Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC
Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC
Opinion of the Court
OPINION
I. INTRODUCTION
This action arises out of the filing of Abbreviated New Drug Application (“ANDA”) No. 207989 by defendant Am-neal Pharmaceuticals LLC (“Amneal”) seeking to produce and market a generic mometasone furoate nasal spray. (D.I. 56) On March 20, 2015, plaintiff Merck Sharp & Dohme Corp. (“Merck”) brought this action alleging infringement of U.S. Patent No. 6,127,353 (“the ’353 patent”).
II. FINDINGS OF FACT AND CONCLUSIONS OF LAW
A. Technology at Issue
1. Development of MFM
Anhydrous mometasone furoate (“MFA”) was first synthesized and patented by a Merck chemist, Dr. Elliot Shapiro, in the early 1980s. (D.I. 163 at 4) After MFA was discovered, its unique physical properties that prevented it from dissolving in water or known pharmaceutically acceptable compounds kept it on the
In the late 1980s, a formulator at Merck, Dr. Yuen, led a project seeking to develop mometasone furoate for nasal applications. As a result of this project, mometasone furoate monohydrate (“MFM”) was developed. MFM has the chemical name, 9a,21-dichloro-16a-methyl-l, 4-pregnadiene-11(33, '17a-diol-3, 20-dione-17-(2’-furoate) monohydrate and the following chemical structure:
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(D.1.163 at 46; ’363 patent)
MFA and MFM are polymorphs. MFM differs from MFA in that every molecule of MFM is associated with a molecule of water, whereas no water' is present in the crystal lattice structure of MFA. The difference between the molecular structures of MFM and MFA causes changes to the solid structure of the two crystalline forms. (D.1.163 at 6; PTX. 18
2. Development of Nasonex
Upon discovering MFM, Dr. Yuen determined that using MFM as á suspension in water with other excipients provided á stable formulation. (D.I. 163 at 6) The formation was further developed and ultimately was approved as Nasonex. The formulation is protected by the ’363 patent. (Id.)
Nasonex is indicated for the treatment of perennial allergenic rhinitis, seasonal allergic rhinitis, nasal polyps, and congestion associated with the nasal symptoms of allergic rhinitis (D.I. 142, ex. 1 at ¶ 26) The product insert for Nasonex states: “[Naso-nex] Nasal Spray 50 meg is a corticosteroid demonstrating potent anti-inflammatory properties.” (Id. at ¶ 35) It further states: “The, precise mechanism of corticosteroid action on allergic rhinitis is'not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types ... and mediators ... involved in inflammation.” (Id.) Nasonex contains MFM as its derive pharmaceutical ingredient (“API”). (Id. at ¶ 34) '
3. The ’353 patent
The ’353 patent, titled “Mometasone fu-roate monohydrate, process for making same and • pharmaceutical compositions,” issued on October 3, 2000. (JTX 1) Merck alleges infringement of independent claims 1 and 6 and dependent claims 9-12. (D.I. 142, ex. 1 at ¶ 15) The patent claims MFM, a process for preparing MFM by . crystallization from a saturated aqueous water miscible organic solution, and aqueous stable pharmaceutical compositions of MFM. (’353 patent, 1:31-48) Independent claim 1
4. The accused ANDA product
Amneal’s ANDA product is a generic mometasone furoate nasal spray, 50 meg, using MFA as the active pharmaceutical ingredient. Amneal’s ANDA product has a proposed shelf-life of two years. Merck does not allege that the pre-formulation active pharmaceutical ingredient used in Amneal’s ANDA product contains MFM or otherwise infringes the ’353 patent. (D.I. 142, ex. 1 at ¶¶ 43-47; D.I. 163 at 3; PTX 23)
B. Infringement Standard
