June 2019
CIPA Journal
Seven years after the Supreme Court’s decision in Mayo Collaborative Services v Prometheus Laboratories1 and five years after Alice Corp v CLS Bank International,2 the law in the United States on patent-eligible subject matter continues to evolve. While many cases deal with software and computer-implemented methods, life sciences and biotechnology also come under scrutiny. And, in particular, the patent eligibility of diagnostic methods and methods of treatment are of particular interest. Four recent Federal Circuit decisions highlight how US courts determine patent eligibility for life sciences and biotechnology inventions and may suggest some consistency in this dynamic area of US patent law.
In Endo Pharmaceuticals v Teva Pharmaceuticals USA,3 the Federal Circuit analyzed method of treatment claims relating to treating pain in renally impaired patients. The Court found the claims patent-eligible. In Natural Alternatives International v Creative Compounds,4 the Federal Circuit analyzed method of treatment claims directed to using natural compounds. The Court again found the claims patent-eligible and possibly suggested a bright-line distinction between diagnostic methods and methods of treatment. In Athena Diagnostics v Mayo Collaborative Services,5 the Federal Circuit analyzed claims relating to methods of diagnosing neurological disorders. The Court found the claims patent ineligible. And in Cleveland Clinic Foundation v True Health Diagnostics,6 the Federal Circuit analyzed claims relating to methods for testing risk of cardiovascular disease. The Court found the claims patent ineligible and discussed the impact (if any) of the USPTO’s own guidance regarding patent eligibility.7
Last year, in Vanda Pharmaceuticals v West-Ward Pharmaceuticals International,8 the Federal Circuit addressed the patent eligibility of methods of treatment using the Mayo/Alice framework for the first time. The Court analyzed claims directed to a method for treating schizophrenia, and a split panel determined they were not directed to a natural law or phenomenon and were, therefore, patent-eligible. Many practitioners viewed Vanda as a milestone decision, and the USPTO updated its internal guidance for determining patent eligibility in view of the Court’s holding, emphasizing that method of treatment claims could be patent-eligible.9 One of the defendants in Vanda, Hikma Pharmaceuticals USA Inc., appealed the decision to the Supreme Court, and its petition for certiorari is currently under review. Notably, the Supreme Court invited the Solicitor General to file a brief expressing the views of the US government regarding possible review, which is often seen as an indication the Supreme Court may grant certiorari and hear the case.
At issue is the Federal Circuit’s reasoning in Vanda applying the Supreme Court’s Mayo/Alice two-step test. At Mayo/Alice step one, the majority (Judges Lourie and Hughes) concluded that the claims were “directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome,” and therefore found them patent-eligible.10 In addition, the majority distinguished the claims in Vanda from those analyzed by the Supreme Court in Mayo, noting “the claims in Mayo were not directed to a novel method of treating a disease.”11 “Instead, the claims were directed to a diagnostic method.”12 Chief Judge Prost dissented, stating that she saw “no distinction from Mayo” and indicating that the majority’s analysis “conflates the inquiry at [Mayo/Alice] step one with the search for an inventive concept at step two.”13 We will have to wait and see if the Supreme Court will let the majority ruling stand (by denying certiorari) or if the Supreme Court will hear the case and add to its Mayo/Alice progeny.
Endo Pharmaceuticals, Inc. v Teva Pharmaceuticals USA, Inc.
The Federal Circuit’s reasoning in Vanda was adopted and applied in Endo. The claims at issue in Endo are directed to a method of treating pain. The representative claim (reproduced below) includes steps of providing a controlled release dosage form, determining a creatinine clearance rate, and administering a dosage depending on the determined rate.
