Multiple SPC Applications Identified for Vildagliptin Products

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GenericsWeb, the leader in established pharmaceutical patent analysis and searching, recently published an article based on its proprietary Pipeline Patent Intelligence that analyses opportunities in launching generic versions of the dipeptidyl peptidase-4 (DPP-4) inhibitor, Vildagliptin. Marketed by Novartis, Galvus® (Vildagliptin) and Eucreas® (Vildagliptin in combination with Metformin) are indicated for the treatment of Type II diabetes with reported global sales for Vildagliptin products of USD $391m in 2010.

The article by GenericsWeb highlights the following observations in relation to generic Vildagliptin:

  •     Galvus and Eucreas are currently available as oral tablet formulations.
  •     Vildagliptin is currently authorised in Europe and Australia, however Vildagliptin is not currently approved in Canada or the US.
  •     The earliest patent family identified as relating to Vildagliptin relates to the use of DPP-4 inhibitors for the treatment of diseases which are based on glucose concentrations, a group amongst which Vildagliptin is included. Opposition proceedings were brought against the granted European patent within this family by Boehringer Ingelheim, Bristol-Myers Squibb, Glaxo, Novartis, Novo Nordisk, Takeda, Tanabe Seiyaku and Pfizer, resulting in revocation of the patent.
  •     Novartis’ molecule patent family protection for Vildagliptin remains in force in all major territories until December 2019. In Europe, Supplementary Protection Certificates (SPCs) and a national patent term extension in Australia extend the Vildagliptin molecule protection until September 2022 and December 2024 respectively.
  •     Additional SPC applications within the molecule patent family have also been filed for the fixed dose combination of Vildagliptin with Metformin. These will provide nearly two months additional protection until November 2022 if granted, however such SPC applications have been rejected in certain European states.
  •     A later filed patent family with expiries of January 2021 claims antidiabetic ‘combinations’, specifically Vildagliptin in combination with Metformin, and as such is considered to be constraining for marketed products containing this fixed combination. Again, SPCs have been filed for this combination with expiries of November 2022 if granted.
  •     In all major territories where Vildagliptin has been marketed, the data and marketing exclusivity do not extend beyond patent protection.
  •     Competing innovator companies with interest in DPP-4 inhibitors appear in the top applicants for patents that can be related to Vildagliptin, including Boehringer Ingelheim (Linagliptin), Bristol-Myers Squibb (Saxagliptin), Takeda (Alogliptin) and GlaxoSmithKline due to cross over of claimed inventions into other, similar products.
  •     Since approval, there has been consistent filing of patent applications in the area of combination, use and analytical method (assay) patents relating to Vildagliptin.

GenericsWeb notes that: “In summary, protection remains in force for the Vildagliptin molecule as a result of specific molecule patents which represent a barrier to generic competition to Galvus®. Furthermore, generic combinations of Vildagliptin and Metformin are also protected for an additional period of less than two months due to subsequent filing of SPCs. However the protection varies significantly across countries even in the EU, where patent protection is sought to be harmonised. Due to the complex patent landscape surrounding Vildagliptin, it is likely that the launch date of Vildagliptin generic products will vary significantly in individual countries. Subsequent protection of molecular forms, processes and formulations for this molecule appear to be relatively weak, thus when generic entry is possible, it is likely that it will be heavily competed.”

The prominence and continuing growth of the global diabetes pharmaceutical industry means that even at this relatively early stage generic companies will closely watch the patent landscape surrounding Vildagliptin and any future developments in its lifecycle.”

You can read the entire article here at: http://www.genericsweb.com/druginfocus/Vildagliptin

ABOUT GENERICSWEB – THE SEARCH IS OVER
GenericsWeb, the leader in pharmaceutical patent analysis and searching holds an impeccable track record in providing quality patent information, and has allowed numerous pharmaceutical companies to successfully navigate intellectual property hazards. GenericsWeb is headquartered in Sydney, Australia, with offices in North America and Europe. All staff are highly skilled and experienced internationally and have extensive experience in pharmaceutical sciences and patent searching. For more information, visit the company's web site at http://www.genericsweb.com.

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Yoann Bretonnet
GENERICSWEB
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