1. Case Name
Martek Biosciences Corp. v. Nutrinova, Inc.
2. Case Cite
Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363 (Fed. Cir. Sept. 3, 2009)
3. Facts of the case
Martek and Nutrinova ("Lonza") both make and sell products that include the ingredient "Docosahexaenoic Acid" (DHA). DHA is an essential omega-3 fatty acid ("HUFA")that is beneficial to an animal's organ (heart, brain, eyes, etc.) development. Humans benefit from supplemental DHA, as it is produced naturally by the body in limited quantities. Both companies harvest DHA from the lipids produced in fermenting microalgae.
Martek sued Lonza for infringement of four patents relevant to DHA production. Martek's four patents at issue relate to specific Thraustochytrium and Schizochytrium ("T" and "S") microalgae and are as follows:
5,340,594 (the '594 patent):
Claims a food product that contains omega-3 (HUFA) produced by "T" and/or "S"
6,451,567 (the '567 patent):
Claims a process for extracting lipids (HUFA) from "euryhaline" organisms such as "T" and "S"
6,410,281 (the '281 patent):
Claims methods for growing/fermenting microorganisms such as "T" and "S" that uses a medium containing non-chloride salt which reduces corrosion in the fermentor.
5,698,244 (the '244 patent):
Claims methods for increasing HUFA in animals by feeding them microorganisms such as "T" and "S"
• Validity of the '594 claims
â–¡ Lanza has asserted that the 594 patent was anticipated by a previously abandoned application. The lower court held that the '594 patent was entitled to the priority date of the abandoned application. Lanza challenges the lower court's finding that the publication was not prior art on the basis that the written description in the abandoned application does not sufficiently describe the '594 patent's first claim's mixed culture limitation and food product limitation.
â–¡ Claim 1, the claim in question reads:
A food product, comprising:
a) lipids extracted from a fermentation process for growing microorganisms selected from the group consisting of microorganisms of the genus Thraustochytrium, microorganisms of the genus Schizochytrium and mixtures thereof, wherein said microorganisms are capable of effectively producing lipids containing mixtures of omega-3 and omega-6 highly unsaturated fatty acids under conditions comprising:
i) salinity levels less salinity levels found in seawater;
ii) a temperature of at least about 15° C.; and
â–¡ The court reviewed the evidence Martek offered at trial. Martek's expert witness testified that the PHOSITA woule be able to tell from the parent application's written description that:
1) The unicellular fungal strains would include "T" and "S", alone or combined.
2) "vegetable or other edible oil" means "food product"
• Infringement of the '281 Claims
â–¡ Lanza challenged the lower court's denial of its JMOL motion to find that Martek had not proven infringement of the '281 patent because it did not conduct comparative testing between Lanza's product and a culture medium containing NaCl as the primary sodium.
â–¡ Martek's Expert witnesses testified that Lanza's NaOH based solution would have less chlorides in it, and PHOSITAs would know that the reduction in chlorides combined with the stainless steel vessel employed by Lanza's process would result in less corrosion.
• Exclusion of Lonza's Prior Inventorship Evidence
â–¡ Lonza argued that the lower court improperly excluded evidence of prior inventorship (102(g)). Lonza had brought forth an abandoned patent application by Dr. Long as well as his testimony regarding further reduction to practice as evidence of prior inventorship. Lonza provided no further corroborating evidence beyond Dr. Long's testimony as the inventor.
• Claim Construction of "Non-Chloride Sodium Salt"
â–¡ Lonza argued that the lower court construed the '281 patent's term "non-chloride sodium salt" too broadly by including NaOH. It argues that Martek disclaimed NaOH during prosecution, and thus it is not a non-chloride sodium salt for the '281 patent.
â–¡ The court examined
® Intrinsic Evidence: The specification does not discuss NaOH, but the '281 prosecution history and found that it explicitly stated that NaOH is a non-chloride sodium salt. It also contained statements by the applicant that distinguished the prior art at issue from the claimed invention on grounds that did not relate to the way NaOH was used in the prior art reference.
® Extrinsic Evidence: Martek provided two treatises that considered NaOH to be a non-chloride sodium salt.
â—‹ Martek's Counter Claims
• Validity of the '567 claims
â–¡ Martek appeals the lower courts finding that all of the '567 claims are invalid for lack of enablement. The lower court held all claims of '567 non-enabled as a matter of law. Lanza's expert focused his testimony on claim 1, the broadest claim. The lower court used this information to make determinations on the more narrow claim 4 and claim 5.
• Claim Construction of "Animal"
â–¡ The district court construed the '244 patent's term "animal" as "any member of the kingdom Animalia, except humans." Because of this construction, Lanza does not infringe the '244 patent. Martek asserts that the lower court was erroneous in construing the claim as it did.
