API and IP Newsletter

Contents

• 505 (b) (2) approvals in January 2025
• General information
• Delhi High Court bars use of NOVITAS after pharma giant Novartis alleges trademark violation
• Microsoft sued by software company Veeva over 'Viva' branding
• Intellectual Property
• Astellas Vs Synthon

 

505 (b) (2) approvals in January 2025

 

We follow 505 (b) (2) approvals every month.

This month, there are two approvals.

 

General information

 

Delhi High Court bars use of NOVITAS after pharma giant Novartis alleges trademark violation

The Delhi High Court on February 3 passed an interim injunction restraining a pharmaceutical company from using the trademark "NOVITAS" in response to a trademark infringement suit filed by global pharmaceutical giant, Novartis

 

News here

 

Microsoft sued by software company Veeva over 'Viva' branding

Pharmaceutical software company Veeva Systems  has sued Microsoft  in California federal court, alleging Microsoft's Viva business software infringes its trademarks.

Veeva asked the court to force the tech giant to stop using its Viva branding and requested an unspecified amount of monetary damages.

News here

 

Intellectual Property

 

 

Astellas Vs Synthon

 

In Europe, enzalutamide (sold under the brand name Xtandi) is approved for the treatment of men with high-risk non-metastatic hormone-sensitive prostate cancer.

Enzalutamide (marketed as Xtandi) was launched in Europe and received marketing authorisation from the European Commission in June 2013

 

This case concerns EP 3725778 (EP 778), issued to Astellas Pharma and Medivation Prostate Therapeutics. Medivation developed enzalutamide with Astellas.

 

The District Court in The Hague upheld EP 3725778.

 

Patent EP 778 protects the formulation of enzalutamide.  The SPC is attached to EP 1893196 till June 2028. This EP 1892196 is the composition of matter patent.

 

EP3725778 will expire in September 2033, and those interested in launching after the expiration of the composition of matter patent must circumvent the claims in EP 778.

EP `778 claims a solid pharmaceutical composition comprising a solid dispersion containing amorphous enzalutamide and a concentration-enhancing polymer, wherein the polymer is hydroxypropyl methylcellulose acetate succinate.

In summary, EP `778 addresses a tablet formulation of enzalutamide.

 

Synthon argued that, on the priority date, it was obvious for the average skilled person to formulate enzalutamide in an amorphous form with a concentration-enhancing polymer as a solid dispersion. Thus, Synthon claimed that the formulation patent lacked inventiveness.

 

Furthermore, the company asserted that the patent was invalid due to the addition of subject matter.

When patents are prosecuted in patent offices, claims are typically amended. Any new technical features or claims introduced during the amendment process that were not originally disclosed in the application as filed, essentially extending the scope of the initial patent disclosure, are regarded as added subject matter, which is strictly prohibited under Article 123(2) of the European Patent Convention (EPC).

 

Astellas argued that EP 778 is inventive because, at the priority date, it was not obvious to the skilled person to choose the claimed formulation. Developing a new formulation for enzalutamide required a lengthy trial-and-error process, and the skilled person would not expect a new formulation to have bioavailability comparable to the Xtandi capsules or to be physically stable.

 

Astellas stated that combining drugs with solubilising polymers does not always enhance bioavailability for low-solubility drugs. A drug's solubilisation depends on its chemical structure and physical properties; therefore, it is not necessarily predictable whether a particular polymer will solubilise a specific drug. Selecting polymers that achieve improved solubilisation is often difficult and time-consuming, as the drug-polymer interaction is poorly understood. For instance, adding polymers may actually accelerate a drug's dissolution rather than increase its concentration.

 

Astellas further argued that the claims in EP 778 are directly and unambiguously derivable from the original application, indicating that there is no added matter.

 

The court commented that the objective technical problem could be formulated as providing an alternative oral solid pharmaceutical composition containing enzalutamide. This composition has a bioavailability comparable to that of Xtandi capsules and sufficient stability, making it easier to take.

 

Given an existing solid oral formulation with adequate bioavailability, the court assumes that a skilled person will not consider other forms of administration, as solid oral is generally preferred.

 

The Court stated that, on the priority date, it was not clear to a skilled person how to formulate enzalutamide in an amorphous form using hydroxypropyl methylcellulose acetate succinate as a solid dispersion, as Synthon claimed. Patent claims were granted.

 

The court rejected Synthon’s arguments for revocation of these claims based on inventiveness.

 

The Court decided in favour of Astellas. Synthon might appeal against this decision.

The decision's English version is unavailable, and the article primarily relies on Google Translate.

 

Decision here.

 

As a side note,

 

1. The composition of matter patent EP 1892196, is also litigated.

2. Viatris has received approval for generic enzalutamide; however, the public domain does      not indicate a generic launch in Europe.

3. The EPO upheld EP ‘778 in the first instance. The Technical Board of Appeal is currently      hearing an appeal against this decision.