A patent is infringed when a person “without authority makes, uses or sells any patented invention, within the United States ... during the term of the patent.” 35 U.S.C. § 271(a). To prove direct infringement, the patentee must establish that one or more claims of the patent read on the accused device literally or under the doctrine of equivalents. See Advanced Cardiovascular Sys., Inc. v. Scimed Life Sys., Inc., 261 F.3d 1329, 1336 (Fed. Cir. 2001). A two-step analysis is employed in making an infringement determination. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). First, the court must construe the asserted claims to ascertain their meaning and scope, a question of law. See id. at 976-77; see also Teva Pharms. USA, Inc. v. Sandoz, Inc., — U.S. -, 135 S.Ct. 831, 837, — L.Ed.2d - (2015). The trier of fact must then compare the .properly construed claims with the accused infringing product. See Markman, 52 F.3d at 976. This second step is a question of fact. Spectrum Pharm., Inc. v. Sandoz Inc., 802 F.3d 1326, 1337 (Fed. Cir. 2015) (citing Bai v. L & L Wings, Inc., 160 F.3d 1350, 1353 (Fed. Cir. 1998)). “Direct infringement requires a party to perform each and every step or element of a claimed method or product.” Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1320 (Fed. Cir. 2009) (quoting BMC Res., Inc. v. Paymentech, L.P., 498 F.3d 1373, 1378 (Fed. Cir. 2007)). “If any claim limitation is absent ..., there is no literal infringement as a matter of law.” Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1247 (Fed. Cir. 2000). If an accused product does not infringe an independent claim, it also does not infringe any claim depending thereon. Ferring B.V. v. Watson Labs., Inc.-Florida, 764 F.3d 1401, 1411 (Fed. Cir. 2014) (citing Wahpeton Canvas Co., Inc. v. Frontier, Inc., 870 F.2d 1546, 1552 (Fed. Cir. 1989) (“One who does not infringe an independent claim cannot infringe a claim dependent on (and thus containing all the limitations of) that claim.”)). However, “[o]ne may infringe an independent claim and not infringe a claim dependent on that claim.” Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 1359 (Fed. Cir. 2007) (quoting Wahpeton Canvas, 870 F.2d at 1552) (internal quotations omitted). The patent owner has the burden of proving literal infringement by a preponderance of the evidence. Octane Fitness, LLC v. ICON Health & Fitness, Inc., — U.S. -, 134 S.Ct. 1749, 1758, 188 L.Ed.2d 816 (2014).
C. Analysis
The question for infringement is whether Amneal’s ANDA product (an aqueous suspension made with prior art MFA) contains any patented MFM during the prod
1. Samples
Amneal produced samples of Batch Nos. BB-ST-13003A (manufactured October 28, 2013), 13005A (manufactured November 22, 2013), and 13006A (manufactured December 9, 2013) (collectively “the Exhibit Batches”) and samples of Batch No. RD-3965-162 (“the R & D Batch”) to Merck.
2. Merck’s thermodynamic stability study
Merck’s expert, Dr. Matzger, conducted a thermodynamic stability test “to establish the thermodynamic stability of the monohydrate relative to the anhydrous form.” He added an amount of MFM equal to the amount of MFA in one of the sample bottles from the Exhibit Batches and subjected the bottle to vigorous shaking at 500 RPM. After 27 days, all of the MFA had converted to MFM. He explained that shaking “increase[s] mass transport” to help the conversion from the “less stable form ... to the more stable form” and “break up the viscosity” of the suspension. Dr. Matzger concluded that “the monohydrate is the more stable form in the environment of Amneal’s formulation.” He testified that the study estab
3. Batch 16001
Merck’s expert, Dr. Bernhardt Trout (“Dr. Trout”), explained that polymorphic conversion is governed by the “basic principles of thermodynamics and chemical kinetics.” Further, polymorphic conversion involves nucleation, which “is the first step in which the smallest- crystal of the new polymorph is formed. And then the second step ... is growth, where that crystal then grows to a larger crystal.” As polymorphic conversion is affected by energy and collisions, “the more one mixes, the more vigorously something is mixed, the more energy [and] the more collisions are imparted.”
