Satisfying Written Description When Therapeutic Effectiveness is Claimed
| June 26, 2019
Nuvo Pharmaceuticals v. Dr. Reddy’s Laboratories
Summary
The CAFC reversed and dismissed a holding by the District Court that the claims of the ‘907 and the ‘285 patents had adequate written description regarding the efficacy of an uncoated PPI. The CAFC states that it not necessary to prove that a claimed pharmaceutical compound actually achieves a certain result. However, if the claim recites said result, then there must be sufficient support in the specification. Herein, the claims were held invalid because the therapeutic effectiveness of uncoated PPI, which was recited in the claims, was not supported by the specification.
Details
The use of a non-steroidal anti-inflammatory drug (hereinafter “NSAID”), such as aspirin, can cause gastrointestinal problems, and thus, some patients are prescribed an acid inhibitor, such as proton pump inhibitor (PPI), to be taken with said NSAID. However, even this combination therapy may be problematic. That is, if the PPI has not taken affect before the administration of the NSAID then gastrointestinal problems may still occur.
The U.S. Patent Nos. 6,926,907 (hereinafter “the ‘907 patent”) and 8,557,285 (hereinafter “the ’285 patent”) are directed towards a coordinated release drug formulation comprising an acid inhibitor/PPI and a NSAID. The coordinated release drug allows for an acid inhibitor to work before the release of the NSAID and thereby minimizes potential gastrointestinal problems. The ‘285 patent is a related patent of the ‘907 patent and both share a specification. Claim 1 of the ‘907 patent and claim 1 of the ‘285 patent are presented below:
Claim 1 of the ’907 patent:
1. A pharmaceutical composition in unit dosage form suitable for oral administration to a patient, comprising:
(a) an acid inhibitor present in an amount effective to raise the gastric pH of said patient to at least 3.5 upon the administration of one or more of said unit dosage forms;
(b) a non-steroidal anti-inflammatory drug (NSAID) in an amount effective to reduce or eliminate pain or inflammation in said patient upon administration of one or more of said unit dosage forms;
and wherein said unit dosage form provides for coordinated release such that:
i) said NSAID is surrounded by a coating that, upon ingestion of said unit dosage form by said patient, prevents the release of essentially any NSAID from said dosage form unless the pH of the surrounding medium is 3.5 or higher;
ii) at least a portion of said acid inhibitor is not surrounded by an enteric coating and, upon ingestion of said unit dosage form by said patient, is released regardless of whether the pH of the surrounding medium is below 3.5 or above 3.5.
(emphasis added)
Claim 1 of the ’285 patent:
1. A pharmaceutical composition in unit dosage form comprising therapeutically effective amounts of:
(a) esomeprazole, wherein at least a portion of said esomeprazole is not surrounded by an enteric coating; and
(b) naproxen surrounded by a coating that inhibits its release from said unit dosage form unless said dosage form is in a medium with a pH of 3.5 or higher;
wherein said unit dosage form provides for release of said esomeprazole such that upon introduction of said unit dosage form into a medium, at least a portion of said esomeprazole is released regardless of the pH of the medium.
(emphasis added)
Nuvo, who owns the ‘907 and ‘285 patents, make and sells Vimovo, which is the commercial embodiment of the patents. The patented drug achieves a coordinated release of the acid inhibitor and the NSAID in a single tablet. The core of the tablet is NSAID, which is coated so as to prevent its release before the pH has increased to a desired level, and an acid inhibitor, like PPI, on the outside of the coating, that actively works to increase the pH to said desired level. The PPI is uncoated. The specifications discloses methods for preparing and making the claimed drug formulations and provides examples of the structure and ingredients of the drug formulations but does not disclose any experimental data demonstrating the therapeutic effectiveness of any amount of uncoated PPI and coated NSAID in a single dosage form. Id. at 6. The specification discloses that coated PPIs avoid destruction by stomach acid but may not work quickly enough and the specification does not have any disclosure regarding the effectiveness of uncoated PPIs being able to raise pH. The inventor of the ‘907 and ‘285 patents recognized that an uncoated PPI is at greater risk of being destroyed by stomach acid, which would undermine the effectiveness of the PPI, but contemplated that uncoated PPI would allow for immediate release into a patient’s stomach and achieve an increase in pH level.
