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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?”

    Federal Circuit Rejects Professor’s Attempt to Patent Cold Fusion Technique

    Patent, Patent Cases 2004,

    In re Dash and Keefe (Fed. Cir. 2004) (Unpublished).

    In 1990 professor John Dash filed a patent application for producing heat energy using nuclear fusion at a low temperature.  Experimental results suggesting that nuclear fusion occurred in their apparatus were submitted to the Patent Office in support of Dash’s attempts to overcome utility rejections mounted by the PTO. 

    Dash appealed the Board’s rejection of his application for lack of enablement and utility.

    On appeal, the CAFC relied on the "scientific community’s considerable doubt" regarding the utility of "cold fusion" in sustaining a prima facie case for lack of utility and enablement — even though the articles relied upon by the PTO were anectodal and not peer-reviewed.

    We are aware of no rule that forbids the examiner from relying on related technology, anecdotal information or sources that are not peer-reviewed to establish a case of inoperability. . . .

    The Examiner must only establish that a person of ordinary skill in the art would reasonably doubt the asserted utility.

    The court then rejected Dash’s Rebuttal Evidence:

    For each type of evidence Dash produced, the examiner found at least one sound reason to disbelieve the evidence.

    Rejection Affirmed.

    Comment: (i) All this comes in the wake of the DOE’s report that they are accepting quality research proposals on cold fusion. (ii) If this were a published opinion, it would be quite a precedent — giving some real teeth to the utility requirement. 

    Here is the conflict: Applicants use statements from experts saying "a certain result cannot be accomplished" to prove that the result is nonobvious.  Now, the court brings a double-edged sword — finding that those statements can now be used to show a lack of utility.

    DMCA weakened again: Court overturns Lexmark injunction

    Articles and Publications, Patent

    Link: Denise Howell has the scoop on the 6th Circuit’s reversal of the Lexmark DMCA injunction.

    “We should make clear that in the future companies . . . cannot use the DMCA in conjunction with copyright law to create monopolies of manufactured goods for themselves[.]”

    Read the opinion. Coverage by Jason Schultz of Copyfight.

    Background on the Case:

    Via EFF: Lexmark’s DMCA case against Static Control is aimed at eliminating aftermarket laser printer toner cartridges. Lexmark has implemented an “authentication” handshake between its printers and toner cartridges. When Static Controls reverse-engineered the authentication procedure in order to enable refilled and remanufactured cartridges to work with Lexmark printers, Lexmark sued in Lexington, KY, claiming both copyright infringement and circumvention in violation of the DMCA.

    Read the Federal Circuit’s rejection of the DMCA.

    California Appeals Court Upholds Genentech Verdict

    Patent, Patent Cases 2004, ,

    Genentech v. City of Hope

    City of Hope v. Genentech (Cal. App. 2004) (B161549). 

    Decision: A California state appellate court has upheld a $500 million verdict against Genentech for back payment of royalties on drug sales from a 1976 agreement with City of Hope National Medical Center.  The court found that Genentech breached a fiduciary duty to City of Hope.

    Genentech does not dispute that it failed to disclose various licenses and pay royalties on those licenses. Rather, it contends that it did not breach any fiduciary duty so long as it was adhering to an erroneous but legally tenable interpretation of the agreement. In essence, Genentech would have us hold that even if it followed an interpretation it knew was contrary to what the parties intended and agreed upon, it could not be held liable so long as that interpretation was objectively sustainable under the law. . . . None of [the cases cited by Genentech] allows a party to profit from a legally tenable contract interpretation when the party knows that the agreement has a wholly different meaning. In any event, it would be antithetical to the very nature of the obligations imposed on fiduciaries for us to hold that a fiduciary could act in the manner suggested by Genentech.

    To the extent Genentech contends that its interpretation of the agreement was held in good faith, that contention fails. The jury’s finding of fraud or malice demonstrates that it believed that Genentech acted in bad faith. That finding . . . is supported by substantial evidence and is sufficient for concluding that Genentech breached its fiduciary duty.

