Tag Archives: Claim Construction

Patent Attorneys Testify to Consistency of Federal Circuit Court of Appeals

Patent, Patent Cases 2005

Patent attorneys often complain about the fractured relationship in the judicial system (i) within the Federal Circuit Court of Appeals and (ii) between the Federal Circuit and the trial courts.  The high rate of reversal on issues such as claim construction is often cited as an example of the disconnect.

Keeping these complaints in mind, yesterday’s testimony in the House of Representatives Intellectual Property Subcommittee was remarkable because of the clear affirmation from all four witnesses that the Federal Circuit should be the court that hears patent appeals. 

The witness list included a representative from the Federal Circuit Bar Association, a law school professor, an in-house counsel, and a practicing patent attorney.  These witnesses all supported legislative changes to overrule Holmes Group v. Vornado (holding that the Federal Circuit does not have jurisdiction over cases where patent issues are raised only in a counterclaim).

In support of their call for a change, the witnesses cited both (i) the legal consistency of the Federal Circuit and (ii) the technical knowledge of the Federal Circuit.  Congressman Lamar Smith (R Tex) chairs the subcommittee.

LINKS:

Snippets: Review of Developments in Intellectual Property Law

Articles and Publications, Patent,

MBHB’s snippetsTM newsletter provides a timely review of developments in intellectual property law. Here is a table of contents of the most recent issue (March 2005: Volume 3, Issue 1):

  1. Daniel Boehnen and Deana Larkin, Trends in E-Discovery: New Local Rules and Recent Judicial Opinions.
  2. Michael Greenfield, Jennifer Pope, Dennis Crouch, and Elaine Chang, The Primary Source for Claim Construction: Dictionary or Specification.
  3. Kevin Noonan, The Continued Confusion Over Written Description.
  4. Dennis Crouch and Baltazar Gomez, Legislative Update: Joint Research Agreements May Protect Patent Rights.

You can e-mail the editor (snippets@mbhb.com) to receive a PDF copy of the newsletter.  Include your mailing address if you would like a hard-copy.  In the e-mail, please indicate your technology and legal interest: (Biotech, Electrical, Software, Chemical, Mechanical, Litigation, and/or Prosecution). 

Past Issues:

CAFC: Claims Construed Based on Specification and Prosecution ‘Read as a Whole’

Patent, Patent Cases 2005

ASM America v. Genus (Fed. Cir. 2005)

In a dispute over a method of sequential atomic layer deposition (ALD), ASM sued Genus for infringement of its patents.  After construing the claims, the magistrate granted summary judgment of non-infringement in favor of Genus.  ASM appealed the construction.

On appeal, the CAFC affirmed, finding that the district court was "on firm ground." 

The disputed construction involved the term "evacuate."   ASM argued that evacuate should encompass use of an inert gas to push gases out.  However, the Appellate Panel found that, "when the specification and the prosecution history are read as a whole, it becomes clear that the insertion of inert gas may help render the process of evacuation more efficient, but is not part of the evacuation itself."

Summary judgment of non-infringement affirmed.

CAFC: References on Face of Patent are Intrinsic Evidence for Claim Construction

Patent, Patent Cases 2005

Inline_skate

V-Formation v. Benetton Group & Rollerblade, Inc. (Fed. Cir. 2005).

By Marcus Thymian

In its March 15 decision, the Federal Circuit affirmed a district court’s grant of summary judgment of non-infringement of the claims of three patents relating to in-line skate technology.  The patents were directed to a particular frame design for attaching the wheels to the boot.  To provide flexibility in frame and wheel adjustment of a skate, the frame included two sidewalls “releasably attached” by a plurality of fasteners to toe and heel plates of the skate.   (For example, see U.S. Patent No. 5,873,584).

The dispute centered on whether rivets could serve as fasteners that “releasably attach.”  The embodiments set forth in the patents-in-suit utilized screws as the releasably attaching fasteners.  The district court had construed the term “releasably attaching” to mean that the fasteners “must permit the sidewalls to be easily removed and replaced” and determined that one skilled in the art would not consider rivets to fall under that definition.  In reaching that conclusion, the district court looked to the specification of the patents-in-suit, as well as the specification of a patent (the “Meibock patent”) cited on the face of one of the patents-in-suit.  Finally, the district court supported its construction by referring to an uncontrolling decision of the Federal Circuit that interestingly addressed the unremovable nature of rivets in in-line skates:  “Screws, unlike rivets and laminates, are meant to be unscrewed, that is, to be removed.  A rivet or a laminate, to the contrary, is meant to remain permanent, unremovable unless one is bent on breaking the permanent structure apart.”

The Federal Circuit first agreed that the intrinsic evidence called for “releasably attaching” to be construed per the district court’s definition.  It agreed that the intrinsic evidence included not only the patent specification, but also the cited Meibock patent:

    The district court properly considered other intrinsic evidence to aid its construction.  For instance, the district court considered [the Meibock patent].  The Meibock patent is prior art that was listed as a reference on the face of the ‘466 patent and in an Information Disclosure Statement.  This prior art reference to Meibock is not extrinsic evidence.  This court has established that “prior art cited in a patent or cited in the prosecution history of the patent constitutes intrinsic evidence. …  The Meibock patent explains that the toe and heel plates are “permanently attached … through the use of rivets or releasably attached through the use of fasteners such as screws or bolts.” …  Thus, the district court correctly concluded:  “[The] Meibock patent provides evidence that rivets are considered by persons of ordinary skill to be permanent fasteners.”

Finally, the Federal Circuit approved of the district court’s reference to its earlier uncontrolling decision addressing the removability of rivets, since the district court had merely used it to supports its independent conclusion in this case.

Marcus Thymian is a partner at McDonnell Boehnen Hulbert & Berghoff LLP in Chicago. Mr. Thymian is experienced in planning, creating, enforcing, and defending against patent portfolios, and has logged many miles on in-line skates over the past 20 years. [link to bio]

Links:

CAFC: Claim language first, specification second, prosecution history third…

Patent

Iowa State and Vanderbilt v. Wiley (Fed. Cir. March 7, 2005, NONPRECEDENTIAL)

By John Smith, PhD < ?xml:namespace prefix ="" o /> 

Iowa State University Research Foundation, Inc. (ISURF), Vanderbilt University, et al. appealed a Judgment as a Matter of Law granted by the District Court for the Southern District of Iowa that U.S. patent No. 5,348,979 was not infringed by Wiley Organics. 

 

ISURF sought injunctive relief and damages for Wiley’s allegedly contributory infringement and inducement of infringement for producing ß-hydroxy-ß-methylbutyric acid, or HMB.  Wiley supplied HMB to < ?xml:namespace prefix ="" st1 />MTI exclusively from 1995 to 2000.  In 2000, Wiley began to distribute the compound to other companies.  At issue on appeal was the construction of the claim terms “subject” and “patient.”  Claim 1 of the patent was considered to be representative:

1. The method of protein sparing, comprising orally or intravenously administering to a human subject an effective amount of ß-hydroxy-ß-methylbutyric acid (HMB) for increasing the retention of nitrogen, said HMB being in an edible or intravenously-administrable form selected from (i) its free acid form, (ii) its sodium, potassium, or calcium salt, (iii) its methyl or ethyl ester, or (iv) its lactone, and continuing the said administration of HMB until the amount of nitrogen in the patient’s urine has substantially decreased.  (Col. 6, ll. 7-16.)

