Global argument in PTO response limits scope of all claims

Patent, Patent Cases 2005

Peer_networkSeaChange Int’l. v. C-Cor (Fed. Cir. 2005).

In another warning to attorneys, the CAFC has limited the term “network for data connection” to include point-to-point connections based on a patent applicant’s response to a first office action.

Seachange sued C-Cor for infringement of its patent on a computer cluster for redundantly storing data. After claim construction in favor of Seachange, C-Cor stipulated to infringement and then lost invalidity issues at trial. 

On appeal, C-Cor argued that the lower court’s improperly applied an ordinary meaning to claim terms whose scope had been disclaimed during prosecution. The CAFC agreed with C-Cor, finding that “Applicant’s response to the First Action was a deliberate surrender of claim scope, unmistakable in its effect because it is not suitable to multiple interpretations.”  Interestingly, the court rejected SeaChange’s arguments to distinguish claim 1 that specifically called out the point-to-point system from claim 37 that did not do so — finding that applicant’s “global arguments” in the Office Action Response applied to all the claims.

As Professor Joseph Miller correctly states, this case also shows that the use of dictionaries “appears to be alive and well in Federal Circuit claim construction.  In this case, the court relied extensively on The New IEEE Standard Dictionary of Electrical and Electronics Terms.

BlackBerry Patent Lawsuit Rises Again; NTP Responds to Patent Office Rejections

Patent, Patent Cases 2005,

PatentlyOImage009NTP v. Research-In-Motion (BlackBerry lawsuit).

In December 2004, the Federal Circuit released its opinion that pushed against the territorial bounds of patent law.  In that opinion, the CAFC found that U.S. patent law covers instances where infringing elements are located abroad — so long as the “control and beneficial use” of the infringing system is within U.S. territory.  Soon thereafter, RIM filed a motion for rehearing en banc that is still pending. 

The CAFC’s decision, strongly in favor of NTP, paved the way for a March 2005 “settlement” that reportedly included $450 million for NTP.  The original settlement announcement was based on a 1/2 page term-sheet reportedly signed by the parties.  As would be expected, 50 square inches of paper turned out to create a whole new level of disagreement between the parties who have been working through court mediation to flesh out the agreement.

Settlement Breakdown: In early June, the settlement issue came to a head and the parties staked out their positions on paper.  In a motion filed with the CAFC, RIM argues that the term-sheet was a settlement of the case, and, as such, the case is now moot.  RIM asked the CAFC to stay its decision on the for rehearing and remand the case to the district court to decide whether there has been a settlement.  On the other hand, NTP has argued that the term-sheet was not a settlement and that there was never a “meeting of the minds.”  The filed motions are attached below:

Reexamination: In a parallel action, the patents at issue in the case (owned by NTP) are undergoing reexamination at the USPTO.  As occurs in almost all inter partes and director-ordered reexaminations, the patent office has issued a non-final rejection in each NTP case that it has examined.  Although this first rejection is a good sign for RIM, a final decision in the reexam will not be any time soon. (i.e., will not be for several years).  NTP has the opportunity to file a response to the non-final rejection.  The PTO may then issue a final rejection, at which point NTP may ask for reconsideration, appeal to the PTO’s internal board (BPAI), and then appeal to the federal courts (i.e., the courts that have already determined that the patents are valid).

This week, NTP filed its first response to a rejection in the reexamination for Patent No. 5,631,946. In the response, NTP made no amendments to existing claims, but did add over 100 new claims — including many multiple dependent claims.  The filed papers are attached below (THESE ARE BIG FILES):

Bottom Line: Unless the parties come to another settlement agreement, this case will continue for several more years.

Case on Obviousness Jurisprudence Gains Support — Microsoft Files Amicus Brief

Patent, Patent Cases 2005

PatentlyOImage025_smallKSR International v. Teleflex (On Petition for Certiorari)

Strong support is beginning to mount for a small case that may have major consequences on the patent law landscape.

In a petition for a writ of certiorari, KSR has asked the Supreme Court to review the “teaching-suggestion-motivation test” for obviousness that has been a stalwart of Federal Circuit jurisprudence for twenty years.  During that time, the Supreme Court has not heard a single obviousness case.  Noted law professor John Duffy is on the KSR brief, which argues that the CAFC’s obviousness test goes against Supreme Court precedent, against precedent of other circuits, and is bad policy.

