merck kgaa v. integra lifesciences
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Merck KGaA v. Integra LifeSciences. Mauricio A. Flores Cathryn Campbell. The Plaintiffs. The Burnham Institute: patent owner Integra LifeSciences: exclusive licensee. The Plaintiffs’ Technology. - PowerPoint PPT PresentationTRANSCRIPT
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© 2005 McDermott Will & Emery. The following legal entities are collectively referred to as "McDermott Will & Emery," "McDermott" or "the Firm": McDermott Will & Emery LLP; McDermott Will & Emery/Carnelutti Studio Legale Associato; McDermott Will & Emery Rechtsanwälte LLP; MWE Steuerberatungsgesellschaft mbH; McDermott Will & Emery UK LLP and McDermott Will & Emery/Stanbrook LLP. These entities coordinate their activities through service agreements.
Merck KGaA v. Integra LifeSciences
Mauricio A. Flores
Cathryn Campbell
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The Plaintiffs
The Burnham Institute: patent owner
Integra LifeSciences: exclusive licensee.
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The Plaintiffs’ Technology
Identification of the amino acid sequence RGD as the site where cells attach to the extracellular matrix
Isolated the cellular surface receptors that bind to the RGD site
Identified other RGD-binding cell surface receptors, called “integrins”
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8. A substantially pure peptide including as the cell-attachment-promoting constituent the amino acid sequence Arg-Gly-Asp-R wherein R is Ser, Cys, Thr or other amino acid, said peptide having cell-attachment-promoting activity, and said peptide not being a naturally occurring peptide.
U.S. Patent No. 4,792,525Entitled: TETRAPEPTIDE
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The Defendants
Merck KGaA:
--Sponsored infringing research at Scripps and infringed by importing RGD peptides
The Scripps Research Institute:
--Performed infringing research
Scripps Principal Investigator Dr. David Cheresh:
--Performed infringing research
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The Trial
28 trial days
Infringement and validity vigorously contested
Fact issues re FDA Exemption
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35 U.S.C. Section 271(e)(1)
NOT “an act of infringement to make use or sell or import into the United States a patented invention . . . 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.”
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”To prevail on this defense, [Merck KGaA] must prove by a preponderance of the evidence that it would be objectively reasonable for a party in [Merck’s] and Scripps’ situation to believe that there was a decent prospect that the accused activities would contribute, relatively directly, to the generation of the kinds of information that are likely to be relevant in the processes by which the FDA would decide to approve the product in question.”
Proposed by Integra
Instruction to the jury
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Merck’s Evidence
Scientist after scientist testified infringing experiments were:
–relevant to safety and efficacy
–of various closely related RGD compounds
–intended for inclusion in an Investigational New Drug application to the FDA
–an essential part of Merck’s drug development program.
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Merck had every advantage
Scripps’ reputation in community
No product sales
Sued for trying to cure cancer
Broad standard for FDA Exemption as articulated in jury instruction
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Result in the Trial Court
Scripps, Cheresh and Merck found to willfully infringe
Claims against Scripps and Dr. Cheresh dismissed because no damages sought against them
Claims based on infringing acts prior to 1995 dismissed by based on common law exception
$15 million verdict against Merck (later reduced to $6.375 million)
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Questions Worth Asking
How could Merck have lost before the jury?
Why didn’t the trial court enter judgment as a matter of law in Merck’s favor based on the testimony of Merck and Scripps scientists?
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Answers worth pondering
Credibility: contradictions in sworn testimonyCredibility: admissions re infringing testsCredibility: admissions that Merck was doing the real FDA work in Germany
Form of Verdict: “Has Defendant Merck KGaA met its burden of proving by a preponderance of the evidence that all of the accused activities are covered by the FDA Exemption?”
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Merck Appeals to the Federal Circuit
FDA Exemption
Claim construction
Damages
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Merck Argues “Rational Predicate”
Everything in the causal chain of research toward FDA approval is exempt
Integra responds:
–not consistent with agreed-upon jury instruction
–In effect a general research exemption
–Would eviscerate value of research tools
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Integra Argues Rule 50, FRCP
Deference to jury assessment of
–Weight of evidence
–Credibility
Merck responds:
–Issue of law not fact
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The Federal Circuit Opinion
Ruled that FDA exemption “does not globally embrace all experimental activity that at some point, however, attenuated, may lead to an FDA approval process”
Went on to rely on a narrow interpretation that is inconsistent with the instruction proposed by Integra and given to the jury
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The Federal Circuit’s Narrow Interpretation of the FDA ExemptionShould not be interpreted to “encompass drug development activities far beyond those necessary to acquire information” necessary for FDA review of an application to market a generic drug
The FDA has no interest in the hunt for new drugs and does not require information about compounds other than the one featured in an IND application
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Judge Newman dissented:
Research should be exempt under either the Common Law Exception or the FDA Exemption.