The ISURF argued that the terms encompassed healthy individuals as well as those in need of treatment with HMB.  The District Court, however, had construed the claims in Wiley’s favor, ruling that the claims did not encompass healthy individuals, but only those with a “negative nitrogen balance” (in need of HMB treatment).

 

In the appellate decision, the Federal Circuit began with the claim language.  It noted that the terms “subject” and “patient” are used interchangeably in the patent, with no qualifications, other than that the individuals are human; the Court noted that there is no language indicating the sick or elderly are the only individuals contemplated to be within the scope of the claims.  The claim language also indicated that a relative change in nitrogen levels was all that was required by the claims; any decrease in nitrogen levels was within the scope of the claims.

 

The Court then proceeded to examine the specification.  It noted that the only experimental example in the specification had normal, healthy individuals as subjects.  The Court also noted that other language in the specification described the treatment of normal, healthy subjects.

 

Last, the Court examined the prosecution history.  It concluded that interpretations of the claim language by the examiner was not important, as the prosecution history revealed that the rejection by the examiner was based on the examiner’s interpretation of the prior art, not whether the claims were limited to treatment of sick individuals.

 

The order granting JMOL was vacated and the case remanded for further proceedings consistent with the Federal Circuit’s claim construction.

John Smith is an attorney at MBHB LLP in Chicago.  He earned both his JD and PhD (inorganic chemistry) from Vanderbilt University. He has co-authored numerous articles and served as a faculty member in the Chemistry Department of Lipscomb University in Nashville, Tennessee.

CAFC: Substantially Flattened Is Defined As Flatter Than A Cylinder

Patent, Patent Cases 2005

[Link to the patent drawings]

The Federal Circuit has given its ruling in a dispute over patented tampon technology.  (U.S. Patent No. 4,536,178 [pdf]).  At the district court level, the judge had awarded summary judgment of noninfringement to the alleged infringer.  However, on appeal, the CAFC reversed, finding that the lower court had improperly interpreted the term "substantially flattened" to mean "flattened."

The issue is whether the patentee properly claimed an oval as a "substantially flattened" circle, or more specifically, an elliptical cylinder as a "substantially flattened" cylinder. In construing the term "substantially flattened surfaces" as something flat in practice the district court erred in going beyond the intrinsic evidence. That evidence clearly indicated that the patent contemplated curved surfaces. Thus, we reverse the district court’s claim construction and conclude that "substantially flattened surfaces" means surfaces, including flat surfaces, materially flatter than the cylindrical front portion of the applicator.

In what may be a fore-shadowing of the upcoming Phillips opinion, the Court rejected the idea that (i) the term was ambiguous; (ii) that an expert’s testimony could be used to modify the ordinary meaning; or (iii) that the drawings limited the scope of the claimed term.

On remand, the Federal Court in Ohio must determine whether the newly interpreted claims cover the allegedly infringing product.

LINK:

  • Download the Decision: Playtex v. P&G (Fed. Cir. 2005) [pdf].

Appeals Court Orders New Trial in $500 Million Microsoft-Eolas Web Browser Case

Patent, , ,

Eolas v. Microsoft

Eolas v. Microsoft (Fed. Cir. March 2, 2005).

Eolas and the University of California sued Microsoft for infringement of its patent that involves a method of using a web browser to open third-party applications using plug-ins.  The District Court for the Northern District of Illinois granted final judgment to Eolas after a jury found that Microsoft infringed the patent and actively induced United States users of Internet Explorer to infringe. The district court also invoked 35 U.S.C. § 271(f) to include foreign sales of Internet Explorer in the royalty awarded to Eolas.  The jury awarded Eolas a royalty of $1.47 per unit of infringing product, which amounted to a total award of $520,562,280.

On appeal, the Court of Appeals for the Federal Circuit (CAFC) found that district court improperly granted judgment as a matter of law (JMOL) in Eolas’ favor on Microsoft’s anticipation and obviousness defenses and improperly rejected Microsoft’s inequitable conduct defense — and thus vacated the district court’s decision and remanded for a new trial on these issues. The CAFC also affirmed the district court’s claim construction and related jury instruction. 

Finally, the biggest news from a patent law perspective is that the Court affirmed the district court’s holding that "components," according to section 271(f)(1), include software code on golden master disks.

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Eight is Enough: Eight important patent cases for Spring 2005

Patent, Patent Cases 2005, , , , , , , ,

There are lots of great cases on the Federal Circuit’s spring calendar.  Several cases pending at either the Federal Circuit or Supreme Court that are ‘worth a special look,’ according to Hal Wegner.  Here are some highlights of Mr. Wegner’s list, with my own comments.

  • Merck v. Integra, Supreme Court decision by June 27, 2005.
  • LabCorp v. Metabolite, petition for cert submitted, Supreme Court has requested Solicitor General’s Opinion on Cert.  The case involves a patentability question — whether Metabolite’s patented method of detecting vitamin B deficiency should be invalid as "because one cannot patent laws of nature, natural phenomena, and abstract ideas." 
  • Purdue Pharma v. Endo, CAFC heard oral arguments in early November on the question of whether patentee’s conduct was ‘inequitable’ for failing to disclose that results used to establish patentability were prophetic rather than experimental. A decision is expected soon.
  • SmithKline Beecham v. Apotex, awaiting decision on petition for rehearing.  This case now revolves around the question of whether use of an invention to confirm utility for FDA approval is an ‘experimental use’ that saves a patent from anticipation under 102(b).
  • Phillips v. AWH, awaiting en banc decision on claim construction methodology.
  • Eolas Technologies v. Microsoft, Federal Circuit decision awaited, hopefully discussing the scope of 271(f). The upcoming appeal of AT&T v. Microsoft presents the same ‘golden master disk‘ scenario as Eolas, and will become important if Eolas is decided on other grounds.
  • Independent Ink v. Illinois Tool Works, In January, the CAFC determined that, in an antitrust tying case, a patent presumptively defines the relevant market as the nationwide market for the patented product itself.  There is some potential for cert in this case.
  • NTP, Inc. v. Research in Motion, Ltd., there is a good chance for a rehearing in this case involving RIM’s BlackBerry product.  This case will be important in defining extraterritorial application of U.S. patent laws in the modern era of networked computing systems.
  • In re Fisher is not yet on the CAFC calendar.  In this case, the BPAI affirmed a rejection for lack of utility and enablement (101 and 112 p1) because the specification lacked a specific teaching of a substantial utility.  According to the decision, without a specific teaching of substantial utility, then virtually all chemicals would meet the requirements of section 101 as at least "useful in research."

Although not patent litigation, Sarah Stirland (one of the few reporters focusing on intellectual property) at the National Journal has written a nice article regarding the potential for legislation in the 109th Congress.

Printable Version

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Supreme Court Briefs: Merck KGaA v. Integra

Patent, Patent Cases 2005, , , ,

Merck KGaA v. Integra (on certiorari at the Supreme Court, 2005).