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:
i. about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof as the sole active ingredient; and
ii. 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) above about 80 mL/min; and
c. orally administering to said patient, independence 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.14
At step one of the Mayo/Alice analysis, the panel considered the patent claims and specification and found that they both describe the invention as a “method of treating pain” in patients with renal impairment.15 The panel compared the claimed method in Endo to the methods analyzed in Vanda and found them to be “legally indistinguishable.”16 The panel found both “recite a method for treating a patient,” include “a dosage regimen,” and “require specific treatment steps.”17 The panel also distinguished the claims in Endo from the claims in Mayo stating that they differ “in material respects.”18 For example, the panel noted that the claims in Mayo “‘indicate’ a need to increase or decrease dosage, without prescribing a specific dosage regimen or other added steps to take as a result of that indication,” while the claims in Endo “prescribe a specific dosage regimen.” 19
With this analysis, the panel concluded that the claims were not merely directed to the relationship between oxymorphone and renal impairment.20 Instead, the claims were “eligible because they are ‘directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific purpose.’”21 And the panel stated that “[Federal Circuit] precedent leaves no room for a different outcome.”22 Because the panel concluded that the claims were not directed to natural phenomena, it ended its analysis at step one of the Mayo/Alice analysis and did not reach step two.23
In both Vanda and Endo, the ultimate determination of patent eligibility turned on the Mayo/Alice step one analysis. And when considering if the claimed methods were directed to natural laws, the analysis focused on the specific steps of the claimed methods. In each decision, the panel found the claims were directed to “a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.” And in both cases, it seemed particularly significant that the claims included a step of administering a prescribed treatment “to achieve a specific outcome.” This distinguished the Vanda and Endo claims because the claim in Mayo “was not directed to the application of a drug to treat a particular disease,” (as the Endo panel observed)24 and did not “prescrib[e] a specific dosage regimen or other added steps to take” (as the Vanda majority observed).25
Natural Alternatives International v Creative Compounds
Around the same time as Endo, the Federal Circuit decided another patent eligibility case that again relied considerably on Vanda and arguably further extended its reasoning.26 The claims at issue in Natural Alternatives are directed to methods of using a natural substance to increase anaerobic capacity in a human. The representative claim (reproduced below) includes steps of providing an amino acid to increase the concentration of beta-alanylhistidine in exposed tissue:
1. A method of increasing anaerobic working capacity in a human subject, the method comprising:
a. providing to the human subject an amount of an amino acid to blood or blood plasma effective to increase beta-alanylhistidine dipeptide synthesis in the tissue, wherein said amino acid is at least one of:
i. beta-alanine that is not part of a dipeptide, polypeptide or oligopeptide;
ii. an ester of beta-alanine that is not part of a dipeptide, polypeptide or oligopeptide; or
iii. an amide of beta-alanine that is not part of a dipeptide, polypeptide or oligopeptide; and
b. exposing the tissue to the blood or blood plasma, whereby the concentration of beta-alanylhistidine is increased in the tissue, wherein the amino acid is provided through a dietary supplement.
The district court concluded the claims were directed to a natural law, e.g., that “ingesting certain levels of beta-alanine, a natural substance will increase the carnosine concentration in human tissue and, thereby, increase the anaerobic working capacity in a human.”27 On appeal, the panel disagreed. Rather than reflecting a subject’s normal biological functions, the panel viewed the claims as inducing a non-natural physiological state by administering above-normal levels of beta-alanine.28
At step one of the Mayo/Alice analysis, the court analyzed the patent specification and the language of the claims, and adopted a key claim construction proposed by Natural Alternatives. The panel agreed that a level “effective to increase betaalanylhistidine synthesis in the tissue” means that it “elevates beta-alanine above natural levels to cause an increase in the synthesis of beta-alanylhistidine dipeptide in the tissue.” Based on this construction, the panel concluded that claims recited a method of treatment, not simply “a method of increasing the anaerobic working capacity in a human.” Specifically, the panel explained:
"Administering certain quantities of beta-alanine to a human subject alters that subject’s natural state. Specifically, homeostasis is overcome, and the subject’s body will produce greater levels of creatine. This, in turn, results in specific physiological benefits for athletes engaged in certain intensive exercise. The claims not only embody this discovery, they require that an infringer actually administer the dosage form claimed in the manner claimed, altering the athlete’s physiology to provide the described benefits.29"
The panel compared the claims in Natural Alternatives to the claims in Vanda and found that both “contain specific elements that clearly establish they are doing more than simply reciting a natural law.”30 In particular, the panel found that the claims in both cases “specify particular results to be obtained,” “specify a compound to be administered to achieve the claimed result,” and “contain a dosage limitation by virtue of the ‘effective’ limitation.”31 The court also dismissed potential similarities between the claims in Natural Alternatives and the claims analyzed in Mayo, because the claims in Natural Alternatives “require specific steps to be taken in order to bring about a change in a subject, altering the subject’s natural state.”32
With that view, the panel concluded that instead of simply being directed to a natural law, the claims “cover using a natural product in unnatural quantities to alter a patient’s natural state, to treat a patient with specific dosages outlined in the patents.”33 To underscore its analysis, the panel explained that Vanda stood for the proposition that claims “directed to particular methods of treatment are patent-eligible.”34 Similar to the panel in Endo, the panel in Natural Alternatives ended its analysis at step one of the Mayo/Alice analysis and did not reach step two.
