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Another interesting written description case . 1
Specifically defined terms entittled to equivalents . 2
Objects in mirror may be less certain than they appear . 3
Broadest reasonable construction is not unfettered discretion . 4
No unenforceability without decptive intent . 4
DJ-licensee has burden of proving noninfringement per MedImmune
Questionable omission is not inequitable conduct . 6
Motivation found in passing statements . 7
ANOTHER INTERESTING WRITTEN DESCRIPTION CASE
By Sean A. Passino, Ph.D., Esq./Partner ([email protected])
A claim reciting a negative proviso is supported by a “written description” of the disadvantages of the embodiment embraced by the written proviso. Santarus v. Par Pharma
, slip ops. 2010-1360 & -1380 (Fed. Cir. Sep. 4, 2012).
Santarus, Inc. is the exclusive licensee of patents including U.S. Pat. No. 7,399,772 directed to formulations of benzimidazole proton pump inhibitors (PPI)–a class of chemical compounds that treat stomach acid-related disorders. Santarus sells omeprazole in the formulations covered by the ‘772 patent with the brand name Zegerid®. Santarus sued Par Pharmaceutical, Inc. after it filed, under the Hatch-Waxman Act and with a paragraph IV certification, an Abbreviated New Drug Application (ANDA) for United States Food and Drug Administration approval to sell a generic counterpart of Zegerid®.
Par defended arguing, among other things, that the claims recite a proviso that is not supported under 35 U.S.C.§112¶1 (written description). Although the district court found that Par’s ANDA products infringe the patents, it held that the asserted claims are invalid for one reason or another, including lack of adequate written description. The United States Court of Appeals for the Federal Circuit reversed.
The negative proviso is in claim 1, which reads as follows:
1. A method for treating an acid-caused gastrointestinal disorder comprising the step of administering to a subject suffering from said disorder a solid pharmaceutical composition comprising:
(a) about 10mg to about 40mg of non-enteric coated omeprazole; and
(b) sodium bicarbonate in an amount of 0.2 mEq to 5 mEq per 2mg omeprazole;
wherein the composition contains no sucralfate
, the acid-caused gastrointestinal disorder is selected from the group consisting of duodenal ulcer, gastric ulcer, gastroesophageal reflux disease, and erosive esophagitis, and the sodium bicarbonate is present in the composition in an amount sufficient to substantially prevent or inhibit acid degradation of at least some of the omeprazole by gastric acid upon administration to the subject.
’772 patent claim 1 (emphasis added). The parent specification states that sucralfate, “possibly the ideal agent for stress ulcer prophylaxis,” is known to occasional produce adverse effects.
According to the majority (Chief Circuit Judge Rader and Circuit Judge Moore), “[n]egative claim limitations are adequately supported when the specification describes a reason to exclude the relevant limitation.” A disclaimer of the excluded embodiment is unnecessary, and the specification may support both the inclusion and exclusion of the same embodiment. Furthermore, expert testimony established that a person of ordinary skill would have understood from the specification that the disadvantages of sucralfate may be avoided by the claimed formulation.
Circuit Judge Newman concurred in judgment, and she emphasized that a negative claim limitation may often be appropriately stated in claims even if the reason for the limitation is not set forth in the specification.
SPECIFICALLY DEFINED TERMS ENTITTLED TO EQUIVALENTS
By Joshua Pritchett, Esq. ([email protected])
In Pozen Inc., v. Par Pharmaceutical, Inc.
, slip op. 2011-1584 (Fed. Cir. Sep. 28, 2012), the Federal Circuit held that “substantially all,” a term specially defined in the specification, is entitled protection under the doctrine of equivalents.
The district court interpreted the claim language “substantially all” to mean “at least 90%, and preferably greater than 95%.” This interpretation matches the definition of the language “substantially all” from the patent U.S. 7,332,183. The accused infringing product had an amount of 85%. The district court found that while 85% avoids literal infringement, the 85% does infringe “substantially all” based on the doctrine of equivalents.
