FREDA L. WOLFSON, District Judge.
This matter comes before the Court on a motion for summary judgment filed by Defendants Biodelivery Sciences International, Inc., Meda Pharmaceuticals Inc., and Aveva Drug Delivery Systems, Inc. (collectively, "Defendants") on the Amended Complaint filed by Plaintiff MonoSol Rx., LLC ("MonoSol," or "Plaintiff"). In the Amended Complaint, Plaintiff asserts patent infringement claims against Defendants on three patents: (1) United States Patent No. 7,824,588 ("the'588 patent); (2) United States Patent No. 7,425,292 ("the `292 patent"); and (3) United States Patent No. 7,357,891 ("the `891 patent"). Following ex parte reexamination of all three patents by the U.S. Patent and Trademark Office ("PTO"), Defendants move for summary judgment on all claims, asserting the defense of intervening rights, and more specifically, absolute intervening rights.
For the following reasons, Defendants' motion is granted.
At issue in this case are various inventions for making ingestible, pharmaceutical films. The following facts are undisputed unless otherwise indicated.
On November 2, 2010, MonoSol filed this action against BDSI, its strategic partner, Meda, and its contract manufacturer, Aveva, for alleged infringement of the `588 patent by BDSI's Onsolis® products. Defs.' Statement of Undisputed Material Facts ("Defs.' Stmt. of Facts") ¶ 1; Dkt. 1. The `588 patent is a "method of making self-supporting therapeutic active-containing film," see `588 Patent Cover Page, and, according to Plaintiff's Complaint, "BDSI, MEDA, and Aveva (collectively, "Defendants") make, use, offer to sell, and/or sell certain pharmaceutical films under the Onsolis™ name." Compl. ¶ 12. BDSI requested that the PTO reexamine the `588 patent on September 12, 2011.
On September 26, 2011, MonoSol amended its Complaint to assert infringement of the `891 patent and the `292 patent. Defs.' Stmt. of Facts ¶ 5; Dkt. 47. The `891 patent is a "process for making an ingestible film,"
On January 23, 2013, the PTO issued a right of appeal notice, rejecting all claims of the `588 patent. Defs.' Stmt. of Facts ¶ 10; see also Jan. 23, 2013 Right of Appeal Notice. On February 22, 2013, MonoSol appealed the rejection to the Patent Trial and Appeal Board (the "PTAB"). Defs.' Stmt. of Facts ¶ 11; see also Feb. 22, 2013 Notice of Appeal. On April 17, 2014, the PTAB confirmed the rejection. Defs.' Stmt. of Facts ¶ 12; see also Apr. 14, 2014 PTAB Decision on Appeal at p. 22. On August 5, 2014, the PTO issued a Certificate of Reexamination cancelling all claims of the `588 patent. Defs.' Stmt. of Facts ¶ 13; see also Aug. 5, 2014 Ex Parte Reexamination Certificate for `588 Patent at Col. 1.
On July 3, 2012, the PTO issued a reexamination certificate for the `292 patent. July 3, 2012 `292 Patent Ex Parte Reexamination Certificate. The original `292 patent contained 22 claims. See `292 Patent. Upon reexamination, the PTO found that (1) claims 1, 10, 13-15, and 17-22 are patentable as amended, (2) claims 2-9, 11, 12, and 16, dependent on an amended claim, are patentable, and (3) new claims 23-55 are added and determined to be patentable. Id. Col. 1.
The original language of each of independent claims 1, 10, 13-15, and 17-22 of the `292 patent is different, but, following reexamination, each of those claims contains the following four additions: (1) "including said active component," (2) "active component comprising," (3) "by rapidly increasing the viscosity of said film upon initiation of drying," and (4) "whereby said compositional uniform distribution is measured by substantially equally sized individual unit doses which do not vary by more than 10% of active component." Defs.' Stmt. of Facts ¶ 16; compare `292 Patent at 26:11-32:13 with `292 Patent Ex Parte Reexamination Certificate at 1:25-6:67. By way of example, Claim 1 of the reexamined `292 patent reads as follows, with the added language underlined:
Defs.' Stmt. of Facts ¶ 17; July 3, 2012 Ex Parte Reexamination Certificate for `292 Patent at 1:25-1:57.
Defendants state that "[d]uring reexamination of the `292 patent, MonoSol attempted to distinguish the claims from prior art including Chen
MonoSol submitted to the Examiner the results of experiments that purportedly demonstrated the `292 patent's invention uniformity of active content comprising particles, distinguishing the less uniform "glossy" and "unmottled" results of the processes of Chen and Strobush. Defs.' Stmt. of Facts ¶ 24 (citing Apr. 4, 2014 Smolenski Decl. at ¶¶ 5-9)). MonoSol added the phrase "active component comprising" twice in each amended independent claim of the `292 patent in the reexamination. Defs.' Stmt. of Facts ¶ 25 (citing July 3, 2012 Ex Parte Reexamination Certificate for `292 Patent at e.g., 1:40 and 1:52). The Examiner noted in his Reasons For Patentability of the `292 patent that "Chen does not discuss compositional uniformity of an active component comprising drug particles." Defs.' Stmt. of Facts ¶ 26 (citing May 11, 2012 Reasons For Patentability). In response to the Examiner's comments regarding prior art, MonoSol reported on a series of experiments that allegedly distinguished the process of the `292 patent claims from Chen and Strobush. The experiments allegedly confirmed that through the Chen and Strobush processes, which do not have "the claimed rapid formation of the visco-elastic film, particularly at the initiation of the drying phase, a useful, uniform active-containing product is not achieved."