Dr. Matzger testified that “the way you mix something [and] the vigor with which you mix something affects the polymorphic conversion.” (D.I. 176 at 108:8-16) Therefore, he “would expect to see at least as much” MFM in the later samples of Batch 16001 as in the Batch 16001 Day 1 sample, and would expect that “the amount would have increased,” because “the additional mixing, if anything, would be expected to increase conversion.”
Dr. Rogers disagreed with Dr. Trout’s opinions, testifying that the conversion of MFA to MFM is difficult, as there is a high energy barrier. He explained that in a solution, conversion is a three-part process—dissolution of the crystal form, nucleation, and crystal growth of the new form. He opined that MFA “has very good physical stability under humidity.”
The parties dispute whether Amneal should-have provided samples from Batch 16001 Day 4 and Batch 16001A (“additional sampled”) to Merck.
4. Raman spectroscopy
Raman spectroscopy is a vibrational spectroscopy technique, which looks at the way a molecule vibrates in a crystal. A microscope is coupled to an excitation laser and a spectrometer. The laser is used to generate a Raman spectrum, which indicates the vibrational modes of molecules and is used to differentiate between crystalline forms. A Raman spectrum is a plot of the intensity (vertical axis) as a function of the vibrational frequency (horizontal axis). Raman maps are a collection of Ra-man spectra (from a hundred to over a million), which may then be analyzed by algorithms (or viewed individually) to determine potential matches to a reference standard. Reference standards are Raman spectra of known compositions. (D.I. 176 at 64-67, 78:20-79:6)
5. Merck’s testing of the Exhibit Batches
Dr. Matzger used a Renishaw Raman spectrometer with point focus mapping (“point focus spectrométer”). This tech-ñique focuses the laser on a point and then steps the laser to different positions on the sample to generate the Raman spectra. In December 2015, Dr. Matzger switched to using a Renishaw StreamLine® Raman spectrometer (“StreamLine spectrometer”), which allows for the collection of more data by elongating the laser into a line and moving the sample continuously. (D.I. 176 at 75:20-23, 76:4-9, 106:1-4; see also D.I. 177 at 318:28-319:9) According to Dr. Matzger, the StreamLine spectrometer “spreads [the laser] power out more evenly over the sample, so it tends' to reduce the chance of damaging the sample with the laser.” (D.1.176 at 76:18-20)
Dr. Matzger tested samples from four bottles of the Exhibit Batches over a period of eight months starting in June 2015. He agreed that he did not find MFM in any of the samples, and that some of the tested samples were over two years old. (I'd at 71:11-72:5, 87:5-9, 127:13-128:13; PTX 40) He testified that he used both point focus spectroscopy (for samples tested prior to December 2015) and StreamLine spectroscopy (for samples tested after December 2015) to test the Exhibit Batches and there was no difference in the results. (Id. at 123:20-24, 178:13-181:10)
There can be no dispute that Amneal provided data to the FDA obtained by testing the Exhibit Batches. The court addressed the issue of additional (or faster) mixing above. The court concludes that the testing of the Exhibit Batches (some of which were tested after the two-year expiration) is relevant to the question of infringement.
6. Merck’s testing of Batch 16001 Day 1
Dr. Matzger tested seven slides prepared from one bottle of Batch 16001 Day 1. Specifically, he briefly shook the glass bottle, used a pipette (or poured) to transfer some material to the slide, allowed the slides to dry, and stored them in Petri dishes. (D.I. 176 at 73:10-74:18, 101:11-25) He performed StreamLine spectroscopy on the slides and generated Raman maps made up of millions of individual spectra. He compared certain individual spectra (under 10% of spectra generated) to reference spectra of MFM and MFA generated on the same equipment.
