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In a recent Memorandum Order, Judge Richard G. Andrews construed the terms (i) “zolmitriptan” and (ii) “buffer,” “buffered,” and “in a buffered,” from U.S. Patent Nos. 6,750,237 and 7,220,767, which are directed to pharmaceutical formulations containing zolmitriptan, an intranasal administration device containing a pharmaceutical formulation containing zolmitriptan, and an aqueous solution of zolmitriptan. Impax Laboratories, Inc., et al. v. Lannett Holdings, Inc., et al., C.A. No. 14-984-RGA (D. Del. Dec. 1, 2015).

Notably, Judge Andrews also found the preamble “[a] pharmaceutical formulation suitable for intranasal administration” to limit the pharmaceutical formulation claims. While Judge Andrews found that the preamble did not provide antecedent basis for the terms in the claim bodies, it still did “more than state an intended use for the formulations.” Id. at 6. As Judge Andrews explained, the preamble “informs the meaning of those formulations—they must possess features making them appropriate for intranasal use.” Id. Judge Andrews also observed that the fact that the “patentees did not rely on the preambles to distinguish prior art during prosecution does not suggest that the preambles are non-limiting because the patent examiner cited only intranasal art,” which provides some indication that the examiner “acknowledged that the patents claim intranasal formulations.” Id.

Judge Andrews went on to further explain why the “the entire preamble gives ‘life, meaning, and vitality’ to the pharmaceutical formulation claims.” Id. at 6-7. First, Judge Andrews observed that “the patents repeatedly refer to the invention as a pharmaceutical formulation for use in intranasal administration.” Id. at 6. Second, Judge Andrews noted that “the specifications identify issues with prior art formulations and explain that the ‘inventors devised an intranasal formulation of zolmitriptan that provided effective and improved fast relief for migraine sufferers.’” Id. at 6. Third, Judge Andrews found “Examples 1-8 of the patents are directed to intranasal formulations and Example 9 of both patents describes a method for administering such intranasal formulations.” Id. at 7. Judge Andrews thus concluded that the foregoing disclosures “demonstrate that the claimed formulation is an improved pharmaceutical formulation of zolmitriptan suitable for intranasal administration.” Id. Judge Andrews finally noted that the “specifications nowhere suggest that the invention relates to formulations not suitable for intranasal use.” Id.

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Several defendants in these cases filed motions to dismiss on the basis that the asserted patent claims are invalid for lack of written description. In briefing, the parties each pointed out that neither side had provided case law addressing whether a District Court does or does not have authority to resolve a written description dispute on the pleadings. Judge Andrews agreed with the “valid concerns” raised by the Plaintiff and denied the motions without prejudice: “Adequate written description is a question of fact. Patent claims are presumed to be valid. In order to invalidate a patent claim on the basis of inadequate written description, I would have to find, by clear and convincing evidence, that the patent specification does not describe the claimed invention sufficiently to reasonably convey to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Typically, to make such a finding requires claim construction and expert testimony about what those skilled in the art would understand from the specification. At this stage of the proceeding, there has been no claim construction, and, of course, on a motion to dismiss there will be no expert testimony. I do not believe that it is appropriate at this time to consider inadequate written description on these motions to dismiss.” Blackbird Tech LLC v. Service Lighting and Electrical, et al., C.A. No. 15-53-RGA, Memo. Or. at 1-2 (D. Del. Dec. 1, 2015) (internal quotations omitted).

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Judge Andrews recently granted a motion to quash a deposition and document subpoena served on a third party, Hill Dermaceuticals. The subpoena sought information about the Hill’s Derma-Smoothe products, where were alleged to be prior art to the patents-in-suit. Judge Andrews first determined that the information sought should be afforded trade secret status both because the defendant, Perrigo, had not seriously disputed the point and because Hill “produced considerable evidence regarding the requested information’s trade secret status and the harm that may result from disclosure to a competitor” such as the defendant. Taro Pharmaceuticals U.S.A., Inc., et al. V. Perrigo Israel Pharmaceuticals Ltd., C.A. No. 14-989-RGA, Memo. Or. at 3 (D. Del. Nov. 30, 2015).

Next, Judge Andrews turned to whether the information sought was relevant to the litigation. His Honor explained, “[t]he secret nature of Derma-Smoothe does not foreclose its relevance to the§ 103 inquiry. Whether in connection with § 102(b) or § 103, [i]f a device was in public use or on sale before the critical date, then that device becomes a reference under section 103 against the claimed invention. . . . Hill’s argument that Derma-Smoothe may not anticipate Taro’s invention under§ 102 does not belie its relevance to an obviousness inquiry under§ 103. Therefore, I find that the requested information is relevant.” Id. at 4 (internal quotations omitted).