MonoSol advised the Examiner during reexamination of the `292 patent: "If one were to incorporate the drying process of Strobush into the teachings of Chen, one would arrive at a process that necessarily . . . slowly ramps up the temperature at which the wet film is dried. This is in direct contrast to the presently claimed invention [that] require[s] a rapid formation of a visco-elastic film as the drying is initiated so as to `lock-in' the active component in place within the time and temperature ranges claimed. Thus, the combination of Strobush and Chen fails to arrive at the present invention." Defs.' Stmt. of Facts ¶ 28 (citing Apr. 6, 2012 Reply to Non-Final Office Action, pp. 36-37).
According to Defendants, "[d]uring an interview, the Examiner suggested that MonoSol add language to claims of the `292 patent concerning the rapid formation of the visco-elastic film to distinguish over prior art."
In response to the Examiner's rejections during reexamination of the'292 patent, on the basis of prior art, Defendants state that "MonoSol stated that Chen and Strobush `fail to disclose the presently claimed uniformity, specifically achieving a uniformity of no more than 10% variance in active content between substantially equally sized unit doses of dried film.'"
Defendants further state that "MonoSol followed the Examiner's suggestion to add language specifying the uniformity of active content, but initially only for some of the independent claims of the `292 patent. The Examiner required MonoSol to amend Claims 21 and 22 of the `292 patent twice because MonoSol did not include the 10% uniformity limitation to distinguish Chen and Strobush in the first set of amendments to those claims."
According to Defendants, "[t]he dependent claims of the reexamined `292 patent are all new."
The PTO issued a reexamination certificate for the `891 patent on August 21, 2012. Defs.' Stmt. of Facts ¶ 34. The original `891 patent contained 9 claims. See `891 Patent. Upon reexamination, the PTO found that (1) claims 1-9 were cancelled, and (2) independent claims 10-11 and dependent claims 12-28 were added. Defs.' Stmt. of Facts ¶ 53; see also `891 Patent Ex Parte Reexamination Certificate Col. 1.
The phrase "wherein said desired level is measured by substantially equally-sized individual unit doses which do not vary by more than 10% of said pharmaceutical or biological active component" was included in independent claims 10 and 11 of the `891 patent during the course of reexamination, which otherwise track the language of cancelled claims 1 and 9. Defs.' Stmt. of Facts ¶ 46 (citing May 1, 2012 Reply By Patentee to Non-Final Office Action, pp. 19-20). By way of example, Claim 10 of the reexamined patent reads as follows, and tracks claim 1, with the additional language underlined:
`891 Patent Ex Parte Reexamination Certificate at claim 10; see also `891 Patent at claim 1.
In a summary of an interview with the Examiner during reexamination of the `891 patent, MonoSol stated, "The Patentee and Examiner discussed clarifying the `desired level' of active in the claims as being measured by `substantially equally-sized individual unit doses which do not vary by more than 10% of said pharmaceutical or biological active component'. This language provides further definition to the language that is already present in the issued claim." Defs.' Stmt. of Facts ¶ 46 (citing May 1, 2012 Summary of the Interview at 3)). Further, Defendants state that "[d]uring the reexamination of the `891 patent, MonoSol attempted to distinguish the claims from prior art including Chen and Strobush."
According to Defendants,"
Defs.' Stmt. of Facts ¶ 47 (citing May 1, 2012 Reply By Patentee to Non-Final Office Action, at 19-20). Defendants further state that "[t]he new claims 10 and 11 of the `891 patent tracked the original claims 1 and 7, respectively, except that claims 10 and 11 had the added language specifying active content uniformity."
Defendants state that "[t]he Examiner ultimately required cancellation of the original claims 1 and 7 of the `891 patent, because claims 1 and 7 omitted the new limiting language requiring measurement by unit doses that do not vary by more than 10% of active component."
In his July 6, 2012 Reasons For Patentability of the `891 patent, the Examiner stated, "Chen does not discuss uniformity or pharmaceutical or biological active component in its doses. Table 4 of Chen gives the grams per dosage film and density for Example 1 with standard deviation based on three or four measurements, but does not give compositional uniformity," and that "Strobush provides no teaching with respect to compositional uniformity." Defs.' Stmt. of Facts ¶ 51 (quoting July 6, 2012 Reasons For Patentability). The PTO issued a reexamination certificate for the `891 patent on August 21, 2012. Defs.' Stmt. of Facts ¶ 52 (citing `891 Ex Parte Reexamination Certificate).
Defendants state that "[n]o original claim remains from any of the three patents that MonoSol has asserted against BDSI in this case."
After the PTO issued its reexamination certificates as to all three patents at issue, and this Court lifted its stay on the proceedings pending the PTO's reexaminations, Defendants moved for summary judgment on Plaintiff's patent infringement claims, on the defense of intervening rights.
A moving party is entitled to judgment as a matter of law where there is no genuine issue as to any material fact. See FED R. CIV. P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986)); Brooks v. Kyler, 204 F.3d 102, 105 n.5 (3d Cir. 2000) (citing FED. R. CIV. P. 56(c)). The burden of demonstrating the absence of a genuine issue of material fact falls on the moving party. See Taylor v. Phoenixville Sch. Dist., 184 F.3d 296, 305 (3d Cir. 1999). Once the moving party has satisfied this initial burden, the opposing party must identify "specific facts which demonstrate that there exists a genuine issue for trial." Orson, Inc. v. Miramax Film Corp., 19 F.3d 1358, 1366 (3d Cir. 1996).
