API and IP Newsletter

 

Contents

• ANDA approvals in October 2024

• General information

• Edwards deals a severe blow to Meril with regular advisors

• Generic Launches - Abbreviated New Drug Applications and 505(b)(2) Applications

• Intellectual Property

• Toray Industries, Inc. EP 2937328 Alcohol Production Method

ANDA approvals in October 2024

We follow ANDA approvals each month. In October 2024, there have been over 90 ANDA approvals and some TAs (tentative approvals). 

The top ANDA approval-seeking companies in October 2024 are the following: many Indian companies are on the top list. 

Company	ANDA approvals
Hetero Labs	7
Macleods Pharms	6
Aurobindo Pharma	4
Dr Reddys	4
Prinston Pharma Inc	4
Alembic	3
Gland Pharma Ltd	3
MSN	3

Some of the other observations are as below:

Drug Name	Company	Comments
LAMOTRIGINE  ANDA  #211821	ALEMBIC	This approval is for 200 mg, 250 mg and 300 mg ER tablets. Several other approvals exist; the competition ANDAs are also approved for the lower strengths.  Lamotrigine ER Tablets 200 mg, 250 mg, and 300 mg have an estimated market size of US$ 163 million for twelve months ending June 2024. Lamotrigine is most commonly used to treat epilepsy.
VARENICLINE TARTRATE.        ANDA  #215931	DR REDDYS	This approval is for 0.5 mg and 1.0 mg varenicline tablets, but there are many others.  According to IQVIA March 2023, varenicline tablets, 0.5 mg and 1 mg, had yearly sales of $501 million in the United States. This is a prescription medicine approved by the FDA to help people quit smoking.
NEBIVOLOL HYDROCHLORIDE.  ANDA  #217397	MSN	This approval is for 2.5 mg, 5 mg, 10 mg, and 20 mg Nebivolol tablets. There are many other approvals.  According to IQVIA, total generic market sales for Nebivolol tablets for the twelve months ending August 2022 were $56.3 million. Recent sales information is not available in the public domain.
ALCAFTADINE.   ANDA  #209290	ALEMBIC	This approval is for ophthalmic drops. There are three other approvals. Alcaftadine Ophthalmic Solution, 0.25% (OTC), temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair, and dander.  The ANDA applicant must circumvent formulation patent US 10617695 (`695) for generic launches.  AbbVie took over the sales of Lastacaft (alcaftadine solution/0.25%) eye drops from Vistakon Pharmaceuticals. The business was licensed from Vistakon Pharmaceuticals, and approved through an sNDA. The product is available as OTC. US patent ` 695 was issued to Vistakon Pharmaceuticals.  The generic launches could be challenging before the expiration of US `695.
MILNACIPRAN HYDROCHLORIDE.     ANDA  #205147	HETERO LABS LTD	This approval is for 12.5 mg, 25 mg, 50 mg, and 100 mg tablets. The US market for Milnacipran Hydrochloride Tablets is approximately USD 145 million. There are only two other products in the US market. Milnacipran is used to treat fibromyalgia. Milnacipran is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs).

General information

Edwards deals a severe blow to Meril with regular advisors

The UPC local division Munich, under presiding Judge Matthias Zigann, ruled on Friday that Meril Life Science infringes on Edwards Lifesciences’ important EP 3 646 825 with its current Myval Octacor Transcatheter Heart Valves.

News here

Generic Launches - Abbreviated New Drug Applications and 505(b)(2) Applications

This blog tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications.

News here

Intellectual Property 

Toray Industries, Inc. EP 2937328 Alcohol Production Method

The opponent (Cooley (UK) LLP.) appealed against the decision of the opposition division to maintain the European patent No. EP 2937328.

The opposition was based on the opposition grounds under Articles 100(a) and 100(b) EPC, for lack of novelty and lack of inventive step (Articles 54 and 56 EPC) and insufficiency of the disclosure. In this write-up, we will discuss inventive steps. 

The contested patent relates to a method for producing alcohol by separating the main component of an alcohol solution, alcohol, from sugar and/or sugar alcohol, which are impurities.  

The patent mentions problems such as decreased yield and quality when alcohol is produced by a fermentation process and purified by distillation due to the presence of sugar and sugar alcohol in the fermentation broth.  

To overcome these problems, the patent provides a technique for efficiently recovering high-quality alcohol while reducing impurities such as sugar and sugar alcohol contained in an alcohol solution.  