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Merck Petitions Supreme Court for Cert “Cancer. Rheumatoid arthritis. AIDS. Heart disease.
Alzheimer’s. Multiple sclerosis. The list could go on for volumes. Deadly diseases, painful disorders, heart wrenching conditions that afflict millions of people. All of them find themselves hoping against hope that someone, somewhere will discover a drug that could cure them or relieve their suffering—and get it to them soon. This case is about how quickly many of those prayers will be answered. The stakes are measurable in millions of lives.”
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Merck Before the Supreme Court
Abandoned its rational predicate theory
Focused its attack on the Federal Circuit’s apparent narrowing of the exemption
Asked the Court to review the evidence and enter judgment in Merck’s favor
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The Solicitor General Before the Supreme CourtAgreed with the Federal Circuit’s rejection of “rational predicate”
Disagreed with the Federal Circuit’s narrow interpretation of the FDA Exemption
Argued that Merck was entitled to judgment as a matter of law because the exemption applies once drug research “progresses beyond basic research and begins efforts to develop a “particular drug”
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Integra Before the Supreme Court
The Federal Circuit did not narrow the scope of the FDA Exemption, but held that the standard articulated in the jury was correct
The evidence, when reviewed under the rules requiring deference to the jury, was sufficient to sustain the judgment for Integra
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Amicus: Wyeth and US Merck
Drug development is like a funnel
Blocking at any point stops the flow of new drugs
Virtually every experiment in drug development after a focus on a specific compound is reasonably related to the FDA process
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Amicus: PhRMA
The Federal Circuit’s interpretation of FDA Exemption represents a “direct and substantial” threat to drug development
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Amicus: BIO
FDA exemption not limited to generic drugs or required regulatory testing
“Reasonably related” inquiry must be fact-specific
And flexible
–E.g. exemption should be applied even where infringer does “more” than what FDA requires.
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Amicus: Genentech and Biogen Idec
Biologics require even more preclinical testing than new drugs
Important to exempt such tests
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Amicus: Applera
Supported Integra
“Solely for uses” means that the sole purpose should be to develop information for the FDA
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Amicus: Invitrogen
Supported Integra
Requested ruling that the FDA Exemption does not extend to patented research tools
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The Question Presented in Integra
“[W]hether uses of patented inventions in preclinical research, the results of which are not ultimately included in as submission to the Food and Drug Administration (FDA), are exempted from infringement by 35 U.S.C. Section 271(e)(1).”
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What The Supreme Court Did NOT DecideWhether activities that infringe biomedical research tool patents may be exempted
Whether the evidence in the record in this case is sufficient to sustain the verdict in Integra’s favor in light of the rules that require deference the jury’s assessment of the weight of the evidence and the credibility of the witnesses
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The Supreme Court’s DecisionThe FDA exemption extends to any activity that is reasonably related to the processes by which the FDA makes its decision, including:
–Preclinical experiments.
–Experiments not ultimately submitted to the FDA.
–Experiments on compounds not submitted to the FDA.
–Experiments that do not comply with Good Laboratory Practices.
The FDA is concerned with efficacy as well as safety at the preclinical stage.
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The Supreme Court’s Decision
The instruction proposed by Integra and given to the jury is not inconsistent with its decision.
Remanded to the Federal Circuit for review the sufficiency of the evidence
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Reasonably Related is a flexible concept
“Properly Construed, Section 272(e)(1) leaves adequate space for experimentation and failure on the road to regulatory approval: At least where a drug maker has a reasonable basis for believing that a patented compound may work, through a particular process, to produce a particular physiological effect, and uses the compound in research that, if successful, would be appropriate to include in a submission to the FDA, that use is ‘reasonably related’ to the development and submission of information under . . . Federal law.”
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The Bottom Line
Reasonable means Reasonable – no categorical exclusions or bright line rules
The standard is broad enough so that any company whose witnesses provide a straightforward, credible account of how their activities relate to the FDA process is likely to get the benefit of the exemption
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The Bottom Line
But the exemption is not a talisman; the party claiming the benefit of the exemption will be required to produce a careful explanation from credible witnesses.
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A Carve-Out for Research Tools?
The Solicitor General stated:
–“The context of Section 271(e)(1) suggests that Congress may not have intended to include research tools within the scope of affected inventions.”
–“Including research tools that are used only in experimentation within the scope of Section 271(e)(1) could adversely impact the only exclusive right that exists with respect to such tools – the right to use them in research.”
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Defining the Carve-Out
An exception to the definition of a “patented invention” ?
Based on the use of a patented invention?
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Consider Protective Provisions
Reps and warranties Obligation for sponsor to monitor
patents and seek licenses Indemnification Sponsor to lead the defense, but
institution to receive separate representation