Perrigo was unable, however, to convince the Court that the information sought was necessary to its case, leading Judge Andrews to conclude that the subpoena should be quashed. “Perrigo may be correct that detailed information about the Derma-Smoothe prior art reference may be uniquely available from Hill. That does not mean, however, that Hill is uniquely positioned to provide Perrigo with information relevant to its obviousness defense. . . . Perrigo has listed twenty-two prior art references in its Invalidity Contentions, most of which are printed publications or patents. Perrigo has made no showing as to how Hill’s Derma-Smoothe, among these, is uniquely necessary to proving its invalidity case. . . . The possibility of obtaining relevant information from alternative sources weighs against a finding of need. . . . Perrigo has in its possession numerous sources relevant to proving the same legal theory. That Perrigo seeks only to supplement its theory with Hill’s trade secrets cuts against a finding that the requested information is ‘reasonably necessary for a fair opportunity to develop and prepare the case for trial.’” Id. at 5-6.

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Chief Magistrate Judge Mary Pat Thynge recently granted a motion for summary judgment of invalidity under § 101 filed by Google relating to the Plaintiff’s search method patent.  Collarity, Inc. v. Google Inc., C.A. No. 11-1103-MPT (D. Del. Nov. 25, 2015).  Judge Thynge agreed with Google that the plaintiff’s patent claimed an abstract idea—“refining search queries . . . by switching some used words in the query but not others”—that could be performed on a general purpose computer or even by a human with pen and paper.  The Court also found that the patent claimed no inventive concept.  While the Plaintiff argued that the claims were specific to improving internet searching, Judge Thynge noted that the claims, themselves, never mentioned the internet at all.  Finally, Judge Thynge disagreed with the Plaintiff’s argument that the PTO’s issuance, post-Alice, of a continuation patent that included nearly identical claim language showed that the Plaintiff’s patent was valid.  As the Court explained, if the Plaintiff’s argument was correct, “any patent issued post-Alice would be inoculated from invalidity under Section 101.  That is not the case.”

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In St. Clair Intellectual Property Consultants, Inc. v. Toshiba Corp., et al., C.A. No. 09-354-KAJ (D. Del. Nov. 23, 2015), Judge Kent A. Jordan denied Defendants’ motion for fees and costs under Section 285 and 28 U.S.C. § 1927. The Court explained that “[w]hile it is true that [Plaintiff] did not present a strong case, and that is position appeared to be weaker in light of certain rulings in limine and at trial, the case for infringement was not so weak as to be ‘exceptional’ . . . nor does the record support a finding that the actions of its attorneys . . . were taken in bad faith.” Id. at 1.

Defendants claimed that Plaintiff did not have sufficient proof of infringement. When its technical expert’s opinion was limited by the Court, Plaintiff had “attempted, improperly, to enter additional, unauthenticated Toshiba schematics into the record using its damages expert . . . [the Court] rejected that maneuver, and [the gap in Plaintiff’s case] remained.” Id. at 6. But the Court observed that, while difficult, “a victory was not impossible” as the technical expert could still testify generally and could have persuaded the jury of infringement, thus there was “a straight-faced basis for arguing for a finding of infringement.” See id. at 6-7. The Court similarly rejected Defendants’ contention that a key limitation was missing from the accused products, as the Court had previously rejected Defendants’ position on this issue. See id. at 7.

Defendants also pointed to Plaintiff’s “behavior before the court,” specifically that it had “shifted litigation positions . . . to avoid summary judgment,” and “presented false royalty calculations.” Id. at 4, 7. Judge Jordan, having been “present for the latter portions of pretrial proceedings and the trial itself,” saw no “evidence of the bad motives [Defendants have] ascribed to [Plaintiff].” Id. at 7. “Royalty calculations, especially in cases with variable and sometimes overlapping infringement theories against large suites of products, may be expected to have a degree of imperfection. That [Defendants] found and successfully exploited such imperfections . . . does not mean that [Plaintiff] was a bad actor. In the same vein, [Defendants’] success in forcing [Plaintiff] to change positions in the course of litigation does not make this case exceptional. Parties should abandon positions or claims when it appears they are unlikely to prove fruitful. . . . [The Court has] no desire to encourage parties to hold on to and litigate discredited positions out of a fear that abandoning them will result in an attorneys fee award[.]”

The Court denied the motion as to 28 U.S.C. § 1927 under the same bases as its Section 285 denial. See id. at 9.

