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

A treatment method including an administering step based on discovery of a natural law is patentable eligible

John M. Wang | June 18, 2019

Endo pharmaceuticals, Et Al. v. Teva pharmaceuticals Et Al.

Summary

The Federal Circuit reversed the district court’s decision holding the claims of U.S. Patent No. 8,808,737 ineligible under 35 U.S.C. §101. The Federal Circuit held that the claims at issue are not directed to a natural law.

Details

Endo owns the ‘737 patent, entitled “method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment.” The inventors of the ‘737 patent discovered that patients with moderately or severely impaired kidney function need less oxymorphone than usual to achieve a similar level of pain management. Accordingly, the treatment method of the ‘737 patent advantageously allows patients with renal impairment to inject less oxymorphone while still treating their pain.

More specifically, the degree of renal impairment of the subjects can be indicated by their creatinine clearance rate. The subjects may be separated into four groups based on their creatinine clearance rates:

Furthermore, the inventors discover that there was a statistically significant correlation between plasma AUC (area under curve) for oxymorphone and a patient’s degree of renal impairment, as shown below:

That is, there was relatively little change in oxymorphone AUC until the subjects had moderate-to-severe renal impairment (creatinine clearance rates below 50 mL/min). Subjects with severe renal impairment (creatinine clearance rates below 30 mL/min) had the highest AUC values.

Claim 1 of the ‘737 patent is as follows:

1. A method of treating pain in a renally impaired patient, comprising the steps of:

a. providing a solid oral controlled release dosage form, comprising:

a) about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof as the sole active ingredient; and

b) a controlled release matrix;

b. measuring a creatinine clearance rate of the patient and determining it to be

a) less than about 30 ml/min;

b) about 30 mL/min to about 50 mL/min;

c) about 51 mL/min to about 80 mL/min, or

d) about 80 mL/min; and

c. orally administering to said patient, in dependence on which creatinine clearance rate is found, a lower dosage of the dosage form to provide pain relief;

wherein after said administration to said patient, the average AUC of oxymorphone over a 12-hour period is less than about 21 ng·hr/mL.

The magistrate judge held, and the district court agreed, that the claims at issue were not patent-eligible because the claims are directed to the natural law that the bioavailability of oxymorphone is increased in people with severe renal impairment, and the three steps a-c do not add “significant more” to qualify as a patentable method.

However, the federal circuit disagrees with the district court, holding that the claims at issue were directed to a patent-eligible application of a natural law. Specifically, The Federal Circuit points out that “it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is ‘directed to.’” Applying this law, the Federal Circuit concluded that claims of the ‘737 patent are directed to a patent-eligible method of using oxymorphone or a pharmaceutically acceptable salt thereof to treat pain in a renally impaired patient. The conclusion is supported by the claim language itself and confirmed by the specification. The claim language recites specific steps a-c in using oxymorphone to treat pain in a renally impaired patient. The specification predominantly describes the invention as a treatment method, and explains that the method avoids possible issues in dosing and allows for treatment with the lowest available dose for patients with renal impairment. That is, the inventors here recognized the relationship between oxymorphone and patients with renal impairment, but claimed an application of that relationship, which is a method of treatment including specific steps to adjust or lower the oxymorphone dose for patients with renal impairment.

Then, the Federal Circuit considered that the claims at issue are similar to those in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd, (Fed. Cir. 2018) and Rapid Litig. Mgmt. Ltd. V. CellzDirect (Fed. Cir. 2016) while distinguishing the claims at issue from those in Mayo collaborative Servs. V. Prometheus Labs., Inc. (SC 2012), and Ariosa Diagnostics, Inc. v. Sequenom, Inc., (Fed. Cir. 2015). For example, the claims at issue in Vanda related to a method of treating schizophrenia patients with a drug (iloperidone), where the administered dose is adjusted based on whether or not the patient is a “CYP2D6 poor metabolizer.” Like the claims in Vanda, the claims at issue here “are directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.” In contrast, the representative claim in Mayo recited administering a thiopurine drug to patient as a first step in the method before determining the natural law relationship. The administering step is not performed based on the natural law relationship, and accordingly is not an application of the natural law.