4. Procedural Posture
§ Appeal from US District Court (DW) decision partially granting and partially denying defendant's JMOL motions as to the validity of 4 patents held by Plaintiff:
â–¡ Lonza has appealed the lower court's denial of its motion for JMOL that (1) the '594 patent claims are invalid as anticipated, that it does not infringe on the '281 patent's claims, that the court excluded Lonza's evidence of prior art, and that the court misconstrued the term "non-chloride sodium salt" to include NaOH.
â–¡ Martek has cross-appealed in order to contest Lonca's granted motion for JMOL that the '567 patent was not enabled and that the court misconstrued the term "animal," thus allowing Lonza to infringe the '244 patent.
â–¡ The '244 spec defines animal explicitly thusly: “The term ‘animal’ means any organism belonging to the kingdom Animalia.â€
â–¡ The '244 spec distinguishes between different kinds of animals in preferred embodiments. Lanza argues that Martek limited the term to non-human animal when the spec is considered in its entirety.
5. Holding
Validity of the '594 claims
In order for an application to get the benefit of an earlier application, each application in the chain must sufficiently satisfy the statutory written description requirement. A sufficient parent application will reasonably convey that the inventor had possession at the time of the later claimed subject matter. The inventor need not have described the claimed subject matter in exactly the same terms in the parent application. Martek's expert witness provided enough substantial evidence for a jury to have found that the written description of the abandoned patent was sufficient to encompass claim 1 of the '594 patent and thus the '594 patent was entitled to the older priority date.
Infringement of the '281 Claims
"A patentee may prove infringement buy any method of analysis that is probative of the fact of infringement." Circumstantial evidence may be sufficient. Martek's expert witness provided substantial non conclusory evidence that supports the jury's finding of infringement by Lanza thus the lower court did not err in denying Lanza's JMOL motion.
Exclusion of Lonza's Prior Inventorship Evidence
An alleged prior inventor must provide independent corroborating evidence IN ADDITION to her own statements and documents. Such additional evidence may include: witness testimony corroborating the RTP, or documentary or physical evidence made contemporaneously with the RTP. Evidence may be excluded by the court if the only corroboration is an abandoned patent application. The lower court did not abuse its discretion by excluding Lanza's 102(g) evidence.
Claim Construction of "Non-Chloride Sodium Salt"
Assertions that the lower court legally erred in construing a claim are reviewed de novo. The district court's claim construction that "non-chloride sodium salt" includes NaOH is valid and upheld.
Validity of the '567 claims
Each issued patent claim is presumed valid. The party asserting invalidity has the burden of proof (CCE) of showing that each asserted claim is invalid. To meet the enablement requirement the spec must teach the PHOSITA how to make and use the full scope of the claimed invention w/o undue experimentation. Undue experimentation may be established via the Wands factors (i.e. quantity of experimentation, amount of guidance presented, presence/absence of working examples ...). Whereas claim 1 may possibly require experimentation with over 10,000 species, claims 4 and 5 would require experimenting with 22. Claims 4 and 5 do not require undue experimentation in order to make or use the invention. The lower court's grant of JMOL as to claims 4 and 5 is reversed.
Claim Construction of "Animal"
When a patentee explicitly defines a claim term in the patent specification, the patentee's definition controls. This includes definitions that differ from conventional meanings, or is specialized. Absent a clear disclaimer of particular subject matter, the fact that the inventor may have anticipated that the invention would be used in a particular way does not mean that the scope of the invention is limited to that context.’ The lower court erred in its claim construction, the term animal
6. Important Dicta
The dissent (Lourie & Rader) took issue only with the way that the majority construed the term "animal." The dissent's view is that the term should be construed by examining the patent in totality, not just by examining a single line "definition" by the lexicographer/inventor. Although the inventor defined the term animal to be "any organism belonging to the kingdom Animalia," the patent frequently distinguished between humans and animals throughout the claims and spec.. The dissent argues that if the lexicographer had intended the term animal to be inclusive, then they would have no need to make such distinctions throughout the patent.
7. Likely future importance or unanswered questions
It seems that this case could have the potential to let "lexicographers" be a bit more imprecise to the effect of allowing them to broaden their terms at a later time.
8. Critical Analysis
Although I think the court got the "animal" claim construction right, I also see the validity of what the dissent says. If an inventor defines a term as A and B and then proceeds to use it as B only, you could run the risk of allowing the inventor to claim more than they have invented possibly.
http://www.patentlyo.com/patent/2009/09/federal-circuit-is-a-human-an-animal-written-description-enablement-and-inventorship.html
Martek Biosciences Corp. v. Nutrinova, Inc.