By the characteristic peak at 1709 cm4, Dr. Matzger identified five MFM crystals on three slides (the slide prepared February 8, 2015 had three particles and the slides prepared on March 13 and 19, 2016 each had one particle).
Amneal’s expert, Dr, Brian Marquardt (“Dr. Marquardt”), analyzed the five spectra from Dr. Matzger’s report and opined that a “shoulder peak” indicative of MFA “could be easily misinterpreted ... as a peak in that space and be misrepresented as MFM,” given the concentrations and the signal to noise levels. He further explained that the spectra show that “this is primarily the MFA form, which is indicated by th[e] secondary doublet and the primary peaks ..., which are indicative of both forms. And it is my opinion that Dr. Matzger misinterpreted this data as MFM.” He concluded that MFM was not present. (Id. at .310-311; DTX 138) Dr. Marquardt testified that in his study of the API particles, the Raman spectra were “well above” a signal to noise ratio of 20/1. (Id. at 308:5-10)
Dr. Matzger opined that a single characteristic peak is sufficient to distinguish between MFM and MFA, as “based on the inspection of the reference patterns, you can find one where they’re well separated.” When asked if a single peak was sufficient to distinguish between MFM and MFA in Amneal’s product, Dr. Matzger responded that Amneal “did a similar analysis .'.. and ... also relied on a single peak in order to differentiate the monoh-ydrate and the anhydrate.”
Dr. Matzger testified that the particles of MFM were in the range of 1-2 microns, but he was unable to measure the size. (Id. at 169:17-170:12) Dr. Marquardt explained that using a scale factor, Raman instrumentation allows the visualization of particles that are one to ten microns in diameter. (D.I. 177 at 323:7—16; see also 463:22-464:6) "
Dr. Matzger testified that he would expect the amount of MFM to increase over time due to crystal growth, but he did not analyze whether the identified MFM, particles did so.
Dr. Matzger relied on his identification of one peak oh a Raman spectra to conclude that MFM particles were present in the tésted Batch 16001 Day 1 samples. He opined that a single peak is sufficient to identify MFM in the ANDA product, but admitted that he could not see any other characteristic peaks for MFM because of the signal to noise limitation. In contrast, Dr. Marquardt testified that three peaks are generally used to identify a polymorph in an unknown sample. In Schering Corp. v. Apotex Inc., 2012 WL 2263292 (D.N.J. June 15, 2012), the court evaluated expert testimony regarding Raman spectroscopy results performed on the product at issue in that case. The court concluded (based on expert testimony) that at least three peaks on a spectra must be used to - identify material based on accepted practices.
7. Amneal’s testing of Batch 16001 Day 1
Dr. Marquardt
According to Dr. Matzger, Dr. Mar-quardt did not “collect[ ] a sufficient number of spectra [or] data ... on a significant number of particles within those spectra to draw the conclusions that he has drawn.” Moreover, “[i]f you want to say that something is not present, it’s pretty typical to do a limit of detection.” (Id. at 483:18-485:4) Dr. Marquardt, on the other hand, explained that “collecting millions and millions of spectra doesn’t do you much good if you don’t actually analyze the data,” and “taking a lot of data doesn’t say much about your scientific data. It just says you have an instrument that can take data very quickly.” (Id. at 331:17-332:5) Dr. Mar-quardt agreed that the detection limit of a technique determines whether a particle may be detected and that he did not do a specific study on the effect of particle size on the detection limit. However, he explained that none of the experts performed limit of detection studies. (Id. at 395:22-397:12)
Dr. Matzger also criticized Dr. Mar-quardt’s use of a spike filter, opining that it throws away data. For that reason, Dr. Matzger does not use a spike filter during data collection for maps, but might use it during post processing when he is viewing the spectra. (Id. at 480:5-21) Dr. Mar-quardt opined that a spike filter is commonly used in Raman spectroscopy and allows the averaging out of random events. (M at 343:6-344:4, 345:5-22)
Merck urges the court to assign no weight to Amneal’s testing and related testimony based on the fact that such experiments only indicate the presence or lack of MFM at that specific point in time, not whether “MFM forms ... during the product’s proposed two-year shelf life.” (D.I. 163 at 37) Neither expert has opined on a “growth rate.” In essence, two experts have tested the same samples and come (not surprisingly) to opposite conclusions. Dr. Marquardt’s testing is at least as relevant as the conclusions drawn by Dr. Matzger.