Not every issue of fact will be sufficient to defeat a motion for summary judgment; issues of fact are genuine "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). Further, the nonmoving party cannot rest upon mere allegations; he must present actual evidence that creates a genuine issue of material fact. See FED. R. CIV. P 56(e); Anderson, 477 U.S. at 249. In conducting a review of the facts, the non-moving party is entitled to all reasonable inferences and the record is construed in the light most favorable to that party. See Pollock v. Am. Tel. & Tel. Long Lines, 794 F.2d 860, 864 (3d Cir. 1986). Accordingly, it is not the court's role to make findings of fact, but to analyze the facts presented and determine if a reasonable jury could return a verdict for the nonmoving party. See Brooks, 204 F.3d at 105 n.5 (citing Anderson, 477 U.S. at 249).
Defendants move for summary judgment under the intervening rights doctrine, arguing that the reexamination proceedings for the `292 and `891 patents substantively changed the claims of the patents on which Plaintiff bases its infringement contentions. On that basis, Defendants contend that they are entitled to absolute intervening rights, precluding any award of damages for Defendants' actions prior to the PTO's issuances of the `292 and `891 reexamination certificates. Plaintiff counters by arguing that the `292 and `891 patent claims were not so substantively changed as to permit Defendants to assert intervening rights.
"The doctrine of intervening rights first developed as courts recognized that permitting substantive changes to the scope of patent claims through post-issuance procedures left the door open for gross injustice where a third party, having already begun to make, use, or sell a given article, finds its previously lawful activities rendered newly infringing under a modified patent." See Marine Polymer Technologies, Inc. v. HemCon, Inc., 672 F.3d 1350, 1361-62 (Fed. Cir. 2012) (en banc) (internal quotation marks omitted). The concept of intervening rights was first codified with respect to reissued patents, and has since been extended to reexamined patents under 35 U.S.C. § 307(b), which provides:
35 U.S.C. § 307(b). Thus, only "amended" or "new" claims in a reexamined patent give rise to the defense of intervening rights. Id.; see also Marine Polymer, 672 F.3d at 1363.
As noted, patent law provides for two types of intervening rights: (1) "absolute intervening rights," which sever liability for an infringer for accused products that were made or used before the reexamination certificate issue; and (2) "equitable intervening rights," where a court, in its equitable discretion, may provide for a party to continue to engage in infringing activities—e.g., to continue to make or use products—after the reexamination certification has issued if the accused infringer made substantial preparations for the infringing activities prior to the reexamination. See 35 U.S.C. §§ 252, 307; Fresenius USA, Inc. v. Baxter Int'l, Inc., 721 F.3d 1330, 1339 (Fed. Cir. 2013). Here, Defendants make clear in their reply brief that they "base their motion solely on absolute intervening rights." Defs.' Reply Br. at 13.
After determining that the claim upon which the intervening rights are premised is new or has been amended, see Marine Polymer, 672 F.3d at 1361-62, the Court must determine whether the accused product or activity infringes on a claim that remains "without substantive change" after the reexamination; if the claim has not been substantively changed, the doctrine of intervening rights does not apply. Seattle Box Co. v. Indus. Crating & Packing, Inc., 731 F.2d 818, 827-28 (Fed. Cir. 1984); Bloom Eng'g Co. v. N. Am. Mfg. Co., 129 F.3d 1247, 1250 (Fed. Cir. 1997) ("Unless a claim granted or confirmed upon reexamination is identical to an original claim, the patent cannot be enforced against infringing activity that occurred before issuance of the reexamination certificate."); see also Kaufman Co. v. Lantech, Inc., 807 F.2d 970, 975-77 (Fed. Cir. 1986) (explaining the relationship between §§ 252 and 307(b) and holding that "identical," as used in § 252, means "without substantive change" under § 307(b)).
Here, there is no dispute among the parties that Defendants' intervening rights defense is based upon claims that have been amended or added in the `292 and `891 reexamination proceedings.
"To determine whether a claim change is substantive it is necessary to analyze the claims of the original and the reexamined patents in light of the particular facts, including the prior art, the prosecution history, other claims, and any other pertinent information." Laitram Corp. v. NEC Corp., 163 F.3d 1342, 1347 (Fed. Cir. 1998) ("Laitram IV") (internal quotation marks omitted). Like with claim construction, these reexamined claims "are not to be interpreted by adding limitations appearing only in the specification." Electro Med. Sys. v. Cooper Life Sciences, Inc., 34 F.3d 1048, 1054 (Fed. Cir. 1994). Overall, the focus is on whether the amended claims are of a "different scope" than the original claims. Laitram IVv, 163 F.3d at 1348.
Claims define the scope of the inventor's right to exclude. Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005). Claim construction is designed to determine the correct claim scope, a determination exclusively for the court as a matter of law. Markman v. Westview Instruments, Inc., 52 F.3d 967, 978-79 (Fed. Cir. 1995) aff'd, 517 U.S. 370 (1996). This interpretive analysis begins with the language of the claims, which is to be read and understood as it would be by a person of ordinary skill in the art. Dow Chem. Co. v. Sumitomo Chem. Co., 257 F.3d 1364, 1372 (Fed. Cir. 2001); see also Markman, 52 F.3d at 986 ("The focus [in construing disputed terms in claim language] is on the objective test of what one of ordinary skill in the art at the time of invention would have understood the terms to mean"); Phillips, 415 F.3d at 1312-13.
