February 2005

Supreme Court to Hear Patent Case on Federal Circuit’s Power to Overturn a Jury’s Verdict

Unitherm Food Systems, Inc., Petitioner  v. Swift Eckrich, Inc., dba Conagra Refrigerated Foods, et al. (Supreme Court 2005).

The Supreme Court has decided to hear an appeal in Unitherm Food v. Swift-Eckrich that was petitioned from the Federal Circuit. The question to be heard will help outline powers of the CAFC.  Specifically, the petition for a writ of certiorari is granted limited to the following question:

Whether, and to what extent, a court of appeals may review the sufficiency of evidence supporting a civil jury verdict where the party requesting review made a motion for judgment as a matter of law under Rule 50(a) of the Federal Rules of Civil Procedure before submission of the case to the jury, but neither renewed that motion under Rule 50(b) after the jury’s verdict, nor moved for a new trial under Rule 59?

In this case, a jury determined that ConAgra’a pre-litigation activities constituted tortious interference and created antitrust violations. On appeal at the Federal Circuit (GAJARSA) affirmed all appealed actions except for the antitrust holdings.

Because the district court erred, however, in allowing the jury to decide Unitherm’s antitrust claims despite the total absence of economic evidence capable of sustaining those claims, we vacate the judgment finding ConAgra liable for violating § 2 of the Sherman Act. We also vacate all damages awarded consequent to antitrust liability. We remand the matter to the district court for further proceedings consistent with this opinion.

Prior to litigation, ConAgra had written to several companies who sell equipment for preparing and browning pre-cooked meats. ConAgra attached a copy of the ‘027 Patent to that letter, which included the explicit warning:

“Others in the industry may approach your company regarding this patent, and we would appreciate it if you would inform them that we intend to aggressively protect all of our rights under this patent.”

The patent (No. 5,952,027) involves a method for “browning precooked, whole muscle meat products” and involves coating a liquid pyrolysis product onto the surface of a precooked meat product.

Eight is Enough: Eight important patent cases for Spring 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

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:

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).

How does your company stack-up in the patent-per-employee efficiency rating?

A new patent blog, Patent Chronicles, has an interesting back-of-the-envelope calculation of patent efficiency. Looking at shear numbers, IBM receives the most patents each year.  But, IBM also employs over three hundred thousand people. 

Here are some sample patenting rates on a per-employee basis for the software/computer industry:

Company       

Employees per patent (annually)

Sun Microsystems

56

Microsoft

82

IBM

98

Oracle

420

SAP

3361

Thus, at IBM, it takes almost 100 employees a full year to get a patent, while Sun only needs 56 employees to get the patent.  Of course, this says nothing about the quality of the patents/inventions.

USPTO: Still No Patent on Life Containing Human Cells

Stuart Newman was in the news last week.  Newman, a professor of biology at the New York Medical College, filed several patent applications on chimeric embryos and animals containing human cells. For instance, in the most recent application, Newman claimed the following:

Claim 1. A chimeric embryo comprising cells from a first and a second animal species, wherein said first animal species is human, wherein said second animal species is non-human, and wherein said second animal species is non-primate.

It turns out that Newman & his partner Jeremy Rifkin had no intention of actually comercializing the human-animal chimera.  Rather, they hope to highlight the issue in the public eye and to set a legal precedent.

In the most recent office action [pdf], they received (among others) a rejection under 35 U.S.C. Section 101 as non-statutory subject matter, and claimed victory.  The OA points out that, although 101 does not explicitly restrict the patentability of humans, the PTO believes that its policy of denying such patents is supported by the statute.

Applicant argues that the statute does not restrict patentability based on whether the claims cover a human being, and that the Director lacks authority to impose a limitation on patenting a human. . . . the Office does not agree that humans are patentable subject matter. (See the earlier office action [pdf] for a more detailed analysis of the statutory authority.)

In its analysis, the Patent Office tries to distinguish Diamond v. Chakrobarty (1980) by differentiating between 'man' and 'those inventions and discoveries that could be made by man.'  It appears that they argue man cannot make man

Newman & Rifkin have decided not to appeal.  And thus, it appears that Russ Krajec's blog title 'anything under the sun made by man' is safe for now. 

Of course, these guys have not created any legal precedent with this case.  As noted by Examiner D. Crouch (No relation to me), "patentability is determined on the totality of the record on a case-by-case basis.  Whether similar claims in other applications may have been treated differently is neither controlling nor dispositive on how they are to be treated in any other application."

Patent Owner Held Liable For Attorney Fees In Case Brought By Licensee

Evident v. Church & Dwight (Fed. Cir. 2005)

Evident sued Church & Dwight for infringement of its licensed technology covering toothpaste. The patent owner, Peroxydent, was joined to the lawsuit early-on through a counterclaim by Church & Dwight.  After a bench trial, the district court found that the inventors had withheld material references from the PTO with intent to deceive.  As a result, the patent was unenforceable due to inequitable conduct.  This holding was affirmed without opinion. Evident Corp. v. Church & Dwight Co., Inc., 78 Fed. Appx. 113 (Fed. Cir. Oct. 9, 2003). The district court also determined that the case was exceptional and awarded almost $1.3 million to Church & Dwight for attorney fees and expenses.  Evident & Peroxydent were found jointly liable for the fees — these fees are the subject of the appeal.