8. Conclusion
Merck offers Dr. Matzger’s testing of Batch 16001 Day 1 as persuasive evidence of MFM in Amneal’s ANDA product. Merck criticizes Dr. Marquardt’s testing, arguing that such testing is insufficient to prove a negative - that MFM is not present in the ANDA product. The court observes that Dr. Matzger’s testimony and Merck’s related arguments are self-serving, i.e., essentially arguing that Dr. Matzger’s testing is “more and better,” therefore, only his opinion should be believed. The court is not so convinced, and finds Dr. Marquardt’s testimony at least as consistent and credible. Weighing the evidence at bar (lack of MFM in the Exhibit Batches
III. CONCLUSION
For the foregoing reasons, the court finds that Amneal does not infrihge the asserted claims.
ORDER
At Wilmington this 30th day of January 2017, consistent with the opinion issued this same date;
IT IS ORDERED that:
1. Defendant does not infringe the asserted claims of the ’353 patent.
2. The clerk of court is directed to enter judgment in favor of defendant and against plaintiff as to the infringement of the ’353 patent.
. The '353 patent is listed in the Food and Drug Administration’s ("FDA’s”) publication titled "Approved Drug Products with Therapeutic Equivalence Evaluations” (known as the "Orange Book”) for Nasonex® ("Naso-nex”). (D.I. 56 at ¶ 15)
. Agreed to by stipulation (D.I. 51) and so ordered by the court.
. The parties agreed to be bound by the claim construction and invalidity decisions in the co-pending litigation Merck Sharp & Dohme Corp. v. Teva Pharmaceuticals USA, Inc., Civ. No. 14-874-SLR (D. Del.). The court concluded that the asserted claims of the '353 patent were valid. (Civ. No. 14-874, D.I. 133, 204, 205)
. Xioming Chen et al., Solid State Characterization of Mometasone Furoate Anhydrous and Monohydrate Forms,. 94 Journal of Pharmaceutics Sciences (2005) (“the Chen article*'). (PTX 18)
. Merck contends that the MFA in Amneal’s product will eventually convert to MFM and the only question is "when” the conversion will occur. (D.I. 163 at 45) Amneal disputes both “if” and "when” the MFA in its ANDA product will convert to MFM, arguing in part that even Merck's expert, Dr. Adam Matzger ("Dr. Matzger”), opined that there are some MFA formulations that will not convert. (D.I. 165 at 29-30; D.I. 176 at 125:22-126:1) The parties spend considerable energy discussing the evidence put forth regarding conversion and disputing the issue of "if” conversion will occur. The court only addresses the arguments material to the infringement question.
. Merck tested the R & D Batch, but did not analyze the results, because it determined that the R & D batch was not relevant to infringement. (D.I. 176 at 87:10-12)
. The court allowed Dr. Matzger to answer a few questions regarding the Commercial Batch, explaining that such information might be appropriate if it pertained to the likelihood of conversion (from MFA to MFM) in the sample environment. Dr. Matzger testified that he identified MFM crystals in the Commercial Batch using both Raman spectroscopy and single crystal XRay diffraction ("SCXRD”), the gold standard for polymorphic identification. He opined that he was able to perform SCXRD, as "the crystals had grown for about a year-and-a-half, so they were larger.” (D.I. 176 at 67:2-21, 68:25-69:5, 69:22-70:9) None of the elicited testimony is helpful to the question at bar.