In 2003 Court of Appeals for the Federal Circuit (CAFC) narrowly interpreted the safe harbor statute that permits a drug manufacturer to perform potentially infringing experiments needed to obtain FDA approval without incurring liability for patent infringement.  Integra LifeSciences I, Ltd. v. Merck KGaA, 331 F.3d 860 (Fed. Cir. June 6, 2003) [PDF] (Interpreting 35 U.S.C. §271(e)(1)). In January 2005, the Supreme Court granted certiorari in the case and will hear the appeal on April 20.  Cert. granted, No. 03-1237 (U.S. Jan. 7, 2005).  The question revolves around what types of experiments are ‘safe’ from liability under the statute. 

The party and amicus briefs are summarized below Of course, the length of individual summaries below does not indicate my view of that brief — in fact, my view is often that the length of an argument has an inverse relationship with the quality of the argument. 

Merck’s substantive brief was filed on February 15. I split Merck’s arguments into two categories.

  1. The Law: The FDA exemption covering any “use . . . reasonably related to the development and submission of information” to the FDA should be interpreted broadly.  Merck argues that any research that is “directed at developing information relevant to an IND application” should fall under the 271(e)(1) safe harbor.
  2. The Facts: The allegedly infringing experiments in this case falls under the safe harbor statute because (i) it was reasonably believed that the compound was a viable drug candidate and (ii) the experiments produced information that is considered in an IND application.

You can download the Merck KGaA brief here [pdf].

Brief of the United States in Support of Merck: The government has already played an important role in this case by filing a brief in support of Merck’s petition for cert.  Now, the Government has filed it brief on the merits.  Essentially, the U.S. argues that the statutory exemption should protect “all activities that are undertaken in the course of attempting to develop a particular drug and are reasonably related to the development of the types of information that would be relevant to an INDA or NDA.”

  1. The exemption should apply to pre-clinical studies.
  2. The exemption should begin to apply once research “progresses beyond basic research and begins efforts to develop a particular drug.”

The Government brief also discusses the research tool market, saying that the CAFC “erred by artificially narrowing the statutory exemption in an effort to protect research tools.”  According to the Government, it is unclear whether the statute even applies to research tools. 

You can download the Government brief here [pdf].

AIPLA’s Amicus Brief:  The AIPLA brief is officially in support of neither party.  However, the brief makes the argument that the Federal Circuit erred on both the facts and the law.  Here is a summary of some of the AIPLA arguments:

  1. Limiting the safe harbor protection to only (i) clinical tests that are (ii) related only to the exact drug for which FDA approval is ultimately sought would leave the statute much too narrow.
  2. The road to FDA approval involves much more than clinical tests.  The Federal Circuit payed too little attention to the FDA regulatory scheme in its decision.
  3. The earliest stage of experiments do not fall under the safe harbor statute.  The brief notes, for instance, that high-throughput screening of drugs for potential activity should not fall within the safe harbor.
  4. Finally, the Supreme Court should not weigh-in on the common-law experimental use exception.  [NOTE: Although I understand the AIPLA’s legal reasoning on this point, I do not understand their motivation.  If not now, when will the Court look at the common-law experimental use exception]

William McGeveran at Foley Hoag was kind enough to supply a copy of the AIPLA brief.  You can download the AIPLA brief here [pdf].

Eli Lilly, Wyeth & Merck as Amicus in Support of Merck: The three big drug manufacturers submitted an eloquently written brief that makes strong practical points:

Virtually Every Experiment is Reasonably Related to FDA Approval: Because the length, risks and costs of innovative drug development are so great, every activity in the development process has a purpose and a clear rationale. Each is designed to generate information that ultimately goes into the decision of whether a potential new drug will progress to the next hurdle. Each is aimed at the same ultimate goal: to gain FDA approval. . . . Innovative new drug development, thus, resembles a funnel. Just as a funnel is widest at the top, so too the early phases of drug development involve many more potential drugs than eventually emerge. The narrowing of the funnel represents the winnowing of less attractive potential new drugs. Blocking the funnel at any point cuts off the entire flow of new drugs. The Federal Circuit in its 1993 decision blocked the funnel.

The decision enables patent holders to prevent others from entering, or moving down the funnel. As a result, drug development will slow and its costs will mount in what is already a lengthy, high risk, high cost process; patients will be deprived of timely access to new, safer, more effective drugs; the entry of generic equivalents will be delayed; promising drugs to treat unmet medical needs will never be developed; and drug development activities along with valuable American jobs will be exported to countries having more favorable legal environments.

You can download the brief here [pdf].

NYIPLA Amicus Brief in Support of Merck: The New York Intellectual Property Law Association is filing an Amicus brief.  (The Brief is available here [pdf] ). The NYIPLA’s conclusions parallel many of those outlined by the AIPLA.  For instance, the NYIPLA argues that the statutory safe harbor was construed too narrowly and that the experiments performed in this case were “reasonably related” to the process of FDA approval.

Additionally, the NYIPLA presents a nuanced statutory construction argument that is derived from Professor Janice Mueller’s recent paper on the Experimental Use Exception (56 Baylor L. Rev. 101 (2004)).

  1. The Federal Circuit misused a de minimis maxim to narrowly construe the safe harbor statute.
  2. The statutory FDA exemption arises from Article 1, Section 8 of the Constitution and from the economic principles echoed in numerous Supreme Court cases. See, e.g., Universal Oil Products Co. v. Globe Oil & Refining Co., 322 U.S. 471, 484 (1944). These first principles indicate that the statute should be given a broader interpretation.

Thanks to David Ryan at Fitzpatrick Cella for providing a copy of the brief.

Amicus Brief for PhRMA in Support of Merck: PhRMA is an association of the largest drug development companies in the U.S. Last year PhRMA members spent $38 billion on drug development and have been responsible for almost all innovative new medicines approved during the last ten years. According to PhRMA’s brief, the CAFC 2003 decision in this case “represents a direct and substantial threat to future drug development.” The brief argues that pre-clinical testing is an essential part of drug development and an FDA requirement.

Download the PhRMA brief here [pdf].

Amicus Briefs of Professors Rochelle Dreyfuss, John Duffy, Arti Rai and Katherine Strandburg:  The professors argue that the Court should not determine the reach of the common-law experimental use exception in this case. And, in fact, the brief asks that a clear disclaimer be placed in the Supreme Court opinion so that the opinion cannot be used by the Federal Circuit to decide issues on experimental use. In the professors’ view, the disclaimer may encourage litigants to bring the common-law issue to the Supreme Court. Of note, the professors find no “generally applicable relationship between the coverage of” the common-law experimental use exception and the statutory safe harbor.

You can download the Professors’ Brief Here [pdf]. Thanks to Professor Strandburg at DePaul for providing a copy of the brief.

Amicus Brief of The Bar Association of the District of Columbia (BADC): According to the BADC, regardless of a statutory safe harbor under 271(e)(1), the allegedly infringing “development activities are of the type that have traditionally been excluded from infringement liability under the common law experimental use exemption. . . .Failure to recognize this important exemption to infringement will deter research in the United States and encourage companies to conduct their research and development off-shore.”

You can download the BADC Brief Here [pdf]. Thanks to Susan Dadio at Burns Doane for providing a copy of the brief. Lynn Eccleston is the counsel of record.

Brief of EON LABS as Amicus Curiae in Support of Merck KGaA: Shashank Upadhye, VP and Counsel at the Generic Manufacturer Eon Labs has submitted a brief that explicitly supports Merck’s position.

