News here.
Intellectual Property
Paliperidone decision by NJ District Court in favor of Brand company
OB listed patent is as below
In January 2018, Janssen initiated a patent infringement lawsuit in the District of New Jersey against Teva, who filed an ANDA seeking approval to market a generic version of INVEGA SUSTENNA before the expiration of US 9,439,906 (the ’906 patent). INVEGA SUSTENNA sale is about USD 3.6 bn in 2020. Here.
The Court held a two-week bench trial in this matter that began on 13 October 2020 and concluded on 30 October 2020. The parties submitted post-trial briefing and proposed findings of fact and conclusions of law in December 2020.
Claim of US 9439906 is as follows:
1. A dosing regimen for administering paliperidone palmitate to a psychiatric patient in need of treatment for schizophrenia, schizoaffective disorder, or schizophreniform disorder comprising
(1) administering intramuscularly in the deltoid of a patient in need of treatment a first loading dose of about 150 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the first day of treatment;
(2) administering intramuscularly in the deltoid muscle of the patient in need of treatment a second loading dose of about 100 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the 6th to about 10th day of treatment; and
(3) administering intramuscularly in the deltoid or gluteal muscle of the patient in need of treatment a first maintenance dose of about 25 mg-eq. to about 150 mg-eq. of paliperidone as paliperidone palmitate in a sustained release formulation a month (±7 days) after the second loading dose.
This write up we will deal with obviousness arguments and how Teva failed to convince the judge starting from prior art ie `548 protocol’.
In US Courts, to prove that an asserted claim of a patent is invalid as obvious, a patent challenger bears the burden of establishing by clear and convincing evidence that the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art (A person of ordinary skill = “POSA.”)
To establish obviousness in `906 patent, Teva relied on three prior art references at trial:
a summary protocol for Janssen’s PSY-3003 clinical study titled “A Randomized, DoubleBlind, Placebo-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (50 Mg eq., 100 Mg eq., and 150 Mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia” (the ‘548 Protocol’);
U.S. Patent No. 6,555,544 (the ‘544 Patent’), a patent assigned to Janssen Pharmaceutica, N.V. titled “Aqueous Suspensions of Submicron 9-Hydroxyrisperidone Fatty Acid Esters”; and
International Patent Publication Number WO 2006/114384 (the “WO’384 Publication”),
The ’548 Protocol is a published two-page summary protocol of Janssen’s unsuccessful PSY-3003 clinical trial aimed at measuring the safety and efficacy of administering “fixed doses” of either 50, 100, or 150 mg-eq. of paliperidone palmitate “in the gluteal muscle” for “treating subjects with schizophrenia.”
In the study, equal doses were to be administered on “Days 1, 8, 36, and 64.”
The hypothesis of the study was that the 3 fixed doses of paliperidone are each more efficacious than placebo in treating subjects with schizophrenia. Janssen received the PSY-3003 results in August 2006, which failed to reach the endpoint.
The results indicated that PSY-3003 failed to demonstrate superiority of any dose of paliperidone palmitate.
The parties agreed that the ’548 Protocol does not contain clinical results or safety data, and that a POSA would have to look beyond this reference in order to understand how the ’548 Protocol worked in subjects.
At trial, Dr. Wermeling, Teva’s expert, explicitly acknowledged that the ’548 Protocol is a protocol without any results and does not provide any safety or efficacy data.
The ’548 Protocol and the ’906 Patent differ in several material respects. The ’548 Protocol discloses equal doses of paliperidone palmitate administered in the gluteal muscle on fixed treatment days, while the ’906 Patent contains regimens comprised of unequal doses, two of which must be administered in the deltoid muscle, and a broader dosing window for the second and monthly maintenance doses.
Teva argued that the ’548 Protocol provides a proper starting point for arriving at the claimed dosing regimens because it provided guidance on using loading doses followed by monthly administration of paliperidone palmitate.
But the Court said, Teva failed to adequately explain why a POSA would modify the ’548 Protocol’s teachings in the precise ways required to achieve the dosing regimens claimed in the ’906 Patent, and the mere fact that the ’548 Protocol and the ’906 Patent contain some similar features is not enough to show obviousness.
The another issue with starting from the ’548 Protocol would be, it contains no information about the safety of the dosing regimen or its efficacy, the study was actually ineffective, and Teva has failed to persuasively argue, how a POSA would know to alter the equal doses in the gluteal muscle described in the ’548 Protocol to arrive at the unequal loading doses in the deltoid claimed by the ’906 Patent without knowing the results of the trial?
In fact, the only way to know how to modify the ’548 Protocol to follow teaching of ’906 Patent. The POSA wouldn’t have reasonable expectation of success starting from ‘548 protocol, and hence `906 is inventive and Janssen succeeded in District Court of New Jersey. Here
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