Case Summary : CAFC Alert

The Federal Circuit indirectly imports limitations from the specification into the claims through claim construction

John M. Wang | April 24, 2017

The Medicines Company v. Mylan Inc. Etc.

April 6, 2017

Before Dyk Wallach, and Hughes.  Opinion by Dyk.

Summary

Mylan submitted two Abbreviated New Drug Applications (“ANDA”) to seek approval of Food and Drug Administration (“FDA”) for selling generic bivalirudin drug products before the expiration of patents-in-suit: the ‘727 patent and the ‘343 patent. In its ANDA, Mylan stated that it would limit the Asp9 level of its generic product to less than 2.0 percent. Medicines sued Mylan for infringement of the ‘727 and ‘343 patents. Mylan filed counter-claims seeking declaratory judgments of invalidity. The district court held that Mylan infringed the ‘727 patent, but not the ‘343 patent. The Federal Circuit reverses in part, and held that Mylan does not infringe both patents.


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Back to Basics: In re Chudik offers a refresher on the law of anticipation for functional limitations

Cindy Chen | April 17, 2017

In re Chudik

March 27, 2017

Before Dyk, Reyna, and Stoll. Opinion by Reyna.

Summary

This decision is a refresher on the basic law of anticipation for functional claim elements. A prior art does not anticipate a functional claim element merely because it is “capable of” performing the recited function, but rather, such capability must be achieved without “distortion” or “modification” to the prior art.


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CAFC refuses to second guess a district court determination on a motion for attorney fees under 285.

Thomas Brown | April 13, 2017

University of Utah v. Max-Planck-Gesellschaft zur Foerderun der Wissenschaften E.V., et al.

March 23, 2017

Before O’Malley, Reyna and Wallach.  Precedential Opinion by Reyna, joined by O’Malley and Wallach

Summary:

University of Utah (UUtah) sued Max-Planck et al. (Max-Planck) for correction of ownership for several of Max-Planck patents (the Tuschl II patents).  The district court granted Max-Planck’s motion for summary judgment but refused to grant its motion for attorney fees under 285.  The CAFC found that the district court did not abuse its discretion and affirmed the refusal to grant the 285 motion.


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Derivation not demonstrated by conception of an idea different from claimed invention, even where the idea would make the claimed invention obvious

Ryan Chirnomas | April 5, 2017

Cumberland Pharmaceuticals v. Mylan Institutional LLC

January 26, 2017

Before Moore, Reyna and Taranto.  Opinion by Taranto.

Summary

In an unusual argument, Mylan posited that Cumberland’s employee was not the inventor of a patent, but rather that the inventor was “someone at the FDA”.  Mylan based this assertion on the FDA’s seeking justification for an ingredient in an earlier formation which was excluded—without a direct substitute—in the claimed later formulation.


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Using Specific Data Structures Does Not Necessarily Survive Alice

John Kong | March 16, 2017

Intellectual Ventures I LLC, et al. v. Capital One Financial Corp., et al.

March 7, 2017

Before: Prost, Wallach and Chen.  Opinion by Prost.

Summary

This is the companion case to Intellectual Ventures I LLC, et al. v. Erie Indemnity Co. et. al., also decided on March 7, 2017.  Here, the court held that the claims are directed to the abstract idea of collecting, displaying, and manipulating data.  The recitation of specific XML data structures did not make the claims any less abstract or satisfy Alice step 2.  The claims also merely recited goals of the patent, in result-oriented language, without detailed features for how those goals are to be achieved.  As such, the claims did not provide the requisite inventive concept under Alice step 2.


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Claims reciting generic, computer implementation of abstract idea found lacking “inventive concept”

Kumiko Ide | March 13, 2017

Intellectual Ventures I LLC, et al. v. Erie Indemnity Co., et al.

March 7, 2017

Before Prost, Wallach, Chen.  Opinion by Prost.

Summary: 

The CAFC affirmed the district court’s determination that claims of both U.S. Patent No. 6,510,434 (“’434 patent”) and U.S. Patent No. 5,546,002 (“’002 patent”) are patent ineligible under 35 U.S.C. § 101.  Applying the two-part analysis from Alice, the District Court found and the CAFC affirmed the claims of both patents as being abstract ideas lacking in “inventive concept,” concluding that the claims are patent ineligible.  In addition, regarding U.S. Patent No. 6,519,518 (“’518 patent”), the CAFC affirmed that Appellants did not own rights to the patent, and therefore Appellants lacked standing to assert infringement.