  1. The statute discusses “reasonably related . . . information.”  Logically, exemption applies to any information that the FDA would normally request or that it mandates be submitted. For instance, the FDA has promulgated regulations that mandate certain pre-clinical or screening information be submitted.
  2. Generic drug companies often engage in the same kind of screening activities that Merck KGaA did in order to find a bio-equivalent product. This activity is shielded.

Eon also provides a nice description of the two most common types of drug research covered by the safe harbor regime: (i) testing and information collection on brand new drugs and proving safety and efficaciousness; and (ii) testing and information collection related to approving a generic bio-equivalent version of a preapproved drug.  Eon argues that the Federal Circuit erred by fixating on policy of safe harbor applying to generic drugs only.

You can download the EON Labs brief here [PDF].

Brief of the Consumer Project and the EFF as Amicus Curiae in Support of Merck KGaA: The consumer brief, filed by professor Joshua Sarnoff, makes the compelling argument that Section 271(e) and the common law experimental use exception provide overlapping protection. Sarnoff asks the Court to “confirm that Congress intended a broad experimental use exception to promote the progress of science and technology.”

It is critically important that the Court take this opportunity to correct the Federal Circuit’s improperly narrow interpretations of the experimental use exception in Roche, Embrex, Madey, and this case. This is likely to be the best (and, given the chill these cases exert, may be the only foreseeable) opportunity to set the historic and statutory record straight and to explain how Section 271(e) and Section 271(a) and its experimental use exception relate to each other.

You can download the Consumer/EFF brief here [pdf].

The Biotechnology Industry Organization (BIO) filed in support of neither party: According to BIO, this “is not a case about whether Section 271(e)(1) is limited to generic drugs and/or required regulatory activity. Instead, it is a case about whether the particular animal and in vitro studies at issue are “reasonably related to the development and submission of information” for regulatory approval and therefore non-infringing under Section 271(e)(1).”

BIO makes four specific arguments:

  1. Section 271(e)(1) is not limited to generic drugs.
  2. Section 271(e)(1) is not limited to required regulatory activity.
  3. Section 271(e)(1) protects “reasonably related” testing activities.
  4. Section 271(e)(1)’s “reasonably related” inquiry must be fact-based. For instance, if a researcher pursues more safety information than what Federal regulators require, the researcher should not be punished for being careful.

Finally, BIO makes the practical point that even the potential for an errant application of Integra could have a great and adverse impact on many avenues of research and funding critical to BIO members. You can download the BIO brief here [pdf].

Amicus Brief for Sepracor in Support of Merck: Michael Dzwonczyk at Sughrue assisted with the Sepracor brief.  He also provided a copy of the brief for Patently-O and the following summary [slightly edited]:

The brief for amicus Sepracor takes the position that the federal circuit misinterpreted the scope of the exemption under §271(e)(1) by suggesting that the statutory immunity is limited to clinical activities in furtherance of FDA approval of a generic version of a commercialized drug. Notwithstanding the Supreme Court’s reliance in Eli Lilly on the public policies underlying the Hatch-Waxman Act that the §271(e)(1) infringement exemption and §156 patent term extension remedy symmetrical, yet opposing, patent term distortions imposed by the FDA regulatory process, the scope of the immunity conferred by §271(e)(1) is not limited to subject matter also encompassed by §156, which is far narrower in scope.  Because FDA routinely requires pre-clinical data in evaluating INDs and NDAs, activities directed to generating this data should be exempt under §271(e)(1).

You can download Sepracor’s brief here [pdf].

AARP in Support of Merck: The AARP’s brief argues that the Federal Circuit mistakenly focused on generic drug approval rather and mistakenly omitted a discussion of how the statute provides a safe harbor for the development of innovative drugs as well.  As would be expected, AARP also argues that a narrow exemption delays medical advancement and increases the costs of prescription drugs.

The Federal Circuit’s unwillingness to allow a broader experimental use exemption to patent infringement as Congress intended will lead to delay of medical advances by hampering the free exchange of scientific knowledge and by postponing competition beyond the patent term. The costs for prescription drugs, which already are so high as to prohibit many people from accessing their benefits, will be driven even higher.

You can download the AARP Brief Here [pdf]. Thanks to Sarah Lens Lock, author of the brief, for providing the PDF copy. 

Genentech and Biogen Idec in Support of Merck: The Biologic companies bring out the important point that drug development of biologics is quite different than that of chemically-synthesized drugs, and that those differences alters the FDA approval process.  The conclusion is that, perhaps even more than traditional chemical drugs, the FDA requires an incredible amount of pre-clinical research before a new biologic will be approved.

You can download the Biologics Brief here [PDF].  Thanks to Raymond Arner for providing a copy of the brief.

Integra LifeScience’s Brief on the Merits: In their brief, respondents Integra and the Burnham Institute attempt to shift the direction of the argument away from whether certain experimental activities may fall within the scope of FDA requirements to an examination of Merck’s activities and whether they were taken recklessly.

[Merck] did not proceed with caution in the face of patent rights held by [Integra].  This case did not arise from a decision by Merck to perform experiments designed to satisfy FDA regulatory requirements. . . This case arose from Merck’s reckless decision to hire [Scripps] to embark on a basic research program to search for new drugs

Integra also asks the High Court to dismiss the case for lack of controversy.  “Given that the parties agree that the District Court’s jury instruction applied the correct legal standard, and given that Merck did not seek a sufficiency of the evidence review of the jury’s verdict in its petition for certiorari, there is essentially no controversy for this Court to adjudicate.

Finally, in an attempt to lessen the perceived importance of the case, Integra argues that companies who “seek a safe harbor under the FDA Exemption for preclinical work in their own laboratories in compliance with FDA regulations have nothing to fear. . . . Merck’s problems in this case are of its own making and are unique to it.”

Benitec Australia’s brief in support of Integra: Benitec argues that the safe harbor does not extend to “identifying, characterizing and developing new drugs.” Such a right would interfere substantially and selectively with the rights of certain patentees and undermines the fundamental principles of the patent system.

Interestingly, the counsel for Benitec (in support of Integra) is the same as for BIO (in support of neither party).

Vaccinex brief in support of Integra: Vaccinex makes the important policy point that patented research tools are essential to the development of new drugs.  Without patent protection, the development of future tools is at substantial risk. As a rule, Vaccinex argues that the exemption extends “only to infringing activities that are ‘solely for uses reasonably related to the development and submission of information’ to the FDA.”

Applera and ISIS brief in support of Integra: Applera argues that from a textual statutory construction, that the plain meaning of section 271(e)(1) limits the exemption to uses that are “solely for the purposes of regulatory approval,” and that the Petitioner’s interpretation of the meaning treats the word “solely” as mere surplusage.

The statute provides that the exemption applies to making, using, and selling “a patented invention . . . solely for uses reasonably related to development” for FDA approval 

Applera’s argument is that the sole pupose of the invention should be for uses related to FDA approval while Merck argues that solely applies to the infringing act.

Invitrogen et al. brief in support of Integra:  The research tool makers request a ruling from the Court that expressly states that the 271(e) safe harbor does not extend to patented research tools. 

WARF brief in support of Integra: Among other arguments, WARF outlines its position that the Federal Circuit’s decision effectively thwarts the purposes of the Bayh-Dole Act.