The analysis and holding in Natural Alternatives may have extended Vanda. Notably, the panel stated that “[t]hese are treatment claims and as such they are patent-eligible,” which could be interpreted as a bright-line rule that claims directed to methods of treatment are, or should be, patent-eligible. Indeed, this would be consistent with the Federal Circuit’s decisions to date addressing patent eligibility of treatment method claims. But the issue is not yet settled as we wait and see if the Supreme Court grants certiorari in Vanda.
Athena Diagnostics, Inc. v Mayo Collaborative Services
After Vanda, and about a month before Natural Alternatives and Endo, the Federal Circuit in a split opinion decided Athena, a patent eligibility case involving claims directed to diagnostic testing methods. The majority opinion was written by Judge Lourie who also wrote the majority opinion in Vanda. The majority in Athena relied on the Court’s earlier decisions in Rapid Litigation Management v CellzDirect,35 Ariosa Diagnostics Sequenom,36 and Cleveland Clinic I (discussed below),37none of which dealt with methods of treatment claims. The Athena decision cites the Vanda decision only once, although the distinction may bolster Vanda and its progeny, possibly emphasizing a distinction between diagnostic claims (Athena) and method of treatment claims (Vanda).38
The claims at issue in Athena are directed methods of diagnosing neurological disorders by detecting antibodies to the protein muscular-specific tyrosine kinase (MuSK). The representative claim (claim 7, reproduced below) depends from an independent claim (claim 1, also reproduced below) that was not at issue in the appeal. Claim 7 includes steps of contacting a sample of bodily fluid with a radiolabeled protein, immunoprecipitating any antibody/protein complexes from the sample, and monitoring the antibody/protein complexes for the labeled proteins. The presence of the label is indicative of the disorder related to MuSK.
1. A method for diagnosing neurotransmission or developmental disorders related to [MuSK] in a mammal comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of [MuSK].