. The court adopts the parties' nomenclature of referring to the ANDA product packaged in nasal-spray bottles on consecutive days as Batch 16001A. (D.I. 163 at 8-10)
. Referencing Chong-Hui Gu, Victor Young, Jr., and David Grant, Polymorph Screening: . Influence of Solvents on the Rate of Solvent-Mediated Polymorphic Transformation, 90 Journal of Pharmaceutical Sciences 11, (2001) ("the Gu article”). (DTX 180) Dr. Trout explained that the Gu article is an example of "one solid crystalline form transforming to another and the effects of agitation” thereon. (D.I. 176 at 258:2-7) Dr. Trout admitted that the Gu article did not specifically study MFA or MFM and focused on solvent mediated transfbrmation of a chemical called SMZ. Moreover, the mixing was done with a wrist shaker. (D.I. 176 at 232-233) The court concludes that the Gu article is not helpful to the issue at hand, i.e., whether mixing would facilitate the conversion of MFA to MFM in the aqueous pharmaceutical suspension at bar.
. The actual mixing speeds and times for the various samples are redacted. (JTX 7-10; DTX 26)
. Referencing the Chen article. (PTX 18) Dr. Trout criticized reliance on the Chen article because it studied the physical stability under humidity, which is completely different than an aqueous suspension. (D.I. 176 at 250-51)
. Dr. Rogers also opined that agitation can increase or decrease the rate of nucleation in a particular system. J.W. Mullin, Crystallization: Chapter 5, Nucleation, 191 (4th ed. 2001). (DTX 84) Dr. Trout criticized the reliance onthis reference, opining that it focuses on nucleation in a solution not in an aqueous suspension. (D.I. 177 at 492-93)
. This has been an ongoing dispute. (D.I. 130, 131, 134)
. The Müller article (acknowledging funding by Merck) describes the selection and SCXRD testing of a crystal to determine which poly-morph was present in a sample of Apotex nasal spray marketed in Canada. The testing identified an MFM crystal present in the sample before the expiration date of the product. P.eter Muller, Mometasone fuorate revisited, or how did the hydrate get in the bottle?, C71 Acta Cryst., 1080 (2015). (PTX 12) Merck argues that this article establishes "that MFA can convert to MFM within the shelf life of an aqueous pharmaceutical suspension that is formulated with MFA.” (D.I. 163 at 16) Merck points to Amnéal’s counsel argument that the formulation at bar is virtually identical to that found non-infringing in the Apotex litigation.
. Nor has Merck demonstrated that Am-neal’s failure to produce additional samples of Batch 16001 warrants an adverse inference. Indeed, Merck did not respond to Amneal’s arguments against such an inference in its reply brief. (D.I. 163 at 53-54; D.I, 165 at 54; D.I. 168 at 28-29); Braintree Labs., Inc. v. Novel Labs., Inc., 2015 WL 3492936 at 13 (D.N.J. June 1, 2015) (citation omitted) (An imposition of adverse inference was not required when defendant "ha[d] not shown any prejudice, surprise, or bad faith on the part of” plaintiff.).