STATUTE: The primary statute relevant to this proceeding is the FDA exemption, found at 35 U.S.C. § 271(e)(1) (2000):

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other process involving site specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

Also at issue are various statutory provisions and regulations governing the FDA: 21 U.S.C. § 355 (2000 & Supp. 2001); 21 C.F.R. §§ 58.3, 312.22-312.23, 314.50 (2004).

Links:

Briefs on the Merits:

  • In Support of Merck:
  • In Support of Neither Party:
  • In Support of Integra:

    • Reference Material:

    • John F. Duffy, Harmony and Diversity in Global Patent Law, 17 Berkeley Tech. L. J. 685 (2002).
    • John F. Duffy, Rethinking the Prospect Theory of Patents, 71 U. Chi. L. Rev. 439 (2004).
    • Rochelle Dreyfuss, Protecting the Public Domain of Science: Has the Time for an Experimental Use Defense Arrived?, 46 Ariz. L. Rev. 457 (2004).
    • Rebecca S. Eisenberg, Patents and the Progress of Science: Exclusive Rights and Experimental Use, 56 U. Chi. L. Rev. 1017 (1989).
    • Janice M. Mueller, The Evanescent Experimental Use Exception from United States Patent Infringement Liability: Implications for University/Nonprofit Research and Development, 56 BAYLOR L. REV. 917 (2004).
    • Katherine J. Strandburg, What Does the Public Get? Experimental Use and the Patent Bargain, 2004 Wisc. L. Rev. (2004).
    • Noonan, Greenfield, and Zuhn, Paradise Lost: The Uncertain Future of Research Tool Patents, 15 INTELL. PROP. & TECH. L.J. 1 (2003).
    • Richard Epstein and Bruce Kuhlik, Is There a Biomedical Anticommons?, Regulation, Summer 2004.

    • Shashank Upadhye, Understanding Patent Infringement Under 35 U.S.C. 271(e): The Collisions Between Patent, Medical Device, and Drug Laws, 17(1) Santa Clara Comp. & High Tech. L.J. 1, 23 2000)(available at http://www.lordbissell.com/Newsstand/UPIUSUpadhye-1999.pdf).

    Phillips v. AWH: Transcript of Oral Arguments

    Patent, Patent Cases 2005, ,

    The IP Law Bulletin provides great coverage of intellectual property issues and how those issues relate to the business world and the legal profession. (Unfortunately there is a subscription fee).

    In today’s copy, they have a great summary article on Phillips v. AWH case and provide a transcript of the oral arguments.  Luckily, I have a transcript too:

    • Download a copy of the Phillips v. AWH transcript [Phillips AWH Transcript.pdf].  I believe that this transcript originally came from Brad Wright at Banner who was at the hearing.

    My Highlights from the transcript:

    Dyk: If the claims are broader than the specification, doesn’t that create a problem?

    Manthie [counsel for Phillips]: No, the specification is written to satisfy the written description, enablement, and best mode requirements, not to define the scope of the claims.

    Bryson: So the specification can be limiting if there is a clear definition, but what about an implicit narrowing, as in Vitronics? Can the specification limit by implication?

    A: No, that’s where the problem arises. Different people have different interpretations of the specification. Its like the famous Supreme Court case you know pornography when you see it. The devil is in the details of implicit . Judge Krieger said that baffle required both an angle limitat ion and an interlocking limitation. The prior panel decision in this case said that only the angle was required by the specification. Judge Dyk in dissent said the specification required neither limitation. There are just too many possibilities. Nothing in the claim mentions the function of deflecting bullets.

    Clevenger: But we are looking at the process what is your posit ion on implicit narrowing based on the specificat ion? Should we require an explicit narrowing in order to narrow a claim term?

    Fischer [Counsel for AWH]: Implicit narrowing is proper.

    Clevenger: How can we tell if something has been implicitly narrowed?

    A: If an element is described as essential to the invention, and there are no other examples given, then it is implicitly narrowed.

    Clevenger: Should we rely on the purposes of the invention? Must it be unequivocally expressed? What if it s a multi-purpose patent?

    A: [none]

    Clevenger: Is it OK to rely on a dictionary? Is it error to use a regular dictionary if it s a technical term?

    Whealan [U.S. government]: If you are dealing with sequencing, that word means something different in electronics and biotech.

    Clevenger: Should we overrule our prior cases?

    A: It should be clarified that the starting point is not the dictionary.

    Dyk: The Supreme Court in statutory construction says to start with the dictionary?

    A: But the dictionary doesn’t reflect one skilled in the art . The place to start is the specification.

    Dyk: What if there is nothing explicit in the specification?

    A: Yes, it’s OK to rely on implicit definit ions or meanings from the specification. The Novartis case not all terms were expressly defined. The next point is when does the specification narrow a claim term? Look at the Bard and Astrazeneca cases. A detailed analysis of the specification and prosecution history. In Brookhill, the same analysis was applied remote was not limited by the specification or prosecution history. So broader is fair. The Brookhill and Bard cases are instructive.

    =======

    As noted by a trusted court observer, the “transcript does not capture the visual image that trumps everything else!” A major highlight of the argument was the change in facial expression of many panel members when they heard appellant’s counsel (Manthie) point to chapter, line and verse of the patent document on his easel to support an alternate embodiment. It appeared that those panel members may have been pursuaded that the term ‘baffle’ should not have been limited, even when using the specification as guide. Bill Heinze connects the dots: “Could a clearly erroneous factual determination ultimately decide the whole case?
    Could a clearly erroneous factual determination ultimately decide the whole case?”

    Phillips v. AWH: Review of Oral Arguments on Claim Construction Methodology

    Patent, Patent Cases 2005,

    baffle

    Today, the Federal Circuit held oral arguments in Phillips v. AWH. Over 250 people attended the arguments and over 30 briefs were filed in the appeal. It was expected that this case would weigh in heavily on policy issues concerning claim construction.  Surprisingly, however, the court did not ask any questions regarding the use of prosecution history, prior art, or expert testimony for claim construction.  Likewise, there was very little discussion of the use of competing dictionaries, such as the use of technical dictionaries versus general dictionaries.

    However, the court did delve into the dictionary/specification dichotomy.  A major concern that the court had was in the are of express versus implied limitations in the specification.  Specifically, should claims be limited by a contextually implied definition of a term? Although not briefed by the parties, Judges Rader and Mayer were interested pursuing the idea of giving deference to district court decisions on claim construction.

    In my point of view, this case is not about whether or not a dictionary is used prior to the specification.  What matters here is giving a framework to district court judges so that their opinions will not be overruled so often.  Others have made the argument, however, that even with a clear decision framework, the Federal Circuit will continue to reverse because the CAFC judges see themselves as often being in a better position to determine claim language — reasons: (i) the CAFC handles technology issues all the time and they are not going to close their eyes to areas of technology that they see everyday and (ii) the CAFC focuses on patent law, and thus should have less deference.  Interestingly, although none of the briefs suggested it, the PTO’s solicitor John Whealan was asked about his position that patent examiners do not rely on dictionaries.

    My Predicted Outcome: (but don’t rely on it). 

