API and IP Newsletter
Contents
New Drugs Approvals in CY 2024 in India
We follow new drug approvals published on the Central Drugs Standard Control Organization (CDSCO) website.
This website has published 18 approvals so far this year; the last approval updated on the website was on 08 October 2024. This write-up will cover approvals from January 2024 to June 2024. Details are here. The name of the applicant or MA holder is not updated on the website on the same webpage, and one should search either on the CDSCO site but a different webpage or some other website in the public domain to find out the name of the MA holder.
General information
GlaxoSmithKline and Northwestern Sue Moderna for Patent Infringement in Trio of Lawsuits
On October 15, 2024, GSK filed two complaints against Moderna in the District Court for the District of Delaware, asserting that Moderna willfully infringes GSK’s mRNA patent portfolio.
GSK accuses Moderna’s Spikevax(R) SARS-CoV-2 S protein mRNA vaccine products of infringing U.S. Patent Nos. 11,291,682, 11,324,770, 11,596,645, 11,690,862, 11,707,482, 11,666,534, and 11,786,467. GSK seeks, among other relief, money damages for the alleged infringement and a compulsory ongoing licensing fee.
News here
Peugeot and August Debouzy keep scooters rolling in France
Piaggio is known for its Vespas but it also manufactures two- and three-wheeled motorcycles. The Italian manufacturer accuses French automotive company Peugeot of infringing several property rights with its motorcycle model “Metropolis”.
The patents originally at issue are EP 1 363 794, EP 1 561 612, EP 1 571 016 and EP 1 635 234 as well as community model 487723-0001. These cover a tilting technology that allows riders of three-wheeled scooters to lean into corners.
Piaggio filed an infringement claim with the Judicial Court Paris in 2015.
Peugeot customers can continue to drive the company's three-wheeled scooters on French roads. The Paris Court of Appeal has now limited a previous first-instance ruling that favoured competitor Piaggio.
News here
Intellectual Property
Exelixis Inc. Vs MSN
The below patents are listed in the Orange Book for Cabozantinib S-Malate (Cabometyx) Tablet and (Cometriq) capsules.
Exelixis, Inc. brought this patent infringement action under the Hatch-Waxman Act against MSN Laboratories Private Limited and MSN Pharmaceuticals, Inc. ("MSN") in Delaware District Court. A four-day bench trial was held from 23 October to 26 October 2023. The decision was handed down last week.
The asserted patents fall into two groups.
The first group consists only of U.S. Patent number 11,298,349 (the " 349 patent"). Exelixis asserted Claim 3 of the '349 patent. The parties disputed whether MSN infringed Claim 3 of the '349 patent.
The parties disputed whether Claim 3 of the '349 patent is invalid as obvious. In this write-up, we are not covering the Court's discussions regarding the first group, i.e., the 349. For the information of readers, the Court said that this pharmaceutical composition patent (i.e., `349) is not invalid and not infringed by MSN’s proposed ANDA product.
The second group consists of U.S. Patent Nos. 11,091,439 (the "'439 patent"), 11,091,440 (the "'440 patent"), and 11,098,015 (the '"015 patent"). This group is called the Malate Salt Patents; they share an identical specification.
The claims at issue are Claim 4 of the '439 patent, Claim 3 of the '440 patent, and Claim 2 of the '015 patent.
MSN stipulated the infringement of the asserted claims of the Malate Salt Patents. The parties dispute whether the asserted claims of the Malate Salt Patents are invalid for lack of written description and obviousness-type double patenting. In this write-up, we will discuss about the obvious type of double patenting.
MSN argued that Claim 4 of the '439 patent is invalid for obviousness-type double patenting of Claim 5 of the '473 patent.
Claim 5 of the '473 patent covers the cabozantinib compound and "pharmaceutically acceptable salts."
Claim 4 of the '439 patent covers the crystalline cabozantinib (L)-malate salt.
The first step of the obviousness-type double patenting analysis is to construe the asserted claims of the earlier and later-issued patents and determine whether there are differences.
Here, the issue to be resolved at step one is whether a POSA (person of ordinary skill in the art) would have recognised that crystalline cabozantinib (L)-malate is a pharmaceutically acceptable salt of the cabozantinib compound.
MSN argued that a POSA would recognise that crystalline cabozantinib (L)-malate is a pharmaceutically acceptable salt of cabozantinib.