Claim 1 of the main request has the following wording:

"A method for producing an alcohol, comprising a step of contacting an alcohol solution comprising sugar and/or sugar alcohol as impurities and comprising an alcohol other than sugar alcohol as a main component, with one kind or a mixture of two or more kinds selected from zeolite, an OH-type strongly basic ion-exchange resin, silica-alumina and alumina, thereby adsorbing and removing the sugar and/or sugar alcohol,

wherein the alcohol other than sugar alcohol is an alcohol having 2 to 6 carbon atoms, and

wherein a concentration of the alcohol other than sugar alcohol in the alcohol solution is 50 weight % or more."

According to claim 1, the patent provides a method for contacting an alcohol solution containing sugar and/or sugar alcohol as impurities and alcohol other than sugar alcohol as a main component with one kind or a mixture of two or more kinds selected from zeolite, an OH-type strongly basic ion-exchange resin, silica-alumina, and alumina, thereby adsorbing and removing the sugar and/or sugar alcohol.

The closest prior art

Document D1 (WO 2004/101479 A2) is the closest prior art. It relates to the purification of biologically produced 1,3-propanediol. Even if, as submitted by the appellant (Cooley), D5 (US 2,504,169) may have more features in common with claim 1, the document relates to a process for the purification of sugars. It thus focuses on the production of sugars rather than alcohol. 

The differing feature

The parties disagreed on the differing features between the method according to claim 1 (of EP 2937328) and the disclosure of document D1. Document D1 does not disclose the use of an OH-type strongly basic ion-exchange resin but a mixed-bed ion exchange resin (see page 14, line 5 to page 15, line 3 and example 7 on page 32, lines 17 to 20). D1 is also silent on the other adsorbents, according to claim 1 of EP 2937328. The differing feature is, thus, at least, the nature of the adsorbent.

The appellant (Cooley (UK) ) argued that document D32 (Experiments for removal of sugar and/or sugar alcohol contained in an aqueous alcohol solution by mixed ion exchange resins, submitted by the patent proprietor) could not be relied upon because the technical effect shown therein was not mentioned in the contested patent as filed.

This argument needs to be more convincing. The application as filed discloses that the use of an OH-type strongly basic ion-exchange resin improves the removal of sugar or sugar alcohol (see paragraphs [0016] to [0018], claim 9, and examples 3, 6, 9, 12, and 18 to 27 of Table 1). 

Document D32 discloses experimental data showing a link between using an OH-type strongly basic ion-exchange resin and the improved removal of sugar or sugar alcohol. Since this effect is derivable from the application as filed, the respondent (i.e., patent proprietor) may rely upon it for inventive steps, even if document D32 was filed after the filing date of the contested patent.

Document D32 shows that the use of the OH-type strongly basic ion-exchange resin SA10AOH leads to better removal rates than the use of a mixed ion exchange resin, which comprises the strong ion exchange resin SK1BH in addition to the OH-type strongly basic ion-exchange resin SA10AOH. 

Document D32 thus demonstrates that an OH-type strongly basic ion-exchange resin leads to better results than a mixed ion-exchange resin, such as the one disclosed in Document D1. The removal rate of the OH-type strongly basic ion-exchange resin is higher.

Thus, the technical problem is providing an improved (OH-type strongly basic ion-exchange resin) or alternative (the other adsorbents) method for producing alcohol.

To solve these problems, a method according to claim 1 is provided, wherein a solution containing sugar and/or sugar alcohol and an alcohol having 2 to 6 carbon atoms other than sugar alcohol in at least 50 weight % of the solution is contacted with the adsorbents according to claim 1, thereby adsorbing and removing the sugar and/or sugar alcohol.

The board is satisfied that the claimed method solves the abovementioned technical problems. The board said, 

1. Document D1 does not suggest using an OH-type strongly basic ion-exchange resin to improve the removal rate of sugar and/or sugar alcohol from the solution purified in example 7. 

2. The document favours a mixed bed polish in the ion exchange purification step (see page 12, lines 10 to 16, and claim 13). It does not suggest an OH-type strongly basic ion-exchange resin, let alone one that would improve the removal rate of sugar and/or sugar alcohol.

3. Document D5 does not relate to the purification of alcohols. Instead, it discloses the recovery of sucrose from molasses, particularly the purification of sugars from cane molasses using absolute ethanol (see example I). 

4. A skilled person looking for an alternative to the method for producing alcohol disclosed in example 7 of document D1 would not consult document D5. Thus, using one kind or a mixture of two or more kinds selected from zeolite, silica-alumina, or alumina in the method of example 7 of D1 to provide an alternative is not obvious to a skilled person.

The patent was maintained, and the appeal was dismissed. 

Decision here