2. Case Cite
Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363 (Fed. Cir. Sept. 3, 2009)
3. Facts of the case
Martek and Nutrinova ("Lonza") both make and sell products that include the ingredient "Docosahexaenoic Acid" (DHA). DHA is an essential omega-3 fatty acid ("HUFA")that is beneficial to an animal's organ (heart, brain, eyes, etc.) development. Humans benefit from supplemental DHA, as it is produced naturally by the body in limited quantities. Both companies harvest DHA from the lipids produced in fermenting microalgae.
Martek sued Lonza for infringement of four patents relevant to DHA production. Martek's four patents at issue relate to specific Thraustochytrium and Schizochytrium ("T" and "S") microalgae and are as follows:
5,340,594 (the '594 patent):
Claims a food product that contains omega-3 (HUFA) produced by "T" and/or "S"
6,451,567 (the '567 patent):
Claims a process for extracting lipids (HUFA) from "euryhaline" organisms such as "T" and "S"
6,410,281 (the '281 patent):
Claims methods for growing/fermenting microorganisms such as "T" and "S" that uses a medium containing non-chloride salt which reduces corrosion in the fermentor.
5,698,244 (the '244 patent):
Claims methods for increasing HUFA in animals by feeding them microorganisms such as "T" and "S"
• Validity of the '594 claims
â–¡ Lanza has asserted that the 594 patent was anticipated by a previously abandoned application. The lower court held that the '594 patent was entitled to the priority date of the abandoned application. Lanza challenges the lower court's finding that the publication was not prior art on the basis that the written description in the abandoned application does not sufficiently describe the '594 patent's first claim's mixed culture limitation and food product limitation.
â–¡ Claim 1, the claim in question reads:
A food product, comprising:
a) lipids extracted from a fermentation process for growing microorganisms selected from the group consisting of microorganisms of the genus Thraustochytrium, microorganisms of the genus Schizochytrium and mixtures thereof, wherein said microorganisms are capable of effectively producing lipids containing mixtures of omega-3 and omega-6 highly unsaturated fatty acids under conditions comprising:
i) salinity levels less salinity levels found in seawater;
ii) a temperature of at least about 15° C.; and
â–¡ The court reviewed the evidence Martek offered at trial. Martek's expert witness testified that the PHOSITA woule be able to tell from the parent application's written description that:
1) The unicellular fungal strains would include "T" and "S", alone or combined.
2) "vegetable or other edible oil" means "food product"
• Infringement of the '281 Claims
â–¡ Lanza challenged the lower court's denial of its JMOL motion to find that Martek had not proven infringement of the '281 patent because it did not conduct comparative testing between Lanza's product and a culture medium containing NaCl as the primary sodium.
â–¡ Martek's Expert witnesses testified that Lanza's NaOH based solution would have less chlorides in it, and PHOSITAs would know that the reduction in chlorides combined with the stainless steel vessel employed by Lanza's process would result in less corrosion.
• Exclusion of Lonza's Prior Inventorship Evidence
â–¡ Lonza argued that the lower court improperly excluded evidence of prior inventorship (102(g)). Lonza had brought forth an abandoned patent application by Dr. Long as well as his testimony regarding further reduction to practice as evidence of prior inventorship. Lonza provided no further corroborating evidence beyond Dr. Long's testimony as the inventor.
• Claim Construction of "Non-Chloride Sodium Salt"
â–¡ Lonza argued that the lower court construed the '281 patent's term "non-chloride sodium salt" too broadly by including NaOH. It argues that Martek disclaimed NaOH during prosecution, and thus it is not a non-chloride sodium salt for the '281 patent.
â–¡ The court examined
® Intrinsic Evidence: The specification does not discuss NaOH, but the '281 prosecution history and found that it explicitly stated that NaOH is a non-chloride sodium salt. It also contained statements by the applicant that distinguished the prior art at issue from the claimed invention on grounds that did not relate to the way NaOH was used in the prior art reference.
® Extrinsic Evidence: Martek provided two treatises that considered NaOH to be a non-chloride sodium salt.
â—‹ Martek's Counter Claims
• Validity of the '567 claims
â–¡ Martek appeals the lower courts finding that all of the '567 claims are invalid for lack of enablement. The lower court held all claims of '567 non-enabled as a matter of law. Lanza's expert focused his testimony on claim 1, the broadest claim. The lower court used this information to make determinations on the more narrow claim 4 and claim 5.
• Claim Construction of "Animal"
â–¡ The district court construed the '244 patent's term "animal" as "any member of the kingdom Animalia, except humans." Because of this construction, Lanza does not infringe the '244 patent. Martek asserts that the lower court was erroneous in construing the claim as it did.
