Specification Issues : CAFC Alert

Satisfying Written Description When Therapeutic Effectiveness is Claimed

Bernadette McGann | 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

Scott Daniels | 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

Lee Wright | 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.


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Improper NDA Defeats Trade Secrets and Overly Broad Patent Claims are Invalid

Tang O. Tang | July 29, 2013

Convolve v. Compaq Computer

July 1, 2013

Panel:  Rader, Dyk and O’Malley.  Opinion by O’Malley

Summary

Convolve, Inc. (“Convolve”) and Massachusetts Institute of Technology (“MIT”) appeal the decision of the U.S. District Court for the Southern District of New York (“District Court”) granting summary judgment in favor of Compaq Computer Corp. (“Compaq”), Seagate Technology LLC. and Seagate Technology, Inc. (“Seagate”).

Convolve and MIT sued Compaq and Seagate in July 2000 for breach of contract; misappropriation of trade secrets listed in Amended Trade Secret Identification (ATSI); direct patent infringement; and inducement of patent infringement along with other complaints such as fraud; violation of California Business and Professions Code §17200 (“CA Unfair Competition”), etc.

In May 2006, the District Court disposed of all other charges from the suit except the breach of contract, misappropriation of trade secrets and patent infringement charges. The District Court later granted summary judgment in favor of Compaq and Seagate and dismissed the remaining charges. With regard to the trade secret charges, the District Court found that:

(1)    some of Convolve’s trade secrets (ATSI 1B, 2A, 2C, 2E, and 3B-D) were covered under a Non-Disclosure Agreement (NDA), which Convolve failed to properly preserve according to the NDA procedures;

(2)    some of Convolve’s trade secrets (ATSI 2A, 6B, and 7A) were public known or common knowledge in the industry, which were not entitled to protection;

(3)    some of Convolve’s trade secrets were never used by the defendants (ATSI 2F and 7E); and

(4)    because New York law does not extend trade secret protection to marketing concepts, some of the trade secrets alleged by Convolve are not recognized by the District Court.

With regard to the patent infringement charges, the District Court found that:

(1)   out of the four models of products alleged by Convolve as infringing Patent’473, none read on the claims of the patent;

(2)   Patent’635 was found invalid for being non-enabling based on the inventor’s testimony; and

(3)   since no direct infringement was found, the claim for inducement of patent infringement must fail.

Taking all inference in favor of Convolve, the CAFC affirmed all counts of summary judgment with regard to the trade secret allegations, as well as the invalidity of Patent’635, but reversed the non-infringement decision about Patent’473.

 

Convolve (原告)与Compaq, Seagate(康柏电脑和希捷数码,被告)就原告开发的一些硬盘技术进行技术合作谈判,双方就谈判涉及内容签订了保密协议。但原告在向被告透露相关技术时没有严格按保密协定约定的程序处理涉密内容。后来改谈判未能达成一致,原告诉被告在谈判涉及的保密内容上侵犯商业机密及在另一些技术问题上专利侵权。一审结果,联邦区域法院裁定原告败诉。

上述法院均认定,尽管侵犯商业机密属于一个侵权法的范畴,然而在已签订合同中原被告双方均已同意以合同条款规定商业机密的范畴,故侵权法默认的商业机密标准不适用。因原告在履行保密协议过程中未遵循商定的处理程序,原告在此案中已丧失对该商业机密的索赔权。

另外, 关于专利侵权案,原告的专利在当年提出申请时对该发明的描述超过了发明人的当时可以实施实际该发明的范畴,故该专利被认定未能适当描述其实施方法因而无效。上述法院部分维持一审法院的判决。


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Clear and Unmistakeable Evidence of a Disclaimer Found in Response to Enablement Rejection

Kumiko Ide | April 24, 2013

Biogen Idec, Inc., et al. v. GlaxoSmithKline LLC, et al.

April 16, 2013

Panel: Dyk, Plager, Reyna.  Opinion by Reyna.  Dissent by Plager.

Summary

During prosecution of the patent, applicants responded to the examiner’s enablement rejection, wherein they failed to challenge the examiner’s understanding of the crucial terms, and limited their invention to what the examiner believed their specification enabled.  The CAFC affirmed the district court’s narrow claim interpretation of the term “anti-CD20 antibody” based on prosecution history disclaimer.

実施可能要件を満たしていないとして発せられた拒絶通知に対して、出願人は、審査官の理解に対して反論することなく、明細書により実施可能であると審査官が判断したものに発明を限定するような主張を行った。よって、「anti-CD20 antibody」という用語について、狭いクレーム解釈を容認した地裁の判断は誤りでなかったとCAFCは判示した。


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CAFC clarifies the presumption that prior art is enabled after In re Antor Media Corp (Fed. Cir. 2012)

Michael Caridi | April 10, 2013

In re Steve Morsa

April 5, 2013

Panel:  Rader, Lourie and O’Malley.  Opinion by O’Malley.

Summary

The Board of Patent Appeals and Interferences (“Board”) had affirmed an Examiner’s finding that a short press release, relied on for an anticipation rejection, was enabling.  In making its decision, the Board had held that arguments alone by the applicant were insufficient to rebut the presumption that a reference was enabling.  The CAFC found that the Board and the examiner had failed to engage in a proper enablement analysis of the reference and vacated the anticipation finding.


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CAFC Draws a Line in the Sand as to Adding “Boundary” Lines; PTO recants earlier design practice

Ryan Chirnomas | 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.


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Applicant’s failure to request claim construction under §112, 6th paragraph may invoke waiver of such claim construction

Yoshiya Nakamura | 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。


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Method Claim Survives Over MPF Claim’s Demise Under Aristocrat

John Kong | 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.


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Like prior art patents, potentially anticipatory non-patent printed publications are presumed to be enabling

Cindy Chen | October 5, 2012

In re Antor Media Corporation

July 27, 2012

Panel: Rader, Lourie and Bryson. Opinion by Lourie.

Summary

Antor Media Corp. appeals from the decision of the Board of Patent Appeals and Interferences rejecting on reexamination the claims of its patent as anticipated and obvious over four prior art references.  The prior art references include three printed publications and one U.S. patent.  The Board found that two of the printed publications anticipated the claims in Antor’s patent. Here, Antor argues that since the printed publications are not enabling, they could not have anticipated the claims. Antor further argues that unlike prior art patents, prior art printed publications are not presumptively enabling.  The principal issue on appeal is therefore whether the presumption that prior art patents are enabling can be logically extended to printed publications. The Federal Circuit answers that it can, holding that a prior art printed publication cited by an examiner is presumptively enabling barring any showing to the contrary by a patent applicant or patentee.


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