In construing the claims, the court may examine both intrinsic evidence (e.g., the patent, its claims, the specification and prosecution history) and extrinsic evidence (e.g., expert reports, testimony and anything else). Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1309 (Fed. Cir. 1999). In interpreting the disputed terms, it is well settled that the court should look first to the intrinsic evidence. Vitronics Corp., 90 F.3d at 1362. Generally, words in patent claims are given their ordinary meaning as understood by one of ordinary skill in the art at the priority date of the patent application. Dow Chem., 257 F.3d at 1372; K-2 Corp. v. Salomon S.A., 191 F.3d 1356, 1362 (Fed. Cir. 1999). The claims must be construed objectively in the context of both the particular claim and the entire patent because "the claims themselves provide substantial guidance as to the meaning of particular claim terms," and claim terms are normally used consistently throughout the patent. Phillips, 415 F.3d at 1313-14.
Moreover, courts are instructed to look to the specification, which is a written description of the invention. "[C]laims `must be read in view of the specification, of which they are a part.'" Phillips, 415 F.3d at 1315 (quoting Markman, 52 F.3d at 979). Indeed, the specification is perhaps "the single best guide to the meaning of a claim term" due to its statutory requirements of being in "full, clear, concise, and exact terms." Phillips, 415 F.3d at 1316; see 35 U.S.C. § 112. "[It] acts as a dictionary when it expressly" or implicitly defines terms used in the claims. Markman, 52 F.3d at 979. In this way, the specification can "set the scope and outer boundary" of the claim. On Demand Mach. Corp. v. Ingram Industries, Inc., 442 F.3d.1331, 1340 (Fed. Cir. 2006). Conversely, "limitations appearing in the specification will not be read into the claim." DSW, Inc. v. Shoe Pavilion, Inc., 537 F.3d 1342, 1348 (Fed. Cir. 2008).
Here, the parties agree that each of the independent claims 1, 10, 13-15, and 17-22 of the `292 patent was amended to include the following claim limitations: (1) "including said active component," (2) "active component comprising," (3) "by rapidly increasing the viscosity of said film upon initiation of drying," and (4) "whereby said compositional uniform distribution is measured by substantially equally sized individual unit doses which do not vary by more than 10% of active component." Defendants contend that these changes are substantive and that they narrowed the scope of the original claims; Plaintiff argues that these changes merely clarified limitations that were always present in the claims. If the Court concludes that one of these changes is substantial, thereby altering the scope of the claim, the remaining amendments need not be addressed. See Laitram IV, 163 F.3d at 1345 ("The added limitations generally address three aspects of the disclosed invention: speed, type quality, and direction of movement. Because our conclusion regarding claim identicality may be based on the type quality amendment alone, we limit our analysis to that limitation."); see also Bloom Eng'g Co. v. N. Am. Mfg. Co., 129 F.3d 1247, 1251 (Fed. Cir. 1997) (affirming summary judgment on the basis of intervening rights despite disagreeing with the district court on whether one of the two claim amendments at issue was a substantive change). For that reason, I begin my analysis of the reexamined `292 patent by examining whether the amendment regarding uniform composition—specifically, the addition of the phrase "whereby said compositional uniform distribution is measured by substantially equally sized individual unit doses which do not vary by more than 10% of active component"— constitutes a substantial change.
First, the prosecution history reveals that the amendment in question had the effect of distinguishing the `292 patent from prior art. Claims 1-20 were initially cancelled because they were unpatentable over prior art. According to the PTO, "[i]t would have been obvious to one of ordinary skill in the art at the time the invention was made to apply the drying method taught by Strobush to the film formation method disclosed by Chen to achieve uniformity in density of the active component in Chen's dried film." Specifically, "it would have been obvious to one of ordinary skill in the art at the time the invention was made to dry Chen's film in, for example, three zones as in Strobush and determine the appropriate parameters, including time, for each zone, so as to dry the film such that it is virtually mottle proof in the first zone and then remove remaining water in the subsequent two zones." Feb. 16, 2012 Office Action in Ex Parte Reexamination, at 9-10.
Id. "The Patentee then explained the results of comparative testing that was performed . . . to determine whether a process using the Chen/Strobush teachings would result in uniformity of content of active per unit dose as compared to the same formulation made in accordance with the present invention." Id. at 4. Three comparative samples were prepared, using (1) the inventive process in question, (2) low heat and top and bottom drying (consistent with Strobush's teaching) and (3) high heat and high velocity top drying. Jan. 20, 2012 Myers Decl., at 3. While "[e]ach of the samples appeared visually uniform and mottle free . . . the Patentee . . . stressed that the two comparative samples were non-uniform in content," as opposed to the result of the samples prepared using the inventive process. Specifically, according to a declaration of Garry Myers, the named inventor of the `292 patent, the comparative testing showed that by using the inventive process at issue, the active content ranges from 102.7% to 107.3% of the targeted label claim. By using a drying method consistent with the teaching in Strobush, the active content ranges from 92.8% to 117.7% of the targeted label claim. By using a high heat, high velocity drying method, the active content ranges from 95.5% to 117.7% of the targeted label claim. Jan. 20, 2012 Myers Decl., at 4. Thus, the inventive process' achievement of less than 10% variation in active content per dose is a critical point of distinction over prior art.
