marine polymer v. hemcon
DESCRIPTION
Can arguments alone give rise to intervening rights?TRANSCRIPT
Marine Polymer Techs v. HemconMarine Polymer Techs v. Hemcon
Can arguments alone give rise to intervening rights?Can arguments alone give rise to intervening rights?
Jeff B. VockrodtHunton & Williams LLP
February 2012
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Federal Circuit goes Federal Circuit goes en bancen banc
– Marine Polymer obtains $29.4 million judgment against Hemcon for infringement.
– Hemcon filed ex parte reexamination but the examiner allowed all of the claims determined to be infringed in litigation.
– Federal Circuit reversed because Marine Polymer’s arguments to the USPTO created intervening rights and thus extinguished all past damage claims, also potential equitable intervening rights.
– January 2012, Federal Circuit vacated its decision and granted en banc review.
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Several amici briefs have been filed. Against argument-based intervening rights: Biotechnology Industry Association and Pharmaceutical Research and Manufacturers of America Soverain Software LLC and Tesserra, Inc.Sealy Co.
In support of argument based intervening rights:Hewlett-Packard CompanyGeico Corporation
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Federal Circuit goes Federal Circuit goes en bancen banc
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Marine Polymer: The PatentMarine Polymer: The Patent
Marine Polymer’s patent discloses methods of making highly pure forms of a biopolymer poly-β-1→4-N-acetylglucosamine (p-GlcNAc) extracted from chitin. Marine Polymer’s p-GlcNAc have low bioreactivity and are useful as anti-coagulents.
The specification disclosed four biocompatibility tests: an elution test, an implantation test, an intracutaneous injection test, and a systemic injection test.
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6. A biocompatible poly-β-1→4-N-acetylglucosamine comprising up to about 150,000 N-acetylglucosamine monosaccharides covalently attached in a β-1→4 conformation and having a molecular weight of up to about 30 million daltons in which at least one N-acetylglucosamine monosaccharide has been deacetylated.. . .
12. The biocompatible poly-β-1→4-N-acetylglucosamine of any one of claims 6-11 which has an elution test score of 0.
13. The biocompatible poly-β-1→4-N-acetylglucosamine of any one of claims 6-11 which has an elution test score of 1.
14. The biocompatible poly-β-1→4-N-acetylglucosamine of any one of claims 6-11 which has an elution test score of 2.
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Marine Polymer: The District Court
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Defendant, Hemcon’s construction:p-GlcNAc from certain algal sources, or biocompatible meant “suitable for biomedical applications.” Patentee, Marine Polymer sought a narrower construction: biocompatible means according to biocompatibility tests.
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Marine Polymer: The District CourtMarine Polymer: The District Court
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The district court chose its own path, which largely aligned with Marine Polymer’s construction:
“biocompatible p-GlcNAc” meant p-GlyNAc “polymers . . . with low variability, high purity, and no detectable biological reactivity as determined by biocompatibility tests.”
But remember dependent claims 13-14?
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Marine Polymer: The District CourtMarine Polymer: The District Court
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Within a month of Hemcon losing all of their claim construction arguments, they filed an ex parte reexam.
The District Court refused to stay case.
And the examiner initially agreed with Hemcon on claim construction!
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Marine Polymer: The ReexaminationMarine Polymer: The Reexamination
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The examiner’s construction was “that ‘biocompatibility’ means ‘low variability, high purity, and little or no detectable reactivity as determined by cytotoxicity elution assays having a test score of 0, 1, or 2.”
Examiner: My construction “avoids creating the situation where claims 4, 5, 13, 14, 21, and 22 would be improper for failing to further limit the claims from which they depend.”
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Marine Polymer: The ReexaminationMarine Polymer: The Reexamination
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In response, and without the input of Hemcon (this is an ex parte reexamination after all), Marine Polymer cancelled claims 4, 5, 13, 14, 21, and 22.
Then Marine Polymer pointed to low bioreactivity of its invention, and how Hemcon’s prior art had documented problems with bioreactivity.
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Marine Polymer: The ReexaminationMarine Polymer: The Reexamination
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The examiner agreed with Marine Polymer and confirmed the remaining claims.