Now, A consortium of five major corporations, including Microsoft, Cisco, and Hallmark have filed as amicus supporting the petition.  Their brief argues that the current structured test for obviousness is too easy a hurdle for patentees and that the formalities of the test undermines courts ability to truly determine whether an invention is obvious to one skilled in the art.

In addition, Teleflex has filed its opposition to the petition — arguing that (1) obviousness is well settled law and need not be revisited; (2) the CAFC’s test is consistent with Graham; and perhaps most importantly (3) this case does not hinge on the obviousness issue.

Documents:

  • Party Briefs
  • Amicus Briefs

    • Links:

    Prima Tek II v. Polypap

    Patent, Patent Cases 2005,

    PatentlyOImage008Prima Tek II v. Polypap (Fed. Cir. 2005).

    Prima Tek and Polypap both sell disposable devices for holding flowers.  Prima sued Polypap for infringement of two of its related patents.

    After first construing the claims, the Southern District of Illinois court granted summary judgment of non-infringement to Polypap.  That decision was reversed in 2003 based on an error in claim construction.

    On remand, and after a bench trial, the district court found the patents not invalid and infringed and thus issued an injunction against Polypap.  Now Polypap appeals the new claim construction.  And, the CAFC has reversed once again, finding that the district court erred by adding a limitation to the term “floral holding material” that deviated from the term’s ordinary meaning.

    Based on the new construction, the CAFC determined that the claims were anticipated based on a piece of prior art considered during prosecution — thus deciding the case.

    In a seeming jab at the Patent Office, the majority noted that the whole patent system “depends primarily on the Patent and Trademark Office’s (“PTO’s”) care in screening out invalid patents during prosecution.” In this case, the court found that the PTO had not lived up to its gatekeeper role.

    CAFC Finds Jurisdiction To Hear Declaratory Judgment Issues After Patentee Files Covenant Not To Sue

    Patent, Patent Cases 2005

    PatentlyOImage007Fort James Corp. v. Solo Cup (Fed. Cir. 2005).

    Fort James sued Solo for infringement of its patents on paper plates. After a trial, the jury found that the patents were not invalid but were likewise not infringed.  Solo then sought attorney’s fees and a counterclaim of unenforceability.  The district court, however, dismissed Solo’s counterclaim as moot after Fort James submitted a covenant not to sue on the patents at issue. Solo appealed that ruling.

    On appeal, the CAFC reversed — finding that the “district court’s literal application” of CAFC precedent was improper.

    The district court erred as a matter of law in holding that it did not have jurisdiction to hear Solo Cup’s counterclaim. The case is remanded for resolution of the issues properly before the court prior to its order to bifurcate, namely Solo Cup’s claims of unenforceability on the basis of inequitable conduct and its request for attorney fees pursuant to 35 U.S.C. § 285.

    Citing the recent Teva v. Pfizer case, Judge Schall argued in dissent that “Fort James’s covenant not to sue eliminated any live case or controversy between the parties and thereby rendered Solo Cup’s unenforceability counterclaim moot.”

    Who’s Your Inventor?: Contradictory Declarations Leads to Summary Judgment Reversal

    Patent, Patent Cases 2005

    ScreenShot016Checkpoint Systems v. All-Tag Security  (Fed. Cir. 2005).

    by Marcus Thymian.

    Checkpoint asserted its patent on disposable, deactivatable security labels against All-Tag and Sensormatic, a customer of All-Tag.  The district court granted summary judgment of invalidity to All-Tag and Sensormatic under 35 U.S.C.  § 102(f) for failing to name an inventor.  In support of its motion for summary judgment, All-Tag had submitted recent declarations of three people, including the named inventor and the supposed omitted inventor, stating that the sole named inventor was one of two actual inventors.

    The Federal Circuit reversed and remanded, agreeing with Checkpoint that earlier declarations by the same three people, made during prosecution, contradicted the more recent declaration, thus creating a “clear” genuine issue of material fact on the issue of inventorship.