7. A method according to claim 1, comprising
contacting MuSK or an epitope or antigenic
determinant thereof having a suitable label thereon,
with said bodily fluid,
immunoprecipitating any antibody/MuSK complex
or antibody/MuSK epitope or antigenic determinant
complex from said bodily fluid and
monitoring for said label on any of said antibody/
MuSK complex or antibody/MuSK epitope or antigen
determinant complex,
wherein the presence of said label is indicative of said
mammal is suffering from said neurotransmission or
developmental disorder related to [MuSK].39
At step one of the Mayo/Alice analysis, the majority considered the claim language and patent specification. The majority determined that the claims “involve both the discovery of a natural law and certain concrete steps to observe its operation.”40 And it further explained that the specification describes the steps for observing the natural law as “conventional” and “standard techniques in the art.”41 The majority compared the claims in Athena to the claims in Ariosa and Cleveland Clinic I, and found them to be directed to a natural law – the only claimed advance was the discovery of a natural law and “the additional recited steps only apply conventional techniques to detect that natural law.”42 The majority was not swayed by Athena’s arguments that the claims recited specific steps and required the use of a manmade molecule to detect the MuSK antibodies.43
Before moving to step two of the Mayo/Alice analysis, the majority briefly addressed Vanda and observed that it was “important at this point to note the difference” between the claims in Athena “which recite a natural law and conventional means for detecting it” and the claims in Vanda, which are “applications of natural laws.”44 Referencing the Athena claims, the majority explained that “claiming a natural cause of an ailment and well-known means of observing it is not eligible for patent because such a claim in effect only encompasses the natural law itself.”45 By contrast, the majority distinguished the claims in Vanda as patent-eligible because “claiming a new treatment for an ailment, albeit using a natural law, is not claiming the natural law.”46
At Mayo/Alice step two, the Athena majority again considered the patent specification and focused on the patentee’s statements that the techniques used were well known and routine. Analyzing the claims, it found that the recited steps “only require standard techniques to be applied in a standard way.” Therefore, the majority concluded that the claims “fail to provide an inventive concept” and found them patent-ineligible.47 The outcome in Athena is consistent with the Federal Circuit’s other post-Mayo analyses of diagnostic method claims (perhaps the primary example being Ariosa). Dissenting in Athena, Judge Newman criticized the Federal Circuit’s decisions as “inconsistent” and would conclude that the claims in Athena are eligible at step one because the claimed method as a whole is “not a law of nature, but a man-made chemical-biomedical procedure.”48
Cleveland Clinic Foundation v True Health Diagnostics LLC
Cleveland Clinic I and Cleveland Clinic II deal with a family of patents directed to the detection of blood myeloperoxidase (MPO), which has a known association with a risk of developing cardiovascular disease. Since Mayo, the Federal Circuit has addressed the patent eligibility of claims directed to diagnostic testing methods in seven cases,49 and each time, the panel concluded that the claims were not patent-eligible.50 It did so in Cleveland Clinic I and Athena, and it did so again just weeks after Endo and Natural Alternatives in Cleveland Clinic II. While the Court’s determination generally follows its analysis of diagnostic claims in earlier cases, the Court made a point in Cleveland Clinic II to address the effect of the USPTO’s patent eligibility guidance on issued claims later reviewed by the courts. In Cleveland Clinic I,51 decided in 2017, the court analyzed a method claim in the parent patent, which recited:
11. A method of assessing a test subject’s risk of having
atherosclerotic cardiovascular disease, comprising
comparing levels of myeloperoxidase in a
bodily sample from the test subject with levels of
myeloperoxidase in comparable bodily samples from
control subjects diagnosed as not having the disease,
said bodily sample being blood, serum, plasma,
blood leukocytes selected from the group consisting
of neutrophils, monocytes, sub-populations of
neutrophils, and sub-populations of monocytes, or any
combination thereo[f];
wherein the levels of myeloperoxidase in the
bodily [samples] from the test subject relative to the
levels of [m]yeloperoxidase in the comparable bodily
samples from control subjects is indicative of the
extent of the test subject’s risk of having atherosclerotic
cardiovascular disease.