連邦巡回裁判所(CAFC)は、特許法第101条に基づき、地裁の米国特許第6,510,434号及び5,546,002号には特許適格性がないという判決を支持した。地裁及びCAFCは、最高裁判決Alice事件の二段階分析(two-part analysis)を適用した上で、特許クレームは、抽象的概念(abstract ideas)であり、発明的概念(inventive concept)がないため、特許適格性がないと判断した。また、米国特許第6,519,518号については、上訴人は、当該特許の特許所有者ではないため、当事者適格がないと判示した。


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The Supply of a Single Component of a Multicomponent Invention Is Not an Infringing Act Under 35 U.S.C. §271(F)(1)

Sung-Hoon Kim | March 6, 2017

Life Technologies Corp. et al. v. Promega Corp.

February 22, 2017

Opinion by Sotomayor

Summary:

Promega sued Life Technologies for patent infringement under §271(f)(1) because Life Technologies assembled a kit for genetic testing in the U.K. with a single component manufactured in the U.S. and sold the product worldwide.  The Supreme Court reversed the Federal Circuit’s holding and held that §271(f)(1) does not cover the supply of a single component of a multicomponent invention.  The Supreme Court held that the term “substantial” in §271(f)(1) should have a quantitative meaning rather than a qualitative meaning.

Details:

Promega’s U.S. Reissue Patent No. 37,984 (“the Tautz patent”) is directed to a kit for genetic testing that can be used in various fields.  Promega (exclusive licensee of the Tautz patent) sublicensed the Tautz patent to Life Technologies, but limited the license to a specific field of use.  The patented kit has five components including a polymerase enzyme.  Life Technologies manufactured the polymerase enzyme in the U.S. and shipped it to the U.K.  Life Technologies manufactured other components, assembled all five components in the U.K, and sold the final product worldwide.  After discovering that Life Technologies was selling the product in the U.S. and overseas outside of the license, Promega sued Life Technologies for patent infringement, claiming that patent infringement liability was triggered under 35 U.S.C. §271(f)(1).

35 U.S.C. §271(f)(1):

Whoever without authority supplies or causes to be supplied in or from the United States all or a substantial portion of the components of a patented invention, where such components are uncombined in whole or in part, in such manner as to actively induce the combination of such components outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.

35 U.S.C. §271(f)(2):

Whoever without authority supplies or causes to be supplied in or from the United States any component of a patented invention that is especially made or especially adapted for use in the invention and not a staple article or commodity of commerce suitable for substantial noninfringing use, where such component is uncombined in whole or in part, knowing that such component is so made or adapted and intending that such component will be combined outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.

District Court:

The jury returned a verdict for Promega, finding that Life Technologies willfully infringed the patent.  Life Technologies then moved for judgment as a matter of law, arguing that 35 U.S.C. §271(f)(1) should not be applied because the phrase “all or a substantial portion” does not encompass the supply of a single component (polymerase enzyme).  The district court granted Life Technologies’ motion.

The Federal Circuit:

The Federal Circuit reversed and reinstated the jury’s verdict finding Life Technologies liable for infringement.  The Federal Circuit held that since the dictionary definition of “substantial” is “important” or “essential,” a single component (polymerase enzyme) could be a “substantial portion of the components.”

The Supreme Court:

The Supreme Court held that the supply of a single component (polymerase enzyme) of a multicomponent invention (genetic testing kit) is not an infringing act under 35 U.S.C. §271(f)(1).

The Supreme Court held that the term “substantial” has a quantitative meaning because neighboring terms “all” and “portion” convey a quantitative meaning, and the phase “substantial portion” is modified by “of the components of a patented invention.”  The Supreme Court rejected Promega’s suggestion to adopt both quantitative and qualitative aspects of the components (“case-specific approach”) because it is too complicated.

The Supreme Court held that reading §271(f)(1) to refer “components” as plural and §271(f)(2) to “any component” as singular allows two provisions to work in tandem.

Finally, the Supreme Court held that the history of §271(f) and Congress’s intent support the conclusion.  §271(f)(1) was enacted by Congress in response to the decision in Deepsouth Packing Co. v. Laitram Corp. case, where the Court held that it was “not an infringement to make or use a patented product outside of the U.S.”

Takeaway:

Shipping a single component of a patented invention to be combined with other components overseas is not patent infringement.  This means that companies can ship only one component of a product abroad without patent infringement liability.

How about shipping two components?  The Supreme Court left open the question of how many components are required to be “substantial portion of the components.”

