API and IP Newsletter

Contents

  • General information
    • 2024 Hatch-Waxman Year in Review
    • Massachusetts AG Sues Insulin Makers and PBMs Over Alleged Price-Fixing Scheme
  • Intellectual Property
    • Honeywell International Inc.Vs Arkema France


List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

 

We regularly follow the USFDA website. There’s a wealth of information.

 

The FDA publishes a list of approved new drug application (NDA) drug products that are not under patent or exclusivity and for which the FDA has not approved an ANDA referencing that NDA drug product. 

 

The FDA updates this list every six months (in June and December) to improve transparency and encourage the development and submission of ANDAs in markets with little competition.

 

Part I of the list identifies the drug products for which the FDA could immediately accept an ANDA without prior discussion. 

 

Part II identifies drug products with potential legal, regulatory, or scientific issues that need to be addressed with the Agency prior to submission of an ANDA. 

 

Sponsors seeking approval for drug products listed in Part II should first submit an initial inquiry to the Office of Generic Drugs (OGD). The FDA advises that some products in Part II may not qualify for submission as an ANDA through the 505(j) pathway; the 505(b)(2) pathway could be a suitable abbreviated approval option.

  

The FDA website recently published a list of such products until December 2024. Many FDF developers will be interested in finding suitable candidates for development from this list.

 

Some of the oral solids in the list Part II are as follows:


A comprehensive list of Parts I and II can be found here.

 

 

General information

 

2024 Hatch-Waxman Year in Review

In 2024, a total of 312 complaints were filed.

The overwhelming majority of ANDA complaints were filed in the District of Delaware and the District of New Jersey. This common trend remains consistent for the same reasons these district courts have always been hubs for ANDA litigation: most pharmaceutical companies are incorporated in Delaware and are commonly headquartered in New Jersey.

 

News here

 

Massachusetts AG Sues Insulin Makers and PBMs Over Alleged Price-Fixing Scheme

Massachusetts Attorney General Andrea Joy Campbell has filed a lawsuit in Suffolk Superior Court against three major insulin manufacturers—Eli Lilly, Sanofi, and Novo Nordisk—and pharmacy benefit managers (PBMs) Optum RX, Express Scripts, and CVS Caremark, accusing them of engaging in an unfair and deceptive pricing scheme that has driven up the cost of insulin for diabetics across the state.

News here

 

Intellectual Property

 

Honeywell International Inc.Vs Arkema France

 

The patent proprietor Honeywell appealed the opposition division's decision to revoke European patent No. EP 2461904

Following prior art documents were cited.


The subject-matter of claim 1 according to the main request reads as follows:

"1. A method for hydrogenating a compound comprising:

contacting a reactant comprising a fluoroolefin, with a supported hydrogenation catalyst under reaction conditions effective to form a reaction product comprising a hydrogenated derivative of said olefin; the method comprising the steps of:

a) adding hydrogen and a fluoroolefin to a reaction vessel containing the hydrogenation catalyst; and

b) reacting said fluoroolefin with hydrogen over said hydrogenation catalyst to produce a hydrofluorocarbon; wherein said fluoroolefin reactant and said hydrofluorocarbon reaction product are selected from the following combinations:

1,1,2,3,3,3-hexafluoropropene (FO-1216; HFP) and 1,1,1,2,3,3-hexafluoropropane (HFC-236ea);

1,2,3,3,3-pentafluoropropene (HFO-1225ye) and 1,1,1,2,3-pentafluoropropane (HFC-245eb);

1,1,3,3,3-pentafluoropropene (HFO-1225zc) and 1,1,1,3,3-pentafluoropropane (HFC-245fa);

1,3,3,3-tetrafluoropropene (HFO-1234ze) and 1,1,1,3-tetrafluoropropane (HFC-254fb); and

2,3,3,3-tetrafluoropropene (HFO-1234yf) and 1,1,1,2-tetrafluoropropane (HFC-254eb);

and wherein said supported hydrogenation catalyst comprises:

a) 90 to 99.9 weight % of alumina, wherein said alumina is at least 90 weight % alpha-alumina; and

b) 0.1 to 10 weight % of at least one zero-valent metal, wherein said at least one zero-valent metal is selected from the group consisting of Ru, Pt, Rh and Ir."

 

We will discuss the Non-obviousness arguments.

1. D14 is a scientific paper on the electrochemical passivation of aluminium surfaces. This document indicates that the formation of a layer of alpha-alumina on aluminium reduces corrosion in the presence of certain corrosive substances, such as HF.

2. The opposition division concluded that when starting from D10 or D11, using alpha-alumina as catalytic support would be an obvious consideration because of D14.

3. In particular, D14 taught that substituting gamma-alumina with alpha-alumina would improve resistance to hydrogen fluoride; it would be obvious to contemplate using the latter to solve the problem of finding an alternative catalyst support with improved resistance in corrosive environments containing HF.

4. The respondent (Archema) also argued that using a catalyst supported by alpha-alumina in hydrogenation reactions was known from D8 or D9. In particular, D8 explicitly stated that employing alpha-alumina as a support material reduced catalyst inactivation and extended its lifespan.

5. Document D9 indicated that alpha-alumina supports are generally a preferred choice for hydrogenation reactions.

Decision of the appeal board

1. The appeal board stated that it could not accept these arguments and, in particular, does not see why a skilled person starting from D10 or D11, while seeking solutions to the problem of providing a method for the hydrogenation of fluoroolefins using a catalyst with improved long-term performance, would consider the teachings of any one of D8, D9, or D14.

2. The board stated that D14 pertains to a process for the electrochemical passivation of aluminium through anodic oxidation and is thus not in the same technical field as the invention, nor even in a neighbouring field.

3. Furthermore, there is no reference in D14 to using alumina material as a catalytic support. In fact, it is clear that the purpose of alumina in D14 is entirely different from that of the invention, as this document discusses aluminium pieces with a protective alpha-alumina film, which not only provides resistance to corrosion but also aims to enhance paint or varnish adhesion due to its porosity.

4. All in all, since none of the documents cited by the respondent (Archema) teaches directly or indirectly that the use of alpha-alumina as support material would solve the problem of improving the long-term performance of the catalyst in a process for the hydrogenation of fluoroolefins, the subject-matter of claim 1 at issue is not obvious from the known state of the art when starting from D10 or D11 as the closest prior art.

The board concluded that the invention, according to the main request, meets the requirements of Article 56 EPC, and the patent was upheld.


 

Decision here




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