A Work Made For Hire Analysis of Code Revision Commission v. Public.Resource.Org, Inc.

Law Books” by Mr.TinDC is licensed under CC BY-NC-ND 2.0.

Mike Chernoff, Associate Member, University of Cincinnati Law Review

I. Introduction

In the United States, copyright protection can be extended to original works of authorship fixed in any tangible medium.1 However, this protection is restricted for works that have been created as a statement of law.The Supreme Court will be hearing a case in the near future that will consider the annotations associated with the Official Code of Georgia Annotated, which were written by a third party, but approved by the Georgia General Assembly.3  Specifically, the case will consider whether these annotations are an official government edict for purposes of a copyright analysis.

Part II of this article will give further background information on United States copyright laws concerning government works and works made for hire. Part III will discuss this arrangement, and the aforementioned lawsuit involving the Official Code of Georgia Annotated lawsuit, Code Revision Commission v. Public.Resource.Org, Inc., that occurred due to a third party website distributing the Code despite the State of Georgia’s claimed copyright over the annotations.4 Part IV will analyze the copyright claim issue by the State of Georgia by viewing the annotations from a “work made for hire” viewpoint.

II. Copyright Background

The Constitution gives Congress the power “[t]o promote the Progress of Science and useful Arts, by securing for limited Time to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.”.5 Congress used this power to pass the Copyright Act, which states, “[c]opyright protection subsists . . . in original works of authorship fixed in any tangible medium of expression.”Authorship is a central point of copyright law, and the statute clarifies that “Copyright in a work . . . vests initially in the author or authors of the work.”

Under United States copyright law, copyright protection is “not available for any work of the United States Government.”8 While this law applies to the federal government, there is no mention of state governments in the federal statute.However, the United States Copyright Office has a policy against registering a government edict that has been issued by any state government, including legislative enactments, judicial decisions, or similar types of official legal materials.10 This view has been confirmed by the courts in rulings that have established that with respect to government works, “the People” are the “author.”11 

The Supreme Court first addressed the issue of copyrighting government edicts in Wheaton v. Peters.12 In Wheaton, the Court unanimously held that “no reporter has or can have any copyright in the written opinions delivered by this Court; and that the judges thereof cannot confer on any reporter any such right.”13 The Supreme Court extended this ruling to state court opinions in Banks v. Manchester.14 Before Banks, an Ohio statute provided for the appointment of an official reporter for the Supreme Court of Ohio and this reporter was tasked with securing a copyright on the court’s decisions.15 The Ohio statute also required the Secretary of State to contract a publisher to have the exclusive right to publish the reports of the official court reporter.16 In Banks, the chosen publisher sued to enforce its copyright interest in the work of the judges of the Supreme Court of Ohio.17 The Court decided against the publisher in Banks because the publisher did not qualify as the author of the works.18 The Supreme Court  explained that the judges could not be the authors of the works because they write opinion in their judicial capacity.19 The Court suggested that preventing the judges from having a copyrightable interest in the opinions was sound public policy and would support the notion that all should have free access to judicial opinions in the interest of  justice.20

III. Case History

In Georgia, the official published set of statutes are collected in the Official Code of Georgia Annotated (“OCGA”).21 Along with the language of the statutes, the OCGA also includes annotations, which consist of history lines, repeal lines, cross references, commentaries, case notations, editor’s notes, excerpts from law review articles, summaries of opinions of the Attorney General of Georgia, summaries of advisory opinions of the State Bar, and other research references.22 These annotations are part of the official code, as stated in the OCGA when the code states that the statutes “shall be merged with annotations . . . and [are] published by authority of the state . . . and when so published [are to] be known and may be cited as the ‘Official Code of Georgia Annotated.’”23 However, these annotations are for convenient reference only and are not part of the law.24

Per an agreement with the State of Georgia, these annotations were initially prepared by Mathew Bender & Co., Inc., which is a part of the LexisNexis Group (“Lexis”).25 Under this agreement, Lexis has the exclusive right of publication of the OCGA, but is also responsible for the ongoing publication and maintenance of the OCGA, including the associated editorial, publication, and distribution costs.26 The agreement directs what types of annotations should appear in the OCGA as well as how Lexis should generate and arrange the content.27 The Code Revision Commission (“the Commission”) is tasked with supervising Lexis’s work and has final editorial control over the OCGA.28 The Commission consists of the Lieutenant Governor of Georgia, four members of the Georgia senate, the Speaker of the Georgia House of Representatives, four additional members of the Georgia House of Representatives, and five members appointed by the president of the State Bar of Georgia.29 After the Commission has approved the annotations, the Georgia General Assembly must vote to the OCGA the official codification of Georgia’s laws, and thus, must vote to incorporate the annotations as part of the OCGA.30

This agreement requires Lexis to create a free, unannotated, online version of the OCGA, and the agreement also limits the price that Lexis can charge for the OCGA.31 In return, Lexis has the exclusive right to produce and sell print, CD-ROM, and online versions of the OCGA.32 Lastly, the agreement provides that all the parts of the OCGA that are copyrightable, “shall be copyrighted in the name of the State of Georgia.”33

Public.Resource.Org (“PRO”) is a non-profit organization that aims to improve public access to government records and primary legal matters.34 For example, PRO has published various state statutory codes online.35 PRO purchased all 186 volumes of the print version of the 2013 edition of the OCGA, scanned the documents, and uploaded the documents  to its own website.36 These documents were then freely accessible to the public, and copies of these documents were distributed to other organizations and other websites.37

The Commission sent cease and desist letters to PRO demanding that it no longer publish the OCGA on the ground that it infringed upon the State of Georgia’s copyright in the work.38 After PRO refused to comply with the cease and desist letters, the Commission sued PRO seeking injunctive relief to restrict PRO from publishing the OCGA, resulting in Code Revision Commission v. Public.Resource.Org, Inc.39 PRO responded by denying that the State of Georgia held an enforceable copyright in the OCGA because the OCGA was a law that was in the public domain.40

The United States District Court for the Northern District of Georgia granted partial summary judgment for the Commission and rejected PRO’s motion for partial summary judgment as the court concluded the annotations in the OCGA lack the force of law and are, therefore, not public domain material.41 The District Court issued a permanent injunction against PRO requiring PRO to no longer produce or display the OCGA.42 PRO appealed this decision and the case was heard by the 11th Circuit Court of Appeals.43

On appeal, the Circuit Court reversed the District Court’s judgment and ruled in favor of PRO.44 The Circuit Court reasoned that the annotations in the OCGA were sufficiently law-like to be considered a work of the government and are not copyrightable.45 Due to the Commission’s direct supervision over Lexis’s work on the annotations, the annotations were created by legislative authority.46 The procedural method of approval, outlined in Part II, for the annotations was relevant to the circuit court’s decision.47  The Georgia General Assembly and the Governor both have to approve of the OCGA each year.48 The Circuit Court reasoned that this exemplifies the American system of government, therefore, the entirety of the OCGA is in effect, authored by the Georgia General Assembly.49 The circuit court also concluded this viewpoint was supported by the authoritative control that the Commission exercised over every stage of the creation of the OCGA annotations.50 

On June 24, 2019, the Supreme Court of the Untied States granted the Commission’s petition for a writ of certiorari.51

IV. Discussion

A potential argument in favor of affirming the circuit court’s decision can be reached by analogizing the agreement between the State of Georgia and Lexis to that of a typical work made for hire under United States copyright law. 

When the creator of a work is hired by another entity, the hiring entity may be considered the “author” for purposes of copyrightability in specific situations.52 A situation in which a work would be considered a “work made for hire” is when the work is “specially ordered or commissioned for use as a contribution to collective work,” as part of one of nine areas of subject matter, which include compilations, and when the parties have expressly agreed in a written instrument that the work shall be considered a work made for hire.53 

The State of Georgia contracted with Lexis for the purpose of creating and drafting the annotations that appear in the OCGA.54 A “compilation” is defined as “something gathered together especially from various sources.”55 The OCGA can be considered a gathering of the laws of Georgia into one document. From this viewpoint, the OCGA has characteristics that satisfy the definition of a compilation, thus satisfying the first element of a work made for hire. The agreement also stated that the State of Georgia would be the holders of any copyright that stemmed from the annotations that Lexis had written.56 While this may not expressly state that Georgia and Lexis had agreed to a work made for hire, the effect would be the same as if the agreement had said so. Both elements of a work made for hire are satisfied, and the State of Georgia could be considered the “author” of the annotations.

Due to the State of Georgia’s status as the legal “authors” of the annotations, the Court should treat the annotations as if the Commission had originally written them. In this analysis, the Court should consider whether a statute annotation that was originally written by the Georgia General Assembly should be considered copyrightable. Based on the Court’s reasoning in Banks, annotations written by Georgia’s Commission or General Assembly are not protected by copyright because the officials involved in these bodies would have written the annotations in their elected capacity.57 If annotations written by members of the Georgia General Assembly were hidden from the public under a veil of copyright, then the public would be deprived from the justice that the annotations provide. The result should be no different if the Georgia General Assembly hired an organization to write the annotations in its place. When the annotations are viewed as a work made for hire for the Georgia General Assembly, the result is clear that the state should not gain copyright protection over any portion of the OCGA.

V. Conclusion

Free and open access to state laws are an integral part of a person’s right to justice. The importance of this right establishes the reasoning behind Section 105 of the Copyright Act and the Copyright Office’s policy on government edicts.58  Hiring a third party should not be a loophole to allow a government to restrict a person’s right to access the laws and judicial opinions of their state. The Supreme Court should consider work made for hire copyright protection doctrine to confirm that the agreement between Georgia and Lexis prescribes Georgia as the authors of the annotations for purposes of copyright. Since the Georgia General Assembly would be considered the author of the annotations and the annotations are an addendum to the law, the state should not be afforded copyright protection on the annotations.

  1. 17 U.S.C. § 102 (2019).
  2. See 17 U.S.C. § 105 (2019); U.S. Copyright Office, Compendium of U.S. Copyright Office Practices § 313.6(C)(2) (3d ed. 2017).
  3. See Code Revision Comm’n v. Public.Resource.Org, Inc., 906 F.3d 1229 (11th Cir. 2018).
  4. Id.
  5. U.S.Const. art. I, § 8, cl. 8.
  6. 17 U.S.C. § 102 (2019).
  7. 17 U.S.C. § 201(a) (2019).
  8. 17 U.S.C. § 105 (2019).
  9. Id.
  10. U.S. Copyright Office, Compendium of U.S. Copyright Office Practices § 313.6(C)(2) (3d ed. 2017).
  11. Code Revision Comm’n v. Public.Resource.Org, Inc., 906 F.3d 1229, 1236 (11th Cir. 2018).
  12. Id. at 1237; Wheaton v. Peters, 33 U.S. 591, 668 (1834).
  13. See Wheaton, 33 U.S. 591, 668.
  14. Code Revision Comm’n, 906 F.3d at 1237; Banks v. Manchester, 128 U.S. 244, 254 (1888).
  15. Banks, 128 U.S. at 245, 249.
  16. Id. at 246.
  17. See id.
  18. Id. at 252.
  19. Id.at 253.
  20. Id.
  21. Code Revision Comm’n v. Public.Resource.Org, Inc., 906 F.3d 1229, 1233 (11th Cir. 2018).
  22. Id.
  23. Ga. Code Ann. § 1-1-1 (2019)
  24. Ga. Code Ann. § 1-1-7 (2019)
  25. Code Revision Comm’n, 906 F.3d at 1234.
  26. Id.
  27. Id. at 1233.
  28. Id.
  29. Id.
  30. Id. at 1245.
  31. Id. at 1234.
  32. Id.
  33. Id.
  34. Id.
  35. Id. at 1235.
  36. Id.
  37. Id.
  38. Id.
  39. Id.
  40. Id.
  41. Id.
  42. Id.
  43. Id.
  44. Id. at 1255.
  45. Id. at 1243.
  46. Id. at 1233.
  47. Id.at 1253.
  48. Id.
  49. Id.
  50. Id. at 1244.
  51. Id. at 1229.
  52. 17 U.S.C. § 101 (2019).
  53. Id.
  54. Code Revision Comm’n, 906 F.3d at 1234.
  55. Compilation, Merriam-Webster Dictionary, https://www.merriam-webster.com/dictionary/compilation (last visited Sep. 10, 2019).
  56. Code Revision Comm’n, 906 F.3d at 1234.
  57. Banks v. Manchester, 128 U.S. 244, 253 (1888).
  58. See 17 U.S.C. § 105 (2019); U.S. Copyright Office, Compendium of U.S. Copyright Office Practices § 313.6(C)(2) (3d ed. 2017).

The Expanding Blocking Patent Doctrine: a Reversal of Burden of Proof?

Patents, Pez #1” by etorov is licensed under CC BY-SA 2.0.

Nathan Potter, Blog Editor, University of Cincinnati Law Review

I. Introduction

Overcoming obviousness is becoming increasingly difficult in some industries due to competitors seeking “blocking” patents.[1] A blocking patent is obtained by one patentee to restrict the make, use, sale, and/or export of an earlier patent owned by a different patentee. This may prohibit both patentees’ use of their respective patents due to the likelihood of infringement. Because a blocking patent may dissuade a competitor from pursuing innovation, it can be difficult to apply the objective indicia of nonobviousness (including commercial success, long felt but unsolved needs, and failure of others) listed in Graham v. John Deere Co.[2] This conflict has been brought to the Supreme Court of the United States in Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc.[3] This petition has been distributed for conference on October 1, 2019.[4]

II. Background

A patent must be a nonobvious invention over prior art.[5] 35 U.S.C. § 103 evaluates nonobviousness from the perspective of a person having ordinary skill in the art (a “PHOSITA”). If a PHOSITA would determine that a potentially patentable invention is an obvious variation or addition to prior art, then the invention is not patentable. When determining whether a potentially patentable invention is obvious, the PHOSITA will use the four Graham factors: (1) the scope and content of the prior art; (2) the differences between the prior art and the claims at issue; (3) the level of ordinary skill in the art; and (4) secondary considerations (or the indicia of nonobviousness).[6]

These “secondary” considerations have become increasingly important since Graham. The Federal Circuit has emphasized the importance of secondary considerations in “guard[ing] as a check against hindsight bias.”[7] The Federal Circuit has also used secondary considerations to reverse district courts’ findings of obviousness.[8] The Federal Circuit has even commented on the necessity of analyzing secondary considerations before pronouncing an invention at issue in a case as obvious.[9]

III. Acorda Therapeutic, Inc. v. Roxane Laboratories, Inc., et al.

Acorda centers on four patents that claim the administration of a medication that is used to improve walking in individuals with multiple sclerosis.[10] Acorda was granted an exclusive license for another patent (the Elan patent) from Elan Corporation.[11] The Elan patent discouraged other companies from researching the administration of medication as detailed in the Acorda patents because of the likelihood that those developments would infringe the Elan patent.

One of Acorda’s arguments was “that the district court improperly applied a categorical rule that a blocking patent (the Elan patent) negates any findings in favor of Acorda on the objective indicia of commercial success, failure of others, and long felt but unmet need.”[12] The Federal Circuit sided with the district court, stating the ruling was based on the factual findings of the case, not a categorical ban.[13] The Federal Circuit continued, stating that a blocking patent, by itself, does not discount evidence of commercial success as a secondary consideration, but it requires a more fact-specific inquiry.[14] However, the existence of a blocking patent does lead to the logical conclusion that competitors may be less commercially motivated to pursue similar research.[15] After losing its appeal to the Federal Circuit, Acorda raised its case to the Supreme Court.

A. Petitioner’s Brief

Acorda’s brief asks whether objective indicia of nonobviousness may be partially or entirely discounted by the existence of a blocking patent, and, if so, whether the defendant must prove implicit or actual blockage.[16] The brief alleges that the Federal Circuit’s opinion is in direct conflict with Graham and opens the obviousness inquiry to hindsight bias.[17] The brief also alleges that the Federal Circuit has overridden the Supreme Court’s decision in Microsoft Corp. v. i4i Limited Partnership, which said that patents are presumed valid under 35 U.S.C. § 282(a) and that it is up to the challenger to prove invalidity, based on obviousness, by clear and convincing evidence.[18]

Acorda argues three key points against the concept of blocking patents within the pharmaceutical industry.[19] First, that 35 U.S.C. § 271(e)(1)’s safe harbor provision will protect researchers from being accused of infringement.[20] Second, that the defendants were capable of researching the art in the Elan patent outside the U.S.[21] And third, that the blocking patent could have been licensed to the defendants for a share of the profits.[22] Acorda then concludes, under these points, that any finding of blockage would have to be implicit.[23]

Acorda also argues that the Federal Circuit improperly applied the “clear and convincing evidence” standard.[24] Further, Acorda stated that the defendants did not have to overcome this standard because the Federal Circuit negated Acorda’s evidence of commercial success and other indicia of nonobviousness.[25] Acorda concludes that the blocking patent doctrine improperly shifted the burden of proof to Acorda.[26]

B. Respondents’ Brief

The Respondents’ brief alleges that the district court correctly found Acorda’s patents to be obvious in light of published studies and other evidence.[27] Respondents also point out that the Federal Circuit’s review was to consider whether the district court’s factual findings were clearly erroneous.[28] They stated that the Federal Circuit correctly sided with the district court while also rejecting any categorical rules regarding blocking patents.[29]

The Respondents’ brief argues that Acorda’s accusation of the creation of a categorical rule in the blocking patent doctrine is incorrect and “illusory.”[30] The brief goes on to say that there is no conflict between the outcome in the present case and any decision by the Supreme Court.[31] In this fact-specific inquiry, the Court must consider that the long felt need and commercial success are due to the blocking patent preventing competitors from devoting resources to do research based off the claimed invention.[32] Finally, Respondents surmise that even with the evidence of objective indicia of nonobviousness, Acorda’s patents would be held obvious under the prior art.[33]

IV. Discussion

The Petitioner and the Respondents both presented compelling arguments. There is no evidence of actual blockage. Licensing is common in the pharmaceutical industry. The Respondents never said they sought a license from Elan or Acorda of the Elan patent. Acorda admits that it was given an exclusive license, but there is no mention whether Acorda was permitted to assign that license. But, is it necessary to show actual blockage when the facts of a case strongly lead to an implicit conclusion?

The standard is clear and convincing evidence, not actual proof. The Respondents provided several secondary sources which backed their opinion that a blocking patent severely inhibits the commercial incentive for the Respondents to have pursued invention based on the Elan patent. However, this is still not concrete proof that the Elan patent actually blocked the Respondents’ research in the area.

Secondary considerations, or the indicia of nonobviousness, carry more weight today than they did in 1966, when Graham was decided. This was due to the recognition that those factors are best suited to tipping the scales on whether a patent is invalid due to obviousness. However, when there is significant research in the field and a patent which blocks others’ commercial viability, the court must view any secondary considerations in the light of the facts surrounding a case. To do otherwise, would allow one patentee to dominate a particular area of a field of research. Therefore, the existence of a blocking patent will almost always negate the effectiveness of secondary considerations in an obviousness analysis.

Acorda understates the importance of Federal Circuit’s standard of review. The Federal Circuit could only overturn the district court if it found the ruling to be clearly erroneous. This provided a great deal of deference to the district court, which tried the case based on the facts. Even though the Federal Circuit reviewed those facts, they came to the same conclusion. 

V. Conclusion

Acorda lost its appeal to the Federal Circuit on the facts of the case. It is undeniable that a blocking patent heavily weighs against a court’s consideration of the indicia of nonobviousness. This is the correct approach. Requiring a defendant to show proof of actual blockage is unrealistic in the world of pharmaceuticals. To suggest that a company is welcome to research the claimed invention outside the U.S. is a weak argument. The district court gave the Acorda patents their presumption of validity; however, the respondents overcame this presumption. Acorda relied too heavily on the indicia of nonobviousness to prove their patents were valid, and so those patents were found invalid. The Supreme Court does not need to grant certiorari on this issue because the Federal Circuit has already provided a correct decision. Requiring a defendant to show proof of actual blockage is too heavy a burden and potentially impossible.


[1] 35 U.S.C. § 103. A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.

[2] 383 U.S. 1, 17 (1966).

[3] 903 F.3d 1310 (Fed. Cir. 2018, cert. pending, Apr. 8, 2019).

[4] Acorda Therapeutics, Inc. vs. Roxane Laboratories, Inc., No. 18-1280 (U.S. Apr 08, 2019).

[5] Prior art is any evidence that your invention is already disclosed to the public. Prior art could be disclosed by the inventor or someone else and does not need to be fixed in a tangible medium.

[6] Graham, 383 U.S. at 17.

[7] In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1079 (Fed. Cir. 2012). See also Apple Inc. v. ITC, 725 F.3d 1356, 1365 (Fed. Cir. 2013).

[8] See Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,699 F.3d 1340 (Fed. Cir. 2012); Plantronics, Inc. v. Aliph, Inc., 724 F. 3d 1343 (Fed. Cir. 2013); Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346 (Fed. Cir. Aug. 12, 2013).

[9] Apple, 725 F.3d at 1365.

[10] Acorda, 903 F.3d at 1313.

[11] Id.

[12] Id. at 1328.

[13] Id. at 1337.

[14] Id. at 1338 (citing Merck Sharp & Dohme Corp. v. Hospira, Inc., 874 F.3d 724 (Fed. Cir. 2017).

[15] Id

[16] Brief for Petitioner at i, Acorda Therapeutics, Inc. vs. Roxane Laboratories, Inc., No. 18-1280 (U.S. Apr. 8, 2019) (https://www.supremecourt.gov/DocketPDF/18/18-1280/95384/20190404120304062_Acorda%20Petition%20TO%20FILE.pdf).

[17] Id. at 2.

[18] Id. at 3.

[19] Id. at 20.

[20] Id.

[21] Id.

[22] Id.

[23] Id.

[24] Id. at 22.

[25] Id.

[26] Id. at 23.

[27] Brief for Respondents at i, Acorda Therapeutics, Inc. vs. Roxane Laboratories, Inc., No. 18-1280 (U.S. Apr. 8, 2019) (https://www.supremecourt.gov/DocketPDF/18/18-1280/102277/20190607120933242_18-1280%20Brief%20in%20Opposition.pdf).

[28] Id.

[29] Id.

[30] Id. at 1.

[31] Id.

[32] Id. at 14.

[33] Id.at 18.

The State of Personalized Medicine in Patent Law

DNA” by e.coers is licensed under CC BY-SA 2.0.

Kris Schroder, University of Cincinnati Law Review

I. INTRODUCTION

In his 2015 State of the Union Address, President Barack Obama launched the Precision Medicine Initiative, which would “lead a new era of medicine — one that delivers the right treatment at the right time.”[1] The mission statement of the Precision Medicine Initiative is to “To enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care.”[2] Individualized care, also known as “Precision Medicine” or “Personalized Medicine”, is the way in which doctors can analyze a patient’s genes to identify whether certain drugs will be effective, non effective, or even dangerous to a patient.[3] While President Obama had dreams of launching a new era of medicine revolving around this type of care, barriers have remained in place which have slowed the growth of this treatment. One of the main barriers until recently was the ability to obtain a patent on a personalized medical treatment.[4] Because patents spur innovation and investment in industries, the ability to obtain a patent for a technology or invention is incredibly important.[5]

The state of obtaining patents for personalized medicine is dependent on the interpretation of 35 U.S.C. § 101 by the Federal Courts.[6] Recent decisions in Mayo Collaborative Servs. v. Prometheus Labs., Inc.,[7] Vanda Pharm. Inc. v. W.-Ward Pharm. Int’l Ltd.,[8] and Endo Pharm. Inc. v. Teva Pharm. USA, Inc.,[9] have clarified how personalized medicine may or may not be patented.

Part II of this article will discuss the legal background of 35 U.S.C. § 101, the Mayo decision, the Vanda decision, the Endo decision, and the language of the relevant patent claims involved in each decision. Part III of this article will discuss the similarities and differences between the ruling in the aforementioned cases and the language used in their respective patents. Part IV will conclude the paper and highlight language to be used in the claims of personalized medicine patent applications. 

II. BACKGROUND

There are certain requirements that must be met in order for an inventor to obtain a patent on their invention.[10] Generally, an invention must first be in a category of eligible subject matter and it must have utility in order to be patentable.[11] The invention must also be novel[12] and nonobvious.[13] Finally, an application for a patent must be clear and descriptive enough such that any person skilled in the related field is enabled to make and use the invention.[14] Section A will dive into case law involving 35 U.S.C. § 101 and discuss the science behind personalized medicine. Section B will analyze the Mayo decision and patent. Section C will analyze the Vanda decision and patent. Finally, Section D will analyze the Endo decision and patent.

A. 35 U.S.C. § 101

The blueprint for every individual human is in the DNA sequence of our genome. Our genome contains over 20,000 genes. Each one of these genes is processed by mechanisms in the body to ultimately form proteins, which have functions that allow for the various cells and organs in the body.  Some of these proteins help break down drugs when they are ingested or injected into an individual.[15] However, not every human’s genome is identical. We have small differences in our genes that may affect the functions of the corresponding protein.[16] Thus, certain drugs may be more effective in one individual compared to another based on the DNA sequence of their genome.[17] With the rise of large bioinformatic data sets that contain the genetic sequences of many individuals, scientists around the world are now able to determine which one of the small differences in our genes are related to the efficacy of specific drugs. This leads to the potential for the increased effectiveness of various treatments for a wide array of diseases. The question then arises of whether these new treatments that factor in the small differences in our genes are able to be patented.

35 U.S.C. § 101 states that an invention must be a “new and useful process, machine, manufacture, or composition of matter” in order for a patent to be obtained.[18] The Supreme Court has stated multiple times that natural phenomena and laws of nature are not patentable subject matter.[19] However, the application of a law of nature may be patentable subject matter.[20] In Association for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court determined that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.”[21] The Supreme Court then discussed the level of the application of a law of nature necessary for patentability in Mayo.

B. Mayo Collaborative Servs. v. Prometheus Labs., Inc.[22]

In Mayo, the issue was whether a patent, which claimed a process for determining whether the dosage of a thiopurine drug to treat autoimmune diseases was too high or too low, was invalid for containing ineligible subject matter under 35 U.S.C. § 101.[23] The Court had to determine whether the claimed process transformed the natural laws sufficiently such that they were patent eligible applications of the natural laws.[24] The Court reasoned that precedential case law warned against patents that were too broad and preempted the use of a natural law.[25] The independent patent claim at issue reads (emphasis added):

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8.times.10.sup.8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8.times.10.sup.8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject. [26]

The District Court granted summary judgment in favor of the alleged infringer, Mayo Collaborative Services, because they reasoned that the patent was invalid for claiming a law of nature – the correlation between the metabolite levels and the efficacy of the thiopurine drug.[27] The Federal Circuit reversed, stating that in addition to the laws of nature, the patent also had an administration step and a determination step that sufficiently transformed the law of nature and brought the patent within definite bounds such that 35 U.S.C. § 101 was satisfied.[28] The Supreme Court reasoned that the additional steps were not sufficient to transform the claim.[29] The Court reasoned the administration step of the claim only determined the relevant audience – doctors treating patients with an autoimmune disorder.[30] Limiting the law of nature to a particular technological environment is not enough for patentability.[31] The wherein clauses simply told the audience about the relevant natural laws – the correlation between the drug levels and the need to increase or decrease the dosage.[32] Finally, the determination step simply tells the audience to determine the level of the metabolite through whatever process they want.[33] Because there were many routine processes out there, this step was determined to be a well understood, routine, conventional activity that is not sufficient to transform an unpatentable law of nature into a patentable application.[34] The Court ultimately determined that “simply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable.”[35] The determining step in the patent claim was too general and covered all processes that would make use of the natural relationship.[36]

After a subsequent Supreme Court case dealing with 35 U.S.C. § 101, Alice Corp. Pty. Ltd. v. CLS Bank Int’l,[37] the United States Patent and Trademark Office (USPTO) released new guidelines for determining subject matter eligibility.[38] The Alice/Mayo Test was used to determine whether an invention was patentable.[39] The first step of the test asks whether the claim is directed to a law of nature, natural phenomena, or abstract idea.[40] If yes, the second prong asks whether the claim recites additional elements that amount to significantly more than the law of nature, natural phenomena or abstract idea.[41] Under USPTO guidelines, additional elements in this step must not be well understood, routine, or conventional activities.[42] However, a recent ruling in Vanda has made an important change to this test that has a drastic effect on personalized medicine.

C. Vanda Pharm. Inc. v. W.-Ward Pharm. Int’l Ltd.[43]

In Vanda, the patent at issue (‘610 patent) revolved around a method of treating schizophrenia with a specific drug and a range of doses based on the patient’s genotype (small difference in their gene as described above).[44] The claim in the ‘610 patent read as (emphasis added):

  1. A method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia, the method comprising the steps of:

determining whether the patient is a CYP2D6 poor metabolizer by:
obtaining or having obtained a biological sample from the patient; and
performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and
if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and
if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day,wherein a risk of QTc prolongation for a patient having a CYP2D6 poor metabolizer genotype is lower following the internal administration of 12 mg/day or less than it would be if the iloperidone were administered in an amount of greater than 12 mg/day, up to 24 mg/day.[1]

[1]U.S. Pat. No. 8,586,610 (Filed September 30, 2005).

The District Court reasoned that although the claims were directed to laws of nature (the relationship between iloperidone, CYP2D6 metabolism, and QTc prolongation), the claims added the CYP2D6 genotyping test to determine the appropriate dosage of the drug.[46] The District Court did not find the test as routine or conventional, therefore the claims were not invalid under 35 U.S.C. § 101.[47] On appeal, the Federal Circuit agreed with the District Court and reasoned that the claims in the ‘610 patent were not “directed to” a natural law.[48] The Court distinguished the case from Mayo by reasoning that these claims were directed to a novel method of treating a claim with a specific drug, not a diagnostic method.[49] The claims were not directed to the relationship of iloperidone, CYP2D6 metabolism and QTc prolongation, but to the application of that relationship.[50] Because the claims in Mayo only determined whether an individual would be better off with an increased or decreased dosage, it tied up a Doctor’s subsequent treatment decision and threatened to inhibit “the development of more refined treatment decisions.”[51] Here, the claims do not tie up the Doctor’s subsequent decision because they are directed to “a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.”[52]

In response to the Vanda decision, the USPTO has revised its guidelines for reviewing subject matter eligibility.[53] Instead of asking whether “the claim is directed to a law of nature…”, the first step has been split into two parts.[54] The first part asks whether the claim recites an abstract idea, law of nature, or natural phenomena.[55] If yes, the second part asks whether the claim recites additional elements that integrate the law of nature into a practical application.[56] This integration can be well understood, routine and conventional.[57] If the answer to this second part is no, then the test moves on to the second step of the Alice/Mayo test and asks whether the claim recites additional elements that amount to significantly more than the law of nature, natural phenomena or abstract idea. These elements must still be well understood, routine, or conventional activities.[58]

Vanda was a 2-1 ruling, with the dissent disagreeing with the notion that the Vanda patent was distinguished from the patent in Mayo.[59] However, the Federal Circuit has already followed the Vanda holding in another case – Endo.

D. Endo Pharm. Inc. v. Teva Pharm. USA, Inc.[60]

In Endo, the patent at issue claimed a method for treating pain in patients that had impaired kidney function with the use of the drug oxymorphone. The natural laws in the patent were the correlation between the blood concentration of the drug over time and the functioning of the kidney as measured by the concentration of creatine excreted in the patient’s urine. The primary independent claim therefore read as (emphasis added):

  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,in dependence on which creatinine clearance rate is found, a lower dosage of the dosage form to provide pain relief;
wherein after said administrationto said patient, the average AUC of oxymorphone over a 12-hour period is less than about 21 nghr/mL.[1]

[1]U.S. Pat. No. 8,808,737 (filed March 3, 2010).

The District Court reasoned that the “providing” step was similar and indistinguishable from the “administering step” in the Mayo patent.[62] The District Court also reasoned that the “determining” step “just directs one to use a well-known method to measure creatinine levels to obtain the necessary information to apply a law of nature.”[63] Based on this reasoning, the District Court did not find that the Endo patent was directed to eligible subject matter.[64]

On appeal, the Federal Circuit disagreed and reversed, holding the patent valid.[65] The court compared the claims in the Endo patent to the claims in the Vanda patent and found that “The claims at issue here are legally indistinguishable from the representative claim in Vanda. Both claims recite a method for treating a patient.”[66] The court pointed out that while the Mayo patent was not directed to the application of a drug to treat a particular disease, the Endo patent was directed a specific application of a relationship with specific steps on whether to adjust or lower the dosage of a drug for patients.[67]

III. DISCUSSION

When comparing the three cases, a clear pattern emerges in the claim language that can be used as a road map for those in patent prosecution. In Mayo, the primary independent claim can be summed up as obtaining a sample via drug administration, then detecting the status of the patient based on the level of that drug in the bloodstream. However, both Vanda and Endo added something more. In Vanda, a sample is obtained, the status is detected through genotyping, and there is a treatment based on this detection. Similarly in Endo, a sample is obtained, the status of the patient is detected based on the rate of creatine clearance, and there is a treatment of different drug dosages based on this detection.

The treatment step that is dependent on the result of the detection is the distinguishing factor between the claim in Mayo and the claims in Vanda and Endo. The treatment step seems to satisfy the new USPTO Subject Matter Eligibility Guidelines by integrating the law of nature into a practical application. 

Additionally, Mayo was directed towards immune-mediated gastrointestinal disorders generally, with a specific level of a drug as a key factor. Vanda was directed towards schizophrenia patients with a specific genotype. Endo was directed towards patients with kidney failure that processed creatine in a specific way. The patent system in the United States works in a quid pro quo way, in which a limited monopoly is granted in exchange for a public disclosure of the invention. The USPTO ultimately has to determine the scope of the limited monopoly (patent) it is willing to give up to the public’s detriment. The balancing of the quid pro quo system and the scope of the patents is likely in play in this personalized medicine issue as well. Mayo is fairly broad, encompassing all immune-mediated gastrointestinal disorders and encompassing all potential treatments by language of its claims.[68] Vanda and Endo are both much more limited to a specific disease and a specific treatment of that disease. The scope of the claims are therefore fairly narrow, and would be much more acceptable for the USPTO to grant in exchange for a patent.

Therefore, it seems that the most effective patent for a personalized medicine technique will have a treatment step and will be specific in both the disease or condition treated and the drug and drug dosages used to treat. This will allow the technique to overcome the USPTO’s Subject Matter Eligibility Guidelines and be narrow enough in scope that the USPTO would feel comfortable granting a patent or limited monopoly. 

IV. CONCLUSION

The Mayo, Vanda, and Endo decisions represent the dual nature of evolution in technology and in law. While law is slow to evolve and react, technology is prone to quick advances. This results in some situations where the law does not adequately keep pace with the advances in technology. While the judiciary has thus far put patchwork fixes in place to handle the developing industry of personalized medicine, there is further need from the legislative branch to make the law more clear for technologies such as software, artificial intelligence, and other biotechnological discoveries. 

Based on the most recent decisions in Vanda and Endo, it seems that the addition of a treatment step to the claims and the narrowing of the patent’s scope by adding a specific disease and drug are both effective measures for getting the claims allowed.


[1]State of the Union 2015: Full transcript, CNN (January 20, 2015), https://www.cnn.com/2015/01/20/politics/state-of-the-union-2015-transcript-full-text/index.html.

[2]THE PRECISION MEDICINE INITIATIVE, THEWHITEHOUSE, https://obamawhitehouse.archives.gov/precision-medicine (last visited June 23, 2019).  

[3]Personalized Medicine, NATIONAL INSTITUTES OF HEALTH, https://www.nih.gov/about-nih/what-we-do/nih-turning-discovery-into-health/personalized-medicine (October 7, 2015). 

[4]See Mayo Collaborative Servs. v. Prometheus Labs., Inc.,566 U.S. 66 (2012).

[5]Patents Spur Innovation, 3M News Center, https://news.3m.com/campaign/patents-spur-innovation (September 12, 2011).

[6]35 U.S.C.S. § 101 (LexisNexis). Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

[7]Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012).

[8]Vanda Pharm. Inc. v. W.-Ward Pharm. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018).

[9]Endo Pharm. Inc. v. Teva Pharm. USA, Inc., Nos. 2017-1240, 2017-1455, 2017-1887, 2019 U.S. App. LEXIS 9189 (Fed. Cir. Mar. 28, 2019).

[10]See 35 U.S.C.S. § 101 (LexisNexis); 35 U.S.C.S. § 102 (LexisNexis), 35 U.S.C.S. § 103 (LexisNexis); 35 U.S.C.S. § 112 (LexisNexis).

[11]35 U.S.C.S. § 101 (LexisNexis).

[12]35 U.S.C.S. § 102 (LexisNexis).

[13]35 U.S.C.S. § 103 (LexisNexis).

[14]35 U.S.C.S. § 112 (LexisNexis).

[15]Tanaka, E., Clinically important pharmacokinetic drug–drug interactions: role of cytochrome P450 enzymes, Journal of Clinical Pharmacy and Therapeutics, 23: 403-416 (1998), https://onlinelibrary.wiley.com/doi/abs/10.1046/j.1365-2710.1998.00086.x. 

[16]What are single nucleotide polymorphisms (SNPs)?, U.S. National Library of References, https://ghr.nlm.nih.gov/primer/genomicresearch/snp (June 11, 2019).

[17]Id.

[18]35 U.S.C.S. § 101 (LexisNexis).

[19]See Gottschalk v. Benson, 409 U.S. 63, 67 (1972) (Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.); Diamond v. Diehr, 450 U.S. 175, 185 (1981) (This Court has undoubtedly recognized limits to § 101 and every discovery is not embraced within the statutory terms. Excluded from such patent protection are laws of nature, natural phenomena, and  abstract ideas.). 

[20]Diamond v. Diehr, 450 U.S. 175, 187 (1981).

[21]Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580 (2013). However, non-naturally occurring DNA in the form of cDNA is patentable. 

[22]566 U.S. 66 (2012).

[23]Id. at 72. 

[24]Id. 

[25]Id.

[26]U.S. Patent No. 6,355,623 (filed April 8, 1999). 

[27]Mayo at 76.

[28]Id.

[29]Id. at 77. 

[30]Id.at 78. 

[31]Id. (citing Bilski v. Kappos, 177 L. Ed. 2d 792, 801 (quotingDiehr, 67 L. Ed. 2d 155)). 

[32]Id. 

[33]Id. at 79. 

[34]Id. 

[35]Id. at 82.

[36]Id. at 87. 

[37]Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014). 

[38]MPEP 2106 (9th ed. Rev. 08.2017, January 2018).

[39]Id. 

[40]Id.

[41]Id.

[42]Id.

[43]887 F.3d 1117 (Fed. Cir. 2018).

[44]Id. at 1121.

[45]U.S. Pat. No. 8,586,610 (Filed September 30, 2005). 

[46]Vanda at 1123.

[47]Id. 

[48]Id. at 1134.

[49]Id. 

[50]Id. at 1135.

[51]Id.

[52]Id. at 1136.

[53]2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 4, 50.

[54]Id. at 53.

[55]Id.

[56]Id.

[57]Id.

[58]Id.

[59]Id. at 1143.

[60]Id.

[61]U.S. Pat. No. 8,808,737 (filed March 3, 2010). 

[62]Endo at ¶6-¶7.

[63]Id. at ¶7.

[64]Id. 

[65]Id. at ¶12.

[66]Id. 

[67]Id. at ¶14-¶15. 

[68]Patent claims can be divided into three parts: the preamble, the transition, and the body. The transition normally consists of the phrases consisting, consisting essentially of, and comprising. “Comprising” is open ended and does not exclude additional limitations to a claim, the only limitations needed for infringement are the limitations listed in the claim. “Consisting” excludes additional limitations that are not listed in the claim. “Consisting essentially of” covers the middle ground and allows only additional limitations that do not materially affect the characteristics of the claimed invention. In Mayo, comprising acts to encompass any invention that has the same administration and determination steps listed – including a multitude of potential treatments.

Federal Circuit Contradicts Itself in Playdom Service Mark Ruling

Author: Jon Siderits, Associate Member, University of Cincinnati Law Review

On March 2, 2015, the United States Court of Appeals for the Federal Circuit affirmed the Trademark Trial and Appeal Board’s (TTAB) decision to cancel David Couture’s registration on the mark PLAYDOM.[1] The Federal Circuit found that Couture, who applied to register the mark on May 30, 2008, failed to sufficiently use the mark in commerce to qualify for a trademark registration.[2] The decision is controversial due to the Federal Circuit’s failure to follow established precedent regarding what constitutes “use” in commerce and its creation of a new distinction between the “use” required for service marks and marks for goods. The decision ignored the Federal Circuit’s own guidance from its previous encounter with the issue, which supported a ruling in favor of Couture, and instead concluded that the “actual provision” of services is required before a service mark may be registered.[3]

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Planting Innovation: A Look into Plant Patent Protection and the Deficiencies of the Plant Protection Act and Plant Variety Protection Act

Author: Ashley J. (Clever) Earle, Contributing Member, University of Cincinnati Law Review

When thinking about patent protection, most individuals likely picture what patent attorneys describe as a “widget”—a physical, mechanical invention. Patent protection however, covers a much broader spectrum of inventions. It may seem natural to grant patents to protect new innovations such as chemical compounds, technological advances, or ornamental designs, but most people would not automatically include plants in the categories of protectable technologies. Plant patent protection is an unassuming, but integral part of the incentives of creativity protected by intellectual property law; however, obtaining plant protection can be very onerous and unnecessarily technical.

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The “Blurred Lines” of Copyright Scope

Author: Jon Siderits, Associate Member, University of Cincinnati Law Review

On March 10, 2015, a federal jury found that Robin Thicke and Pharrell Williams infringed a copyright owned by the heirs of Marvin Gaye, by copying substantially from Gaye’s song “Got to Give It Up” when they created their 2013 hit “Blurred Lines.”[1] While other recent copyright disputes involving major recording artists have settled without either party ever filing suit, the battle between the “Blurred Lines” writers and Gaye’s heirs was particularly contentious, all the way up to the uncertain ending.[2] While the heirs have ultimately triumphed (assuming Thicke and Williams do not appeal), a pre-trial decision by the presiding judge to limit the scope of their copyright to a set of written sheet music, rather than the song’s recording, easily could have derailed their case and led to the opposite outcome. Despite the judge’s effort to apply the correct, albeit antiquated, law to the issue, extending the copyright protection to the recording would have been an appropriate, legally supported decision that would have sent a clear message to would-be infringers, and likely would have resulted in an earlier resolution of the case.

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Federal Circuit No Longer to Review Patent Claim Construction Entirely De Novo

Author: Jon Siderits, Associate Member, University of Cincinnati Law Review

On January 20, 2015, the Supreme Court announced its decision in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., and did away with the Federal Circuit’s longstanding application of a purely de novo standard when reviewing a district court’s construction of a patent claim.[1] Specifically, the Supreme Court held that the Federal Circuit must review the district court’s resolution of any subsidiary factual matters under a clear error standard of review, and only then may it resolve the ultimate legal question of claim construction de novo.[2]  Marking a significant shift in the role of the district court judge in claim construction, and realigning the appellate court’s role with the Federal Rules of Civil Procedure, the Teva decision ensures that the lower court’s construction will play a more dispositive, rather than disposable, part in patent infringement cases.

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Design Patents: How Close Is Too Close? Vacillating Court Decisions Provide Little Guidance, as Shown in Apple v. Samsung

Author: Ashley Clever, Contributing Member, University of Cincinnati Law Review

When marketing a new product, a business will often need to protect both the functionality and the overall design of a product to prevent competitors from producing an identical copy. While a utility patent covers a product’s functional features—how it works and what it does, a design patent can product a product’s aesthetic features—its design and how it looks.[1] Design patents however, provide notoriously little protection and are often construed only to cover the exact design. The Federal Circuit Court of Appeals has provided very little guidance in defining what a design patent protects, with even minute changes in design or ornamentation sometimes enough to overcome a patented design.[2] The recent case of Apple v. Samsung depicts the vacillating decisions in the court’s determination of what does or does not constitute design patent infringement.[3] These fluctuating court decisions create unnecessary confusion in determining the proper scope of design patent protection, leaving inventors as well as competitors with increasing uncertainty.

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What’s in a Name? A Look into the Washington Redskins Trademark Dispute

Author: Ashley Clever, Contributing Member, University of Cincinnati Law Review

Many currently debate whether or not the Washington Redskins name and logo should be changed for disparaging Native Americans, but a closer look into trademark protection raises questions about the role of the United States Patent and Trademark Office (USPTO) and where this push for change should ultimately come from. A quick search on the Trademark Electronic Search System (TESS) reveals 130 records of trademarks containing the f-word (26 of which are currently being used in commerce). Live trademarks include “F—k You,” “F—k It,” “F—k Yeah,” and, quite possibly the most original, “All You F—n’ Hillbillies Shut the F—k Up,” which claims to be a brand of t-shirts.[1] Numerous comedy shows have poked fun at the trademark controversy, such as the South Park episode “Go Fund Yourself,” in which the characters begin a start-up company using the trademark “the Washington Redskins.”[2] While the controversy is being parodied in the news, it raises very relevant questions of why trademarks exist, what can be trademarked, and when a trademark should be canceled. The USPTO may have had good intentions in cancelling the trademark, but all they succeeded in accomplishing was potentially harming consumers by making it more difficult for the Washington Redskins to prevent companies from producing counterfeiting goods bearing the Redskins logo.

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Ohio Considers Joining the Fight Against Patent Trolls

Author: Jon Kelly, Associate Member, University of Cincinnati Law Review

Patent trolls have become a serious headache for small businesses, and states are beginning to fight them without the federal government.  The Ohio General Assembly is currently debating House Bill 573 (H.B. 573), which would allow patent holders to sue patent trolls for “bad faith” claims.[1] Although Ohio has a strong interest in preventing patent trolls from hindering small businesses’ operations, it is uncertain whether the federal government’s exclusive jurisdiction over patent law would preempt H.B. 573 and prevent state courts from accepting patent abuse cases under the law. Considering the current state of relevant case law, however, Ohio’s H.B. 573 should survive any preemption challenge because the law does not attempt to validate patents themselves, but instead sanctions the conduct of patent trolls.

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