    According to a California based patent attorney, several amici curiae — including Intel Corp., TechNet and the California Chamber of Commerce — pleaded with the court to reverse the judgment, saying that imposing fiduciary status as a cost of using third-party intellectual property would impede innovation.  Genentech has announced its plans to appeal the decision to the California Supreme Court.

    About the Case: In 1978, City of Hope biologists Arthur Riggs and Keiichi Itakura developed a technique for splicing into a bacteria gene the DNA for human insulin, which became the world’s first biotechnology drug. Genentech agreed to pay City of Hope 2% on net sales of products that were tied to the DNA provided by the cancer center.  (see Patent No. 4,704,362). Royalties had been paid for sales of insulin and on sales growth hormone products, but the cancer center is asking for royalties on products made under 20 other license agreements. 

    TV Guide Patent on Program Schedule Given Second Chance

    Patent, ,

    TV Guide (Gemstar) v. ITC (Fed. Cir. 2004).

    TV Guide owns several patents relating to interactive program guides in digital cable television set-top boxes that enable viewers to search through TV schedules and pre-select programs for viewing and recording.  In a case before the ITC, the commission concluded that Scientific-Atlanta did not infringe the patents and that one of the patents was unenforceable because an inventor was improperly excluded from the patent.

    TV Guide Appealed: In an opinion released September 16, the Federal Circuit (CAFC) found that the ITC erred in claim construction and erred in determining that Mr. Neil was an unnamed co-inventor. 

    Inventorship is presumed correct without clear and convincing evidence otherwise:

    Because Neil failed to present facts supported by clear and convincing evidence of his co-inventorship, the ITC erred in holding Neil to be an unnamed co-inventor….  Neil principally relies on his own testimony and the content of two product disclosure documents, an original disclosure document and a “second version” of the disclosure document.   

    The ITC found that Neil’s testimony was “credible and straightforward,” while Young’s testimony “lacked those characteristics.”  Under our precedent, more than just the alleged co-inventor’s testimony is required to establish co-inventorship by facts supported by clear and convincing evidence.  Trovan, 299 F.3d at 1302.  The mere fact that the ITC found the alleged inventor’s testimony to be more credible than the named inventor does not itself rise to the level of clear and convincing evidence.

    Affirmed-in-part, vacated-in-part, reversed-in-part, and remanded for further proceedings.

    Now, the case is returned to the ITC to for another determination of whether the devices imported by Pioneer, EchoStar, and Scientific-Atlanta infringe the patents in suit in violation of 19 U.S.C. 1337.

    Federal Circuit: DMCA does not create a new property right for copyright owners

    Patent, Patent Cases 2004, ,

    garage_door
    Chamberlain Group v. Skylink Technologies (Fed. Cir. 2004).

    In a well reasoned opinion, the Federal Circuit (GAJARSA) affirmed a district court’s dismissal of a suit arising under anti-trafficking provisions of the Digital Millennium Copyright Act (DMCA).

    The DMCA does not create a new property right for copyright owners.  Nor, for that matter, does it divest the public of the property rights that the Copyright Act has long granted to the public.  The anticircumvention and anti-trafficking provisions of the DMCA create new grounds of liability.  A copyright owner seeking to impose liability on an accused circumventor must demonstrate a reasonable relationship between the circumvention at issue and a use relating to a property right for which the Copyright Act permits the copyright owner to withhold authorization-as well as notice that authorization was withheld.  A copyright owner seeking to impose liability on an accused trafficker must demonstrate that the trafficker’s device enables either copyright infringement or a prohibited circumvention.  Here, the District Court correctly ruled that Chamberlain pled no connection between unauthorized use of its copyrighted software and Skylink’s accused transmitter.  This connection is critical to sustaining a cause of action under the DMCA.  We therefore affirm the District Court’s summary judgment in favor of Skylink.

    This case involved electronic garage door technology with a “rolling code” to encrypt signals transmitted signals.  Skylink distributes a universal remote that can decode the encrypted rolling code.  In an attempt to control the aftermarket in remote control units, Chamberlain sued.

    The court’s basic premise is that an element of a DMCA cause of action is an underlying copyright violation — without such a violation, there can be no remedy.

    Updates: According to Ernest Miller, the court rescued the DMCA from “one of its most absurd aspects.” He is still concerned, however, that the Act, even as narrowly interpreted, will continue “stifling creativity and innovation.” More on the story from copyfight.

