Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC

United States Court of Appeals, Federal Circuit

February 9, 2018

MERCK SHARP & DOHME CORP., Plaintiff-Appellant

         Appeal from the United States District Court for the District of Delaware in No. 1:15-cv-00250-SLR-SRF, Judge Sue L. Robinson.

          Nicolas Barzoukas, Reed Smith LLP, Houston, TX, argued for plaintiff-appellant. Also represented by Joshua Davis, Lisa M. Thomas.

          Thomas J. Meloro, Willkie Farr & Gallagher LLP, New York, NY, argued for defendant-appellee. Also represented by Devon Edwards, Matthew S. Freimuth, Michael Johnson.

          Before Taranto, Clevenger, and Stoll, Circuit Judges.

          Stoll, Circuit Judge.

         Merck Sharp & Dohme Corp. ("Merck") owns U.S. Patent No. 6, 127, 353, which claims mometasone furoate monohydrate, the active ingredient in Merck's Nasonex® nasal product. Amneal Pharmaceuticals LLC ("Amneal") submitted an Abbreviated New Drug Application ("ANDA") to the U.S. Food & Drug Administration ("FDA") seeking approval to market a generic mometa-sone furoate nasal spray. Merck filed an infringement suit in the District of Delaware alleging that Amneal's proposed ANDA product would infringe the '353 patent if approved by the FDA.

         Following a bench trial, the district court found that Merck failed to prove by preponderant evidence that Amneal's ANDA product will infringe the '353 patent. On appeal, Merck argues that the district court abused its discretion by not compelling Amneal to produce additional samples of its ANDA product for testing before trial. Merck also argues that the district court's noninfringement finding must be reversed because it was not based on Amneal's final commercial product. Merck also challenges the district court's fact-finding that a Raman spectroscopy three-peak analysis was required to confirm the infringing form of mometasone furoate in Amneal's product.

         For the reasons explained below, we conclude that the district court did not abuse its discretion in denying Merck's request for additional samples and a new trial. Further, we hold that the district court did not err in finding that Merck failed to demonstrate that Amneal's ANDA product, which formed the basis for the district court's noninfringement finding, was not representative of Amneal's final commercial product. Finally, we conclude that the district court did not clearly err in finding that three Raman peaks were required to prove infringement. Accordingly, we affirm.


         In the early 1980s, Merck scientists discovered and synthesized the corticosteroid anhydrous mometasone furoate or "MFA." After initial setbacks with dissolving MFA in water and pharmaceutical compositions, Merck discovered a solvent that eventually allowed it to develop MFA for the treatment of psoriasis.

         In the late 1980s, Merck sought to further develop MFA into nasal formulations. That research led to the discovery of a polymorph of MFA, mometasone furoate monohydrate, also referred to as "MFM." MFM and MFA differ in that every molecule of MFM is associated with water, whereas no water is present in the crystal lattice structure of MFA. These differences cause conformational changes to the solid crystal lattice structure in the two crystalline forms. In certain aqueous suspensions, MFM is the more stable polymorphic form.

         The discovery of MFM led to the development of Merck's Nasonex® nasal product, which is approved for the treatment of perennial allergic rhinitis, seasonal allergic rhinitis, nasal polyps, and congestion associated with nasal symptoms of allergic rhinitis. The '353 patent claims MFM and pharmaceutical compositions comprising MFM.

         In November 2014, Amneal filed ANDA No. 207989, seeking approval to market a generic mometasone furoate nasal spray comprising MFA (as opposed to MFM) as the active ingredient. In February 2015, Amneal sent Merck a notice letter, informing Merck of its ANDA filing and certifying that its proposed product would not infringe the '353 patent and that the '353 patent was invalid. As a result, in March 2015, Merck filed an infringement suit against Amneal asserting claims 1, 6, and 9-12 of the '353 patent. Merck alleged that although Amneal's ANDA product contained MFA, its ANDA product would convert to the infringing MFM form over time. Thus, the issue of infringement before the district court was whether Am-neal's ANDA product would contain any patented MFM during Amneal's product's two-year shelf-life.

         Relevant to the issues in this case, Amneal manufactured three 100 kilogram ANDA submission batches ("Exhibit Batches") of its proposed ANDA product and provided the FDA data on those samples. Amneal produced samples of the Exhibit Batches to Merck. Although Amneal also gave the FDA data on samples from a 1, 000 kilogram commercial-sized batch ("Commercial 157 Batch"), Amneal did not produce those samples to Merck. As a result, Merck moved to compel production of the Commercial 157 Batch samples, which the district court ordered on November 24, 2015.

         On December 10, 2015, the district court ordered that the case would be stayed unless Amneal filed a declaration attesting that the Exhibit Batch samples provided to Merck were representative of Amneal's commercial ANDA product. The district court further ordered "Amneal [to] immediately make available to Merck samples of any further representative commercial batches sent to the FDA." J.A. 82. On December 21, 2015, Amneal filed a declaration, representing that its Exhibit Batch samples were representative of its commercial ANDA product. Amneal's declaration indicated, however, that Amneal amended its ANDA to change its commercial batch size from 1, 000 kg to 100 kg and would manufacture its commercial ANDA products using the same formulation and manufacturing process as the Exhibit Batch samples provided to Merck. Based on this amendment, the district court later excluded the Commercial 157 Batch samples from trial, concluding that Amneal "has identified the Exhibit Batches as its Generic Product to the FDA and there is no credible indication that [Amneal] could realis- tically use the [Commercial] 157 Batch manufacturing process instead." J.A. 149.

         Because Amneal's ANDA specification allowed for a maximum bulk suspension hold of up to four days, the FDA required Amneal to complete a bulk-hold study, in which Amneal's commercial batch would be held for a four-day period before being packaged into nasal spray bottles. On January 11, 2016, Amneal manufactured another 100 kilogram commercial batch for the bulk-hold study ("Batch 16001"). Amneal drew samples from the batch on the first day ("Day 1 Batch") and again on the fourth day ("Day 4 Batch"). Before sampling the Day 4 Batch, Amneal additionally mixed the batch at 840 revolutions per minute ("RPM") for 30 minutes. After the bulk-hold study was completed, Amneal again mixed the Batch 16001 mixture and bottled it for storage, re-designating the batch as "Batch 16001A" (hereinafter referred to as the "A Batch"). On February 29, 2016, Amneal responded to the FDA, providing data on samples from the Day 1 and Day 4 Batches from the requested bulk-hold study. Amneal did not provide the FDA data on samples from the A Batch.

         On January 12, 2016 and February 11, 2016, Amneal produced samples from the Day 1 Batch to Merck, indicating that they were representative of Amneal's finished commercial product. On March 10, 2016, Amneal completed its document production to Merck, which included its February 29, 2016 response to the FDA providing the results of the bulk-hold study. On April 25, 2016, Amneal served a rebuttal expert report on infringement, in which Amneal's expert opined ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.