. Merck asserts that whether Amneal should produce the samples is governed by Federal Rule of Civil Procedure 26(b)(1), and contends that "it has established that the additional mixing that the 16001 Day 4 and 16001A samples underwent increases the likelihood of formation of MFM, thereby maldng those samples relevant to infringement.” (D.I. 168 at 26)
. Merck states that on the record at bar, the Exhibit Batches were mixed at one-third to one-half of the lowest acceptable values specified by Amneal’s current ANDA. (D.I. 168 at 1-2) Although Amneal’s counsel represented that typographical errors existed regarding the mixing speeds, on the evidence presented, the court accepts Merck’s representations. (D.I. 165 at 15, 32-33)
. Dr. Matzger explained that a reference standard is collected with a high signal to noise ratio, allowing the visualization of "all of the peaks that would be different between the two forms” and the identification of "other maybe minor characteristic peaks.” (D.I. 176 at 188:7-189:3)
.Dr. Matzger opined that he did not find MFM particles on the other four slides, but did not perform extensive searches of those slides, as the searches were time consuming. He "didn’t see the point of doing additional searching” after identifying MFM on the other slides. (D.I. 176 at 87-88, 153:24-154:9) He also explained that he would not have had time to perform an extensive analysis of the other four slides. (Id. at 186:24-187:20) He testified that when particles are very small (as in the samples at issue), "[t]he search algorithms are just not that reliable,” and potential matches must be inspected by hand. (Id. at 67:25-68:5)
. Dr. Matzger opined that none of the excipi-,ents would have a peak at 1709 cm, He did not analyze pure samples of the excipients in the ANDA formulation, nor a placebo containing all of the ingredients except the API to determine if any other peaks existed in the general vicinity of 1709 cm to 1711 cm. He stated that he. "had a number of experiments ■where there was excipient and [he] did not identify peaks at that location.” (Id. at 165-167) He also relied on Amneal’s ANDA stating that "excipient spectra will not have peaks at wave numbers 1725±3 (or 1705), 1611 cm-1.” .(PTX 26 at AMLMF 4670)
. Validation of Compendial Procedures, USP 37. (PTX 67 at 3)
. In contrast, Dr, Marquardt opined that applying a smoothing algorithm to- high resolution Raman spectra/ like that of Dr. Matzger, "can actually cause [one] to misinterpret, possibly even generate [an] artificial peak.” (D.I. 177 at 309:8-20)
. Dr. Matzger opined that his spectra are "essentially the same” as certain of Amneal’s spectra from a limit of detection study.. (D.I. 176 at 100:22-101:10; PTX 39, 84)
. Amneal performed and provided the results of certain testing to the FDA, including Raman spectroscopy. (PTX 38) One of Am-neal’s scientist agreed that they “would look at 1705 for monohydrate and 1725 for anhyd-
. Merck points out that it asked Amneal multiple times if it would be allowed to supplement the testing and Amneal refused, therefore, Merck did not request supplementation of the expert record from the. court. (D.I. 176 at 171:3-23)
. Merck argues that the need for three peaks only applies to the x-ray crystallographic powder diffraction pattern analysis opined on by the expert in the Apotex litigation and not ' to Raman spectroscopy. The Federal Circuit heard the same argument from Merck and subsequently affirmed the district court’s judgment. See Merck Sharp & Dohme Corp. v.
. The court declines to reach Amneal’s collateral estoppel argument.
. Dr. Marquardt is the CEO and founder of MarqMetrics, a company providing measurement solution services and developing Raman technology. (D.I. 177 at 297:17-298:3) Dr. Marquardt’s assistant at MarqMetrics, Dr. Andrew Knight ("Dr. Knight”), prepared the slides and performed the Raman testing under Dr. Marquardt’s direction. Dr. Knight has experience in crystalline materials. (Id. at 327, 389:5-8) Having reviewed Dr. Mar-quardt’s background information, the court disagrees with Merck’s representation that Dr. Marquardt is only an expert in Raman spectroscopy "in a general sense,” and that neither he nor MarqMetrics has the requisite experience or skill to conduct any meaningful tests of Amneal’s ANDA product. (D.I. 163 at 38-41) The court separately addresses Merck's specific concerns regarding Dr. Mar-quardt’s testing.
. The court addressed Merck’s concerns regarding the relevance of the Exhibit Batches above.
. The court recognizes that Dr. Matzger used a different testing protocol (Streamline spectroscopy) and has addressed Merck’s concerns about Dr. Marquardt’s testing above.
. The court does not reach Merck’s contributory infringement arguments. (D.I. 163 at 58)
Reference
- Full Case Name
- MERCK SHARP & DOHME CORP. v. AMNEAL PHARMACEUTICALS LLC
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- 1 case
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- Published