The panel found the claimed method was directed to the patent-ineligible natural law that blood MPO levels correlate with atherosclerotic cardiovascular disease (“CVD”).52 It further held that, because the patent did not invent techniques used to detect MPO or other components used in the claimed method, the claims recited no further inventive concept sufficient to transform the natural law into a patent-eligible application of the natural law.53
In Cleveland Clinic II, decided almost two years later, a new panel54 analyzed method claims in continuation applications that share a common specification with the patent at issue in Cleveland Clinic I.55 Unlike the claims in the parent patent, which recited steps of assessing atherosclerotic CVD risk from blood MPO, the claims in the continuations recite methods of identifying and detecting MPO. For example, a representative claim recited:
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.56
Under Mayo/Alice step one, the panel repeated its analysis from Cleveland Clinic I and found the methods were directed to the natural law that blood MPO levels correlate with atherosclerotic CVD.57 The panel rejected Cleveland Clinic’s argument that the patents were directed to techniques for detecting elevated levels of MPO (not assessing risk of CVD) and therefore distinguishable from the parent patent as “overly superficial.”58 It noted that the patents did not claim any new methods or techniques, and the “rephrasing of the claims does not make them less directed to a natural law.”59 Despite finding the claims ineligible at Mayo/Alice step one, the panel briefly considered step two and determined that the claims contained no inventive concept.60
Separately from the Mayo/Alice analysis, Cleveland Clinic II argued that its claims mirrored an example provided in the Patent Office’s guidance as an exemplary claim that was patent-eligible.61 The panel generally dismissed this argument, stating that “[w]hile we greatly respect the [US]PTO’s expertise on all matters relating to patentability, including patent eligibility, we are not bound by its guidance.”62 The panel pointed out that the USPTO’s example was “strikingly similar” to a claim in Ariosa63 that the Court found ineligible.64 The panel explained that “we are mindful of the need for consistent application of our case law,” and therefore, “Ariosa must control.”65 The court added that any deference to an examiner’s decision to allow claims is incorporated into the presumption that a patent once issued is valid.
Ultimately, the Federal Circuit’s dicta in Cleveland Clinic II may be more interesting and informative than its ruling. The patent owner attempted to redraft claims in continuation applications and followed USPTO guidance regarding patent eligibility. Practitioners should be mindful of the Court’s guidance that “rephrasing of the claims does not make them less directed to a natural law” and should be aware that reliance on the USPTO’s patent eligibility guidance may have limited weight beyond patent examination.
Conclusion
The Federal Circuit’s analysis and holdings in these four decisions raise at least two questions: (1) whether methods of using natural compounds are generally patent eligible; and (2) whether Vanda created a bright-line rule that methods of treatment are patent-eligible.
We will have to wait and see whether the Federal Circuit will extend the Natural Alternatives holding to other methods of using natural compounds or limit it to its specific facts. While practitioners may be optimistic, time will tell if the Natural Alternatives holding is limited.
The statement in Natural Alternatives – “These are treatment claims and as such they are patent-eligible” – seems to suggest a bright-line rule at least for method of treatment claims. And the Federal Circuit seems to be applying this approach finding each post-Mayo diagnostic testing method patent to be ineligible and finding each treatment method patent to be eligible. With this in mind, and looking to the claims at issue in Vanda, Endo, and Natural Alternatives as examples, claims that include specific steps to be taken in order to bring about a change in the subject, include particular results to be obtained by practising the method, or include dosage limitations may likewise be found to be patent-eligible. Until the Court more explicitly adopts a bright-line rule against diagnostic method patents, practitioners may consider drafting claims that include specific steps applying or utilizing the results of a claimed diagnostic test.
Stay tuned as we monitor this area of US patent law and, in particular, wait to see if the Supreme Court will grant certiorari in Vanda. The specific question presented is “whether patents that claim a method for medically treating a patient automatically satisfy section 101 of the Patent Act, even if they apply a natural law using only routine and conventional steps.”66 The Solicitor’s brief is expected later this year, with the Supreme Court’s certiorari decision sometime thereafter.
Endnotes
1 Mayo Collaborative Services v Prometheus Laboratories, Inc., 566 U.S. 66 (2012) (“Mayo”).
2 Alice Corp v CLS Bank International, 573 U.S. 208 (2014) (“Alice”).
3 Endo Pharmaceuticals, Inc. v Teva Pharmaceuticals USA, Inc., 919 F.3d 1347 (Fed. Cir. 2019) (“Endo”).
4 Natural Alternatives International, Inc. v Creative Compounds, LLC 918 F.3d 1338 (Fed. Cir. 2019) (“Natural Alternatives”).