Par argued that the language “substantially all” is a ‘fuzzy’ qualitative term and not entitled to doctrine of equivalents protection. The Federal Circuit disagreed, pointing to the clear definition supplied in the specification. The Federal Circuit further stated that because the definition set forth in the specification failed to establish 90% as an absolute floor, Par’s product having an amount of 85% infringes under the doctrine of equivalents as an insubstantial change.
The Federal Circuit finding a range lower than the specially defined range is surprising because the special definition specifically mentions a preferred range having a higher
percentage. One may think that the inclusion of the preferred range would act to limit expansion of an outer range; however, the Federal Circuit did not find the preferred range to be an impediment in this case. Based on this opinion, so long as a specially defined range is not characterized as setting absolute limits, the doctrine of equivalents might apply to values outside the specially defined range.
OBJECTS IN MIRROR MAY BE LESS CERTAIN THAN THEY APPEAR
By Randy Noranbrock, Esq./Partner ([email protected])
This case, Mirror Worlds v. Apple
, slip op. 2011-1392 (Fed. Cir. Sept. 4, 2012), is an appeal from the United States District Court for the Eastern District of Texas in which Mirror Worlds sued Apple for direct and induced infringement of various claims of three patents. Both before and after a jury found in favor of Mirror Worlds and awarded over $200 million in damages, the district court entered judgment as a matter of law in Apple’s favor and found Apple not liable for infringement and vacated the damages verdict. Specifically, the district court found that Mirror Worlds had failed to submit any evidence of performance of the patented method. The lack of an equivalent to the claimed “cursor or pointer” in the accused products was also relied on by the district court in the finding of no infringement under the doctrine of equivalents.
The patents at issue are directed to searching, displaying, and archiving computer files wherein sliding a cursor over a file representation causes the display of a preview of the file content. The files are displayed in a chronological stream view.
The issue in the case was whether Apple’s Cover Flow user interface, used in the Macintosh operating system of Apple’s computers and servers and in the iOS operating system of Apple’s iPod, iPad, and iPhone products, infringed the claims of Mirror Worlds’ patents. In particular, the specific issue was whether Mirror Worlds provided substantial evidence showing: (1) that Apple's products have an equivalent for the cursor or pointer claim limitation; and (2) that Apple itself (a) directly infringed or (b) induced customers to infringe certain method claims.
Regarding (1), Mirror World relied exclusively on expert testimony which asserted that Apple’s Cover Flow has an equivalent to the literal pointer claimed because “the user always is looking at the center where the glance view is going to pop up, and that is where the cursor or pointer is by default.” The Federal Circuit found this testimony inadequate and akin to arguing that “the absence of a feature is equivalent to its presence, which is a negation of the doctrine of equivalents.” Thus, Mirror Worlds failed to establish the presence of an equivalent for the cursor or pointer limitation.
Regarding (2)(a), Mirror Worlds’ own damages expert contradicted their evidence presented regarding direct infringement testifying that a particular piece of evidence “was not an infringing version.” Presumably as a last ditch effort, Mirror Worlds argued that the presentation by an Apple executive during the trial constituted evidence of infringement. “But demonstration to a jury during trial does not constitute evidence of infringement on which a claim of infringement can be based.”
Regarding (2)(b), Mirror Worlds failed to present sufficient evidence of direct infringement and the Federal Circuit affirmed the district court’s grant of judgment as a matter of law finding no inducement of infringement. Similar to the lack of evidence presented for direct infringement by Apple, the district court found that Mirror Worlds failed to provide sufficient evidence of direct infringement and thus there was no basis for a finding of inducement. The Federal Circuit found the user manuals relied on by Mirror Worlds to be insufficient by themselves to
show direct infringement because, although the individual steps of the method may be taught, there was no teaching that all of the steps were performed together. Further, Mirror Worlds’ relied on expert testimony was with respect to the capabilities of the products and not to the performance of the claimed method steps. The Federal Circuit found that even though the products could infringe, Mirror Worlds failed to present evidence or testimony of actual use in an infringing manner.
Thus, it is important to present evidence on each of the predicate facts necessary to a finding of infringement, no matter how “inconceivable to [the plaintiff it was] that the accused features were not practiced.”
