Case Summary : CAFC Alert

Claims Directed to the Abstract Idea of Encoding/Decoding Image Data are Found Not Patent Eligible

Bill Schertler | May 22, 2017

RecogniCorp v. Nintendo

April 28, 2017

Before Lourie, Reyna and Stoll.  Opinion by Reyna.

Summary:

RecogniCorp sued Nintendo in district court for infringement of U.S. Patent No. 8,005,303 (“ the ‘303 patent”) directed to a method and apparatus for encoding/decoding image data.  Nintendo filed a motion for judgment on the pleadings, asserting that the claims were ineligible under 35 U.S.C. §101.  The district court concluded that RecogniCorp’s claims failed the Alice test, and granted Nintendo’s motion.  On appeal, the Court of Appeals for the Federal Circuit (CAFC) affirmed, finding that the ‘303 patent’s claims are directed to the abstract idea of encoding and decoding image data, and the claims do not contain an inventive concept sufficient to render the claims patent eligible.


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The On-Sale Bar Under the America Invents Act Does Not Require a Public Disclosure of the Invention

Andrew Melick and Yoshiya Nakamura | May 9, 2017

Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc.

May 1, 2017

Before Dyk, Mayer and O’Malley. Opinion by Dyk

Summary:

Helsinn Healthcare S.A.’s (“Helsinn”) patents were invalidated based on the on-sale bar of § 102. One of the patents invalidated is an AIA patent, so the CAFC addressed whether the law for the on-sale bar has changed under the AIA. The CAFC declined to adopt the change proposed by Helsinn to require that the invention be publicly disclosed in the terms of a sale agreement for the on-sale bar to apply. The CAFC essentially stated that if the law has changed under AIA it is only that the fact of the sale be public, not that the terms of the sale include a description of the invention that is made available to the public. In this case, the fact of the sale was made public without publicly disclosing details of the invention. The CAFC held that this is enough in this case for the on-sale bar to apply for both pre-AIA § 102 and AIA § 102.

Japanese Summary

本件は、米国改正法(AIA)102(a)(1)条における新規性欠如要件の1つである「販売行為(on sale)」の解釈について争われたケースである。改正前では、発明を秘密にした状態の販売行為(secret sale)も場合により「販売行為」に該当し得るとされていた(判例法)。たとえば、出願可能な程度に発明が完成しており、第三者と販売のライセンス契約等が成立すると「販売あるいは販売の申し出」をしたことになる。しかし、改正により発明新規性の条文が大幅に変わり、102(a)(1)条においては「販売された」等に加えて「その他公に利用に可能とった(or otherwise available to the public)」発明には特許を付与しないと規定された。この「公に利用可能となった」のフレーズが挿入されたため、販売に際しても、いわゆる秘密販売を除外したと説明されているが(特許庁ガイドライン)、曖昧な点が多く、改正法下での判例法の蓄積が待たれている。

本件では、出願人と第三者との間で、出願前に発明薬剤の販売についてライセンス契約が行われ、そのライセンス契約の内容が公開された。しかし、クレームに記載されていた特定の投与量の情報は開示されなかった(ただし当事者間ではその投与量の使用に合意はあった)。

地裁は、ライセンス契約で特定の投与量の情報が開示されなかったため、クレームの発明が開示されたことにはならないとして、「販売された」の要件を満たさず、特許は有効と判断した。控訴審(CAFC)はその地裁の判断を覆した。CAFCは、「販売された」というためには、発明の詳細(すべてのクレーム要素)が開示されている必要はないと判示し、上記ライセンス契約により特許は無効であると判決した。すなわち、改正法下でも「販売された」の意味は実質的に変わらず、「販売」の成立に際して、必ずしも発明が「公に利用可能となる」ことが要件ではないと示唆された。なお、本件では、契約内容が秘密である場合の秘密販売(secret sale)やいわゆる公用(public use)のケースについてCAFCは判断を避けており、これらのケースについては別の判例を待つ必要があるであろう。


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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

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