ORDER ON MOTIONS FOR SUMMARY JUDGMENT AND MOTION TO STRIKE

DONALD M. MIDDLEBROOKS, District Judge.

THIS CAUSE comes before the Court upon Plaintiffs'1 Motion for Summary Judgment that the '720 Patent is not Invalid Under 35 U.S.C. § 112 (DE 118), filed December 21, 2012, and Defendants'2 Motion for Summary Judgment of Non-Infringement (DE 122), filed under seal on December 26, 2012. The Court has reviewed the Motions, Responses, Replies, and the record in this case, and is otherwise fully advised in the premises.

I. Background

On May 8, 2012, Plaintiffs filed the instant action against Defendants. The Amended Complaint, filed under the Hatch-Waxman Act, alleges Defendants' infringement of United States Patent No. 6,773,720 (the "'720 Patent"). The '720 Patent, which is assigned to Plaintiff Cosmo, is titled "Mesalazine Controlled Release Oral Pharmaceutical Compositions." (See DE 43 at ¶ 33). Plaintiff Shire Development is the owner of New Drug Application ("NDA") No. 22-000, which is FDA-approved3 for the manufacture and sale of mesalamine-delayed release tablets commercialized under the name "Lialda." (See id. at ¶ 24).4 The '720 Patent is listed in the FDA's publication "Approved Drug Products with Therapeutic Equivalence Evaluations" as covering Lialda. (See id. at ¶ 25).

When Plaintiffs were notified that Defendants had submitted to the FDA an Abbreviated NDA ("ANDA"), assigned number 203817, seeking approval of a generic version of Lialda before the expiration of the '720 Patent's exclusivity period, Plaintiffs filed suit. In short, Plaintiffs argue that Defendants' submission of the ANDA No. 203817 (the "ANDA product") infringes the '720 Patent. (See id. at ¶ 38).5

In responding to the Amended Complaint, Defendants filed two counterclaims against Plaintiffs. First, Defendants seek a declaration that their ANDA product would not infringe any claim of the '720 Patent. (See DE 52 at 15-16). Second, Defendants seek a declaration that the '720 Patent and its claims are invalid under 35 U.S.C. § 112, for lack of written description and lack of enablement, to the extent the claims are alleged to cover any products set forth in the ANDA No. 203817. (See DE 56 at 16-17).

On December 20, 2012, the Court held a Markman hearing on the issue of claim construction. The Court subsequently issued an Order (DE 147) construing the terms of Claim 1 of the '720 Patent.

On December 21, 2012, Plaintiffs filed their Motion for Summary Judgment (DE 118), arguing that the '720 Patent should be deemed not invalid under 35 U.S.C. § 112 as a matter of law. Defendants filed a Response (DE 135) to the Motion on January 14, 2013, to which Plaintiffs filed a Reply (DE 156) under seal on January 25, 2013.

On December 26, 2012, Defendants filed under seal their Motion (DE 122) seeking summary judgment of non-infringement "because there is no genuine issue of material fact but that Watson's ANDA product lacks one or more of the patent claim elements." (DE 122 at 20). Plaintiffs filed under seal their Response (DE 146) to the Motion on January 16, 2013, to which Defendants filed a Reply under seal on January 28, 2013.

II. Summary Judgment Standard

Summary judgment shall be rendered "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(c). In making its assessment of summary judgment, the Court "must view all the evidence and [reasonably draw] all factual inferences ... from the evidence in the light most favorable to the nonmoving party." Stewart v. Happy Herman's Cheshire Bridge, Inc., 117 F.3d 1278, 1285 (11th Cir.1997). Additionally, the Court "must resolve all reasonable doubts about the facts in favor of the non-movant." United of Omaha Life Ins. Co. v. Sun Life Ins. Co. of America, 894 F.2d 1555, 1558 (11th Cir.1990).

"By its very terms, this standard provides that the mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment; the requirement is that there be no genuine issue of material fact." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) (emphasis in original). "As to materiality, the substantive law will identify which facts are material. Only disputes over facts that might affect the outcome of the suit under the governing law will properly preclude the entry of summary judgment. Factual disputes that are irrelevant or unnecessary will not be counted." Id. at 248, 106 S.Ct. 2505. Likewise, a dispute about a material fact is a "genuine" issue "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Id.