    The Court frames several issues that are potentially more interesting than the main inventorship issue, but declines to rule on those issues, given its reversal.  These issues include:  (1) applicability of the doctrine of assignor estoppel to a party that is merely in privity with the assignor; (2) applicability of the corroboration rule to testimony by inventors/assignors challenging validity; and (3) whether 35 U.S.C. § 256 (allowing the patent office to correct inventorship upon application of the parties/assignees) could be used to correct inventorship, if it were found to be incorrect in this case.

    Marcus Thymian is a partner at McDonnell Boehnen Hulbert & Berghoff LLP in Chicago.  Concentrating primarily on the electrical, software, and mechanical arts, he is experienced in planning, creating, enforcing, and defending against patent portfolios. [Marcus Thymian’s Bio]

    [Copyright 2005 – Originally published at www.patentlyo.com]

    Supreme Court to Reexamine the Interplay Between Patents and Unlawful Tying Agreements

    Patent, Patent Cases 2005,

    IllinoisToolThe Supreme Court has decided today to hear Illinois Tool Works v. Independent Ink (04-1329). 

    In this case, the Court of Appeals for the Federal Circuit determined that a rebuttable presumption of market power sufficient to restrain trade under antitrust law arises from the patentee’s possession of a patent used in an explicit tying agreement.

    The suit involves an ink jet device patented by Trident, a subsidiary of Illinois Tool Works.  Independent Ink manufactures unpatented ink that is usable in Trident’s patented device.  However, Trident’s license/purchase agreements require use of Trident’s ink under certain circumstances.

    Independent Ink sued alleging an illegal tying arrangement in violation of Section 1 of the Sherman Act.  The district court dismissed the claim on summary judgment, but the CAFC reversed — ordering the lower court to presume market power based on the patent tying agreement.

    In its opinion, the CAFC admonished the district court for not following clearly established Supreme Court precedent and for dismissing the High Court’s holdings as “vintage.”  The appellate panel noted that, although it may be time to abandon the doctrine, it is up to the Supreme Court or Congress to expressly overrule its own precedent — this prerogative does not lie with the district courts.  The High Court is expected to hear the case next fall.

    Amicus briefs in the petition were filed by the AIPLA, ABA, Pfizer, and the IPO.

    Link:

    Will US Courts Adjudicate Foreign Patents or Will Comity Prevail?

    Patent, Patent Cases 2005

    VodaCatheter

    Voda v. Cordis Corp. (Fed. Cir. 2005)

    The past year has seen an expansion of the reach of U.S. patent laws based on the Federal Circuit’s decisions in Eolas v. Microsoft and RIM v. NTP. A third case in the pipeline is now ready to burst at the seams.

    In August 2004, an Oklahoma district court granted Dr. Jan Voda’s motion to amend the complaint to add claims of infringement of five foreign patents. In February, the CAFC granted an interlocutory appeal request, which will likely be heard this fall.

    Dr. Voda is a cardiologist in Oklahoma City who has patented a number of catheters and other medical devices used in the practice of medicine. Voda has alleged that Cordis has infringed patents both on U.S. soil and abroad. In order to save resources and establish a uniform judgment, Voda has asked, and the court has granted, permission to consolidate the world-wide patent issues into a single case.

    In an impressive brief, Cordis argues forcefully that the supplemental jurisdiction statute (28 USC 1637) does not apply to foreign patent claims.

    Two major IP organizations (AIPLA & IPO) have recently filed amicus briefs asking the CAFC to reverse the lower court’s decision — essentially arguing that “comity” should rule. Of course, the CAFC only months ago rejected comity arguments in both Eolas and RIM. Noted commentator and professor Hal Wegner has listed Voda atop his “Top Ten Pending Patent Cases.”

     

    Links:

    CAFC: Patent Laws Preempt Unjust Enrichment Claim

    Patent, Patent Cases 2005

    PatentlyOImage004Ultra-Precision Manufacturing v. Ford Motor Co. (Fed. Cir. 2005).

    Ultra disclosed an engineering design to Ford without any confidentiality agreement.  Ford later began selling a product that allegedly included the design. Ultra then sued for unjust enrichment — arguing that Ford owed a portion of the savings accrued through using the product.

    The CAFC affirmed the district court’s dismissal of the claim, holding that the claim was preempted by the patent statute:

    Ultra-Precision seeks a patent-like remedy for Ford’s conduct in making, using, and selling products embodying information Ultra-Precision was not successful in protecting under the federal patent laws and which is free for all the world to enjoy. In the absence of an incremental benefit conferred, any attempt to obtain a patent-like royalty for the making, using, or selling of a product in the public domain under the rubric of state unjust enrichment law is preempted.