5 Athena Diagnostics, Inc. v Mayo Collaborative Services, 915 F.3d 743 (Fed. Cir. 2019) (“Athena”).
6 Cleveland Clinic Foundation v True Health Diagnostics LLC, 2019 WL 1452697 (Fed. Cir. 2019) (“Cleveland Clinic II”).
7 The Finnegan team recently discussed the Patent Office’s revised guidance on how it will analyze claims for patent eligibility in a separate article.
8 Vanda Pharmaceuticals Inc. v West-Ward Pharmaceuticals International, Ltd, 887 F.3d 1117 (Fed. Cir. 2018) (“Vanda”).
9 2019 Revised Patent Subject-Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019).
10 Vanda, 887 F.3d at 1136.
11 Id. at 1134.
12 Id.
13 Id. at 1140, 1143 (Prost, C.J., dissenting).
14 Endo, 919 F.3d at 1354.
15 Id. at 1353.
16 Id. at 1353-54.
17 Id. at 1353-54.
18 Id. at 1354.
19 Id. at 1354.
20 The patent recognizes that reduced kidney function (renal impairment) causes a patient to have higher concentrations of oxymorphone in the blood, compared to a patient with normal kidney function receiving the same dose. US Patent No. 8,808,737 at 10:15-22.
21 Endo, 919 F.3d at 1355.
22 Id. at 1355.
23 Id. at 1357.
24 Id. at 1354.
25 Vanda, 887 F.3d at 1135.
26 Natural Alternatives, 918 F.3d at 1343.
27 Id. at 1344.
28 Id.
29 Id. (internal citations omitted).
30 Id. at 1345.
31 Id. at 1345-46.
32 Id. at 1345.
33 Id. at 1346-47.
34 Id. at 1344.
35 Rapid Litigation Management Ltd. v CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016)
36 Ariosa Diagnostics, Inc. v Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015)
37 Cleveland Clinic Foundation v True Health Diagnostics, LLC, 859 F.3d 1352 (Fed. Cir. 2017) (“Cleveland Clinic I”).
38 Athena, 915 F.3d at 752.
39 Id. at 747.
40 Id. at 751.
41 Id.
42 Id.
43 Id. at 752.
44 Id.
45 Id. at 752-53.
46 Id. at 753.
47 Id. at 757.
48 Athena, 915 F.3d at 762 (Newman, J, dissenting).
49 Cleveland Clinic Found. v True Health Diagnostics LLC, 2019 WL 1452697 (Fed. Cir. 2019); Athena Diagnostics, Inc. v Mayo Collaborative Servs., 915 F.3d 743 (Fed. Cir. 2019); Roche Molecular Sys., Inc. v CEPHEID, 905 F.3d 1363 (Fed. Cir. 2018); Cleveland Clinic Found. v True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017); Genetic Techs. Ltd. v Merial LLC, 818 F.3d 1369 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015); In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig., 774 F.3d 755 (Fed. Cir. 2014).
50 See Athena, 915 F.3d at 763 n.7 (Newman, J., dissenting) (collecting cases).
51 Cleveland Clinic Found. v True Health Diagnostics, LLC, 859 F.3d 1352 (Fed. Cir. 2017) (“Cleveland Clinic I”)
52 Id. at 1360-61.
53 Id. at 1360-61.
54 Cleveland Clinic I was before Judges Lourie, Reyna, and Wallach; Cleveland Clinic II was before Lourie, Moore, and Wallach.
55 Cleveland Clinic II, 2019 WL 1452697, at *1, n1.
56 Id. at *2-3.
57 Id. at *4.
58 Id.
59 Id.
60 Id. at *5.
61 Id. at *5-6.
62 Id. at *6.
63 In both Ariosa and the USPTO example, the claimed method used known techniques to detect a newly-discovered molecular target of interest.
64 Id. at *6.
65 Id.
66 Petition for Writ of Certiorari at 2, Hikma Pharm. USA Inc. v Vanda Pharm. Inc., No. 18-817 (filed Dec. 27, 2018)
Originally printed in CIPA Journal on June 2019. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm's clients.
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