Dr. Reddy’s Laboratories, Inc., Mylan Pharmaceuticals, and Lupin Pharmaceuticals (hereinafter “the Generics”) submitted an Abbreviated New Drug Applications (ANDAs) to the U.S. Food and Drug Administration seeking approval to sell a generic version of Vimovo. Dr. Reddy’s submitted a second ANDA wherein the product would contain a small amount of uncoated NSAID on the outermost layer of the tablet, which is separate from the coated-core-NSAID.
Nuvo sued the Generics in the U.S. District Court for the District of New Jersey, in order to prevent the Generics from entering the market upon approval of the ANDAs, alleging all ANDAs products would infringe the ‘907 and ‘285 patents. The Generics stipulated to infringement, except for Dr. Reddy’s second ANDA product, and then countered that the ‘907 and ‘285 patents were invalid for obviousness, lack of enablement and inadequate written description.
The District Court granted Dr. Reddy’s motion for summary judgment of noninfringment of the ‘907 patent with regards to the second ANDA product. A bench trail was held regarding the validity of the ‘907 patent, the ‘285 patent, and whether the second ANDA product by Dr. Reddy infringed the ‘285 patent. It was concluded that the claims were not obvious over the prior art “because it was nonobvious to use a PPI to prevent NSAID-related gastric injury, and persons of ordinary skill in the art were discouraged by the prior art from using uncoated PPI and would not have reasonably expected it to work.” Id. at 8. It was also held that the claims of both patents were enabled and there was sufficient written description. The District Court held that the second ANDA by Dr. Reddy infringes the claims of the ‘285 patent.
At the District Court, the Generics argued that, “if they lose on their obviousness contention, then the claims lack written description support for the claimed effectiveness of uncoated PPI because ordinarily skilled artisans would not have expected it to work and the specification provides no experimental data or analytical reasoning showing the inventor possessed an effective uncoated PPI.” Id. at 9. Nuvo countered that “experimental data and an explanation of why an invention works are not required, the specification adequately describes using uncoated PPI, and its effectiveness is necessarily inherent in the described formulation.” Id. at 9. The District Court rejected Nuvo’s argument that effectiveness does not need to be described because effectiveness is inherent. The District Court acknowledged that the specification of the ‘907 and ‘285 patents did not describe efficacy of uncoated PPI. However, the District Court did conclude that there was sufficient written description because “the specification described the immediate release of uncoated PPI and the potential disadvantages of coated PPI, namely that enteric-coated PPI sometimes works too slowly to raise the intragastric pH. The district court did not explain why the mere disclosure of immediate release uncoated PPI, coupled with the known disadvantages of coated PPI, is relevant to the therapeutic effectiveness of uncoated PPI, which the patent itself recognized as problematic for efficacy due to its potential for destruction by stomach acid.” Id. at 10. The Generics appeal the written description ruling and Nuvo cross-appeals the District Court grant of summary judgment of noninfringement. Based solely on the written description issue regarding the claim language of “efficacy”, the CAFC reversed the appeal and dismissed the cross-appeal.
Before the CAFC, the Generics argued that the patents claim uncoated PPI that raises the gastric pH to at least 3.5, but that in view of the District Court’s holding, as part of the obviousness analysis, a skilled artisan would not have expected uncoated PPI to be effective to raise gastric pH, and that the specification of the patents fails to disclose the effectiveness of uncoated PPI. Id. at 12. Nuvo argued that “the claims do not require any particular degree of efficacy of the uncoated PPI itself, it is enough that the specification discloses making and using drug formulations containing effective amounts of PPI and NSAID, and experimental data and additional explanations demonstrating the invention works are unnecessary.” Id. at 12. The CAFC held that the District Court’s analysis does not support its conclusion of adequate written description and gave a review of the record to establish that the clear error standard has been met. “A written description finding is review for a clear error.” Id. at 11.