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In Two-Way Media Ltd. v. Comcast Cable Communications, LLC, et al., C.A. Nos. 14-1006, 14-1212-RGA (D. Del. Nov. 17, 2015), Judge Richard G. Andrews resolved two disputes regarding the parties’ proposed protective orders. First, Judge Andrews found that Plaintiff should not “be allowed to share Highly Confidential Information received from a defendant in one of the above-captioned cases with a defendant in the other case.” Id. at 1-3. Specifically, Judge Andrews pointed to the fact that “¶6(C) permits disclosure of Highly Confidential Information to outside counsel ‘of the receiving party’ in particular, and therefore does not contemplate disclosure to counsel for another party.” Id. at 3. Moreover, Judge Andrews found that Defendants showed good cause to prevent Plaintiff from sharing Highly Confidential Information across cases. Specifically, Judge Andrews found that if Plaintiff were permitted to disclose the Highly Confidential Information of one defendant to outside counsel and experts in the other case, “Defendants would suffer prejudice.” Id. Judge Andrews provided the following example: “If Plaintiff were allowed to use . . . Comcast’s Highly Confidential Information in its expert report in the Verizon case, Verizon’s in-house counsel would be prohibited from viewing those portions of Plaintiffs expert report. Such a circumstance would impair Verizon in its defense.” Id. On the other hand, the parties seemed to agree that “if the Protective Order permitted disclosure of one defendant’s Highly Confidential Information to in-house counsel of defendants in the other case, that information would be unacceptably compromised.” Id.

Second, Judge Andrews found that the prosecution bar should not extend to post-grant proceedings. Judge Andrews explained that “[i]nvolvement in post-grant proceedings does not raise the same risk of competitive misuse as does involvement in prosecution.” Id. at 4. Judge Andrews further noted that “[p]ost-grant proceedings, including reexamination, inter partes review, and covered business method review, all involve assessing the patentability of existing claims.” Id. In addition, “only narrowing claim amendments may be made during post-grant proceedings.” Id. Judge Andrews therefore concluded that “[t]here is . . . little risk that confidential information learned in litigation will be competitively used to draft claims that read on Defendants’ products” and that “Defendants have not recited any circumstances specific to proceedings related to these patents that suggest otherwise.” Id. Accordingly, “[t]he risk of inadvertent disclosure or competitive use of Defendants’ confidential information [was] outweighed . . . by the potential harm to Plaintiff by denying its choice of counsel in post-grant proceedings.” Id. at 5.

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In a recent Report and Recommendation, Magistrate Judge Christopher J. Burke recommended that the court grant plaintiff’s motion for summary judgment of no invalidity based on (i) non-enablement and (ii) insufficient written description for U.S. Patent No. 5,735,892 (“the ‘892 patent”), which is directed to thin-wall intraluminal graft devices. W.L. Gore & Associates, Inc. v. C.R. Bard, et al., C.A. No. 11-515-LPS-CJB (D. Del. Nov. 16, 2015).

First, Judge Burke found that defendants failed to present evidence sufficient to raise a genuine issue of fact regarding whether plaintiff failed to satisfy the enablement requirement. Id. at 17. As Judge Burke observed, “[t]he crux of the parties’ dispute with respect to enablement is whether the ‘892 patent enables the full scope of the claimed ‘tubular covering’ of ePTFE.” Id. at 8. Defendants argued that “because the covering limitation is not limited to those made from films, the ‘892 patent fails to enable the skilled artisan to practice the full scope of the claimed invention because it does not teach the use of coverings made from extruded tubes.” Id. As Judge Burke explained, however, “where a product claim does not limit a component part to the method of making (as here), it is irrelevant whether an alternative method requires undue experimentation—since . . . only one method of making the invention need be enabled.” Id. at 16. Accordingly, “[i]n circumstances like these—where a material difference has not been demonstrated in an end product made by two different methods—the method of constructing the claimed covering using extruded tubes simply amounts to an improved mode of achieving the claimed invention that need not be enabled by the patent.” Id. at 16-17.

Defendants raised a similar argument as to the written description requirement, contending that the ‘892 patent “does not convey that the inventors had possession of any embodiment of the invention that used extruded tubes to achieve the claimed device.” Id. at 18. Judge Burke found this argument failed “[f]or the same reasons that [defendants’] arguments failed with respect to enablement.” Id. at 18-19. Judge Burke thus found defendants failed to raise a genuine issue of fact as to whether plaintiff failed to satisfy the written description requirement. See id.