    PTO Board Places Enablement Burden on Examiner

    Patent, Patent Cases 2004

    Ex parte FALSAFI (BOARD OF PATENT APPEALS AND INTERFERENCES) (2004) (Unpublished)

    During prosecution of their patent application for a new dental cement composition, the applicants added the term “about” to modify an upper concentration range. The Examiner rejected addition of “about,” arguing that the broadened claims were not enabled.

    The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. Extending the claimed range beyond the range described in the specification is not enabling and is new matter.

    On appeal, the BPAI overturned the Examiner’s rejection, holding that the Examiner had not “met the required burden of proof for a rejection based on lack of enablement.”

    The claims are directed to a dental composition and nothing in the specification indicates that minor differences in concentration render the composition unsuitable. The Examiner simply has provided no basis for the conclusion that one of ordinary skill in the art would not have been able to make the dental compositions at the slightly higher levels of the claims, if, indeed, the upper levels are outside the ranges discussed in the specification.

    Federal Circuit: Koito Manufacturing v. Turn-Key-Tech (Patent Case)

    Patent, Patent Cases 2004, , ,

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    Koito Manufacturing v. Turn-Key-Tech (Fed. Cir. 2004) (PDF).

     

    In February 2002, Koito brought a declaratory judgment action against Turn-Key, requesting that Turn-Key’s patent covering an injection molding technique be declared invalid, unenforceable, and not infringed. (< ?xml:namespace prefix ="" st1 />U.S. Patent 5,045,268). The Jury issued a special verdict finding the patent invalid for lack of enablement, written description, and the addition of new matter. Additionally, the Jury found that the patent was not infringed and that several claims were anticipated and obvious. After the verdict, however, the district court judge granted in-part Turn-Key’s JMOL.  On appeal, the Federal Circuit affirmed-in-part and remanded.  The Appellate Panel held that Koito had not met its burden of showing non-enablement, lack of written description, impermissible new matter, anticipation, or obviousness.

     We affirm (1) the jury’s verdict that Koito did not infringe the ’268 patent and (2) the district court’s grant of a JMOL with respect to the jury’s finding that the ’268 patent was not enabled, did not meet the written description requirement, and impermissibly added new matter.  However, we vacate the district court’s denial of Turn-Key’s JMOL with respect to anticipation and obviousness.  On remand, the district court should evaluate the evidence proffered by Koito … to determine whether the jury’s verdict of anticipation and obviousness was adequately supported.

    Affirmed-in-part, Vacated-in-part, and Remanded.

     

    Update:

    The unanimous decision, which was returned by a three-judge panel on Monday, August 23, upheld an April 2003 jury verdict in the same case.  As in this case, the court found that the manufacturing process Koito used to mold plastic tail light lenses in no way infringed on a patent for another process that was held by Turn-Key-Tech. (LINK)

    Federal Circuit: Linear Technology v. Impala Linear and Maxim Integrated

    Patent, Patent Cases 2004, ,

    Linear Technologies Figure

    Linear Technology v. Impala Linear and Maxim Integrated (Fed. Cir. 2004)

    After losing an appeal last month, Maxim filed a request for an en banc rehearing.  Although the court denied the petition to rehear, it did issue a substitute opinion in the case.

    Summary:

    Because genuine issues of material fact have been raised concerning Maxim’s contributory infringement or inducement, we vacate the district court’s summary judgment of no contributory infringement or inducement of the current reversal method claims of the ’178 patent.  Because Maxim failed to raise a genuine issue of material fact, the matter of inventorship was amenable to determination on summary judgment on the undisputed factual premises.  On these premises, the district court correctly held that Vinsant was not a joint inventor of the ’178 patent.

    As in the prior opinion,the court found error in the district court’s claim construction.  Vacated-in-part, affirmed-in-part, and remanded.

    Read the original federal circuit opinion.

    Federal Circuit: In re WILHELM ELSNER

    Patent, Patent Cases 2004

    In re WILHELM ELSNER (Fed. Cir. 2004)

    German plant breeder William Elsner filed for a plant patent on his new variety of geraniums.  After receiving a 102(b) rejection from the Examiner that was affirmed by the BPAI, Elsner appealed to the Federal Circuit.