First, the CACF rejected Nuvo’s argument that the claims do not recite an efficacy requirement for uncoated PPI. As noted above, claim 1 of the ‘907 patent discloses “an acid inhibitor present in an amount effective to raise the gastric pH of said patient to at least 3.5” and claim 1 of the ‘285 patent discloses “therapeutically effective amounts of (a) esomeprazole….” The CAFC held that the claims of both patents require an amount of uncoated PPI effective to raise the gastric pH to at least 3.5. Id. at 14. Further, the CAFC noted that Nuvo’s argument, which is an attempt to “either recharacterizing the written description dispute or rewriting the claim language”, is being presented for the first time on appeal and is thus forfeited. The CAFC held that, before the District Court, the parties characterized that “claims require a therapeutically effective amount of uncoated PPI that would raise the gastric pH to at least 3.5”, that this understanding was “a fair reading of the claim language” and this understanding will not be altered in the appeal. Id. at 16.
Next, Nuvo argued that the expert testimony of Dr. Williams identified four portions of the specification that provided written description support. The Generics argued that the noted portions only disclose typical dosage amounts of uncoated PPI, the use of uncoated PPI in a drug formulation and did not discuss or explain efficacy of uncoated PPI. The CAFC agreed with the Generics. “We have expressly rejected the “argument that the written description requirement … is necessarily met as a matter of law because the claim language appears in ipsis verbis in the specification.” Enzo Biochem, Inc. v. GenProbe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002).” Id. at 18. The CAFC noted that the case law does not requirement experimental data to establish effectiveness or an explanation of how or why a claimed composition will be effective. Id. at 18. Nevertheless, the CAFC held that the “record evidence demonstrates that a person of ordinary skill in the art would not have known or understood that uncoated PPI is effective.” Id. at 18. The CAFC held that the specification is fatally flawed since the “the specification provides nothing more than the mere claim that uncoated PPI might work, even though persons of ordinary skill in the art would not have thought it would work…. It does not demonstrate that the inventor possessed more than a mere wish or hope that uncoated PPI would work, and thus it does not demonstrate that he actually invented what he claimed: an amount of uncoated PPI that is effective to raise the gastric pH to at least 3.5” Id. at 19. The inventor’s own testimony confirms this holding. At trial, the inventor admitted “that he only had a ‘general concept of coordinated delivery with acid inhibition’ using uncoated PPI at the time he filed his first patent application.” Id. at 19.
Lastly, Nuvo argued that the written description requirement was satisfied due to the disclosure of how to make and use the claimed invention and accept that therapeutic effectiveness of uncoated PPI is a matter of inherency. Id. at 20 and 21. The Generics argued that Nuvo’s assertion did not satisfy written description but would only satisfy the enablement requirement, which is a separate and distinct requirement. Nuvo cited Alcon Research Ltd. v. Barr Laboratories, Inc., 745 F.3d 1180 (Fed. Cir. 2014) for support but the CAFC quickly dismissed this and noted that the factual circumstances of Alcon were “markedly different”. Id. at 22. In Alcon, the patent reference presented example formulations and disclosed data showing stability testing of the claimed invention. Further, the CAFC stated that only “under a narrow set circumstance” would inherency satisfy the written description requirement. Nuvo cited Allergan to support their argument that the claimed efficacy of uncoated PPI is necessarily inherent in the specification’s explicit disclosure of methods for making and using drug formulations containing uncoated PPI. The CAFC agreed with the Generics that the factual circumstances of Allergan are not applicable to the present case. In Allergan, the parties did not dispute the therapeutic efficacy of the claimed formulation and the specification in Allergan presented experimental results that established a trend in clinical effectiveness.