MSN cited Dr Steed, Dr Koleng, and Dr Trout's testimony that crystalline (L)-malate is a pharmaceutically acceptable salt of cabozantinib.
Exelixis contended that neither the specification of the Malate Salt Patents nor the specification of the '473 patent mentioned malic acid.
Exelixis argued that a POSA would not know that crystalline cabozantinib (L)-malate is a pharmaceutically acceptable salt of cabozantinib.
The Judge favoured Exelixis and said Exelixis' arguments are more appropriate for step two of the obviousness-type double patenting analysis.
The issue under step one is whether there are differences between Claim 4 of the '439 patent and Claim 5 of the '473 patent.
Claim 4 of `439 (latter issued)
4. The N-(4-{[6,7-bis(methyloxy)quinolin-4-yl]oxy}phenyl)-N′-(4-fluorophenyl) cyclopropane-1,1-dicarboxamide, malate salt according to claim 3, wherein said salt is the (L)-malate salt.
Claim 5 of `473 (reference patent)
5. The compound which is represented by the following structure:
Or a pharmaceutically acceptable salt thereof.
Step one of the obviousness-type double patenting analysis is whether the asserted claim of the later-issued patent is directed to a species of the reference patent's genus claim.
Claim 5 of the '473 patent is very broad. It encompasses the genus of all pharmaceutically acceptable salts of cabozantinib.
The Judge said he credits Dr Steed, Dr Koleng, and Dr Trout's testimony that crystalline (L)-malate is a pharmaceutically acceptable salt of cabozantinib. Therefore, Claim 4 of the '439 patent is directed to a species of the '473 patent's genus claim, i.e., crystalline cabozantinib (L)-malate.
However, the obviousness-type double patenting inquiry does not end here. "Obviousness is not demonstrated merely by showing that an earlier expiring patent dominates a later expiring patent. It is well-settled that a narrow species can be non-obvious and patent eligible despite a patent on its genus."
The Judge said that if the later expiring patent is an "obvious variation" of the earlier expiring patent, it is invalid for obviousness-type double patenting. The Judge further analysed whether crystalline cabozantinib (L)-malate is "merely an obvious variation" of cabozantinib and its pharmaceutically acceptable salts.
In this regard, MSN argued that a POSA would be motivated to make a salt of cabozantinib. MSN argued that the '473 patent claims the salt form of cabozantinib. Dr Steed testified that half of all drug products have APIs in salt form and that the prior art taught salt formation was a way to improve the API's properties, including solubility and dissolution rate.
Exelixis disputed that a POSA would be motivated to form a salt.
Exelixis contended that MSN must show some reason for a POSA to develop a salt when the POSA already had the free base.
Exelixis cited the Merck case to prove the point. It was opined in Merck’s case that the mere fact that the prior art covers the sitagliptin free base and pharmaceutically acceptable salts of sitagliptin would not, in and of itself, have motivated a POSA to abandon the free base form of sitagliptin to go in search of an acid-addition salt of this compound.
Dr. Steed testified that if the free base was free of problems, a POSA would pursue it as a first formulation option.
However, Dr. Steed also testified that the free base had a solubility issue, which would justify pursuing a salt.
Exelixis argued that there were no problems with the free base reported in the prior art, so a POSA would have no reason to make a cabozantinib salt.
Dr. Trout testified that the prior art did not disclose reasons to form a salt of cabozantinib.
Dr. Trout testified that a POSA would have considered cabozantinib's permeability to drive its bioavailability rather than trying to solve the solubility issue to improve bioavailability.
The Judge said the question is not whether malic acid is a possible alternative but whether a POSA would consider it when so many more promising alternatives exist.
The Judge found a POSA would not. The Judge opined.
A POSA would not be motivated to use malic acid to form a salt of cabozantinib.
MSN does not show whether a POSA would reasonably expect success in forming a crystalline salt.
MSN cited Dr Steed's testimony that most salts can be crystallised to argue that a POSA would reasonably expect success in forming a crystalline salt.
This argument could not persuade the Judge. He said a POSA would not be motivated to use malic acid to form a salt and would not have a reasonable likelihood of success in obtaining a crystalline salt using malic acid. Therefore, he found the asserted claims of the Malate Salt Patents are non-obvious.
With this decision, and as the situation stands today, the earliest that MSN may be permitted to launch its proposed generic product in the U.S. commercially is 15 January 2030.
Decision here