    • The new rule will be: Even when the specification does not explicitly define a term, the court should interpret claims in the context of the specification and rely on dictionaries and other sources when the district court judge needs more clarity. Thus, dictionaries will receive a lower emphasis.
    • The CAFC is going to do the best it can to provide a framework for district court decisions, but I’m not convinced they will find a solution without broaching the issue of deference.
    • Even though everyone wants some deference given to lower courts on claim construction, this issue will not be decided in this opinion.

    Claim construction is at issue in almost every patent infringement lawsuit.  This case will likely change the structure of arguments over claim construction at the district court.

    Notes:

    Olympia Group v. Alltrade: Preliminary Injunction Denied — Plaintiff did not show likelihood of infringement

    Patent, Patent Cases 2005

    Gorilla Bar

    Olympia v. Alltrade (Fed. Cir. 2005).

    Olympia makes the Gorilla Bar, an embodiment of their patented pry-bar invention.  Alltrade makes the Cobra Bar, "a slightly curved pry-bar with an hourglass-shaped shank.

    Olympia sued for infringement and requested a preliminary injunction (PI).  However, the California district court denied the PI because "Olympia had not shown a substantial likelihood that the Cobra Bar infringed . . . because Alltrade’s Cobra Bar did not have an elliptical cross section or a linear shank" as required by the claim language.

    On appeal, Olympia asked the Federal Circuit to overturn the PI denial based on improper claim construction by the district court.

    In its decision, the appellate panel first noted that before determining if there is a likelihood of infringement, a district court "must first construe the meaning of the relevant claims."

    Although the appellate panel found errors in the district court’s construction, based on the district court’s proper analysis with respect one claim element, Olympia did not meet its burden of showing a likelihood of success on the merits of the infringement claim.

    The decision of the district court is therefore affirmed, and Alltrade may legally continue to sell the Cobra Bar.

    Comment:

    It is difficult to get an appellate court to overturn a denial of a preliminary injunction on appeal.  "[W]hen a preliminary injunction is denied, the movant carries a heavier burden to obtain a reversal." New England Braiding Co. v. A.W. Chesterton Co., 970 F.2d 878, 882 (Fed. Cir. 1992).  The Federal Circuit’s standard of review for a denial of a PI is as follows:

    This court reviews a denial of a preliminary injunction by the district court for abuse of discretion, which can be established by showing the district court decision is based on clearly erroneous factual findings, an error of law, or a clear error of judgment in weighing the relevant factors.

    Links:

    The Dissent in Merck v. Teva: Patentees Need Direction in How to Define Their Terms

    Patent, Patent Cases 2005

    Merck v. Teva (Fed. Cir. 2005) The Dissent

    When there is a dissent, I read it first.  Dissents get to the point quickly and rarely mince words.  They are often fun to read and relatively short.  Judge RADER’s dissent in Merck v. Teva fits these attributes quite well. Rader made two specific points: (i) that the majority erred in its analysis of the lexicographer doctrine and (ii) that the majority should have given some deference to the lower court’s decision.

    (i) Can a Patentee Be His Own Lexicographer Anymore?

    Rader disagreed sharply with the majority’s finding that the word "about" had not been defined in the specification.  In the specification, the patentee noted that nomenclature in the area was unclear and outlined an example meaning of "about 70 mg of [the drug.]":

    Because of the mixed nomenclature currently in use by those o[f] ordinary skill in the art, reference to a specific weight or percentage of a bisphosphonate compound in the present invention is on an acid active weight basis, unless otherwise indicated herein. For example, the phrase "about 70 mg of a bone resorption inhibiting bisphosphonate selected from the group consisting of alendronate, pharmaceutically acceptable salts thereof, and mixtures thereof, on an alendronic acid active weight basis" means that the amount of the bisphosphonate compound selected is calculated based on 70 mg of alendronic acid.

    According to RADER, this passage is a classic example of the patentee’s attempt to invoke the lexicographer doctrine.  Specifically, the patentee defined the phrase by stating that "the phrase ‘about 70 mg of [the drug]’ means …"  And, to underscore the definition, the patentee gave a reason for calling out the definition, "mixed nomenclature currently in use."

    Therefore, even a casual reader, let alone one with skill in this art, would immediately recognize that the patentee intended to avoid any ambiguity inherent in "mixed nomenclature" by explicitly defining the entire phrase.

    (ii) Deference – Truth in Advertising

    According to Judge Rader, the court "often hears criticism from district court judges that its reversal rate on claim construction issues far exceeds that of other circuit courts. . . . In response, nearly every judge on this court has publicly professed to accord some level of deference to district courts regardless of this court’s de novo."

    In Rader’s view, after this case profession of deference is "rather hollow."

    This is the classic "close case," so close in fact that ultimately two federal judges and the USPTO agreed with Merck, and two federal judges agreed with Teva Pharmaceuticals. The District Court tried this case from March 4 – 7, 2003, then issued a 75-page opinion analyzing the claims and arguments in consummate and accurate detail. This [appellate] court received the typical briefs from the parties, an appendix containing selected portions of the record, and heard a total of approximately thirty minutes of argument by the parties on the issues before this court. Despite the district court’s superior tools and time to evaluate the complete record, to hear and inquire from expert and fact witnesses, to delve into countless related details, to probe the scientific and semantic context, and to entertain argument as long as necessary for clarity, this court with its reading three briefs before its half-hour hearing becomes enamored with its own analysis of a very close issue and reverses the district court.

    Response:

    Professor Polk Wagner, for one, believes that "Rader is absolutely dead wrong on this argument." 

    The majority does exactly what it should do: any fair reading of the specification does not clearly convey to a PHOSITA an intent to use the term "about 70mg" to mean "exactly 70mg" [as found by the district court]; at best, the language is unclear and ambiguous.

    Further, Rader’s suggestion that this case means that patentees shouldn’t use the lexicographer option is specious: the message of this case is that the court isn’t going to infer a definitional statement where one doesn’t exist, and — more importantly — that attorneys can’t dress up the tired old arguments about how the specification limits the claims by inference in the guise of lexicography.  Rader’s approach would take us exactly the wrong direction: towards patent
    claims that have no meaning whatsoever until several years of litigation proceed, and no finality until a Federal Circuit panel divines a so-called ‘contextual’ meaning that varies according to the idiosyncratic senses of the judges involved.

    Kudos to Gajarsa for getting this one right.  Let’s hope the majority in Phillips similarly holds back the tides of hysteria over clarifying the rules.

    Dennis Crouch’s January 2005 Report on New Academic Research

    Articles and Publications, Patent, , ,

    Each month I post a note discussing the academic side of patent law.  My on-line sources for material are the SSRN electronic library, a few hard copy journals, and several more that are freely available on-line.  Most of my material, however, comes from articles directly e-mailed to me from professors and law review editors.  Please feel free to e-mail articles for February’s edition. (Include information on where the article is being published). — DDC

    1) In a forthcoming paper, Professor Joseph Miller provides a new solution for making claim construction more predictable.  His idea is to require that patentees provide certain additional disclosures up-front — Disclosures that will appear in express statements on the face of the patent itself. 