Based on the specific facts of certain cases, it is unnecessary to prove that a claimed pharmaceutical compound actually achieves a certain result. But when the inventor expressly claims that result, our case law provides that that result must be supported by adequate disclosure in the specification. In this case, the inventor chose to claim the therapeutic effectiveness of uncoated PPI, but he did not adequately describe the efficacy of uncoated PPI so as to demonstrate to ordinarily skilled artisans that he possessed and actually invented what he claimed. And the evidence demonstrates that a person of ordinary skill in the art reading the specification would not have otherwise recognized, based on the disclosure of a formulation containing uncoated PPI, that it would be efficacious because he or she would not have expected uncoated PPI to raise gastric pH. Under those facts, the patent claims are invalid for lack of adequate written description pursuant to § 112, ¶ 1.
(emphasis added). Id. at 24.
The CAFC holds that the ‘907 patent and the ‘285 patent invalid for lack of adequate written description with regards to the claimed effectiveness of uncoated PPI. The CAFC did not address the other issues on appeal and cross-appeal.
Takeaway
- Before
filing an application, one may consider identifying the written description support
in the specification for each individual feature of a claim
- Given the narrow set of circumstances, try not to rely upon inherency to satisfy written description
- If possible, include experimental data of drug formulations
Instruction from PTO on Software Composition Claims
| August 28, 2013
Ex parte Mewherter, 2012-007962 (PTAB, 2013)
The Patent Office rarely designates decisions of the Patent Trial and Appeal Board as being “precedential,” but when it does, practitioners take note. The Patent Office’s designation last week of Ex parte Mewherter, 2012-007692 as falling in that category will be of particular interest to those handling software patent applications.
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Amending to exclude a species via a negative limitation may violate the written description requirement
| August 7, 2013
In re Bimeda Research & Development Limited
July 25, 2013
Panel: Rader, Clevenger, Prost. Opinion by Clevenger. Concurrence by Rader.
Summary:
The court held a negative limitation to exclude a genus does not provide 112, first paragraph written description support to claim a negative limitation that excludes a species, which species was never mentioned in the application.
Tags: genus > negative limitation > species > written description
CAFC Draws a Line in the Sand as to Adding “Boundary” Lines; PTO recants earlier design practice
| April 3, 2013
In re Owens
March 26, 2013
Panel: Prost, Moore and Wallach. Opinion by Prost.
Summary
Although a practice previously endorsed by the USPTO, the CAFC now holds that the addition of a “boundary” line to a design application constitutes the addition of new matter. Since the parent application gave no indication of one portion of the design being separable from the remainder, the CAFC held that there was no “possession” of the later modification in the original application.
Tags: design > design patents > new matter > possession > written description
Applicant’s failure to request claim construction under §112, 6th paragraph may invoke waiver of such claim construction
| January 23, 2013
In re Avid Identification Systems, Inc.
January 8, 2013
Panel: Lourie, Clevenger and Bryson. Opinion by Lourie. Dissent by Clevenger.
Summary:
The Examiner rejected claims of a patent at issue, and the PTO board maintained the rejection finding that a means-plus function limitation was found in prior art where its broadest reasonable meaning was given. CAFC affirmed the PTO decision, and denied the Applicants’ request for a claim construction under § 112, 6th paragraph, instead of the broadest reasonable interpretation. CAFC reasoned that the Applicants waived that claim construction by failing to raise the issue during the procedure in the PTO. The dissenting opinion pointed out that the claim construction according to § 112, 6th paragraph is mandatory as the statutory requirement where the claim term clearly invokes the application of § 112, 6th paragraph.