BROADEST REASONABLE CONSTRUCTION IS NOT UNFETTERED DISCRETION
By Martin J. Cosenza, Esq./Partner ([email protected])
In In re Abbott Diabetes Care Inc.
, slip op. 2011-1516 (Fed. Cir. Sep 28, 2012), a unanimous panel of the Court of Appeals for the Federal Circuit vacated a decision by the United States Patent and Trademark Office’s Board of Appeals and Interferences upholding a patent examiner’s anticipation rejection in an ex parte
reexamination of patent claims (with infringement litigation stayed pending the outcome). The Federal Circuit found that the examiner and the Board erred in their determination of the broadest reasonable interpretation of the claim limitation “electrochemical sensor.”
Specifically, the Board found that in the absence of an express limiting statement, features of prior art sensors were not excluded by the recitation of “electrochemical sensor.” The Federal Circuit reversed, relying on the fact that the specification “contain[ed] only disparaging remarks with respect to the” prior art features and every embodiment disclosed a sensor without such features. Moreover, the claim as a whole “suggested” a sensor without the prior art’s features, and the primary purpose of the “invention” was to provide a device that alleviates the shortcomings of sensors in the prior art.
While this case is arguably limited to its facts, these are facts are similar to those faced by patent prosecutors on a frequent basis, especially those prosecuting applications claiming priority pursuant to the Paris Convention or the PCT.
NO UNENFORCEABILITY WITHOUT DECPTIVE INTENT
By Tony Chang, Esq. ([email protected])
The Federal Circuit reviewed per curiam the district court’s decision regarding a declaratory judgment filed by Outside the Box Innovations (doing business as Union Rich) against the patentee, Travel Caddy, of U.S. Pat. Nos. 6,823,992 & 6,991,104. Outside the Box Innovations, LLC v. Travel Caddy, Inc.
, slip op. 2009-1171 (Fed. Cir. Sep. 21, 2012). Among other things, the district court held that the ’992 and ’104 patents are unenforceable on the grounds that (1) Travel Caddy did not disclose to the USPTO the existence of the litigation on the ’992 patent during prosecution of the ’104 application, and (2) Travel Caddy paid small entity fees to the USPTO but was not entitled to small entity status. The Federal Circuit reversed the district court’s unenforceability ruling because there was not clear and convincing evidence of specific intent to deceive the USPTO.
The Federal Circuit stated that, “[t]o establish unenforceability based on inequitable conduct in the PTO, it must be shown that information material to patentability was withheld from the PTO, or material misinformation was provided to the PTO, with the intent to deceive or mislead the patent examiner into granting the patent.” See Therasense, Inc. v. Becton, Dickinson & Co.
, 649 F.3d 1276, 1290-92 (Fed. Cir. 2011) (en banc). Also, “[w]ithholding of
material information and intent to deceive or mislead must be established by clear and convincing evidence. Id.
With regard to the withholding of the litigation on the ’992 patent, Travel Caddy asserted that that validity of the ’992 patent had not been included in the Union Rich’s complaint nor otherwise placed at issue during the time when the ’104 application was pending. The district court found it incredible that the Travel Caddy’s patent attorney believed that the current litigation to be irrelevant to the prosecution of the ’104 application. The Federal Circuit disagreed, because the issue was whether the existence of the ’992 litigation was “material” instead of “relevant” to the patentability of the ’104 patent, and there was not clear and convincing evidence of withholding information material to the patentability of ’104 patent. The district court also inferred deceptive intent from the fact of non-disclosure. The Federal Circuit disagreed, because the inference of deceptive intent must be the single most reasonable inference able to be drawn from the evidence to meet the clear and convincing standard. However, the Federal Circuit stated that there was no evidence on which to base an inference of deceptive intent.
With regard to the incorrect claim of “small entity” status, the district court found that the small entity status was deprived by the licensing clause in a sales agreement between Travel Caddy’s and Rooster Product International. The district court drew the inference of the deceptive intent, because Travel Caddy’s patent attorney is an experienced patent attorney.