The moving party "always bears the initial responsibility of informing the district court of the basis for its motion, and identifying those portions of `the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any,' which it believes demonstrate the absence of a genuine issue of material fact." Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). Summary judgment is proper "against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." Id. at 322, 106 S.Ct. 2548. In those cases, there is no genuine issue of material fact "since a complete failure of proof concerning an essential element of the nonmoving party's case necessarily renders all other facts immaterial." Id. at 323, 106 S.Ct. 2548.

III. Invalidity

In their Second Counterclaim, Defendants allege that the '720 Patent is invalid under 35 U.S.C. § 112 for lack of written description and lack of enablement.6 Plaintiffs move for summary judgment of non-invalidity under 35 U.S.C. § 112, arguing that Defendants' invalidity argument is improper and fails as a matter of law because the invalidity claim is conditioned upon infringement. As noted by Plaintiffs, "The present motion presents no issues of fact, but instead only a purely legal issue." (DE 118 at 6) (emphasis in original).

In response, Defendants argue that Plaintiffs' proposed claim constructions for the terms "matrix," "inner lipophilic matrix," and "outer hydrophilic matrix" — constructions that were subsequently adopted by the Court — would result in a claim scope that the '720 Patent "neither describes nor enables." (DE 135 at 2).7 In essence, Defendants respond with largely factual arguments, as opposed to the legal arguments made by Plaintiffs in their Motion.8

Although Plaintiffs' Reply counters the factual contentions made by Defendants in their Response, the Court opts to limit the summary judgment analysis to the question presented in the original Motion: Whether Defendants' invalidity counterclaim fails as a matter of law because it appears to be conditioned upon the accused product's infringement of the '720 Patent.

Although Plaintiffs have compiled ample case law explaining that patent infringement and invalidity are separate and distinct issues, they have failed to provide any support for the contention that Defendants' counterclaim fails as a matter of law.9 As such, Plaintiffs have failed to meet their burden, and the Court must answer the question presented in the negative.

IV. Infringement

"Patent infringement, whether literal or by equivalence, is an issue of fact, which the patentee must prove by a preponderance of the evidence." Siemens Med. Solutions USA, Inc. v. Saint-Gobain Ceramics & Plastics, Inc., 637 F.3d 1269, 1279 (Fed.Cir.2011) (citing Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1310 (Fed.Cir.2005)). "Summary judgment on the issue of infringement is proper when no reasonable jury could find that every limitation recited in a properly construed claim either is or is not found in the accused device either literally or under the doctrine of equivalents." U.S. Philips Corp. v. Iwasaki Elec. Co. Ltd., 505 F.3d 1371, 1374-75 (Fed.Cir.2007) (citing PC Connector Solutions LLC v. SmartDisk Corp., 406 F.3d 1359, 1364 (Fed.Cir.2005)).10

In the Amended Complaint, Plaintiffs assert that Defendants' ANDA product will infringe one or more Claims of the '720 Patent. (DE 43 at ¶ 45). Claim 1 of the '720 Patent is independent, whereas Claims 2-4 of the '720 Patent are dependent upon Claim 1. Because Claims 2-4 necessarily contain all of the limitations of Claim 1, Defendants' product can only infringe Claims 2-4 if it infringes Claim 1. Said differently, if Defendants' product does not infringe Claim 1, it cannot infringe any of Claims 2-4.11 Thus, Defendants focus their arguments on Claim 1, which provides:

DE 1-1 at 5.

Defendants move for summary judgment of non-infringement, arguing that their proposed generic version of Lialda does not infringe any of Claims 1-4 of the '720 Patent. Specifically, Defendants assert that the "undisputed material facts establish that [Defendants are] entitled to summary judgment of [non-]infringement for at least three reasons." (DE 122 at 4). First, Defendants argue that their product does not have an "inner lipophilic matrix" in which mesalamine is dispersed. Second, Defendants argue that their product does not have an "outer hydrophilic matrix" in which mesalamine is dispersed. Last, Defendants argue that their product does not contain a lipophilic substance with a melting point below 90°C.13

As noted above, Defendants' first argument is that their product does not infringe because it has no inner lipophilic matrix in which mesalamine is dispersed.14 Specifically, Defendants argue that their product does not have a lipophilic matrix at all, as their product's "compressed core" contains one lipophilic substance — magnesium stearate — and only as a lubricant in the subsequent tablet-compression step.15 Thus, Defendants say, their ANDA product does not have a lipophilic matrix containing mesalamine dispersed therein. Additionally, Defendants assert that the only mesalamine-containing granules in the ANDA product do not contain any lipophilic substances. (See DE 122 at 17).