     The appellate panel drew a line between contract claims and unjust enrichment claims — finding that states had a right to enforce contracts, but that unjust infringement “has the potential to take aim at the federal scheme.”

     File Attachment: Ultra-Precision v. Ford.pdf (173 KB).

    SmithKline Beecham v. Apotex: A Conclusion?

    Patent, Patent Cases 2005,

    SmithKline Beecham Corp. (SKB) v. Apotex Corp. (Fed. Cir. 2005).

    Case History:

    • 2003.03.03 Judge Richard Posner, sitting by designation, found the patent valid but either (i) not infringed or (ii) if infringed, the infringement excused under Posner’s newly created equitable defense.
    • 2004.04.23 CAFC (RADER, J.) affirms, but on other grounds — finding that the drug (PHC hemihydrate) had been in public use during clinical trials.  Specifically, the court found that the clinical trials tested only the safety and efficacy of PHC hemihydrate as an anti-depressant and did not qualify as an experimental use. In concurrence Judge Gajarsa derided the Majority’s approach, saying that it has created "unfortunate precedent that will complicate future considerations of the experimental use doctrine."
    • 2005.04.08 Without opinion, en banc CAFC vacates the experimental use portion of the original panel decision.  Judge Newman’s dissent from the order declining to hear the case en banc was essentially a written as a dissent from the new panel decision issued the same day.
    • 2005.04.08 The original CAFC panel issues a new opinion dropping the experimental use issue and basing the decision on “inherent anticipation.”
    • 2005.06.15 CAFC denies a petition for an en banc rehearing of the new panel decision, but does not issue any opinion.

    Links:

  • File Attachment: SKB Apotex en banc order (49 KB)
  • File Attachment: SKB Apotex Panel Decision (230 KB)
  • SKB Apotex Original Panel Decision (From Georgetown Law Center)
  • File Attachment: SKB Apotex District Court.pdf (2443 KB)
  • Discussion of the original panel opinion: Part I, Part II, Part III, and part IV.
  • Discussion of the en banc order and new appellate opinion: Part V, Part VI.
  • Howard Bashman provides an excellent commentary on the case via one of his readers.

    • Seed License Agreement Does Not Implicate Plant Variety Protection Act

    Patent, Patent Cases 2005

    PatentlyOImage003Showmaker v. Advanta USA (Fed. Cir. 2005)

    By Alison Baldwin

    Illinois farmer, Edward Showmaker, filed suit against Advanta USA, claiming that the language of the shrinkwrap license agreement on Advanta’s soybean seed violated the misbranding provision of the Plant Variety Protection Act (PVPA). The Advanta’s Garst Brand Seed D445N, Variety 57004 purchased by Mr.. Showmaker was neither patented or PVPA certified. However, the agreement on each of Advanta’s bags stated:

    “The soybean seed in this bag contains genetics developed, licensed or owned by Seller. All rights to make, produce or sell seed products derived from this seed reside solely with Seller. Buyer acknowledges this ownership and agrees to the following conditions: … Buyer will not resell or supply any of this seed to any other person or entity. Furthermore, Buyer is strictly prohibited from saving or selling, for seed purposes, any gain products from this seed. Buyer further agrees not to alter, or permit the alteration of the seed … through either genetic engineering, conventional breeding activities or other techniques.”

    The United States District Court for the Southern District of Illinois dismissed the case for failure to state a claim upon which relief can be granted because the contractual language in the Agreement did not implicate the PVPA’s misbranding provisions. The Federal Circuit affirmed because Advanta’s shrinkwrap license did not specifically reference the PVPA, any issued PVPA certificates or any pending PVPA applications. Furthermore, Advanta’s shrinkwrap license did not use the terms “Unauthorized Propagation Prohibited” or “Unauthorized Seed Multiplication Prohibited,” which are specifically set forth in PVPA Section 2568(a)(3). The Court stated that Advanta’s contract language did not put the potential purchaser or the public on notice of a plant variety owner’s rights, it merely restricted some activities of the buyer.

