API and Ip Newsletter

 

Contents

• Recent Paragraph IV filings

• General information

• You can file a patent application for an AI-assisted invention

• Australia's Mayne Pharma sues Sun Pharma over patent infringement

• Intellectual Property

• L'OREAL Vs Henkel AG

Recent Paragraph IV filings

We follow P-IV filings. In May 2024, there were two paragraph-IV filings. The FDA site uploaded this information on 08 July 2024. Once Generic notifies Brand, and if sued ( in this case, it would be certain that Brand would sue Generic), then one would come to know who had filed ANDAs. 

Drug Name	Date of Submission	Sidvim Comments
Capmatinib Dosage Form Tablets Strength  150 mg and 200 mg RLD/ NDA Tabrecta. 213591	06 May 2024	This is an is an anticancer medication used for the treatment of metastatic non-small cell lung cancer.  Novartis had protected pharmaceutical formulations of Capmatinib with increased dosage amounts, enhanced bioavailability, and improved dissolution at higher pHs (pH 4.5-6.8) in US 10596178. This must be the marketed formulation by Novartis.  One ANDA filed on NCE-1 date. The ANDA filer must either circumvent this patent and be bioequivalent to Tabrecta or challenged the validity of this patent. Natco, Teva imported API and formulation of Capmatinib. One of them (or both in coordination) could have filed ANDA on NCE-1 date.
Selpercatinib Dosage Form Capsules Strength 40 mg and 80 mg RLD/ NDA Retevmo 213246	08 May 2024	This is a medication for the treatment of cancers.  US 10112942 claims compound and would expire in 2037.  WO 2019/075108 patent family describes various crystalline forms of selpercatinib including an anhydrous Form 1, hydrates Form 2 and Form 7, and an IPA solvate Form 8.  The application teaches that Form 1 of selpercatinib is the most stable form. In US, these forms are protected till 2038. Only one ANDA was filed on NCE-1 date. Teva had imported API and might have used in development of generic Retevmo. Teva had filed patent application WO2022020279A1 for Form SI of Selpercatinib and hence there is a high probability that Teva could have filed ANDA on NCE-1 date.  There are other companies who had filed patent applications for different polymorphs and one of them also could have filed ANDA on NCE-1 date.

General information

You can file a patent application for an AI-assisted invention

Artificial intelligence cannot be an inventor. The Federal Court of Justice recently decided this for Germany. The court nevertheless allowed the application for an AI-generated invention, a success for Stephen Thaler, who created Dabus. Malte Köllner, a patent attorney in the Dabus case, explains to JUVE Patent the ruling's implications for the industry. 

News here

Australia's Mayne Pharma sues Sun Pharma over patent infringement

In the lawsuit filed at the United States District Court for New Jersey, Mayne Pharma accused its rival of violating all 20 Orange Book-listed patents linked to IMVEXXY - a vaginal insert aimed at reducing pain during sexual intercourse after menopause. 

News here 

Intellectual Property 

L'OREAL Vs Henkel AG

This is about EP 2846761 issued to L'OREAL

This is titled as Composition comprising (2,5-diaminophenyl)ethanol, an alkylpolyglucoside nonionic surfactant, an oxyethylenated sorbitan ester or a polyalkoxylated or polyglycerolated fatty alcohol in a medium rich in fatty substances, dyeing process and device therefore.

Henkel AG & Co. KGaA opposed the patent and obtained favourable decision from the first instance ie the Opposition Division at EPO.

The patent proprietor (appellant) L'OREAL  appealed the decision of the Opposition Division to revoke its patent under Articles 101(3)(a) and (b) EPC.

The patent deals with compositions useful in oxidative hair dyeing processes. Claim 1 of the patent reads as follows:

"Composition for dyeing keratin fibres, in particular human keratin fibres such as the hair, comprising:

a) one or more fatty substances not containing any salified or unsalified carboxylic acid groups being neither polyoxyalkylenated, nor polyglycerolated;

b) one or more alkyl(poly)glucoside nonionic surfactant(s), and/or one or more oxyethylenated C8 to C30 fatty acid ester(s) of sorbitan, and/or one or more (poly)alkoxylated fatty alcohol(s) and/or one or more (poly)glycerolated fatty alcohol(s);

c) one or more oxidation base(s) chosen from 2-beta-hydroxyethyl-para-phenylenediamine and also acid salts thereof or solvates thereof such as hydrates;

d) optionally one or more coupler(s);

e) optionally one or more basifying agent(s);

f) one or more chemical oxidizing agent(s); and

the fatty substance content representing in total at least 25% by weight relative to the total weight of the composition."