Still within the summary section titled "Discussion of the Cited References, Chen and Strobush," the Examiners addressed the suggested amended language as follows:
Apr. 6, 2012 Summary of the Interview, at 4 (emphasis added).
This interview summary excerpt indicates that the amendment to the claim language in the `292 patent relating to the uniform distribution of the active component had the effect of distinguishing the `292 patent from the Chen and Strobush combination by focusing the claims upon the achievement of a uniform distribution of drug particles over that of a glossy or mottle-free film. See Mar. 30, 2012 Ex Parte Reexamination Interview Summary (prepared by Alan Diamond, a Patent Reexamination Specialist, and noting that "[t]he degree of uniformity of the instant film . . . was discussed relative of Chen and Strobush. Patent Owner argued and attempted to show that minimizing the formation of mottle as in Strobush doesn't necessary[il]y lead to uniform drug content in the film. Patent Owner argued that in the first 4 minutes of drying in the instant process, the drug particles are locked into place so as to obtain the uniformity. Patent Owner will consider adding claim language to specify the uniformity, such as a film having no more than 10% variance of the drug particles per unit dosage." (emphasis added)).
Finally, the comment accompanying the Notice of Intent to Issue Reexamined Patent notes at the outset that "[t]he compositional uniform distribution [of the amended claims] is measured by substantially equally sized individual doses which do not vary by more than 10% of the active component, which comprises drug particles" and states, in relevant part, that "Chen does not discuss compositional uniformity of an active component comprising drug particles. Table 4 of Chen gives the grams per dosage film and density . . . with standard deviation based on three or four measurements, but does not give compositional unity." Further, "Strobush provides no teaching with respect to compositional uniformity, and it is noted that . . . the films produced by the inventive process can often appear `mottled' but also have a uniform distribution of active per unit dose."
That this amendment had the effect of distinguishing over prior art, notably, Chen and Strobush, combined with the fact that the `292 patent's original claims were rejected upon reexamination due to being unpatentable over Chen and Strobush, among other prior art, is "highly influential" evidence demonstrating that the amendment was substantive. Laitram IV, 163 F.3d at 1348 ("Most significantly, . . . the addition of the `type quality' limitation, along with the other amendments, resulted in the allowance of claims that had been rejected in the reexamination proceeding over prior art; this is a highly influential piece of prosecution history.").
Second, the amendment's language was not implicit in the claims as originally written. Plaintiff argues that "[t]he additional language is supported by the specification and merely states how a person of ordinary skill in the art would understand the original language." Pl.'s Opp. Br. at 18. Specifically, Plaintiff points to language in the specification stating that "[a] still further aspect of the present invention includes a pharmaceutical and/or cosmetic dosage form including a polymeric film having no more than a 10% variance of a pharmaceutical and/or cosmetic active per unit area." `292 Patent at Col. 6. Plaintiff further argues that "[i]n the pharmaceutical field, 10% variation of active ingredients is well understood" and, therefore, "a person with ordinary skill in the art would read the amendment as being consistent with the teachings of the specification." Id. In that regard, there is additional language in the specification stating that, "[c]urrently, by law, dosage forms may not vary more than 10% in the amount of active present. When applied to dosage units based on films, this virtually mandates that uniformity in the film be present." `292 Patent, Col. 2.
However, while "claims `must be read in view of the specification, of which they are a part,'" Phillips, 415 F.3d at 1315 (quoting Markman, 52 F.3d at 979), the case law is clear that "a court may not import limitations from the written description into the claims." Laitram IV, 163 F.3d at 1347.
SRI Int'l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 (Fed. Cir. 1985) (en banc) (citations omitted); see also Electro Med. Sys., S.A. v. Cooper Life Sciences, Inc., 34 F.3d 1048, 1054 (Fed. Cir. 1994) ("[A]lthough the specifications may well indicate that certain embodiments are preferred, particular embodiments appearing in a specification will not be read into the claims when the claim language is broader than such embodiments.").
Here, the specification's mention of no more than 10% variation in "a still further aspect" of the invention merely refers to a preferred embodiment of the claim. The specification describes numerous "aspects" of the invention, each encompassing a slightly different method of film formation. See `292 Patent, Cols. 3-6. The case law is in accord with this conclusion. Altus Partners, LLC v. Globus Med., Inc., No. CIV.A. 13-822, 2013 WL 5803784, at *4 (E.D. Pa. Oct. 28, 2013) ("Statements in the specification describing `one aspect of the present invention' are references to the preferred embodiment and are not claim limitations." (citing Sandisk Corp. vs. Memorex Prods., 415 F.3d 1278, 1286 (Fed. Cir. 2005))); Flexhead Indus., Inc. v. Easyflex, Inc., No. CIV.A. 06-11898-DPW, 2008 WL 4813797, at *3 (D. Mass. Nov. 3, 2008). ("Statements describing `one aspect' or `another aspect' of the invention cannot reasonably be read to describe the invention `as a whole.' They are more properly treated as embodiments of the invention. Embodiments described in the specification do not limit claim terms." (citing Moore U.S.A., Inc. v. Standard Register Co., 229 F.3d 1091, 1111 (Fed. Cir. 2000), cert. denied, 532 U.S. 1008 (2001) (treating a reference in the patent to "one aspect of the present invention" as a preferred embodiment))); see also, e.g., Morningware, Inc. v. Hearthware Home Products, Inc., No. 09 C 4348, 2011 WL 1376920, at *5 (N.D. Ill. Apr. 12, 2011). Therefore, I find that the specification's description of a no more than 10% variance in a "still further aspect" of the invention to be contained in a preferred embodiment and, thus, that the description may not be imported into the claims. Laitram IV, 163 F.3d at 1247; see also, e.g., Flexhead Indus., 2008 WL 4813797, at *3.