4. Procedural Posture
§ Appeal from US District Court (DW) decision partially granting and partially denying defendant's JMOL motions as to the validity of 4 patents held by Plaintiff:
â–¡ Lonza has appealed the lower court's denial of its motion for JMOL that (1) the '594 patent claims are invalid as anticipated, that it does not infringe on the '281 patent's claims, that the court excluded Lonza's evidence of prior art, and that the court misconstrued the term "non-chloride sodium salt" to include NaOH.
â–¡ Martek has cross-appealed in order to contest Lonca's granted motion for JMOL that the '567 patent was not enabled and that the court misconstrued the term "animal," thus allowing Lonza to infringe the '244 patent.
â–¡ The '244 spec defines animal explicitly thusly: “The term ‘animal’ means any organism belonging to the kingdom Animalia.â€
â–¡ The '244 spec distinguishes between different kinds of animals in preferred embodiments. Lanza argues that Martek limited the term to non-human animal when the spec is considered in its entirety.
5. Holding
Validity of the '594 claims
In order for an application to get the benefit of an earlier application, each application in the chain must sufficiently satisfy the statutory written description requirement. A sufficient parent application will reasonably convey that the inventor had possession at the time of the later claimed subject matter. The inventor need not have described the claimed subject matter in exactly the same terms in the parent application. Martek's expert witness provided enough substantial evidence for a jury to have found that the written description of the abandoned patent was sufficient to encompass claim 1 of the '594 patent and thus the '594 patent was entitled to the older priority date.
Infringement of the '281 Claims
"A patentee may prove infringement buy any method of analysis that is probative of the fact of infringement." Circumstantial evidence may be sufficient. Martek's expert witness provided substantial non conclusory evidence that supports the jury's finding of infringement by Lanza thus the lower court did not err in denying Lanza's JMOL motion.
Exclusion of Lonza's Prior Inventorship Evidence
An alleged prior inventor must provide independent corroborating evidence IN ADDITION to her own statements and documents. Such additional evidence may include: witness testimony corroborating the RTP, or documentary or physical evidence made contemporaneously with the RTP. Evidence may be excluded by the court if the only corroboration is an abandoned patent application. The lower court did not abuse its discretion by excluding Lanza's 102(g) evidence.
Claim Construction of "Non-Chloride Sodium Salt"
Assertions that the lower court legally erred in construing a claim are reviewed de novo. The district court's claim construction that "non-chloride sodium salt" includes NaOH is valid and upheld.
Validity of the '567 claims
Each issued patent claim is presumed valid. The party asserting invalidity has the burden of proof (CCE) of showing that each asserted claim is invalid. To meet the enablement requirement the spec must teach the PHOSITA how to make and use the full scope of the claimed invention w/o undue experimentation. Undue experimentation may be established via the Wands factors (i.e. quantity of experimentation, amount of guidance presented, presence/absence of working examples ...). Whereas claim 1 may possibly require experimentation with over 10,000 species, claims 4 and 5 would require experimenting with 22. Claims 4 and 5 do not require undue experimentation in order to make or use the invention. The lower court's grant of JMOL as to claims 4 and 5 is reversed.
Claim Construction of "Animal"
When a patentee explicitly defines a claim term in the patent specification, the patentee's definition controls. This includes definitions that differ from conventional meanings, or is specialized. Absent a clear disclaimer of particular subject matter, the fact that the inventor may have anticipated that the invention would be used in a particular way does not mean that the scope of the invention is limited to that context.’ The lower court erred in its claim construction, the term animal
6. Important Dicta
The dissent (Lourie & Rader) took issue only with the way that the majority construed the term "animal." The dissent's view is that the term should be construed by examining the patent in totality, not just by examining a single line "definition" by the lexicographer/inventor. Although the inventor defined the term animal to be "any organism belonging to the kingdom Animalia," the patent frequently distinguished between humans and animals throughout the claims and spec.. The dissent argues that if the lexicographer had intended the term animal to be inclusive, then they would have no need to make such distinctions throughout the patent.
7. Likely future importance or unanswered questions
It seems that this case could have the potential to let "lexicographers" be a bit more imprecise to the effect of allowing them to broaden their terms at a later time.
8. Critical Analysis
Although I think the court got the "animal" claim construction right, I also see the validity of what the dissent says. If an inventor defines a term as A and B and then proceeds to use it as B only, you could run the risk of allowing the inventor to claim more than they have invented possibly.
http://www.patentlyo.com/patent/2009/09/federal-circuit-is-a-human-an-animal-written-description-enablement-and-inventorship.html