In addition, the Supreme Court did not reach the issue of how to identify a component part of a patented invention under §271(f)(1).

The Supreme Court finally provided a bright-line patent law rule: liability under §271(f)(1) requires more than one component.

Full Opinion

The Phrase “Consist Of” Creates Strong Presumption That Anything Not Specified Is Excluded.

Sadao Kinashi | March 3, 2017

Shire Development v. Watson Pharma

February 10, 2017

Before: Prost, Taranto and Hughes. Opinion by Hughes.

Summary

Shire sued Watson for infringing USP 6,773,720 by filing Abbreviated New Drug Application (ANDA) with the FDA seeking to market a generic version of Shire’s brand drug.  The Patent claim recited “outer hydrophilic matrix consisting of . . . .”  Watson’s ANDA product included a small amount of Mg stearate (which is lipophilic). The district court found infringement, but CAFC reversed and held that Watson’s ANDA Product does not satisfy claim 1(b), and remanded with instructions to enter judgment of non-infringement.

Shire社は、Watson社の新薬簡略承認申請(ANDA)が米国特許USP 6,773,720を侵害するとして提訴した。特許クレームは「外部親水性基質は、~なる群から選ばれた物質のみからなる(consisting of)」と限定していた。Watson社の申請新薬の外部親水性基質は、クレームにある群に含まれないステア燐酸Mg(しかも親油性)を少量含んでいた。CAFCは、Watson社の申請新薬を非侵害とした地裁判決を覆し、該新薬はクレーム1の限定(b)を満たさないとして、非侵害とした。

I.   BACKGROUND

A.  Patent Claims

The patent is directed to a controlled-release oral pharmaceutical composition of mesalamine used to treat inflammatory bowel diseases.  The composition includes (a)the mesalamine active ingredient; (b) an inner, lipophilic matrix; (c) an outer, hydrophilic matrix; and (d) other optional excipients.  In relevant part, claim 1 reads:

  1. Controlled-release oral pharmaceutical compositionscontaining as an active ingredient 5-amino-salicylic acid, comprising:

a) an inner lipophilic matrix consisting of substances selected from the group consisting of unsaturated and/or hydrogenated fatty acid, salts, esters or amides thereof, fatty acid mono-, di- or triglycerids, waxes, ceramides, and cholesterol derivatives with melting points below 90° C., and wherein the active ingredient is dispersed both in said [sic] the lipophilic matrix and in the hydrophilic matrix;

b) an outer hydrophilic matrix wherein the lipophilic matrix is dispersed, and said outer hydrophilic matrix consists of compounds selected from the group consisting of polymers or copolymers of acrylic or methacrylic acid, alkylvinyl polymers, hydroxyalkyl celluloses, carboxyalkyl celluloses, polysaccharides, dextrins, pectins, starches and derivatives, alginic acid, and natural or synthetic gums;

c) optionally other excipients . . . .

When the outer hydrophilic matrix interacts with a person’s digestive fluids, the matrix creates a swollen barrier to prevent aqueous solution from reaching the inner lipophilic matrix.  This delay permits the product to proceed through the digestive system until the water breaks apart the outer matrix, releasing the lipophilic granules.

B.  District Decision

The district court concluded that Watson’s ANDA Product satisfied the “inner lipophilic matrix” and “outer hydrophilic matrix” limitations and that Watson’s ANDA Product satisfied the Markush limitations because the excipients falling outside the Markush groups were “unrelated” to the invention since they did not drive the water-affinity property of their respective matrices.  Watson appealed.

I.  CAFC DECISION

CAFC noted that (a) and (b) in claim 1 use the phrase “consisting of,” to characterize the matrix, and “consisting of” to define the groups, which creates a very strong presumption that the claim element is closed and excludes any elements or ingredients not specified in the claim.   CAFC also noted that overcoming this presumption requires “the specification and prosecution history” to “unmistakably manifest an alternative meaning,” such as when the patentee acts as its own lexicographer.

Although the presumption is very strong, there can be rare exception for “aspects unrelated to the invention.” Norian Corp. v. Stryker Corp., 363 F.3d 1321, 1331 (Fed Cir. 2004). In Norian, CAFC considered whether adding a spatula to a calcium phosphate chemical kit designed to repair teeth and bones took the accused product outside the scope of the asserted patent.  The claim recited only aspects of the chemicals, and CAFC concluded that “infringement is not avoided by the presence of a spatula, for the spatula has no interaction with the chemicals, and is irrelevant to the invention.”