    The Appellate Panel vacated and remanded.

    We agree that the publication of the (international) applications coupled with foreign sales of the plants may constitute a §102(b) bar to patentability.  However, because the record is silent on the extent to which the foreign sales were known to the public, and because the Board did not adequately address the degree to which availability of the plants through foreign sales enabled the preparation of the claimed plants, we vacate the Board’s decisions in both cases and remand for further proceedings.

    Federal Circuit: Lack of Enablement Affirmed

    Patent, Patent Cases 2004,

    img044
    ELSTER ELECTRICITY v. SCHLUMBERGER (Fed. Cir. 2004) (NONPRECEDENTIAL)

    In this appeal of a summary judgment of invalidity for lack of enablement, the Federal Circuit affirmed.

    Elster’s patent relates to a power supply of an electric energy meter that uses a specialized transformer. (U.S. Patent 5,457,621). At the district court, the judge found that the patent lacked enablement because the specification only enabled a “controller that responds to the third winding,” while the claim required a response to the “second winding.” Elster appealed, but the Appellate Panel affirmed, holding that the “written description fails to teach a response between the second and third winding, the district court ccorrectly concluded that [the] claims … were not enabled.”

    Phillips v. AWH: Rader Concurring

    Patent, Patent Cases 2004, ,


    This is Part III of our coverage of the Phillips – AWH en banc order. Read Part I and Part II.

    … In concurrence, Judge Rader argued for en banc ruling on another issue. Rader’s concern is whether claim construction is even amenable to “strictly algorithmic rules.” As an example, Rader questions whether an approach of first looking at the specification, folowed by examining dictionary definitions would be workable. Alternatively, claim construction may be better achieved by chosing a methodology on a case by case basis — “thus entrusting trial courts to interpret claims as a contract or statute.”

    Nokia – NTP settle over BlackBerry Patent Infringement

    Articles and Publications, Patent,

    rim_blackberry_design_patent
    ZD Net is reporting that Nokia has obtained a licensing agreement from NTP for use of patents that allegedly cover RIM’s BlackBerry device. BlackBerry enabled Nokia devices should be available in the U.S. “in two to three months.”

    The patent infringement case between RIM and NTP is ongoing. The Federal Circuit recently heard oral arguments in an appeal of the district court’s patent infringement finding. A ruling is expected within the next several weeks. Read more about the lawsuit here.

    Although the terms of the agreement have not been made public, the license gives Nokia two big advantages. First, it allows Nokia to hedge its bets against the outcome of the RIM lawsuit. Second, and perhaps more important, Nokia is setting itself up to get a “first-mover” advantage over other carriers.

    “There is a reasonable likelihood that they might not get all the patents thrown out,” said patent lawyer Brad Hulbert of McDonnell, Boehnen, Hulbert & Berghoff LLP in Chicago. “It’s better to pay now than pay more later.” (Bloomberg)

    (Drawing is from RIM’s U.S. Design Patent D479,233).

    Blocking patents

    Articles and Publications, Patent

    The headline: Patent royalties threaten new mobile service

    Patent royalties are posing threats to a new digital mobile broadcasting service in Korea before it is even launched. Digital mobile broadcasting, or DMB, is a service that enables users to view television through cellular phones by means of satellite transmission.

    TU Media Corp. announced yesterday that Toshiba Corp., the Japanese company that holds the core technology for satellite mobile broadcasting, is demanding royalties for terminals sold in Korea. TU said Toshiba requested royalties of 2 percent per terminal for all gadgets that will use the satellite broadcasting service, reports JoonGang Daily.Commentary: The facts here don’t appear to show a great “threat” or that the patent owner plans to block all use of DMB — Toshiba just wants a piece of the action.

    In re American Academy of Science Tech Center

    Patent, Patent Cases 2004,

    In re American Academy of Science Tech Center (Fed. Cir. May 13, 2004)
    ScreenShot008

    The Federal Circuit affirmed the Patent Board’s rejection of several claims during reexamination.