To counter this assertion, Plaintiffs present evidence from Dr. David Bugay indicating that magnesium stearate is found throughout the interior of each of the ANDA product's mesalamine granules. (See Bugay Decl. at ¶ 6) ("The SEM-EDX and Raman results show that the magnesium stearate in the Watson ANDA product is dispersed homogeneously within the mesalamine granules."). Given Plaintiffs' expert testimony and testing done of the ANDA product, there remains a genuine issue of material fact that cannot be resolved at summary judgment.

Defendants also argue that "[b]ecause there is no inner lipophilic matrix, there necessarily is no `outer [hydrophilic] matrix' in the Watson ANDA product" as required by Claim 1 of the '720 Patent. (DE 122 at 19).16 However, given the Court's finding that Plaintiffs have provided sufficient evidence to create a genuine issue of material fact as to whether there is an inner lipophilic matrix in the ANDA product, this argument must fail as well.

Defendants next argue that they cannot infringe because mesalamine is only contained in Defendants' mesalamine granules and is not separately dispersed within the "extragranular" sodium starch glycolate ("SSG").17 While it is admitted by Defendants that there is a hydrophilic substance (SSG) "outside" of the mesalamine granules (which Plaintiffs assert contain the inner lipophilic matrices), Defendants dispute the notion that SSG forms an outer hydrophilic matrix, let alone contains mesalamine dispersed within.

Plaintiffs introduce evidence supporting the following arguments that counter Defendants' contention that mesalamine is not dispersed within the "extragranular" hydrophilic substance (SSG). First, Plaintiffs claim SSG is present at the surface of the granules (where SSG is agglomerated) and is in contact with and dispersed with the mesalamine in that region. Second, outside of the granules there are "fines"18 that exist throughout the ANDA product. Plaintiffs provide evidence indicating that these fines contain mesalamine, and, more generally, that mesalamine is present both inside and outside the granules. Third, Plaintiffs claim the SSG material will swell massively upon ingestion of the tablet and infusion of liquid into the tablet, "thus expanding throughout the outer space surrounding the mesalamine-containing granules and the mesalamine-containing fines." (DE 146 at 9). As a result of this expansion, "the outer SSG hydrophilic matrix with be homogeneously dispersed with mesalamine as it continues to transit and release in the gastrointestinal tract." (Id.).

With respect to whether mesalamine is dispersed with the SSG matrices outside of the mesalamine granules, I find that there remains a genuine issue of material fact, as Plaintiffs have provided adequate evidence indicating that a hydrophilic matrix is present in the ANDA product and mesalamine is dispersed within it. Even if doubt remains as to whether mesalamine is dispersed — or sufficiently mixed to incorporate one substance with another — with the SSG, all reasonable doubts as to facts must be resolved in favor of the nonmovant. Thus, summary judgment is precluded.

Last, Defendants argue that the ANDA product does not infringe as a matter of law because the magnesium stearate used in its product has a melting point well above 90°C. Specifically, Defendants provide evidence that their magnesium stearate supplier, Mallinckrodt, provides a product with a melting point between 150°C and 170°C. If this is true, the ANDA product would not infringe because Claim 1 requires the substance or substances creating the lipophilic matrix to have a melting point below 90°C.

However, summary judgment of non-infringement on this issue is not appropriate, as Plaintiffs offer evidence disputing whether Mallinckrodt is the magnesium stearate supplier for the ANDA product. (See DE 148-28). Plaintiffs assert, and provide supporting evidence, that Covidien is the actual supplier of the magnesium stearate for the ANDA product, and the magnesium stearate supplied by Covidien has a melting point below 90°C. (See DE 142 at ¶ 28). Additionally, Plaintiffs' dispute several of Defendants' references that supposedly report a melting point of magnesium stearate "well above" 90°C. Thus, a genuine issue of material fact remains with regard to the melting point of the magnesium stearate in the ANDA product.19

V. Motion to Strike

After Plaintiffs served their Response and attached exhibits in opposition to Defendants' Motion for Summary Judgment, Defendants filed a Motion to Strike (DE 160) on January 28, 2013. In their Motion, Defendants move to strike the declaration of Joseph Paller and several portions of other Plaintiffs' experts' declarations on the basis of untimeliness pursuant to Federal Rule of Civil Procedure 37. Specifically, Defendants seek to strike the following:

I have reviewed the Motion, Plaintiffs' Response (DE 167), and the Reply brief (DE 167), and I am otherwise fully advised in the premises.