Here, Watson’s ANDA Product does not facially satisfy the claim 1(b) Markush limitation. The Product’s extragranular space (which correspond to the outer hydrophilic matrix) contained Mg stearate, an excipient not within the claim 1(b) Markush group within the extragranular space.  Nonetheless, the district court found that Watson infringed because the component outside of the Markush group (i.e., the lipophilic Mg stearate in the hydrophilic outer matrix) is unrelated to the invention and falls within the exception (like spatula in Norian).

However, CAFC disagreed with the district court conclusion.

The district court concluded that the “Mg stearate in the extragranular space is overwhelmed by the hydrophilic properties of the sodium starch glycolate in the extragranular space” and credited expert testimony that the hydrophilic “sodium starch glycolate is more potent than the Mg stearate” when “outside” the granules.

The district court thereby found that the Mg stearate exerted lipophilic influence in the outer matrix, and that finding is well supported: Shire’s expert acknowledged that “the Mg stearate in the spaces between the granules is no less lipophilic than the Mg stearate in the granules,” and the court found that Mg stearate is so strongly lipophilic that it may “impart lipophilic characteristics to a composition even in low concentrations.”

CAFC noted that no one has suggested that Mg stearate is neither lipophilic nor hydrophilic when in the outer matrix, and CAFC concluded that, based on the district court’s findings, the Mg stearate retains its lipophilic character in the extragranular space, and that the Mg stearate structurally and functionally relates to the invention, and its presence in the outer matrix violates the “consisting of” requirement in claim 1(b).

Regarding Shire argument that the Mg stearate in Watson’s product—which Watson includes as a lubricant rather than for its lipophilic properties—is unrelated to the invention because it is not sufficiently lipophilic to render the outer matrix lipophilic.  But CAFC ruled that Norian did not restrict “related” components to only those that advance or are intended to advance a Markush group’s allegedly inventive elements.

CAFC also distinguished “consisting of” from “consisting essentially of”, which does not exclude unspecified element unless it materially affect to the novel properties of the invention.

Thus, CAFC reversed the district court’s judgment and remanded for entry of judgment of non-infringement and other proceedings consistent with this opinion.

 Takeaway

 The phrase “consisting of” creates a very strong presumption that the claim element is closed and excludes any elements or ingredients not specified in the claim.

Even if an unspecified element is overwhelmed by the properties of the specified element, Norian exception is not applied as long as the unspecified element has some effect.

The phrase “consisting essentially of” is preferable to “consisting of”, but Examiners often reject to “consisting essentially of” and we have problem of support to effectively rebut the rejection.

How about the case where the unspecified element is detectable but too little to have recognizable effect?

Full Opinion

Another Patent Invalidated by Inter Partes Review and BRI Standard

Stephen G. Adrian | February 27, 2017

MPHJ Technology Investments, LLC v. Ricoh Americas Corporation, XEROX Corporation, Lexmark International, Inc.

February 13, 2017.

Before Newman, Laurie and O’Malley.  Opinion by Newman

Summary

This decision is another example of a patent being invalidated by prior art in an inter partes review based upon the broadest reasonable interpretation (BRI) standard. Interestingly, MPHJ had argued that a narrower interpretation should have been employed based upon the description in its provisional application. Although a provisional application can contribute to understanding the claims, the CAFC found that the non-provisional application had deleted the more limiting language which was in the provisional application. As such, the CAFC affirmed the PTAB’s claim construction, which resulted in affirmance of anticipation by the prior art.


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When the acts of one are attributable to the other.

Adele Critchley | February 16, 2017

Eli Lilly and Company, v. Teva Parenteral Medicines, Inc., APP Pharmaceuticals LLC., Pliva Hrvatska D.O.O., Teva Pharmaceuticals USA, Inc., Barr Laborites, Inc.

January 12, 2017

Before Prost, Newman and Dyk.  Opinion by Prost.

Summary:

The case centered on Eli Lilly’s patent directed to methods of administering a chemotherapy drug after pretreatment with two common vitamins. The drug was marketed under the brand name ALIMTA®. The Defendants had submitted ANDAs seeking approval of a generic version of ALIMTA®. The CAFC upheld the district counts findings, in favor of Eli Lilly’s patent, in full. The issues addressed were induced infringement, and invalidity issues of indefiniteness, obviousness and obvious-type double patenting.