Further, the specification's reference to "current law" has no relevance to the claims. The specification's reference reads in full as follows:
`292 Patent, Col. 2. I find that this part of the specification merely speculates about the possibility of meeting FDA guidelines; it does not imply that all embodiments of the `292 patent achieve such a maximum variance. Nor do I find that this section in the specification proves that an ordinary person skilled in the art would necessarily assume that the uniform distribution of the active component would mean a variation of no more than 10%.
Finally, the amendment constitutes a limitation because it surrenders territory. Specifically, the claims now exclude processes whereby the uniform distribution of a self supporting, edible film having a substantially uniform distribution of components, composed of (1) an edible water-soluble polymer component, (2) water, and (3) an active component comprising drug particles, is not measured by substantially equally sized individual unit doses which do not vary by more than 10% of active component. See Bloom Eng'g Co. v. N. Am. Mfg. Co., 129 F.3d 1247, 1251 (Fed. Cir. 1997) ("The amendment narrowed the claims to exclude an injected gas stream that includes combustion air, and to require a separate combustion air stream."); see also, e.g., Convolve, Inc. v. Compaq Computer Corp., 33 F.Supp.3d 316, 342-43 (S.D.N.Y. 2014) ("Plaintiff here, having amended its claims to limit the patented method's application only to `seek' acoustic noise, argues that the original claims were already implicitly limited to `seek' noise. But the original claims employ the term `acoustic noise' with no modifier, which—by its plain language—covers situations where `spindle' or other acoustic noise, as well as `seek' acoustic noise, is targeted by the claimed method.") (internal citation omitted).
Therefore, I find that the phrase "whereby said compositional uniform distribution is measured by substantially equally sized individual unit doses which do not vary by more than 10% of active component" constitutes a substantive change to the `292 patent's independent claims, and, thus, that it also substantially changes the `292 patent's dependent claims.
However, out of an abundance of caution, I will also proceed to analyze whether the amendment regarding the rapid increase of viscosity of the film—specifically, the addition of the phrase "by rapidly increasing the viscosity of said film upon initiation of drying"—also constitutes a substantial change. I find that it does.
As stated supra, the prosecution history demonstrates that the amendment had the effect of distinguishing over prior art. While Chen and Strobush both encompass methods for drying, neither method utilizes a rapid drying process at a high heat that rapidly forms a visco-elastic film and locks in the uniformity of the active component. Apr. 6, 2012 Summary of the Interview ("Whereas Strobush requires a very small change in the heat transfer rate over time, the inventive process requires a larger change in heat transfer rate starting from the initiation of the drying process, in order to rapidly form the visco-elastic film and `lock-in' place the uniformly distributed active."); see also March 30, 2012 Examiner Interview Summary Record ("Patent Owner argued that in the first 4 minutes of the drying process, the drug particles are locked in to place so as to obtain the uniformity.").
In its Notice of Intent to Issue a Reexamination Certificate, the PTO noted that the amended claims had the effect of distinguishing among the drying processes utilized by the present inventive process, Chen, and Strobush. May 11, 2012 Notice of Intent to Issue a Reexamination Certificate, at 2 ("While Chen exemplifies drying at 9 minutes . . . it does so at 50 degrees C . . . and Chen does not discuss what happens within the first 4 minutes of drying . . . [T]he drying [taught by Chen] . . . resulted in a lower initial transfer rate, the wet film dried more slowly and was thereby subjected to mass transfer (flow) prior to locking in the desired content of active per unit dose area." Meanwhile, "Strobush . . . desires to keep its heat transfer rate. . . below a threshold value to prevent mottle."). I find this fact "highly influential" and that it weighs heavily in favor of finding that a substantive change occurred. Laitram IV, 163 F.3d at 1348.
Further, I find that the amendment is not implicit. Plaintiff argues that "[t]he amended language merely describes what happens in the originally claimed drying step." Pl.'s Opp. Br. at 15. However, while the claims themselves state that the visco-elastic film is formed "by applying hot air current at temperatures of about 60° C. to about 100° C. to said bottom side of said surface with substantially no top air flow to prevent flow migration and intermolecular forces from creating aggregates or conglomerates of said drug particles thereby maintaining the compositional uniform distribution of components," the claims do not necessarily imply that the initiation of this heating process rapidly increases the visco-elasticity of the film to "lock-in" the placement of the drug particles. Nor can this fact be implied from the specification; rather, in describing the drying process, the specification merely states, in relevant part:
`292 Patent, at Col. 16-17. While the specification mentions that the drying process may have an impact on the distribution of the active component, it merely discusses various preferred embodiments of the invention which utilize different drying methods, only some of which even require the application of heat. See Laitram IV, 163 F.3d at 1348. Finally, I find that this amendment constitutes a limitation, because it excludes pharmaceutical film drying processes that otherwise conform to the claims as written but which do not "rapidly increase the viscosity of said film upon the initiation of drying." See Bloom, 129 F.3d at 1251. Therefore, I find that the amendment "by rapidly increasing the viscosity of said film upon the initiation of drying" to constitute a substantive change to the `292 patent.