The following documents are referred to in the present decision:

D1	EP 2 198 927
D3	Experimental Report, filed by the appellant during examination proceedings on 7 July 2017
D5	DE 10 2006 012 575 A1
D11	EP 0 727 203
D12	Experimental Report, filed by the appellant during opposition proceedings on 11 October 2021
D13	Experimental Report, filed by the appellant during appeal proceedings on 12 May 2022

The patent had been opposed under Article 100(a) EPC for lack of novelty and inventive step (Articles 54/56 EPC). 

In its decision the Opposition Division concluded that 

1. neither the compositions defined in claim 1 of the granted patent nor the compositions defined in claim 1 of auxiliary request 1 were novel over D5.

2. The compositions defined in claim 1 of auxiliary requests 2-9 were found to lack inventive step over a combination of D1 and D11.

In appeal proceedings the appellant ie L'OREAL argued that the decision of the Opposition Division was erroneous in denying novelty and inventive step over the cited documents. Additionally, with its statement setting out the grounds of appeal  L'OREAL  filed new experimental evidence D13 in order to support inventive step.

L'OREAL requested the decision of the Opposition Division to be set aside and the patent to be maintained as granted, or in amended form based on any of auxiliary requests (ARs)1 to 5, as filed together with the statement setting out the grounds for appeal. 

Closest prior art

D1 discloses hair dyeing compositions which have favourable colouration properties, in particular with respect to intensity and homogeneity of the colouration. This corresponds to the goals that the disputed patent tries to achieve. It was undisputed between the parties that D1 represents the closest prior art to the claimed compositions.

L'OREAL  argued

1. The compositions defined in the claims of the granted patent EP 2846761 differ from the compositions disclosed in example 1 of D1 in the nature of the dye precursor, namely 2-beta-hydroxyethyl-para-phenylenediamine, as opposed to toluene-2,5-diamine used in example 1 of D1. 

2. Although D1 also mentions 2-beta-hydroxyethyl-para-phenylenediamine, there is no disclosure of a composition as specific embodiment containing this compound as an oxidation base together with the other components defined in claim 1 of the granted patent.

3. The technical problem to be solved was the provision of dyeing compositions leading to more homogeneous colouration along the hair fibre. In view of the technical reports D3 and D12 this problem has been solved by the provision of the claimed compositions, which are characterized by the use of 2-beta-hydroxyethyl-para-phenylenediamine as dye precursor. All this was undisputed between the parties.

Obviousness of the claimed solution

1. The disputed issue was whether this technical problem had been solved in an obvious way. According to the reasoning of the Opposition Division D11 (ie EP 0 727 203) taught already that 2-beta-hydroxyethyl-para-phenylenediamine may be used as dye precursor in order to achieve a particularly homogeneous colouration along the hair fibre.

2. It is correct that D11 does not teach a superiority of 2-beta-hydroxyethyl-para-phenylenediamine with respect to other dye precursors of the family proposed in D1. 

3. However, D11 clearly teaches that the use of this oxidation base leads, under the conditions compatible with D1, to a particular homogeneous colouration of the hair. D11 discloses compositions for oxidative hair dyeing that contain the oxidation base 2-(2,5-Diaminophenyl)-ethanol, see claim 1 of D11.

4. A skilled person, trying to improve colouration homogeneity starting from example 1 of D1, would of course look to a document describing an oxidation base as particularly useful for this purpose, and try whether the expected advantages materialize. 

5. This applies even more if, as presently the case, this oxidation base is already listed in D1 itself as a possible alternative and a skilled person has thus no reason to expect any incompatibility of the compound with the compositions used in the closest prior art.

6. Thus, the Appeal Board opined that the Opposition Division's finding that the claimed solution of the objective technical problem would have been obvious for a skilled person is correct. In simple words, it would have been obvious for a skilled person from D11 that replacing the oxidation base used in example 1 of D1 by the alternative one mentioned in paragraph 0086 of D1. The skilled person could have arrived at 2-beta-hydroxyethyl-para-phenylenediamine, which would lead him to more homogeneous hair colouration.

7. Hence the Appeal Board decided the claimed compositions are obvious for a skilled person when combining the teachings of D1 and D11.

Decision Here