    NOTE: Alison Baldwin is a partner at McDonnell Boehnen Hulbert & Berghoff LLP in Chicago.  Her patent litigation experience has covered a diverse range of topics, from recombinant DNA technology to digital television. In addition to her law degree, Ms. Baldwin holds degrees in biochemistry and plant pathology and has conducted research on the molecular mechanisms involved in plant disease resistance. [Brief Biography].

    PTO Board: Disclosure of Sequence Enables at least 5% of Natural Variance.

    Patent, Patent Cases 2005,

    Blast_equationEx parte Bandman, No. 2004-2319, (BPAI 2005)

    By Donald Zuhn

    In an appeal from a final rejection, the PTO Board reversed rejections based on both the written description and enablement requirements of 35 U.S.C. § 112, first paragraph, and entered a new ground of rejection under 35 U.S.C. § 112, second paragraph one of the claims. (U.S. Application No. 09/915,694). 

    Pointedly, the Board found that claims directed to a naturally occurring amino acid (or polynucleotide) sequence at least 95% identical to the disclosed amino acid (or polynucleotide) sequence were enabled and met the written description requirement.

    (more…)

    CAFC: Distinguishing Feature of Invention Reflected in Claim Construction

    Patent, Patent Cases 2005

    PatentlyOImage020Boss Control v. Bombardier and Sports Cars, Inc. (Fed. Cir. 2005).

    In a dispute over a power interrupter, the CAFC affirmed a summary judgment of noninfringement, finding that the patentee had given a special limiting definition to a disputed claim term during prosecution.

    Specifically, the court looked to how the patentee had distinguished the invention from prior art and incorporated that distinguishing feature into the claim language.

    File Attachment: Boss Control.pdf (56 KB)

     

    CAFC: Jury’s conclusions on obviousness reviewed de novo.

    Patent, Patent Cases 2005

    PatentlyOImage019Princeton Biochemicals v. Beckman Coulter (Fed. Cir. 2005).

    Princeton owns a patent on a capillary electrophoresis device and sued Beckman for infringement.  A jury decided in favor of Princeton on all issues including infringement and nonobviousness.  However, in a post-trial judgment, the district court issued a JMOL setting aside the jury verdict — instead finding all counts in favor of Beckman.

    Princeton appealed.

    According to the CAFC, a jury’s “conclusions on obviousness” are a question of law — reviewed without deference.  The underlying findings of fact are reviewed for substantial evidence.

    The legal conclusion, that a claim is obvious within § 103(a), depends on at least four underlying factual issues: (1) the scope and content of the prior art; (2) differences between the prior art and the claims at issue; (3) the level of ordinary skill in the pertinent art; and (4) evaluation of any relevant secondary considerations. Graham v. John Deere.

    In this case, the CAFC agreed with the district court, that there was not substantial evidence to support the jury verdict.

    JMOL of obviousness affirmed.

    Pain for Purdue Pharma: CAFC affirms inequitable conduct finding

    Patent, Patent Cases 2005,

    Surprisingly DiscoveredPurdue Pharma L.P. v. Endo Pharms. Inc. (Fed. Cir. 2005).

    by Marcus Thymian

    The Federal Circuit affirmed a finding by the District Court for the Southern District of New York that Purdue’s Oxycontin patents-in-suit are unenforceable due to inequitable conduct that occurred during prosecution of the patents.  The decision, if it withstands further appeal efforts, would open the door to generic equivalents of Purdue’s popular controlled-release pain treatment medication.  According to various news stories on the Federal Circuit ruling, Purdue has indicated it plans to request en banc review of the 3-judge panel decision by the full 12-judge Federal Circuit. 

    The inequitable conduct determination was based primarily on variations of the following Purdue statement:

      It has now been surprising discovered that the presently claimed controlled release oxycodone formulations acceptably control pain over a substantially narrower, approximately four-fold [range] (10 to 40 mg every 12 hours — around the clock dosing) in approximately 90% of patients.  This is in sharp contrast to the approximately eight-fold range required for approximately 90% of patients for opioid analgesics in general.

    The district court found that Purdue repeatedly referred to this “surprising discovery” during prosecution, but did not inform the PTO that the “discovery” was based on “insight” without “scientific proof.”  The Federal Circuit decided that the district court did not error in finding the two elements of inequitable conduct: materiality and intent.