Therefore, I find that at least two of the amendments made to the `292 patent's independent claims (and, by incorporation, its independent claims)
I next turn to whether the `891 patent was substantively changed upon reexamination. While the patent's original nine claims were cancelled, the two independent claims what were added, claims 10 and 11, appear to be identical to the cancelled claims 1 and 7, except the following phrase was added to both claims: "wherein said desired level is measured by substantially equially-sized [sic] individual unit doses which do not vary by more than 10% of said pharmaceutical or biological active component." The added phrase modifies the existing phrase "wherein said pharmaceutical or biological active component is maintained at said desired level."
First, the prosecution history reveals that this amendment to original claims 1 and 7 had the effect of distinguishing the `891 patent over prior art. Claims 1 and 7, both processes "for making an ingestible film having a substantially uniform distribution of components and a desired level of a pharmaceutical or biological active component," were cancelled because they were unpatentable over prior art. Specifically, Claim 1 was unpatentable because, according to the PTO,
March 1, 2012 Office Action in Ex Parte Reexamination, at 8-9. Further,
Id. at 10. Claim 7 was rejected because "[i]t would have been obvious to one of ordinary skill in the art at the time the invention was made to have prepared Chen's premix in one mixing vessel, then transferred it to another vessel of a cooler temperature, and then stirred in heat sensitive active ingredients such as proteins because such is conventional processing in the art and so as to avoid degradation of the heat sensitive materials." Id. at 11. Further, "[i]n order to achieve uniformity in density of the active component in Chen's dried film[,] it would have been obvious to one of ordinary skill in the art at the time the invention was made to dry Chen's film in, for example, three zones as in Strobush as discussed above, and determine the appropriate parameters, including time, for each zone, so as to dry the film such that it is virtually mottle proof in the first zone and then remove remaining water in the subsequent two zones." Id. 12.
In an interview held between the Examiners, the Patentee's representative, and MonoSol representatives, which was summarized by Daniel A. Scola, attorney for the patentee, "[t]he Patentee and the Examiners discussed various amendments that may be included in the claims. In particular, the Patentee and the Examiners discussed clarifying the `desired level' of active in the claims as being measured by `substantially equally-sized individual unit does which do not vary by more than 10% of said pharmaceutical or biological active component." May 1, 2012 Summary of the Interview, at 3.
In the PTO's comments accompanying the July 7, 2012 Notice of Intent to Issue Ex Parte Reexamination Certificate as to the amended `891 patent, the PTO noted that "Chen does not discuss uniformity or pharmaceutical or biological active component in its doses. Table 4 of Chen gives the grams per dosage film and density for Example 1 with standard deviation based on three or four measurements, but does not give compositional uniformity," and that "Strobush provides no teaching with respect to compositional uniformity."
Second, this amendment was not implicit in the original claims. Indeed, the mere fact that claims 1 and 7 were rejected as unpatentable, and that the approved claims 10 and 11 track the language of claims 1 and 7, except for the amended language, suggests that the original language did not inherently contain the amendment at issue. Cf. Yoon Ja Kim v. Earthgrains Co., 451 Fed. App'x 922, 925 (Fed. Cir. 2011) ("Why, if the claims are of identical scope, did [the patentee] amend them?"). Plaintiff argues that this limitation is present in the specification and should thus be read into the claims. In the "Background of the Related Technology" section of the specification, it is stated that "Currently, as required by various world regulatory authorities, dosage forms may not vary more than 10% in the amount of active present. When applied to dosage units based on films, this virtually mandates that uniformity in the film be present." Id. Col. 2. This language is strikingly similar to the language used in the `292 patent's specification as to the FDA standard for dosage forms. Compare id. with `292 Patent, Col. 2. Further, in the "Detailed Description of the Invention" section, the specification states the following:
`891 Patent, Col. 14.
This Court found supra that the `292 patent's reference to FDA dosage uniformity standards should not be read in to that patent's claim language on uniformity. Likewise, I find that the `891 patent's reference to world regulatory dosage requirements should not be read into measuring the uniformity of the desired levels of active component in that patent's claims. The specification language merely generally comments on the possibility of obtaining regulatory approval to someday market any medicines developed using its method. It does not demonstrate that an ordinary person skilled in the art would necessarily understand that the desired level of active component mentioned in the `891 patent's claims would be measured by equally sized dosage units which do not vary by more than 10% of the active component.
As to the specification's other language about a no more than 10% variance in the amount of active present, I find that Plaintiff is requesting the Court to read in the above limitation from the specification into the claim, which is impermissible. Laitram IV, 163 F.3d at 1347. The specification defines uniformity of the present invention as "determined by the presence of no more than a 10% by weight of the pharmaceutical and/or cosmetic variance throughout the matrix." `891 Patent, Col. 11. However, the original claims merely describe a "process for making an ingestible film having a substantially uniform distribution of components and a desired level of a pharmaceutical or biological active component." `292 Patent, Claim 1; see also Claim 7 (emphasis added). As the Federal Circuit has recognized, "the term `substantially' is a descriptive term commonly used in patent claims to `avoid a strict numerical boundary to the specified parameter,. . . .'" Ecolab, Inc. v. Envirochem, Inc., 264 F.3d 1358, 1367 (Fed. Cir. 2001); see also Dana Corp. v. Am. Axle & Mfg., Inc., 110 Fed. App'x 871, 876 (Fed. Cir. 2004). In Ecolab, which involved an invention for a solid detergent cast, the Federal Circuit found in relevant part that (1) "no basis exists for inferring a numerical limitation as to what is a `substantially uniform' cast," and (2) "`substantially' avoids the strict 100% nonuniformity boundary.'" 264 F.3d at 1365-67. I find similarly in this case. Specifically, here, (1) the term "substantially uniform" is a non-numerical limitation, and (2) a measure of "uniformity" would not necessarily capture a distribution of active component that was merely "substantially uniform." As the Patentee described it in the prosecution history, the amendment "clarifies that the active component is maintained in a known and useful amount," thus distinugishing over prior art in which the active component varies more across dosage units. May 1, 2012 Reply by Patentee to a Non-Final Office Action Pursuant to 37 C.F.R. § 1.111, at 19. This clarification is otherwise absent in the claims as originally written; therefore, the amendment was not implicit.