Details:

Eli Lilly is the owner of U.S. Patent No., 7,772,209 (patent ‘209), directed to methods of administering the chemotherapy drug “pemetrexed’ after pretreatment with two common vitamins (folic acid and vitamin B12). The purpose of the dual vitamin pretreatments is to reduce the toxicity of the pemetrexed to the patients. The drug was marketed under the brand name ALIMTA®.

The Defendants notified Eli Lilly that they had submitted ANDAs seeking approval of a generic version of ALIMTA®. After the ‘209 patent issued, Defendants sent Eli Lilly notices that they had filed Paragraph IV certifications under 21 U.S.C. §355(j)(2)(A)(vii)(IV), declaring that the patent was invalid, unenforceable or would not be infringed. Eli Lilly subsequently brought a consolidated action against the Defendants for infringement, alleging that the generic drug would be administered with folic acid and vitamin B12 pretreatments.

Eli Lilly asserted a number of claims at trial, all of which required patient pretreatment by ‘administering’ or ‘administration of’ folic acid, and a number of dependent claims which defined dosage restrictions.

The parties agreed for the purpose of appeal that no single actor performs all steps, rather they are divided between patient and physician.  Specifically, physicians administered vitamin B12 and pemetrexed, while the patient folic acid.

Initially, in June 2013, Defendants conditionally conceded induced infringement under the then-current law set forth in Akamai II (Akamai II held that “induced infringement can be found even if there is no single party who would be liable for direct infringement”). At the time, Akamai was subject of a petition to the Supreme Court for a writ of certiorari. The parties’ stipulation included a provision reserving Defendants right to litigate infringement if the Supreme Court reversed or vacated Akamai II.  While an appeal on invalidity was pending (district court had held the claims were not invalid), the Supreme Court reversed Akamai II, holding the liability for inducement cannot be found without direct infringement. In view of this, the parties in this case filed a joint motion to remand the matter to the district court for the limited propose of litigating infringement. CAFC granted the motion. The district court held a second bench trial and concluded that Defendants would induce infringement of the ‘209 patent. The court had applied the intervening Akamai V decision, which had broadened the circumstances in which others’ acts may be attributed to a single actor to support direct infringement liability.

Defendants timely appealed. The CAFC upheld the district courts findings, addressing each issue in turn.

(I) “Whoever actively induces infringement of a patent shall be liable as an infringer.” Importantly, liability for induced infringement “must be predicated on direct infringement.” (Akamai III). The patentee must also show that the alleged infringer “knew or should have known his actions would induce actual infringements.” A patentee seeking relief under §271(e)(2) bears the burden of prove.

The district court relied in part on the Defendants’ proposed product labeling as evidence of infringement. The labeling consisted of two documents: the Physician Prescribing Information and the Patient Information. Amongst other things, the information provides the following:

Instruct patients to initiate folic acid 400 [m]g to 1000 [m]g orally once daily beginning 7 days before the first dose of [pemetrexed]…

Instruct patients on the need for folic acid and vitamin B12 supplementation to reduce treatment-related hematologic and gastrointestinal toxicity…

To lower your chances of side effects of [pemetrexed], you must also take folic acid and vitamin B12 prior to and during your treatment with [pemetrexed].

It is very important to take folic acid and vitamin B12 during your treatment with [pemetrexed] to lower your chances of harmful side effects.  You must start taking 400-1000 micrograms of folic acid every day for at least 5 days out of the 7 days before your first dose of [pemetrexed].

The CAFC held that where, as here, no single actor performs all the steps of the method claim, direct infringement only occurs if “the acts of one are attributable to the other such that a single entity is responsible for the infringement.” Akamai V. In Akamai V, the CAFC held that directing or controlling other’s performance includes circumstances in which an actor (1) conditions participation in an activity or receipt of a benefit upon another’s performance of one or more steps of a patented method, and (2) establishes the manner or timing of that performance. The district court applied this two-point prong test to the subject case.

With respect to the first prong – the CAFC agreed with the district court’s findings. Specifically, the labeling information repeatedly instructs the patients to take folic acid and provides information about the dosage range and schedule. The labeling information explains that the folic acid is a “requirement for premedication” in order to “reduce the treatment-related hematologic and gastrointestinal toxicity” of pemetrexed. Eli Lilly’s expert testified that it is “the physician’s responsibility to initiate the supplementation of folic acid.” The patient information also informs patients that a physician may withhold pemetrexed treatment based on blood tests. Eli Lilly’s expert testified that a physician would withhold treatment if the patient had not taken their required dosage of folic acid to avoid toxicity.