出願人はクレームが自明であるとして拒絶した特許庁審判部の判断を不服として、ＣＡＦＣに控訴した。問題のクレームには、ミーンズプラスファンクション（”means for”の用語を用いた限定 ）を記載がある。そのような記載があると通常、特許法112条第6パラグラフの適用があり、その機能限定は明細書に開示されている構造もしくはそれと均等な構造を記載していると限定解釈される。しかしながら、本件では、特許庁審査官および審判部は、そのミーンズプラスファンクションの限定を、一般的な構造限定のときのように合理的な範囲で最も広い意味（broadest reasonable meaning）の基準を用いて解釈した。この広い解釈に基づいてその機能限定は先行技術に記載されていると特許庁は判断した。この経緯に関してＣＡＦＣは、出願人は特許庁の手続きにおいて112条第6パラグラフの適用を自ら主張しなかったためその機会を放棄したと判断し、出願人の主張を退けた。ＣＡＦＣ裁判官の１人は、112条第6パラグラフの適用は制定法上の要求であり、出願人や審査官が同法に基づく限定解釈を要求しなくても先ずその解釈を採用すべきであるとの反対意見を述べた。
Tags: means > means-plus-function > procedural issues > waiver
Method Claim Survives Over MPF Claim’s Demise Under Aristocrat
| November 28, 2012
ePlus, Inc. v. Lawson Software, Inc.
November 21, 2012
Dyk, Prost, O’Malley. Opinion by Prost.
Summary:
This case serves as a reminder of the importance of having different claim types. ePlus’ jury verdict of infringement of two systems claims was vacated because the Federal Circuit found one means-plus-function element recited therein to lack the requisite corresponding structure being disclosed in the specification, thereby rendering the claims indefinite under 35 USC §112, second paragraph. However, the infringement of a similar method claim reciting the same function as the means-plus-function element was affirmed.
Tags: §112 > §112 sixth paragraph > Aristocrat > claims drafting > indefiniteness > means > means-plus-function
When should incorporation by reference language be taken care of?
| July 11, 2012
Hollmer v. Harari
June 7, 2012
Panel: Prost, Mayer, O’Malley. Opinion by Prost
Summary
During the interference proceedings, Harari relied on the disclosure of 07/337,579 (‘579 application) which had been originally incorporated by the earliest 3rd great grandparent application 07/337,566 (‘566 application) of the subject application 09/310,880 (‘880 application). The ‘566 application included the disputed incorporation statement and had been abandoned. Two intervening applications copied the same statement and had been patented. The subject application (‘880 application) included the copy of the statement, but Harari corrected the incorporation statement by preliminary amendment which, according to Hollmer, was new matter because it would newly introduce the disclosure of ‘579 application. CAFC decided for Harari by applying the relaxed “reasonable examiner” standard (Harari I, 602 F.3d 1348). However, Harari was not allowed to claim the benefit of the filing date of the ‘566 application because CAFC found that the intervening applications in the chain leading back to the earlier ‘566 application did not comply with the written description requirement due to the ambiguous incorporation statement by applying the strict “person of ordinary skill” standard.
本件は、米国特有の”incorporation by reference”プラクティスに関するものである。インターフェアレンス手続において、Harariは最先の出願(566出願)が”incorporation by reference”によって引用した米国出願(579出願)の開示内容に依存した。566出願は不十分な”incorporation by reference”の記述を含んでいたがそのまま放棄された。566出願の出願日の利益を主張する出願がその後5代に渡って続き、全ての出願は当該不十分な”incorporation by reference”の記述をコピーしていた。Harariは5代目の本願(880出願)を予備補正して”incorporation by reference”の記述を訂正したが、2代目と3代目の中間の出願はそのような訂正を経ずに特許になってしまっていた。本願に関する予備補正が新規事項の追加になるか否かの争いについて、CAFCは、ゆるやかな「審査官の観点」の基準を適用して予備補正が適切であると判断した。一方、本願が特許法第120条の利益を享受して最先の出願日に遡るためには全ての中間の出願が” written description requirement”の要件を満たす必要がある。この要件が不十分な”incorporation by reference”によって妨げられるか否かの争いについて、CAFCは、より厳しい「当業者の観点」の基準を適用して第120条の利益を認めなかった。
[実務上の指針] 最先の出願日に遡るためには、その間にある全ての中間の出願を補正して適切な”incorporation by reference”の記述を含むようにしておくことが必要。
Tags: §120 > Incorporation by reference > written description
Means-Plus-Function: The Achilles’ Heel
| May 9, 2012
Noah Systems, Inc. v. Intuit, Inc.