Take away

  1. Adding an application step such as an administering step based on discovery of a natural law will render the claims patent eligible.
  • There is a potential problem of divided infringement issue here in the subsequent enforcement effort. But direct infringement against physicians and induced infringement against pharmaceutical companies have been found based on similar patent claims. Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., Appeal No. 2015-2067 (Fed. Cir. Jan. 12, 2017).

Absent information essential for customers to make a purchasing decision, a webpage specimen is not an acceptable display associated with the goods, but a mere advertisement

Kumiko Ide | May 10, 2019

In re: Siny Corp.

Nonprecedential Opinion Issued January 14, 2019

Precedential Opinion Issued April 10. 2019

Summary

The Trademark Trial and Appeal Board ruled, and the Court of Appeals for the Federal Circuit affirmed, a webpage specimen lacking information sufficient for a customer to make a decision to purchase was mere advertising material and not an acceptable specimen of use for goods.  An indication of a phone number and email address under “For sales information” on a website showing the goods and the trademark used in close proximity was found insufficient for consumers to actually make a purchase, as it only shows how consumers could obtain more information necessary to make a purchase.

The CAFC had previously issued a nonprecedential opinion on January 14, 2019, but issued a precedential opinion on April 10, 2019 for this case pursuant to a request by the United States Patent and Trademark Office.

単なる宣伝資料は、商品の使用証明として不適切である。商品の近くに商標の表示されているウェブサイトにおいて、「販売情報」として電話番号とメールアドレスが掲載されていたとしても、それは、消費者が購入するために必要な情報を取得するための手段を示しているだけで、そのウェブサイトに掲載されている情報のみで消費者が実際に商品を購入することはできない。よって、そのようなウェブサイトは、商品についての単なる宣伝資料であり、使用証明にはならない。

Details

Siny Corp. filed an application for a trademark, seeking to register the standard character mark CASALANA for “Knit pile fabric made with wool for use as a textile in the manufacture of outerwear, gloves, apparel, and accessories.”  To meet the requirements of a use in commerce application under Section 1(a) of the Lanham Act, 15 U.S.C. § 1051(a), the applicant submitted a specimen of use for goods, a webpage showing the trademark used in close proximity to the photograph of the goods.  The examining attorney refused registration, finding the specimen of use to be a mere advertising material, failing to show the required use in commerce for the goods.  The applicant appealed to the Trademark Trial and Appeal Board, and the Board affirmed in a split decision.  The Board found that the specimen submitted by the applicant is submitted as a “display associated with the goods,” and for such a display to be found an acceptable specimen of use, it must be a “point of sale” display.  The Board then found that the website submitted by the applicant lacked information sufficient for a customer to make a decision to purchase, such as “a price (or even a range of prices) for the goods, the minimum quantities one may order, accepted methods of payment, or how the goods would be shipped.”  While the Board appreciated the applicant’s contention that the goods were “industrial materials for use by customers in manufacture,” and the sales transaction must involve the applicant’s sales personnel, the Board also found that “…if virtually all important aspects of the transaction must be determined from information extraneous to the web page, then the web page is not a point of sale.”  The Board added that in cases where the goods are technical and specialized, and the applicant and examining attorney disagree on the point-of-sale nature of a submitted specimen, the applicant is advised to provide additional evidence and information regarding the manner in which purchases are made, such as providing verified statements from those knowledgeable about what happens and how.

The CAFC agreed with the Board.  The CAFC disagreed with the applicant that the Board applied “overly rigid requirements” in reaching the determination that the specimen submitted by the applicant did not qualify as a display associated with the goods, and noted that the Board’s decision was made by carefully considering the contents of the submitted specimen.

Takeaway

  • Catalogs and webpages that merely indicate contact information are usually not good specimens.
  • If the goods are highly technical or specialized such that price/quantities/methods of payment/how goods will be shipped cannot be indicated on a display associated with the goods (i.e., website), consider submitting an affidavit.
  • The USTPO has been reviewing specimens of use a lot more closely in recent years, and finding appropriate specimens of use for submission has become even more crucial.