    Four additional patentee disclosures: (a) the field of art to which the claimed invention pertains; (b) all problems that the claimed invention helps solve; (c) a lexicon of all claim terms to which the applicant gives a meaning other than its accustomed meaning to people having ordinary skill in the pertinent art; and (d) a list of preferred objective reference sources, such as technical treatises and dictionaries (general or specialized), to which an interested reader should refer to learn about the ordinary meaning of the remaining claim terms to a person having ordinary skill in the art. [SSRN Link]

    According to Miller’s approach, in any subsequent claim construction process, whether for licensing, design-around, or litigation purposes, parties would have the benefit of patents enriched with this new information.  The paper will come out in March in the Lewis & Clark Law Review.

    2) I just found out that an old college friend is quickly becoming a leader in the area of Patent-Antitrust law.  In the recent Issue of the Richmond Journal of Law & Technology, Aaron Rabinowitz writes on Antitrust Liability for Refusals to Deal in Patented Goods. The article highlights the circuit split between the Ninth Circuit and the Federal Circuit over whether patent holders must have a business reason for refusing to sell or license patented products.  In Kodak II, 125 F.3d 1195 (9th. Cir. 1997), the California based appeals court determined "that a patentee who refuses to license his patented invention to others without legitimate business justifications for doing so has violated antitrust law."  However, CSU v. Xerox, 203 F.3d 1322 (Fed. Cir. 2000), the Federal Circuit held that a patentee may refuse to license or sell a patented invention without violation of the patent laws, regardless of his business justification.

    3) Bill Burgess, a 3L at Penn has written an interesting comment on the "Failed Promise of Cybor" published in the UPenn Law Review.  In Cybor, the Federal Circuit held that claim construction is a matter of law that is reviewed de novo by the Appellate Court.  Bill makes the arguments that (i) the ‘bright-line rule’ of Cybor has resulted in less rather than more consistency in how claims are construed and (ii) Cybor is actually inconsistent with the Supreme Court’s Markman decision.

    Fosamax case: Patentees should elect the lexicographer option at their own risk

    Patent, Patent Cases 2005,

    Bone Resorption

    Merck v. Teva (Fed. Cir. 2005)(Fosamax case). 

    Merck has FDA approval to market a once-weekly dose of alendronate monosodium trihydrate, which it does under the trade name Fosamax.  In 2000, TEVA amended an existing ANDA, and sought FDA approval to market a generic version of Fosamax.  Merck sued, alleging infringement of Merck’s patented "Method for Inhibiting Bone Resorption."

    After construing the claims, the district court found the patent valid (not invalid) and delayed the effective date of the FDA approval of Teva’s ANDA until the patent expires.

    Teva appealed the court’s claim construction and non-obviousness findings.  On appeal, the Federal Circuit Reversed. 

    Claim Construction:

    In a Markman proceeding, the district court determined that the claim term ‘about’ had been specifically defined by the patentee — and thus given a special meaning.  The Federal Circuit disagreed, finding that ‘about’ had not been clearly redefined in the specification.

    Because the patentee did not clearly redefine "about" in the specification, and because the district court construed the claim term in a manner inconsistent with the specification, we reverse the district court’s claim construction. We thus hold that the term "about" should be given its ordinary and accepted meaning of "approximately."

    Validity:

    Next, the appeals court vacated the district court’s determination that the invention was not obvious.  The court went on to specifically find claims 23 and 37 invalid as obvious and not infringed.

    A. Graham Factors

    Amongst the several errors explained by the appellate court, an interesting error came from the district court’s weighing of secondary considerations of non-obviousness.

    Although the district court correctly found Merck’s once-weekly dosing of Fosamax was commercially successful, in this context that fact has minimal probative value on the issue of obviousness. . . . Financial success is not significantly probative of that question in this case because others were legally barred from commercially testing the [] ideas.

    According to the CAFC panel, commercial success is not probative on obviousness if others are barred from commercially testing the patented ideas.  Couldn’t this same theory be applied in other non-drug cases?

    B. Weight Given To Prior Art

    In its decision, the district court discounted one piece of prior art that had been published in the Lunar News because the article was not published in a peer-reviewed journal or authored by one skilled in the art.  The federal circuit diagreed again —

    The Lunar News Article had clearly suggested the once-weekly dosing . . . to avoid or minimize problems related to dosing frequency. And as shown above, the district court itself found this particular set of problems were of greatest concern in the art. Indeed, to the extent the district court finds Merck’s weekly-dosing idea non-obvious because it went against prevailing wisdom, the court must still explain why Merck and not Dr. Mazess should get credit for the idea. Because Merck’s idea added nothing to what came before, the district court’s answer comes down to nothing more than the credentials of the authors. In this case that difference is not enough to avoid invalidating the claims.

    The district court’s judgment of infringement was therefore REVERSED.

    DISSENT:

    In a scathing dissent, Judge Rader made several conclusions based on the majority opinion, including:

    • Patentees should elect the lexicographer option at their own risk — it is paid only lip-service by the court.

    • In this case, this court eschews all deference, a particularly striking choice in the face of a very close case and a district court whose diligent and intelligent process and resolution earned more respect than it received. . . . [T]his case . . . certainly makes any protestations of deference in fact sound rather hollow.

    This dissent is likely indicative of the approach Rader will take in the Phillips v. AWH rehearing.

    Battle over Pet Food: Mars wins at district court

    Patent, Patent Cases 2005

    Mars filed a patent infringement suit against Del Monte, alleging infringement on its patented pet food. (U.S. Patent 6,312,746)(A dual texture animal food product with a soft inner component surrounded by a harder, more rigid shell). After a Markman hearing, the district court issued summary judgment of noninfringement to Del Monte.  On appeal, the Federal Circuit reversed.  In the Mars appellate decision, the appellate court modified the claim construction and remanded.

    Now, based on the new claim construction, the California district court has decided the case in favor of Mars.  The trial moves to a damages phase next month.  According to Teresa F. Lindeman at the Pittsburgh Post-Gazette,

    A jury trial has been ordered next month to determine whether Mars will get $2.3 million in compensatory damages, plus additional damages for willful infringement and a permanent injunction to stop Del Monte from making the so-called dual-textured products.

    Mars’s affected products include Pounce Purr-fections and Meaty Bones Savory Bites.  An appeal is expected.

    Phillips v. AWH: Patent Examiners Do Rely on Dictionaries

    Articles and Publications, Patent, ,

    An e-mail from a UK patent examiner prompted me to reconsider the U.S. Government’s brief in the Phillips v. AWH rehearing.

    For those who have not followed this case, the Federal Circuit has decided to rehear the Phillips v. AWH in order to determine the proper method of construing claim language of a patent.  The two major theories of claim interpretation involve (i) the use of dictionaries and (ii) the use of the patent documents filed by the inventor.

    The government brief argues that dictionaries should not be a primary reference for claim construction, in part because dictionaries are not used by examiners during prosecution.  This assertion by the government certainly overstates the facts.  When an examiner starts at the PTO, they are given a copy of Webster’s.  Examiners also regularly use www.Dictionary.com to find various definitions for terms.  While it is true that the Examiner rarely explicitly relies on a dictionary in an office action, the definition of terms is always in the background.  For instance, examiners often use the dictionary to examine the clarity of the claims and as a way to asses the scope of terms used in the application.

    Although this discrepancy was not raised in any of the briefs, it may come up in oral arguments slated for Tuesday, February 8, 2004. 