On appeal, Peroxydent and Evident argue that Evident had no standing to sue in the first place, and thus, that the court did not have jurisdiction to find attorney fees.

In effect, Evident and Peroxydent, being on the losing side of both their own patent infringement claim and an opposing claim for attorney fees, now appear to seek escape from the judgment by arguing that Evident lacked standing in the first place and that the original lawsuit was improperly filed.

The court found that the defendants’ counterclaim that brought Peroxydent into the suit eliminated any standing problem.

Nonetheless, regardless whether Peroxydent was brought into the suit by the accused or the licensee, there is no standing problem. . . . Accordingly, we conclude that Peroxydent’s presence in the litigation as a third-party defendant fully satisfied any standing requirements.

Affirmed

Filing Counterclaim Does Not Waive Objections to Personal Jurisdiction

Patentlyo028

Rates Technology v. Nortel Networks (Fed. Cir. 2005).

by Bradley Crawford

The defendant, Nortel, was sued for patent infringement but raised the affirmative defense of lack of personal jurisdiction. Later, the defendant filed a permissive counterclaim. The plaintiff subsequently asserted that Nortel waived its lack of personal jurisdiction defense when it filed its permissive counterclaim. The district court disagreed. It ruled that the defendant’s filing a permissive counterclaim did not waive the lack of personal jurisdiction defense. It also ruled that it lacked personal jurisdiction over the defendant and dismissed the case.

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Department of Health & Human Services Requests Reexamination of Patent

U.S. Patent No. 6,653,104 covers an anti-cancer antibody and is owned by the pharmaceutical company Immunomedics.  In a seemingly unprecedented move, the U.S. Government Department of Health & Human Services (HHS) has requested an inter-partes reexamination of the issued patent. 

Does Immunomedics have any case for arguing that the reexamination request should be denied and that the U.S. Government can only obtain reexamination through a Director Ordered Reexam?

Link:

The Practical Nature of Software Patents

Many object to U.S. patent laws that allow patenting of software.  Critics argue that software patent stifle innovation and that the open source model is a better approach.  However, Martin Fink, Vice President of HP was quoted in Today’s NYTimes with words that will resonate with entrepreneurs who are hoping to make money from their software:

It’s fine to object to software patents, but it’s foolhardy not to try to acquire them.

Fink is an open source advocate, but also a realist.

An End To Revival of Unintentionally Abandoned Applications?

In the recent case of Field Hybrids, A Minnesota District Court chided the Patent Office for allowing the patentee to revive its abandoned patent application.  The Appeals Court found that the patentee had failed to prove to the PTO that the application was unintentionally abandoned.

Now, a Patently-O reader questions the statutory authority allowing revival of unintentionally abandoned applications that were abandoned for failure to reply to an office action.

The Rules (CFR) provide for revival of missed reply dates, the Law (USC) does not:
37 CFR 1.137 provides for reviving patent applications that were abandoned either (a) unavoidably or (b) unintentionally.  This rule is based on 35 USC 133.  However, Section 133 only provides for revival of applications determined by the Director to be unavoidable.  Section 133 does not discuss unintentionally abandoned applications.
Thus, the statute does not authorize revival of applications that were abandoned unintentionally
UPDATE:
As noted by another reader, the Statute does provide some support for revival of unintentionally abandoned applications.  Specifically, under 35 U.S.C. 111, an application abandoned for failure to submit a fee and oath may be revived if the omission is deemed unintentional.

Upcoming Conferences

There are a few March ’05 conferences here in Chicago that look promising.

1) FTC’s town-hall meeting on patent reform will be held in Chicago on March 4, 2005.  Kenneth Dam, University of Chicago Professor and formerly of the Deputy Secretary of Treasury will be a keynote speaker.  USPTO Director Jon Dudas will be speaking as well. [Brochure] [Online Registration].

2) The Japan-America Society of Chicago is presenting a discussion of the recent Blue LED patent litigation and the meaning of ‘reasonable compensation’ for inventors in Japan.  Mr. Katsuyuki Akutagawa Senior IP Manager at Nichia Corporation and Yasuharu Nagashima founder of Nagashima, Ohno & Tsunematsu will be speaking.  Everyone is welcome, but there is a $50 fee for non-members ($25 for students). March 4, 2005 — 2-4 pm at the Gleacher Center.  Pre-Registration is preferred.

3) The ABA’s TECHSHOW will be held in Chicago on March 31-April 2.  Sessions include: How to Jump Start Your Practice; Meet the Bloggers; and Using Technology to Avoid Malpractice. [Registration] [More info here, here, here, here, and here].

Shoot me an e-mail if you would like to meet-up during these events.

Reebok Wins in Patent Case

Gyory v. Reebok (Fed. Cir. 2005) (UNPUBLISHED).