More Diagnostic Patent Claims Fall—Despite following USPTO Guidelines

Ryan Chirnomas | May 3, 2019

Cleveland Clinic v. True Health Diagnostics

April 1, 2019

Lourie, Moore and Wallach.  Opinion by Lourie.  (non-precedential)

Summary

In a non-precedential opinion, the CAFC considered diagnostic patent claims ineligible.  The CAFC dismissed recitation of detection of a biomarker using conventional tools as an “overly superficial” rephrasing of claims that were previously considered ineligible.  The CAFC also indicated that it is not bound by USPTO guidelines, and implied that the relied-upon USPTO Example is inconsistent with Ariosa.

Details

This case relates to a diagnostic to detect heart disease.  Myeloperoxidase (MPO) is an early marker of heart disease associated with atherosclerotic plaques.  It was known in the prior art that MPO can be detected in surgically removed plaques, but it was not known that MPO is present in elevated levels in the blood of patients having atherosclerotic cardiovascular disease.  The inventors disclosed a method of detecting MPO by lab techniques such as colorimetric-based assay, flow cytometry, ELISA etc, and then correlating the detected MPO to heart disease.  Notably, the specification states that MPO can be detected “by standard methods in the art,” and that commercially available kits can be modified to detect MPO.

In Cleveland Clinic I, the CAFC held that method claims reciting “a method of assessing risk of having atherosclerotic heart disease” were invalid as reciting a law of nature without anything significantly more.   See Cleveland Clinic v. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017), cert. denied, 138 S. Ct. 2621, (2018).   In that case, the claims only recited a step of “comparing” MPO levels of a subject with MPO levels in a known non-diseased person.

However, this case presents slightly different claims based on same technology.  Rather than reciting diagnosis or treatment, the present claims recite methods of detecting and identifying elevated MPO, with more detail.  Specifically, the relevant claims are as follows:

Patent 9,575,065:

1.  A method of detecting elevated MPO mass in a patient sample comprising:

a)  obtaining a plasma sample from a human patient having atherosclerotic cardiovascular disease (CVD); and

b)  detecting elevated MPO mass in said plasma sample, as compared to a control MPO mass level from the general population or apparently healthy subjects, by contacting said plasma sample with anti-MPO antibodies and detecting binding between MPO in said plasma sample and said anti-MPO antibodies.

Patent 9,581,597:

1.  A method for identifying an elevated myeloperoxidase (MPO) concentration in a plasma sample from a human subject with atherosclerotic cardiovascular disease comprising: a)  contacting a sample with an anti-MPO antibody, wherein said sample is a plasma sample from a human subject having atherosclerotic cardiovascular disease;

b)  spectrophotometrically detecting MPO levels in said plasma sample;

c)  comparing said MPO levels in said plasma sample to a standard curve generated with known amounts of MPO to determine the MPO concentration in said sample; and

d)  comparing said MPO concentration in said plasma sample from said human subject to a control MPO concentration from apparently healthy human subjects, and identifying said MPO concentration in said plasma sample from said human subject as being elevated compared to said control MPO concentration.

2.  The method of claim 1, further comprising, prior to step a), centrifuging an anti-coagulated blood sample from said human subject to generate said plasma sample.

Prosecution

In prosecution of these patents, the Applicant argued by analogy to Example 29 of the May 2016 USPTO eligibility guidelines.  Example 29 presents two claims:

1.  A method of detecting JUL-1 in a patient, said method comprising:

a.  obtaining a plasma sample from a human patient; and

b.  detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.

2.  A method of diagnosing julitis in a patient, said method comprising:

a.  obtaining a plasma sample from a human patient;

b.  detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody; and

c.  diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.

According to the 2016 guidelines, claim 1 is eligible, because it does not recite a law of nature (pass on step 2A).  However, in the USPTO’s view, claim 2 is ineligible because it recites a law of nature without reciting something significantly more (fail on steps 2A and 2B).

In prosecution, the Applicant argued that the “detecting” claim of the ‘065 patent is more similar to the “detecting” claim 1 of Example 29 (eligible) than it is to the “diagnosing” claim 2 of Example 29 (ineligible).  The Examiner agreed and allowed the application.

As to the ‘597 claims, the Applicant successfully argued in prosecution that the “identifying” claim recites significantly more than a judicial exception, also relying on Example 29.  The Applicant argued that it was not known to identify elevated MPO in plasma of patients having atherosclerotic cardiovascular diseases, even though it was previously known to detect MPO in plaques.    The Examiner agreed and allowed the application. 