The Defendants argued that the product labeling was mere guidance and insufficient to show conditioning. The Defendants also argued there is no evidence that physicians go further to “verify compliance” with their instructions. The CAFC replied that conditioning does not necessarily require double checking.

Next, the Defendants argued that an actor can only condition the performance of a step by imposing a legal obligation to do so. The CAFC rejected this argument, stating that infringement is not limited solely to contractual arrangements, and the like.

With respect to the second prong – the CAFC agreed with the district court’s findings. Specifically, the Physician Prescribing Information instructs physicians to tell patients to take folic acid at specific dosages and at a specific schedule. Moreover, the testimony of a Dr. Chabner was highlighted in part affirming that “it is the doctor” who “decided how much” the patient takes.

Defendants argued that patients are able to seek additional outside assistance regarding folic acid administration, but the CAFC held this was immaterial.

Thus, the two-point prong test of Akamai V was met. However, the mere existence of direct infringement by physicians is not sufficient to find liability for induced infringement. Eli Lilly carried this burden.

The district court held that the administration of folic acid before pemetrexed administration was ‘not merely a suggestion or recommendation, but a critical step,’ in light of the Defendants proposed labeling.

Defendants argued that Eli Lilly has not offered any evidence of what physicians do in general but only speculation about how they may act. They argued that physicians must go beyond labeling. The CAFC found this argument unavailing. For the purpose of inducement “it is irrelevant that some users may ignore the warnings in the proposed label,” if the label “encourage(s), recommend(s) or promote(s) infringement.” The product labeling included repeat instructions and warning regarding the importance of folic acid.

(II) Indefiniteness of “vitamin B12” – the Defendants argued in view of Nautilius that vitamin B12 is indefinite as the term is used in two different ways in the intrinsic record (vitamin B12 and Cyanocobalamin).

The district count accepted the testimony of Eli Lilly’s expert that one of ordinary skill in the art would understand in the context of the patent claims vitamin B12 to mean Cyanocobalamin. The CAFC saw no error in the districts court findings, holding that vitamin B12 has a plain meaning to one of skill in this particular art.

In addition, it was noted that claim 1 required administering a “methylmalonic acid lowering agent…” and claim 2 “vitamin B12.” Therefore, if vitamin B12 was to refer to a whole class of compounds it would be the same scope as claim 1. However, the doctrine of claim differentiation presumes that dependent claims are of narrower scope, and so reading the claims as to require ‘vitamin B12’ of claim 2 to be a specific compound within the scope of “methylmalonic acid lowering agent” avoids this problem.

The Defendants argued that if vitamin B12 means Cyanocobalamin, the given Markush group in claim 1 of the “methylmalonic acid lowering agent,” lists the same compound twice. The CAFC held that the mere fact that a compound may be embraced by more than one member of a Markush group recited in the claim does not necessarily render the scope unclear. The CAFC held the redundancy is support by the prosecution history (the Examiner had stated they were the same, in response the patentee removed Cyanocobalamin, but later put the term back into the claim).

(III) Obviousness – the CAFC agreed with the district counts finding that a skilled artisan would have concluded that vitamin B12 deficiency was not the problem in pemetrexed toxicity.

In brief, the Defendant had relied upon an Abstract published from an Eli Lilly scientist that showed homocysteine levels served as an indicator of either a folic acid or vitamin B12 deficiency and that such levels were elevated with increased pemetrexed toxicities. However, the levels of another marker methylmalonic acid (MMA), which more specifically is an indicator of just vitamin B12 deficiency, showed no correlation. The CAFC indicated this was sufficient for the claims not to be rendered obvious.

(V) Obviousness-type double patenting – the Defendants argued that the claims are not valid over an Eli Lilly’s earlier patent (US 5,271,974 – ‘974). The district court disagreed, and the CAFC upheld.

In brief, the ‘974 patent more broadly claimed a much greater amount of folic acid with an antifolate agent administrated to a mammal.  The claims of the subject patent are much more specific with regards to the amount of folic acid and the administration of a specific antifolate agent to a patient. The CAFC held this was sufficient for the claims to be patentably distinct.

Comments:

Method claims drafted to encompass actions of a single entity are still preferable, in order to reduce burden of proving infringement. However, where no single entity performs all the steps, direct infringement can be found if the steps of the method claim are performed under the control or direction by a single entity.

Naturally, patent specification drafters should always endeavor to be careful in their use of claim terminology.  Even so, where claim terms are have a specific meaning in their relevant arts, the courts tend to not apply those terms contrary to their common understanding, unless the applicant clearly intended to redefine the term.

Full Opinion

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