    Materiality was based on the district court’s examination of the entire record.   Purdue had repeatedly argued that the four-fold dosage range distinguished the invention over prior art, according to the district court.  The district court found that Purdue’s use of language that “implied, if not suggested” experimental results, when in reality the “discovery” was based solely on inventor “insight,” constituted withholding material information from the PTO.

    Intent was inferred from the context in which Purdue’s statements were made.  Purdue’s “carefully chosen language suggests that it had obtained clinical results, and that suggestion was left unclarified by any disclosure that discovery of the four-fold dosage range for oxycodone was based on insight.”  The Federal Circuit agreed that Purdue had engaged in a “clear pattern of misdirection throughout prosecution of Purdue’s controlled release oxycodone patents.”

    This case is an interesting exercise in standards of review and burdens of proof and persuasion.  Inequitable conduct requires a showing by “clear and convincing evidence,” which is quite high (patent infringement requires only a showing by a “preponderance of the evidence”).  The Federal Circuit conducted a deferential review of the district court’s inequitable conduct ruling.  This heightened standard involves reviewing the materiality and intent factual findings for “clear error” and reviewing the ultimate inequitable conduct conclusion for an “abuse of discretion.”  So, while an initial inequitable conduct showing is a tough burden, if a district court’s ruling is well supported, it may be relatively tough to overturn. 

    Marcus Thymian is a partner at McDonnell Boehnen Hulbert & Berghoff LLP in Chicago.  Concentrating primarily on the electrical, software, and mechanical arts, he is experienced in planning, creating, enforcing, and defending against patent portfolios. [Marcus Thymian’s Bio]

    [Copyright 2005 – Originally published at www.patentlyo.com]

    CAFC affirms evidentiary rulings: Inventor is not Expert

    Patent, Patent Cases 2005

    PatentlyOImage018Air Turbine Technology v. Atlas COPCO (Fed. Cir. 2005).

    Air Turbine (ATT) sued Atlas for infringement of its patent on pneumatic turbine pencil grinder as well as Lanham Act violations and for unfair competition under Florida law.  The district court dismissed the non-patent claims on summary judgment. At trial, however, the jury returned a verdict against ATT on patent infringement.

    On appeal, ATT argued that the court should have granted a new trial on the patent infringement claim because of three “prejudicial evidentiary rulings.”  Specifically, ATT complained that (i) its infringement expert was prevented from fully testifying (about a matter not disclosed under FRCP 37(c)(1)); (ii) certain co-inventor testimony was excluded because the co-inventor was not considered an expert; and (iii) an Atlas employee located in Sweden was not properly produced via teleconference because the court believed it lacked jurisdiction to compel testimony.

    Applying 11th Circuit precedent that evidentiary rulings are only reversed for clear abuse of discretion, the CAFC affirmed.  Finding that:

    (i) A court may properly exclude expert testimony that is not disclosed in the expert report;

    (ii) An inventor is not necessarily an expert — especially an expert on the accused device; and

    (iii) Determining whether to allow testimony in open court via contemporaneous transmission from a different location is well within the discretion of the district court.

    Non-infringement affirmed.

    [Copyright 2005 Dennis D. Crouch – Originally published at www.patentlyo.com]

    Hatch-Waxman 180-Day Exclusivity Does Not Restrict NDA-Holder’s Ability to Sell Generic Version of Patented Drug

    Patent, Patent Cases 2005

    ScreenShot008Teva Pharmaceuticals v. Crawford (FDA), No. 05–5004, (D.C. Cir. 2005).

    As the first ANDA filers on a generic version of gabapentin (Neurontin), Purepac & Teva (joint agreement) were eligible for a 180–day exclusivity period during which no other ANDA for the same drug may be approved.

    However, Teva also sued to stop the patentee Pfizer from selling a generic version of its name brand Neurontin during the 180 day period of exclusivity.  After losing at the district court level, Teva appealed to the D.C. Circuit, arguing for a “functional” interpretation of the statute (21 USC 355(f)(5)(B)(iv)).

    Teva argued that the purpose of the statute was to grant the first ANDA filer complete generic exclusivity for 180 days, and that allowing the patentee to sell the generic would “defeat the statutory purpose.”

    Writing for the panel, Chief Judge Ginsberg affirmed the lower court’s judgment. 