District Court

The district court interpreted the claims as being directed to a law of nature, based on the recitations of “detecting elevated MPO mass in a patient sample…”, “….from a human having atherosclerotic cardiovascular disease”, and “identifying an elevated [MPO] concentration in a plasma sample from a human subject with atherosclerotic cardiovascular disease.”  The district court concluded that the method is only useful for detecting elevated MPO associated with cardiovascular disease.  In other words, the method is only useful for detecting a natural phenomenon.

As such, the district court concluded that the claims do not recite a general laboratory technique and instead are trying to “recast [a] diagnostic patent as a laboratory method patent.”  The district court concluded that the claims are directed to detecting the correlation between MPO and the disease, rather than to detecting MPO more generally.  Thus, the claims fail step 2A.  Further, the additional steps are all well-known and conventional and thus fail step 2B.  Specifically, the district court stated that “[i]f merely using existing, conventional methods to observe a newly discovered natural phenomenon were enough to qualify for protection under §101, the natural law exception would be eviscerated.”

CAFC

The CAFC agreed in holding that the claims are ineligible.  Cleveland Clinic argued first that the claims are not directed to a natural law, but rather to a technique of using an immunoassay to measure MPO.  However, the CAFC considered this distinction to be “overly superficial,” and stated that the claims are directed to a natural law (correlation between MPO and the disease).  The CAFC characterized the difference between the claims at issue and the claims of Cleveland Clinic I as a “rephrasing” that does not make the claims less directed to a law of nature.

Cleveland Clinic also argued that the correlation is not a natural law because it can only be detected using certain techniques.  However, the CAFC saw through this, and stated that the same is true for many of the natural laws at issue in previous cases.  Specifically, the CAFC stated that “[i]nadequate measures of detection do not render a natural law any less natural.”

The CAFC also held that the claims do not recite an additional inventive concept. Cleveland Clinic argued that using a known technique in a standard way to observe a natural law confers an inventive concept.  However, the CAFC stated that this reasoning has been dismissed is previous cases such as Athena Diagnostics v. Mayo and Ariosa v. Sequenom.  Further to this point, the CAFC stressed that the MPO is detected using known techniques without significant adjustments.

Finally, the CAFC addressed the USPTO guidelines.  Cleveland Clinic stated that the district court erred by not giving appropriate deference to Example 29 noted above.  The CAFC agreed with True Health in stating the USPTO guidelines are neither persuasive nor relevant to the claims at issue, because the district court reached the correct decision. 

The CAFC did not include an extensive discussion of the USPTO guidelines, but stated as follows:

While we greatly respect the PTO’s expertise on all matters relating to patentability, including patent eligibility, we are not bound by its guidance.  And, especially regarding the issue of patent eligibility and the efforts of the courts to determine the distinction between claims directed to natural laws and those directed to patent-eligible applications of those laws, we are mindful of the need for consistent application of our case law.

Further with regard to Example 29, the CAFC stated that its claim 1 is “strikingly similar” to ineligible claim 1 of Ariosa. As such, the CAFC stated that although they have considered Example 29 and related arguments, Ariosa must control.  Thus, the CAFC did not follow the USPTO’s guidelines.

Takeaway

  • Patent eligibility of diagnostic methods continues to be highly problematic.   However, Chris Coons (D-DE) and Thom Tillis (R-NC) have recently been holding meetings on the issue, and released a “framework” on April 17, 2019:

However, in view of competing interests of the life sciences industry and the software industry, as well as reluctance to change a long-standing law, legislative change may be farther away than one might hope.

  • One relies on USPTO guidelines at their own risk.  Here, less than 3 years after publication, a CAFC panel has declined to follow the USPTO’s guidelines.  Since such guidelines do not have the force of law, the courts are not required to follow them.  In fact, in this case, the CAFC was somewhat dismissive of the USPTO’s efforts regarding §101. It is quite possible that the much-lauded USPTO guidelines issued on January 4, 2019 might suffer the same fate.
  • If trying to claim a diagnostic as a detection method, it is probably better to omit recitation of a specific disease and a high/low comparison in the claims.  In the rare case it is possible, it would be ideal to disclose a non-diagnostic use of the detected compound in the specification.
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