The Federal Circuit circumvented the issue of whether the false assertion of small entity status is per se
material. Rather, the Federal Circuit again emphasized that the district court’s ruling is erroneous, because there was not clear and convincing evidence of intent to deceive the USPTO. The Federal Circuit also found support in the 37 C.F.R. §1.28 where good faith mistakes can be remedied by making a deficiency payment, and thus the regulations do not contemplate that an incorrect claim of small entity status, with no evidence of bad faith, is punishable by loss of the patent.
Therefore, the Federal Circuit’s position in this per curiam decision appears to be that the omission of a notice of relevant litigation or a false claim of small entity status does not automatically render the patent unenforceable as long as the mistake is not made in “bad faith.” Nevertheless, although the mistakes Travel Caddy made may not be punishable by surrendering the enforceability of the patents in litigation, the mistakes had become appealable issues and were indeed “punishable” by the time and expenses for litigating these issues, which could have been avoided by an IDS filing.
DJ-LICENSEE HAS BURDEN OF PROVING NONINFRINGEMENT PER MEDIMMUNE
By Martin J. Cosenza, Esq./Partner ([email protected])
A licensee of a patent bringing a MedImmune
declaratory judgment action bears the burden of proving “noninfringement.” In Medtronic, Inc. v. Boston Scientific Corp.
, slip op. 2011-1313 (Fed. Cir. Sep. 18, 2012), a unanimous panel ruled that a licensee seeking a declaratory judgment of noninfringement against a licensor of a patent, pursuant to the provisions of the United States Supreme Court’s decision in MedImmune v. Genentech
, 594 U.S. 118 (2007), bears the burden of proving that its products and/or actions do not fall within the scope of the patent claims. The licensor need not present evidence of infringement in such an action. This as contrasted with a normal patent infringement action (including counterclaims arising from a declaratory judgment action) where there is no license between the parties, and the patent owner bears the burden of proving infringement.
More specifically, the Court previously ruled in MedImmune
that a licensee of a patent may
bring a declaratory judgment action for noninfringement against the licensor even though the licensee continued to make royalty payments. In the present case, the Federal Circuit ruled that because it is the licensee seeking to change the status quo by petitioning the court, and the licensor cannot bring a counterclaim for infringement (the continued royalty payments bar a counterclaim of patent infringement against the licensee as a matter of law), the licensee bears the burden of proof to show that the claims do not cover its products and/or actions. This is the opposite of the burden of proof in a normal patent litigation. “If neither party introduced any evidence regarding infringement or noninfringement there is no principled reason why the licensee should receive the declaration of noninfringement.”
The Federal Circuit approached this case as a contract dispute, albeit one with underlying patent-related issues, and looked towards cases involving insurance litigation to support its position. The opinion emphasizes that it was the licensee that sought to disturb the status quo, and contrasted this situation to a declaratory judgment case where the patent owner’s actions raised the specter of litigation (characterizing such as merely an “inverted [patent] infringement suit”). The governing principal of this case was essentially articulated by the Court in Schaffer v. Weast
, 546 U.S. 49, (2005), which stated that “the person who seeks court action should justify the request.” Recognizing the policy considerations associated with the case, the opinion specifically states that to force the licensor to prove infringement would “allow licensees to use MedImmune
’s shield as a sword – haling licensors into court and forcing them to assert and prove what had already been resolved by license.”
QUESTIONABLE OMISSION IS NOT INEQUITABLE CONDUCT
By Deidre McAuley, Esq./Associate ([email protected])
Failure to submit relevant references may not be considered inequitable conduct. 1st Media, LLC v. Electronic Arts
, slip op. 2010-1435 (Fed. Cir. Sep. 13, 2012). For example, 1st Media, LLC (“1st Media”) owns U.S. Patent No. 5,464,946 (“’946 patent”) directed to an entertainment system for use in purchasing and storing songs, videos, and multimedia karaoke information. 1st Media filed a complaint alleging infringement of at least claim 16 of the ‘946 Patent by Electronic Arts, Inc., Harmonix Music System, Inc., Viacom Inc., and Sony Computer Entertainment America Inc. (collectively “Appellees”). The Appellees asserted an inequitable conduct defense and counterclaimed for declaratory judgment of inequitable conduct.