    UPDATE I: L&C Law Professor Joseph Miller, in his recent article on the role of dictionaries, has noted that ‘[w]e know anecdotally that examiners sometimes cite and quote dictionary definitions in their interactions with patent applicants.’  Manuscript page 50.  Miller and his co-author James Hilsenteger cite Cordis v. Medtronics, 339 F.3d 1352, 1359 (Fed. Cir. 2003), as a case where the examiner used the definition of the claim word ‘slots’ from Webster’s Ninth New Collegiate Dictionary to help explain to the applicant how a prior art reference showed the claimed structure. 

    UPDATE II: I received a comment from a former USPTO primary examiner who made several points:

    • The example cited in Professor Miller’s article of an examiner citing a dictionary definition in an office action is the exception rather than the rule. 
    • The Office did not emphasize the use of dictionaries to assign meaning during training. (although dictionaries may have been mentioned in training sessions as ‘available sources for determining the meaning of a claim term’)
    • Rather, examiners are primarily taught to give each claim term its "broadest reasonable meaning." 
    • "The examination process is so fast-paced that I believe examiners do not use any formal methodology when construing claims. Instead, an examiner relies more on intuition, on what a word or phrase means to him or her.  If a word is foreign to an examiner, he or she would likely consult a dictionary, but only to get a "feel" for the word. 

    Field Reporter Needed: I am not going to be able to attend the Phillips v. AWH rehearing, but I would like to post an article on the oral arguments written by an attending patent attorney.  Let me know if you would like to write a brief article (<750 words) on the topic for the Patently-O Blog. (We operate on same-day service, so you would need to write it within a couple of hours after hearing the arguments).  You’ll get some good publicity — we have a fairly wide circulation with over 10,000 hits each week from people working in the patent field. (crouch@mbhb.com).  Also, I would like to post an .mp3 file of the oral arguments if anyone would be willing to get the set of tapes from the clerk and convert them.

    How to Jump-Start your Business Method Cases: Part II

    Patent, Patent Prosecution,

    We are discussing the unusually long pendency of financial services business method patent applications (Class 705).  There are many cases where applications have been on file at the PTO for 4+ years without receiving any substantive response from the Office. 

    A little more digging found the PTO’s statistics on issuances from class 705:

    Class 705 1995 1996 1997 1998 1999 2000 2001 2002 2003
    Applications Filed 330 584 927 1340 2821 7800 8700 6782 6000
    Patents Issued 126 144 206 420 585 899 433 493 495

    This table is a bit misleading because of the problem of long pendency.  For example, very few, if any, of the almost five hundred patents that issued in 2002 were among the 6,782 that were filed that year. However, the table does illustrate the point that very few financial services patents are making it through to issuance.

    John Love is director of TC 1600, the center that handles class 705 patent applications.  A couple of years ago, John, along with Wynn Coggins, produced a white-paper outlining their view on "Successfully Preparing and Prosecuting a Business Method Patent Application."  The paper is a nice read and has some useful tips for avoiding unnecessary delays in prosecution.  Some highlights:

    1. If you are concerned about a lengthy pendency (we are), consider filing a Petition to Make Special under 37 CFR 1.102. (more on this later)
    2. Include a clear description of the invention.
    3. Identify any practical application of the invention.
    4. Do a search and discuss the best known prior art that is related to the invention.
    5. Ask a colleague to review the claims without reading the specification.
    6. Use "Jepson-type" claim construction. I.e., "the improvement comprising . . . "
    7. Do not hesitate to call the Technology Center Director if your questions or problems are not being resolved.

    Be careful with some of John’s suggestions.  Jepson-type claims and full discussion of the prior art both come with potential risks.  A mischaractarization of the prior art, for instance, may run the risk of invalidating the patent.  However, other suggestions are great! Of course, write clearly and fully describe the invention. 

    For today, I would add three more practices that help to reduce pendency:

    Do not be the cause of delay: Often, delay at the patent office is due to something that the applicant failed to do.  In reviewing file histories, there were many cases where the applicant did not pay the filing fee, did not file a proper declaration, or did not promptly respond to a request from the Office. 

    In class 705, you will not receive an office action on the merits when you have outstanding problems or missing parts.  Once you get those parts in, your application will likely return to the tail end of the queue.  Make it your practice to file complete applications when you file business method patent applications.

    Provisional Applications May be A Waste of Time: Your application doesn’t even get to the end of the line until you file a utility application. 

    Business Method Patents are Easy to Write but Hard to Prosecute: The technology is usually easy to understand but it is often difficult to get around prior art references.  And, it takes time and diligence to pursue these claims.  Bottom line — prosecution of these types of applications will be more expensive than the preparation. Have a loose enough budget to allow your attorneys to call the patent office to chat up the examiner or TC director.

    Links:

    palmOne Comes Out on Top in NCR’s Patent Infringement Appeal

    Patent, Patent Cases 2005

    Screenshot026

    NCR v. Palm and Handspring (now collectively known as "palmOne") (Fed. Cir. 2005).

    by Marcus Thymian

    In an unpublished decision, the Federal Circuit affirmed the Delaware District Court’s claim construction, essentially putting to rest NCR’s patent infringement suit against palmOne for its popular Palm and Handspring handheld devices.  NCR’s Patent Nos. 4,634,845 and 4,689,478 are directed to a handheld device and system employing such a device.  The claims generally call for a handheld device having discrete display elements overlapped with discrete switches, along with control means and circuitry for interfacing with another device.

    The Federal Circuit focused on the "plurality of discrete switches" and the closely related "means for entering data" elements.  In an attempt to read on palmOne’s resistive touchscreen technology, NCR argued that the "plurality of discrete switches" should be construed as "more than one individually distinct programmed device for indicating that one of alternative states or conditions have been chosen."  The Federal Circuit rejected this "programmed device" definition, and instead adopted the district court’s "physical switch" definition:  "two or more distinct and separate manual or mechanically actuated devices for making, breaking, or changing the connections in an electric circuit."  It based its decision on the claim language (which contradicted NCR’s assertion that software integrated into the plurality of switches, rather than the "control means," handled variable user instructions), and the patent specifications, which showed an array of switches made of "a few plastic-film layers and strips of conductive material."  Similarly, the Federal Circuit agreed that the "means for entering data," a means-plus-function element under 35 U.S.C. § 112 ¶ 6, was limited to the physical switches set forth in the patent specifications.

    Marcus Thymian is a partner at McDonnell Boehnen Hulbert & Berghoff LLP in Chicago.  Mr. Thymian is experienced in planning, creating, enforcing, and defending against patent portfolios, and was part of the team from McDonnell Boehnen Hulbert & Berghoff that represented Palm (now palmOne) before the Delaware District Court and on appeal.  [Marcus Thymian’s Bio]

    LINKS:

    • [Link] Ina Fried has a CNET report on the case;
    • [Link] 2003 CNET Report on the district court case won by Palm.

    Claim Construction Showdown set for February 8, 2005.

    Patent,

    [Link] The en banc rehearing of Phillips v. AWH is scheduled for Tuesday, February 8, 2005 at 10:00 a.m. in Washington DC.  It is expected that the outcome of this case will help define the mechanics and legal basis for patent claim construction.

    [Link] More information on the case, and a review of the briefs filed can be found here.  I reviewed the major arguments common to the various briefs in the December 2004/January 2005 edition of PatentWORLD magazine (Issue 168).