April 9, 2012
Panel: Rader, O’Malley and Reyna. Opinion by Judge O’Malley
Summary
This decision illustrates that a patent could become invalidated even after surviving challenges of reexamination, which strengthen the presumption of validity, when a challenger discovers the Achilles’ Heel of a means-plus-function claim element resulting in a summary judgment of invalidity by the CAFC. Noah appeals the granting, by the United States District Court for the Western District of Pennsylvania (DC), of Intuit’s Motion for Summary Judgment of Invalidity of USP 5,875,435 (the ‘435 patent) based on indefiniteness for a means-plus-function claim element without the DC hearing evidence of how one of skill in the art would view the specification. The CAFC affirms by finding that the specification discloses no algorithm when the specification discloses an algorithm that only accomplishes one of two identifiable functions performed by the means-plus-function limitation.
Tags: accounting > algorithm > expert testimony > financial > indefiniteness > invalidity > means-plus-function > software > summary judgment > ThomasBrown
The Patent Court revisits IPXL doctrine regarding prohibition on hybrid claiming
| February 29, 2012
HTC Corporation v. IPCom GmbH & Co.
January 30, 2012
Panel: Bryson, Linn and O’Malley. Opinion by O’Malley.
Summary
HTC Corporation and HTC America, Inc. sued IPCom GmbH & Co., KG seeking a declaration that it did not infringe claims of IPCom patents. IPCom counterclaimed alleging infringement. HTC moved for summary judgment of invalidity on the ground that claims 1 and 18 of U.S. Patent No. 6,879,830 owned by IPCom were indefinite because (1) they claimed both an apparatus and method steps; and (2) the means-plus-function limitation “arrangement for reactivating,” found in the last paragraph of claims 1 and 18, was indefinite because the patent failed to disclose structure corresponding to the claimed function. On summary judgment, the district court agreed with HTC that claims 1 and 18 were indefinite based on the Federal Circuit’s precedent in IPXL Holdings, L.L.C. v. Amazon.com, Inc prohibiting hybrid claiming of apparatus and method steps in the same claim, but rejected HTC’s argument that the claims were indefinite for failing to disclose the structure corresponding to the means-plus-function limitation. On appeal, the Federal Circuit reversed the district court’s judgment of invalidity based on hybrid claiming, but did not disturb the district court’s finding regarding the means-plus-function limitation. The Federal Circuit held that the district court misconstrued the asserted claims and that the patent did not describe any improper hybrid claiming of apparatus and method steps in the same claim because the claims, when properly construed, were drawn to only an apparatus and the prohibition on hybrid claiming under IPXL was inapplicable to claims 1 and 18.
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Tags: claim construction > hybrid claiming > indefiniteness > means-plus-function > preamble-within-a-preamble
More on Typhoon: Knowledge in the Art as a Factor in Determining Sufficiency of Corresponding Algorithm
| January 4, 2012
Since the CAFC was relatively quiet last week due to the holidays, this week we revisit Typhoon, which we discussed in our post last week. In the second half of this case, the CAFC continued their review of the district court’s claim interpretation. The CAFC reviewed the MPF claim term “means for cross-referencing responses to said inquiries with possible responses from one of said libraries.” The CAFC chose to emphasize a 1985 case, Shatterproof Glass, in indicating that the amount of detail required in the specification is related to the existing knowledge in the field of endeavor.