    The patent claims a priority date back to 1982 and describes distributing processing functionality among several computers:

    user applications are run on the user stations, while the database resides on a dedicated database computer. Several user stations are networked to the database computer so that a user application running on a user station can store data to and retrieve data from the database residing on the database computer. The patent describes using a “data base simulator” to “enable[ ] an application program . . . at the user station to call for storage or retrieval of data from the data center as though it were calling for data from a data base resident at the user station . . . .”

    The Federal Circuit agreed that the broadest reasonable construction of the claim language allows prior art to read on the claims. Thus, the claims were properly held invalid.

    New Theory Supporting the Doctrine of Equivalents

    Articles and Publications, Patent

    The Doctrine of Equivalents (DOE) has traditionally been justified as a way to overcome language limitations, mistake, and unforeseeability. Ironically, these elements are missing from leading DOE case law.

    Michael Meurer and Craig Nard have released a working paper that brings to light a new justification for the DOE. According to Meurer and Nard, a highly skilled and motivated patent attorney / inventor team would not need the doctrine of equivalents. Through thoughtful and clever claim drafting, the team could obtain patents that would directly cover any potential infringers. This thoughtfulness and cleverness, however, will have a large price tag (i.e., many hours for a highly paid patent attorney).

    We develop a better explanation of why claim breadth falls short of the maximum breadth allowed by patent law. Our explanation replaces the passive patent attorney depicted in the friction theory with an active inventor and attorney who are capable of responding effectively to the frictions mentioned above. Whether an inventor obtains the broadest permissible claim breadth depends mostly on the talent and effort of the inventor and attorney in identifying what has been enabled. A good attorney predicts the embodiments that could be chosen by infringers and finds appropriate language to draft a suitably broad claim. We call this process claim refinement, and we develop a refinement theory of the doctrine of equivalents.

    Because the pricetag associated with patent drafting is so large, Meurer and Nard argue that such a cost will not be socially optimal. The DOE serves to accomodate less-than-perfect claim drafting — thus allowing a better allocation of resources.

    Smithkline Beecham v. Apotex (Paxil)

    Patent, Patent Cases 2004,

    Smithkline Beecham Corp. (SKB) v. Apotex Corp. (Fed. Cir. 2004)

    (Figure shows IR spectrum for Paxil)

    Always controversial Judge Richard A. Posner of the 7th Circuit sat as the district judge in this case. His outcome was preserved on appeal, but only after two of his holdings were reversed. This is a very well written, interesting opinion by Judge Rader. If you only read one every three-months, this should be it.

    Simplification: The case involved PHC anhydrates (without water) and PHC hemihydrates (some water). In the 70’s PHC anhydrates were invented in the UK. In 1984, SKB invented PHC hemihydrates and eventually patented a PHC hemihydrate compound. (U.S. Patent No. 4,721,723) In 1998, Apotex filed an ANDA to market a prior art PHC anhydrate.

    The holding is simple: 1) SKB’s clinical trials that occurred more than one year prior to filing are a public use under §102(b). The clinical trials were not a form of experimental use because the trials were experiments of the medical usefulness of the claimed compound (a PHC hemihydrate) and did not reflect upon the structure or ability to enable the claimed compound. 2) There is no room for a policy-driven inquiry during claim construction. Posner erred in adding a “commercially significant” limitation into the compound claim.

    The most interesting aspect of Posner’s opinion was left for another day as moot. In his opinion, Posner created a new equitable defense to infringement that would bar enforcement of a patent when the patentee’s own conduct significantly inhibits non-infringing practice of the prior art. In this case, Apotex’s ANDA request involved making a prior-art PHC anhydrate. SKB argued that after 1984, the environment became seeded with hemihydrate crystals, and that it was no longer possible for Apotex to make PHC anhydrate that would be free of infringing hemihydrate. Under Posner’s new defense SKB would be estopped from enforcing its patent because its conduct (manufacturing hemihydrates and seeding the environment) had effectively eliminated Apotex’s ability to practice the prior art.

    There is much more to this opinion including a thought provoking concurrence by Judge Gajarsa.

    Read Part II, Part III, and part IV.

    Here is a link to Judge Posner’s Opinion. (Thanks Howard Bashman)