The reexamination certificate issued after the district court decision finding Hemcon infringed, but before the Federal Circuit briefing and oral
argument.
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Marine Polymer: The ReexaminationMarine Polymer: The Reexamination
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Marine Polymer: the Federal CircuitMarine Polymer: the Federal Circuit
Hemcon: original district court construction was wrong and Marine Polymer effectively narrowed its claims during reexamination.
Marine Polymer: intervening rights requires us to amend the claims—arguments are not enough.
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“Although we have not directly addressed whether arguments made to the USPTO during reexamination can amend the scope of the claims for purposes of intervening rights doctrine, we have consistently held that arguments made to the PTO during reexamination can create an estoppel or disavowal and thereby change the scope of the claims even when the language of the claims did not change.”
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Marine Polymer: the Federal CircuitMarine Polymer: the Federal Circuit
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Marine Polymer:
But claims 12 and 20, which required an elution test of zero, never changed in scope.
Federal Circuit: Yes, they did! Those claims under the correct interpretation of biocompatibility required only elution test of zero, but after the reexamination those claims allowed for no bioreactivity under any test.
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Marine Polymer: the Federal CircuitMarine Polymer: the Federal Circuit
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Marine Polymer: RecapMarine Polymer: Recap
Patent Owner Argument
Prior art
correctpost-reexamconstruction
REEXAM
Prior Art ?
correct pre-reexamconstruction
district courtconstruction
accusedproduct accused
product
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Absolute intervening rights: The specific things made before the date of the reexamination which infringe the new reexamination claims are absolutely free of the reexamined patent and may be used or sold after the date of reexamination without regard to the patent.
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Marine Polymer: the Federal CircuitMarine Polymer: the Federal Circuit
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Equitable intervening rights: The doctrine of equitable intervening rights allows the court to “permit[]the continued manufacture, use, or sale of additional products covered by the reissue[d] [or reexamined] patent when the [accused infringer] made, purchased, or used identical products . . . Before the reissue [or reexamination] date.”
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Marine Polymer: the Federal CircuitMarine Polymer: the Federal Circuit
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Equitable intervening rights factors include: 1. whether non-infringing goods can be manufactured
from the inventory used to manufacture the infringing product,
2. whether there are “existing orders” for the products, 3. whether the accused infringer made “substantial
preparation” to manufacture the products before the reexamination or reissue, and
4. whether the accused infringer relied on the original patent scope in making these preparations.
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Marine Polymer: the Federal CircuitMarine Polymer: the Federal Circuit
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Marine Polymer: Judge Lourie DissentMarine Polymer: Judge Lourie Dissent
Lourie: “I respectfully dissent”
“We should have the benefit of the district court’s view on the effect of the reexamination proceeding rather than
review it ourselves in the first instance.”
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Marine Polymer: Judge Lourie DissentMarine Polymer: Judge Lourie Dissent
Lourie: intervening rights by argument is not consistent with the statute involving the effect of reexamination certificates, which states:
(b) Any proposed amended or new claim determined to be patentable and incorporated into a patent following a reexamination proceeding will have the same effect as that specified in section 252 of this title for reissued patents . . . .
35 U.S.C. § 307(b) (emphasis added).
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Marine Polymer: Typical Marine Polymer: Typical Prosecution DisclaimerProsecution Disclaimer
Patent Owner Argument
Prior art
correctpost-reexamconstruction
REEXAM
Prior Art ?
district courtconstruction
accusedproduct accused
product
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Marine Polymer: Expanded Marine Polymer: Expanded Intervening RightsIntervening Rights
Patent Owner Argument
Prior art
correctpost-reexamconstruction
REEXAM
Prior Art ?
district courtconstruction
accusedproduct
accusedproduct
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Marine Polymer: What can Patent Marine Polymer: What can Patent Owners Do?Owners Do?
• Do not make arguments during reexamination that characterize the claim language.
• Consider falling back to dependent claims that are known to be infringed in reexamination. – MP never tested accused product under elution test.
Hemcon never raised the issue, but DC held Hemcon waived its non-infringement argument. MP could not fall back to dependent claims due to flimsy infringement showing.