The district court ruled that the inventor and the attorney who prosecuted a chain of related applications including the ‘946 Patent had committed inequitable conduct by failing to disclose three “relevant” references cited in the other related applications at various times including after mailing of the Notice of Allowance and prior to payment of the issue fee in the ‘946 Patent. The inventor and the attorney testified that they did not appreciate the materiality of the references. The district court found that the inventor and the attorney’s explanations were not credible and granted the declaratory judgment of inequitable conduct, held the ‘946 Patent unenforceable, and dismissed 1st Media’s complaint.1st Media v. doPi Karaoke, Inc.
, No. 07-cv-1589 (Apr. 23, 2010).
1st Media appealed to the Federal Circuit, arguing that the district court did not find that either the inventor or the attorney made a deliberate decision to withhold the references from the USPTO.
The Federal Circuit reversed the district court’s decision. Specifically, the Federal Circuit applied a two-part standard, that the defendant must prove by clear and convincing evidence both of the following separate requirements, that (1) “the patentee acted with the specific intent to deceive the PTO;” and (2) “the non-disclosed reference was but-for material.” The
Federal Circuit asserted that “because the record contains no evidence of a deliberate decision to withhold those references from the PTO as required under Therasense, Inc. v. Becton, Dickinson & Co.
, 649 F.3d 1276 (Fed. Cir. 2011) (en banc
), and because Appellees admit that the record is complete, this court reverses.”
MOTIVATION FOUND IN PASSING STATEMENTS
By Sean A. Passino, Ph.D., Esq./Partner ([email protected])
Droge appealed from the final decision by the Board affirming the rejection of claims of U.S. Patent Application No. 10/082,772 (’772 application) as obvious under 35 U.S.C. §103. The representative claim reads as follows:
29. A method of sequence specific recombination of DNA in a eukaryotic
(a) providing said eukaryotic cell, said cell comprising a first DNA segment integrated into the genome of said cell, said first DNA segment comprising an [attB, attP, attL,
sequence or derivative thereof] . . . ;
(b) introducing a second DNA segment into said cell . . . ;
(c) further comprising providing to said cell a modified bacteriophage lambda integrase Int, wherein said modified Int is Int-h or Int-h/218, which induces sequence specific recombination through said attB
’772 application, cl.29 (emphasis added).
The prior art, Crouzet, discloses a method of using bacteriophage λ and wild-type Int protein to insert a foreign DNA sequence into a host cell using the attB
recognition sites. Crouzet further states that this method “may be carried out in any type of cell host,” such as “bacteria or eukaryotic
cells.” Crouzet does not disclose use of modified integrases like Int-h or Int-h/218.
The prior art, Christ & Droge, discloses that modified integrase proteins Int-h and Int-h/218 mediate sequence-specific recombination in prokaryotic
cells. Christ & Droge teaches that, compared to wild-type Int, the modified proteins Int-h and Int-h/218 have an advantage of an increased binding affinity for core binding sites present in the att
regions. Christ & Droge also discloses that Int-h and Int-h/218 can perform recombination in vivo
even in the absence of certain protein co-factors that assist with recombination, such as the integration host factor (IHF), present in prokaryotic
cells but not in eukaryotic
The Board held that claim 29 is obvious, finding that one of ordinary skill in the art would have had a reasonable expectation of success that Int-h and Int-h/218 would also function “at some level in eukaryotic cells.”
The Federal Circuit affirmed. It reviewed facts for substantial evidence, i.e., “such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.”
The references teach all the claim elements. Droge, nevertheless, argued that the prior art’s use of Int-h and Int-h/218 to facilitate recombination in prokaryotic
cells would not lead one of ordinary skill in the art to expect that Int-h and Int-h/218 would also work in eukaryotic
cells. The Federal Circuit disagreed, because Crouzet teaches that wild-type Int can induce recombination in any cell. Christ & Droge teaches that Int-h and Int-h/218 have increased affinity for core binding sites in the att
regions. For these reasons, the Federal Circuit affirmed
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