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Judge Sue L. Robinson recently found several claim terms indefinite in a claim construction order relating to coffee brewing machines.  Courtesy Prods., L.L.C. v. Hamilton Beach Brands, Inc., Civ. No. 13-2012-SLR (D. Del. Nov. 18, 2015).  Specifically, Judge Robinson found that the following claim terms indefinite:

  • “sufficiently large to hold one of the filter packs and the heated water while brewing without a level of the heated water rising above and overflowing the open top”
  • “sufficiently large to hold at least one of the filter packs and the heated water while brewing without a level of the heated water rising above and overflowing the open top”

These terms were found indefinite because the specification provided no information about “the variables involved (such as flow of water into and out of the reservoir and the impact of the filter pack permeability.”  “Without any detail on such variables that would influence the ‘level of the heated water,’ the court concludes that the disputed limitations are not precise enough to afford clear notice of what is claimed and do not provide reasonable certainty as to the scope of the invention.”  Id. at 5 (internal quotation marks omitted).

The Court also found the following terms indefinite:

  • “the brew baskets being inserted into the location in the beverage brewing machine”
  • “the brew baskets being individually inserted into the location during an associated brewing operating”
  • “the brewing machine heating water from the water reservoir”

These terms were found indefinite for reciting both an apparatus and a method of using that apparatus.  See IPXL Holdings, L.L.C. v. Amazon.com, Inc., 430 F.3d 1377, 1384 (Fed. Cir. 2005).  Here, Judge Robinson found that “a person of ordinary skill in the art would not understand whether the claims at bar are infringed by an apparatus capable of heating water and having brew baskets inserted or when a person actually uses the beverage brewing system to heat water and inserts a brew basket.”  Id. at 11.  The Court found five more claim terms indefinite for the same reason.

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Chief Judge Leonard P. Stark recently issued the Court’s claim construction opinion for the disputed terms of U.S. Patent No. 8, 316,445, titled “System and Method for Protecting Against Malware Utilizing Key Loggers.”  Trusted Knight Corporation v. International Business Machines Corporation, et al., C.A. No. 14-1063-LPS-CJB (D. Del. Nov. 19, 2015).  Judge Stark found two claim terms invalid as indefinite.  Judge Stark found the term “in response to the software key logging through the API stack to an internet communication port” indefinite because “it is unclear what action is performed ‘in response to the software key logging.'”  Id. at 8 (emphasis in original).  The Court found the second term indefinite after determining it was missing the verb “is.”  Id. at 11.  Corrected, the term would read “a process of passing the encrypted data to a 3-ring level where a hook is inserted by a hook-based key logger.” Id. (emphasis in original).  Judge Stark determined that the Court could not correct the term because Plaintiff’s proposed correction was the “subject of reasonable debate.”  Id.at 12.

Making Plaintiffs requested correction . . . would appear to make this limitation operative only in response to a hook (i.e., a form of malware) being inserted. Yet the specification – and, as noted in connection with the preceding term dispute, Plaintiff as well – states that the claimed invention operates even in the absence of malware (i.e., without a hook being inserted by a hook-based key logger). This seeming contradiction and, at minimum, ambiguity – demonstrate that Plaintiffs proposed correction to the claim language is subject to reasonable debate.

Id. (emphasis in original).  Judge Stark also noted that other corrections were feasible.  As such, the Court could not correct the claim term and, uncorrected, a person of ordinary skill in the art would not know the meaning of the term with reasonable certainty.  Id. at 12-13.

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In W.L. Gore & Associates, Inc. v. C.R. Bard, Inc., et al., C.A. No. 11-515-LPS-CJB (D. Del. Nov. 9, 2015), Magistrate Judge Christopher J. Burke considered a number of references, related to the stent-graft work of three different physicians (Lee, Vallbracht, and Palmaz), that Defendants claimed anticipated the U.S. Patent No. 5,735,892, entitled “Intraluminal Stent Graft.”

The Court concluded that the Lee references, and one Vallbracht reference, did not disclose certain limitations of the asserted claims, and thus recommended that Plaintiff’s motion for summary judgment of no anticipation be granted as to those refernces. See id. at 8-20; 26-28. On the other hand, the Court concluded that issues of material fact remained with respect to whether another Vallbracht reference, as well as all the Palmaz references, anticipated certain claims of the patent-in-suit. See id. at 21-26; 28-32. Accordingly, the Court recommended that Plaintiff’s motion be denied-in-part.

UPDATE: In a Memorandum Order dated November 24, 2015, Chief Judge Stark has adopted Judge Burke’s order in all respects. See W.L. Gore & Assocs., Inc. v. C.R. Bard, Inc., et al. C.A. No. 11-515-LPS-CJB, Memo. Or. at 4-5 (D. Del. Nov. 24, 2015).

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