Third, the amendment constitutes a limitation. As explained supra, the phrase "wherein said desired level is measured by substantially equally-sized individual unit doses which do not vary by more than 10% of said pharmaceutical or biological active component" narrows the scope of the "desired level" of the pharmaceutical or biological active component by excluding levels that vary by more than 10% of the pharmaceutical or biological active component. See Bloom, 129 F.3d at 1251; see also, e.g., Convolve, 33 F. Supp. 3d at 342-43.
Therefore, I find that the phrase "wherein said desired level is measured by substantially equially-sized [sic] individual unit doses which do not vary by more than 10% of said pharmaceutical or biological active component," as included in independent claims 10 and 11 of the `891 patent upon reexamination, constitutes a substantive change to independent claims 1 and 7 of the patent, which claims 10 and 11 replaced. Thus, I find that the amendment also substantially changes the `891 patent's dependent claims.
For the foregoing reasons, Defendants' motion for summary judgment is granted.
For background, "[w]hen a patent claim is reexamined by the PTO, there are three possible outcomes—it can be cancelled as unpatentable, it can be confirmed as originally written, or it can be modified." Ever Win Int'l Corp. v. Radioshack Corp., 902 F.Supp.2d 503, 505 (D. Del. 2012). 35 U.S.C. § 305 governs the conduct of reexamination proceedings. "In any reexamination proceeding under this chapter, the patent owner will be permitted to propose any amendment to his patent and a new claim or claims thereto, in order to distinguish the invention as claimed from the prior art cited under the provisions of section 301, or in response to a decision adverse to the patentability of a claim of a patent. No proposed amended or new claim enlarging the scope of a claim of the patent will be permitted in a reexamination proceeding under this chapter." Id.
Pl.'s Response to Defs.' Stmt. of Facts ¶ 20.
In their reply brief, Defendants argue that they base their motion solely on absolute intervening rights and that "[t]he proposed order that MonoSol cites is directed to dismissal of MonoSol's claims for the time period after reexamination certificates issued because no accused product has been made or sold since before those certificates issued." Defs.' Reply Br. at 13 (emphasis removed). Further, Defendants argue that "MonoSol now seeks an advisory opinion from this Court on whether the amended claims of the `292 and `891 patents would be infringed if, in the future, Defendants are (1) able to obtain FDA approval to make a fentanyl product and (2) then reintroduce that still-to-be approved product on the marketplace." Defs.' Reply Br. at 14.
The Court will solely consider on this motion the issue of whether Defendants are entitled to assert the defense of absolute intervening rights during the period before the `292 and `891 reexamination certificates were issued. Thus, the Court declines to issue any orders about potential infringement that may occur after reexamination had concluded.
Pl.'s Opp. Br. at 20. This argument is unavailing, because Plaintiff does not meaningfully distinguish variation between dosage units and variation per unit dose. Further, based on the prosecution history, it appears that both statements refer to the fact that the inventive process at issue provides for the uniform distribution of content throughout the film, resulting in variation of less than 10% of active content among dosage units. Compare Apr. 6, 2012 Summary of the Interview, at 4 ("the Patentee discussed controlling the rapid formation of the viscoelastic film in order to `lock in' the active (i.e., drug) content during the drying process, thereby ensuring maintenance of the uniformity of content in the dried film, i.e., each unit dose of film, has substantially the same amount of active present.") with Apr. 6, 2012 Reply by Patentee to a Non-Final Office Action Pursuant to 37 C.F.R. § 1.111 (explaining that "the independent claims have been amended to recite that the compositional uniform distribution, i.e., the active content uniformity, is measured by substantially equally sized individual unit doses which do not vary by more than 10% of active component. Thus, . . . when unit doses are cut from the same film, each unit dose will contain substantially the same amount of active, and the variance of active of such unit doses is no more than 10%.").
Moreover, to the extent Plaintiff points to self-serving statements in the prosecution history, made by the Patentee's attorney, for the proposition that this amendment was not necessary to distinguish over prior art, the Court disregards such statements. See, e.g., HTC Corp. v. Tech. Properties Ltd., No. 5:08-CV-00882-PSG, 2013 WL 5225043, at *9 (N.D. Cal. Sept. 17, 2013), appeal dismissed (Jan. 7, 2015) ("[T]he court should not credit self-serving testimony from the prosecution history.") (citing Moleculon Research Crop. v. CBS, Inc., 793 F.2d 1261, 1270 (Fed. Cir. 1986)).
Finally, as with its argument as to the `292 patent amendments, Plaintiff does not cite to any case law specifically applying its argument that the Court should read in the above language in the specification into the claims at issue here. See generally Pl.'s Opp. Br.