    [A]s Teva’s counsel conceded at oral argument, prior to the Hatch-Waxman Amendments, nothing in the Act prohibited the holder of an approved NDA from marketing a “brand-generic” version of its drug; thus Teva asks the court to declare that a previously lawful practice became unlawful when the Congress passed a statute that said nothing about that practice.

    Thus, the court affirmed that the exclusivity provision “clearly does not prohibit the holder of an approved NDA from marketing, during the 180–day exclusivity period, its own ‘brand-generic’ version of its drug.”

    Links:

    Next Steps in Patent Reform

    Patent, Patent Cases 2005

    ConstitutionPatent reform is expected to be taken to a new level this week with two events.

    • A version of the patent reform committee draft is expected to be introduced in the House of Representatives — perhaps as early as Tuesday, June 7, 2005. The House subcommittee on the Courts and Intellectual Property is scheduled to hold a hearing on the legislation on June 9, 2005.
    • Also on June 9, 2005, the NAS and AIPLA are hosting a wrap-up conference on patent reform in DC.  (Conference schedule). 

    Matthew Buchanan has created the Patent Reform Library to serve as a repository of available material on patent reform including legislative material, articles, and background information. Bookmark it.

    Samples not warranted to ensure injunction compliance.

    Patent, Patent Cases 2005

    LuteinKemin Foods v. Pigmentos (S.D. Iowa 2005).

    In a battle over Kemin’s patented form of purified lutein a jury that Pigmentos had infringed one of Kemin’s patents. (Lutein is a color additive with no vitamin A activity).

    A jury found for Kemin on one patent.  In addition to requesting a permanent injunction, Kemin also asked for the court to order the defendant to provide representative samples of its products to ensure compliance with the injunction.

    In considering this motion, the district court found that that it had the power to “fashion an appropriate remedy” to ensure that the injunction would be enforceable.  However, the injunction should not be“a sword for wounding a former infringer who has made a good-faith effort to modify a previously adjudged or admitted infringing device to remain in the marketplace.”

    As a result, court refused to order the samples — holding that “Kemin has been able to obtain samples in the past, and despite the affidavit provided by Kemin, the Court is not convinced it will be unable to do so in the future.”

    Links:

    CAFC: Patent Licensee in Good Standing has No Standing for Declaratory Relief

    Patent, Patent Cases 2005

    ChimericImmunoglobulinMedImmune v. Centocor (Fed. Cir. 2005).

    Centocor is the exclusive licensee of a patent on lymphocytic cells that produce chimeric immunoglobulins. (U.S. Patent No. 5,807,715). After a period of negotiations, MedImmune sub-licensed the patent and began paying royalties. Even after signing the agreement, MedImmune asserted to Centocor that it did not infringe and that the patent was unenforceable/invalid.  Centocor responded that “it expected MedImmune to continue to adhere to its license obligations.”

    MedImmune then filed suit, asking for declaratory judgment that it owes no royalties. The district court, however, dismissed the case for lack of an actual controversy.  On appeal, the CAFC affirmed — finding Gen-Probe v. Vysis (Fed. Cir. 2004) dispositive.

    In Gen-Probe, we considered the case of a licensee in good standing who sought a declaratory judgment that it was not infringing the licensed patent, and that the licensed patent was invalid. . . . [W]e determined that the license, “unless materially breached, obliterated any reasonable apprehension of a lawsuit,” and that once the licensor and licensee “formed the license, an enforceable covenant not to sue, the events that led to the formation [of the license] became irrelevant.”

    MedImmune argued that Gen-Probe should not be followed because it is “inconsistent with Supreme Court Precedent and with prior Federal Circuit precedent.”  The CAFC rejected that argument — finding the cited opinions to be consistent with Gen-Probe.

    From a policy perspective, the Court rejected MedImmune’s argument that Gen-Probe creates an unacceptable “Hobson’s choice.”

    Every potential infringer who is threatened with suit, or who is sued, for patent infringement must decide whether to settle or fight. In short, the “Hobson’s choice” about which MedImmune complains arises not from Gen-Probe, but from Article III’s requirement that, before a district court exercises jurisdiction in a declaratory judgment suit, there must be an actual controversy between the parties. For the reasons set forth above, such a controversy does not exist here.

    Dismissal affirmed.