Rule 37(c)(1) provides:

Fed.R.Civ.P. 37(c)(1). Rule 26 requires parties to disclose expert opinion reports in the time frame stipulated by the parties or otherwise ordered by the court. Fed. R.Civ.P. 26(a)(2)(D). These reports must include "a complete statement of all opinions the witness will express and the basis and reasons for them." Fed.R.Civ.P. 26(a)(2)(B)(i).

"The burden of establishing that a failure to disclose was substantially justified or harmless rests on the nondisclosing party." Mitchell v. Ford Motor Co., 318 Fed.Appx. 821, 824 (11th Cir.2009) (citing Leathers v. Pfizer, Inc., 233 F.R.D. 687, 697 (N.D.Ga.2006)). In determining whether a failure to sufficiently disclose an expert witness is substantially justified or harmless, courts should consider (1) the importance of the testimony, (2) the reasons for the failure to disclose the witness earlier, and (3) the prejudice to the opposing party if the witness is allowed to testify. Cooley v. Great S. Wood Preserving, 138 Fed.Appx. 149, 161 (11th Cir.2005) (quoting Bearint v. Dorell Juvenile Grp., Inc., 389 F.3d 1339, 1353 (11th Cir.2004)).

A. Dr. Paller's Declaration

Dr. Paller's declaration (DE 143-1) provides Dr. Paller's opinions regarding whether stearic acid is formed from the interaction between magnesium stearate and simulated intestinal fluid ("SIF"), or acetic acid. (See DE 143-1 at ¶ 12) ("In conclusion, treatment of Magnesium Stearate with either modified SIF or Acetic Acid leads to the formation of a band at 1700cm-1, which is possibly Stearic Acid."). He arrived at his opinions after conducting laboratory testing. Defendants only learned of Dr. Paller when Plaintiffs provided his declaration in support of their opposition to Defendants' Motion for Summary Judgment, as he was not otherwise disclosed as an expert witness.

With regard to this new opinion, Plaintiffs argue that Dr. Paller's findings are "neither controversial nor prejudicial" to Defendants. Plaintiffs also claim that any potential prejudice would be cured by allowing Defendants to depose Dr. Paller. However, Plaintiffs fail to provide a reason why Dr. Paller was not previously disclosed as an expert witness as required by the Federal Rules of Civil Procedure, the Court's scheduling orders, and the Parties' stipulations.

After considering the factors listed above and arguments by both Parties, I find that Plaintiffs have not met their burden to demonstrate that the late disclosure of Dr. Paller was substantially justified or harmless. Thus, Rule 37 requires the Court to exclude Dr. Paller as an expert witness for Plaintiffs and strike his declaration in its entirety.

B. Declarations of Drs. Little, Bugay, and Sinko

With regard to portions of the remaining declarations filed in support of Plaintiffs' opposition to Defendants' Motion for Summary Judgment, I find that allowing such is harmless and does not prejudice Defendants. Specifically, I find that the opinions in the relevant portions of the declarations were already substantially covered by the respective experts. Further, allowing the disputed declarations will not prejudice Defendants, as the same or similar topics were covered by other experts, and Defendants have had several opportunities to question the experts on these topics and rebut any opinions with their own experts. Additionally, these disputed areas are central to the Plaintiffs' case, and excluding such on the eve of trial may result in prejudice to Plaintiffs.

VI. Conclusion

For the foregoing reasons, both Motions for Summary Judgment are due to be denied. Also, Defendants' Motion to Strike is granted in part and denied in part, with only Dr. Paller's declaration to be stricken and his testimony excluded.

Accordingly, it is hereby

ORDERED AND ADJUDGED as follows:

Further, it is hereby

ORDERED AND ADJUDGED as follows: