Mometasone - USA

Product: Nasonex, 0.05 mg base/spray, Metered, Spray

Innovator: Merck Sharp & Dohme (MSD)

Generic Filer: Amneal

Patent: US6127353

Points to ponder: Non Infringing formulation. (Conversion of forms during Stability in exhibit batches & commercial batches)

District court's determination: Generic's (Amneal) formulation does not contain infringing Mometasone Furoate Monohydrate. (There is no conversion of Mometasone Furoate Anhydrous in to Mometasone Monohydrate through out the stability. One identical peak of Mometasone Furoate Monohydrate in Raman Spectra is not sufficient to provide presence of Mometasone Furoate Monohydrate in Amneal's ANDA. For absolute confirmation typically at least three identical peaks required.)

Appeal Court's determination (17-1560): Upheld the decision of District Court. (District Court did not err in finding of facts)

Back ground & Key Events:

Merck's formulation Nasonex is Spray, Metered (0.05 mg base/spray) dosage form available in market since 01st Oct, 1997. Nasonex contains drug substance form Mometasone Fuaroate Monohyrate which is protected by Merck' own patent US'6127353. US'353 will going to expire 03rd Apr, 2018.

Independent Claims of US'353 is as below:

1. 9.alph a.,21-dichloro-16.alpha.-methyl-1,4-pregnadiene-11.beta.,17.alpha.-diol-3,2 0-dione-17-(2'-furoate) monohydrate.
2. A pharmaceutical composition comprising an antiinflammatory amount of mometasone furoate monohydrate in a pharmaceutically acceptable carrier. 

5. The compound 9.alpha.,21-dichloro-16.alpha.-methyl-1,4-pregnadiene-11.beta.,17.alpha.-d iol-3,20 dione-17-(2'-furoate) monohydrate exhibiting a x-ray crystallographic powder diffraction pattern having essentially the following values.
6. A pharmaceutical composition comprising mometasone furoate monohydrate in a carrier consisting essentially of water. 

Court Events: 

In November 2014, Amneal filed Abbreviated New Drug Application (ANDA207989), seeking approval to market a generic Mometasone Furoate Nasal Spray comprising Mometasone Furoate Anhydrous (MFA) as the active ingredient.

In March 2015, Merck filed an infringement suit against Amneal asserting claims 1, 6, and 9–12 of the US’353 Patent in answer of Amneal's Notice latter submitted to Merck in February 2015.

Merck alleged that although Amneal’s ANDA product contained Mometasone Furoate Anhydrous (MFA), its ANDA product would convert to the infringing Mometasone Furoate Monohydrate (MFM) form over time. Thus, the issue of infringement before the district court was whether Amneal’s ANDA product would contain any patented Mometasone Furoate Monohydrate (MFM) during Amneal’s product’s two-year shelf-life.

After hearing testimony from Amneal's expert CAFC affirms the decision that for Amneal's formulation contain single peak in Raman Spectra which is related to Mommetasone Furoate Monohydrate (MFM). However, For absolute confirmation of presence of Mometasone Furoate Monohydrate (MFM) in Amneal's sample at least three typical peaks of Raman Spectra require in complex mixture like MFM.

Three Raman peaks were required, the district court also noted that the district court in Schering Corp v. Apotex Inc., No. 09-6373, 2012 WL 2263292 (D.N.J. June 15, 2012), likewise concluded that three peaks were required to confirm MFM.

Market:

as per IMS 2016 December, sales of Brand and Generics in US is 653 Million USD.

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