Gyory filed suit against Reebok for infringement damages on a patent that had expired in 1996.  The district court dismissed for failure to state a claim.  The Federal Circuit Affirmed: 

Because "no recovery shall be had for any infringement committed more than six years prior to the filing of the complaint," 35 U.S.C. § 286, and because an act must be performed "during the term of the patent" to constitute an act of infringement, 35 U.S.C. § 271(a), Györy cannot recover and his complaint was properly dismissed for failure to state a claim.

In what appears to be a generous gesture, the court declined to award attorneys fees to Reebok.

Notes:

  • Seasoned IP litigator Phil Mann, gives us his well reasoned take on the issue: "Mr. Gyory got very lucky on this one."

Federal Circuit Expands Experimental Exception

Rack and Pinion Steering System

Lisle Corp. v. A.J. Mfg. (Fed. Cir. 2005)

Lisle owns the patent on a tie-rod tool for servicing a rack and pinion steering system.  Lisle sued A.J. for infringement.  Lisle won infringement on summary judgment and validity (no prior public use) in a jury verdict.  A.J. appealed.

On the public use issue:

  • May 1989: Lisle had developed an early prototype of its device that would certainly be infringing;
  • Dec 1989: Lisle delivered the prototype (freely) to repair shops in Omaha without a formal confidentiality agreement;
  • June 1992: (30 months later) Lisle filed for a patent application.

Despite the fact that Lisle delivered the prototype well over a year prior to filing the application, the Federal Circuit upheld the jury’s findings that the repair shops use of the device was ‘experimental’ and thus did not create a patentability bar.

This will be an important case – read it.

Trademark Case: The fame of a mark is determined by the class of customers and potential customers rather than the entire consuming public

Palm Bay v. Veuve Clicquot Ponsardin (Fed. Cir. 2005)

By John Smith

Trademark applicant Palm Bay Imports appealed a decision sustaining an opposition (against its mark “Veuve Royale”) from the United States Trademark Trial and Appeal Board (TTAB).  Palm Bay maintained that there was no likelihood of confusion with opposer Veuve Clicquot Ponsardin Maison Fondee en 1772’s marks “Veuve Clicquot Ponsardin,” “Veuve Clicquot,” and “The Widow.”

The Federal Circuit indicated that the term common to the marks in question, “veuve,” is distinctive, and that the same distinctive term, (especially when it appears as the first word) in both parties’ marks enhances the likelihood of confusion. Likewise, when a term common to two or more separate marks is generic or non-distinctive, there is less likelihood of confusion.

The Court also stated that evidence available only to a trade, such as a guide for distributors, does not show the extent to which consumers encounter a mark in the marketplace. Rather, such evidence only shows that the consuming public could potentially be aware of another use of a mark term. In the same vein, the Court maintained that the question of fame related to the class of consumers or potential consumers of the product, as opposed to the entire consuming public.

The Court found that the Board had made conflicting findings with respect to the mark “The Widow;” the Board had found that many Americans speak French and therefore would translate “veuve” into “widow,” (under the doctrine of foreign equivalents) but later also found that most Americans would not translate “veuve” into “widow.”

The Court affirmed the Board’s finding of a likelihood of confusion with respect to the marks “Veuve Clicquot Ponsardin” and “Veuve Clicquot,” but reversed the Board’s finding of a likelihood of confusion with respect to the mark “The Widow.” The refusal to register Palm Bay’s “Veuve Royale” mark was affirmed.

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.

NOTES:

  • For more info on the case and some nice pictures, see John Welch’s TTABlog.

Consent Judgment Narrowly Interpreted: Successor-In-Interest Cannot Sue

TEVA(R) Sandal

Thatcher v. Khol’s Department Stores (Fed. Cir. 2005).

Thatcher sued Kohls and Associated Footware for infringement of Thatcher’s TEVA(R) sandals that were protected by a patent and by trade dress.  The case settled, and the defendants agreed to stop making & selling the infringing sandals.  Thatcher then sold his interest to Deckers Outdoor Corporation who sued Kohl’s again alleging that the department store had begun once again to sell copy-cat sandals.  However, the district court dismissed the case, finding that Deckers lacked standing to enforce the 1997 consent judgment because the consent judgment did not extend Thatcher’s rights to successors-in-interest. Citing United States v. Armour & Co., 402 U.S. 673 (1971). 

On appeal, the Federal Circuit applied the law of the regional circuit (7th circuit) to interpret the consent judgment.  "The Seventh Circuit views a consent decree or a consent judgment as a form of contract, and, as such, the rules of contract interpretation apply. . . . There is nothing expressly set out in the consent judgment between Thatcher and Kohl’s extending Thatcher’s rights to any third party, including any "successor-in-interest." This silence is the functional equivalent of the parties’ express intent to exclude language of assignment."

Judgment Affirmed.

Notes:

  • Judges: Michel, MAYER, & Linn
  • Cite: Mark Thatcher, et al. v. Kohl’s Department Stores, Inc., et al., 2005 WL 310875 (Fed. Cir. 2005).

Phillips v. AWH: Transcript of Oral Arguments

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.

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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?”