Wonder of Wonders, Miracle of Miracles[1]: Lite-Netics v. Nu Tsai Capital

March 2, 2023

With decision affecting state anti-patent statutes,[2] the Federal Circuit unexpectedly but explicitly held that regulation of speech related to patent infringement is pre-empted by federal patent law. As a result, state tort law is not relevant unless the person asserting state law liability initially establishes that a communication was sent in bad faith.

Lite-Netics filed a lawsuit in federal district court against HBL and asserted infringement of its patents for a holiday lights technology. Before and after filing the lawsuit Lite-Netics sent notices to HBL’s customers which stated that companies were infringing its patents by selling specific holiday lights. Subsequently one notice specifically named HBL as the infringer which Lite-Netics had sued. Based upon these notices, HBL counterclaimed by asserting unfair competition and defamation under Colorado state law. The district court found that Lite-Netics had sent these notices in bad faith, and consequently HBL was likely to prevail on it state law claims. The court then granted a preliminary injunction to prevent Lite-Netics from further notifying HBL customers that (i) they could become defendants in patent infringement lawsuits, or (ii) HBL infringed Lite-Netic’s patents.

The Federal Circuit[3] vacated the preliminary injunction and held that federal patent law preempts state law counterclaims if there is no bad faith distribution of related communications. Furthermore, under federal law bad faith requires that (i) these notices be objectively baseless, and (ii) this baselessness must be established prior to determining subjective bad faith.  The court also held that objective baselessness does not necessarily result from a patent owner’s mistake in asserting patent infringement. In addition, the Federal Circuit stated that commercial speech is protected under the First Amendment, and the preliminary injunction was not properly tailored to Constitutional requirements.[4]

Based upon this decision and its federal predecessors, as well as the Federal Trade Commission Report,[5] there appears to be a race to two court houses: One party to federal court and the opposing part to state court. At this point an outcome may hinge upon one party side filing a lawsuit first in a respective court.

©2023 Adrienne B. Naumann, Esq. All rights reserved. Ms. Naumann does not endorse or sponsor the advertisements at adriennebnaumann@wordpress.com.

[1] From Fiddler on the Roof.

[2] Since 2005 most states have enacted laws known as ‘anti-patent statutes.’ The asserted purpose of these statutes is prevention of frivolous patent infringement notices from patent licensing companies.

[3] U.S. Court of Appeals for the Federal Circuit.

[4]  Federal appellate decisions have continuously held that state law business torts are pre-empted by federal law absent objective bad faith. These decisions also hold that the First Amendment generally prohibits prior restraints upon commercial speech, such as patent infringement notices. For example, in Globetrotter Software, Inc. et al. v. Elan Computer Group, Inc. et al., 362 F.3d 1367, 1374 (Fed. Cir. 2004), the alleged infringer filed counterclaims for state law business torts, because Globetrotter had notified Elan’s potential purchaser of Elan’s asserted patent infringement.   The Federal Circuit held that federal patent law preempts state tort liability for a patent holder’s good faith patent related communications. This decision also explicitly held that bad faith must be established even if bad faith is not an element of the state law tort. Globetrotter further held that federal law governs even if these patent related communications occurred outside actual litigation.

[5] Federal Trade Commission Patent Assertion Entities Study 2016.



November 14, 2022

Throughout my thirty years of prosecuting United States (U.S.) patent applications, the following issues most consistently arose with clients: fees, provisional applications, subject matter eligibility and sufficient technical information.

Three kinds of fees are necessary for obtaining a U.S. utility patent.[1] First and foremost are attorney fees which are primarily allocated to drafting and submission of documents to the U.S. patent office. Secondly there are mandatory non-attorney patent office fees where the amounts primarily depend upon applicant characteristics such as business entity, individual natural person and income. Finally, there are non-attorney fees for costs such as postage and photocopies. This last category also includes non-attorney fees for outsourced professional application illustrations of the invention. There may also be consulting fees for evaluating and/or testing the invention.  Consulting fees could run into thousands of dollars, or perhaps a few hundred dollars, depending upon the project. Many potential applicants are truly surprised at the extent of the fees.

By law, U.S. provisional applications must meet the same content requirements as a U.S. utility patent application.[2] However, a provisional application never becomes a patent unless it is affirmatively converted to a utility application within a year of the provisional’s submission.[3]   Specifically, the provisional application must provide sufficient technical information to demonstrate that the inventor possessed of all the technical features when the application was originally submitted. Also under U.S. patent law, the application must comprise sufficient technical invention information so a person of ordinary skill in the relevant technology could, without undue experimentation, recreate the invention exclusively from the resulting patent.

Success in application prosecution and infringement litigation often requires obtaining the earliest submission date for a series of patents directed to a single invention. If this information is absent from the provisional application, then that application is fatally defective. The problem is that even if this defective provisional was the earliest filed, the subsequent related utility application(s) cannot generally reach back for the required technical information of the provisional application.  A possible scenario is that the provisional application has the only filing date prior to the patent law’s application submission deadline. However, the subsequent utility applications cannot rely upon that earlier defective provisional filing date for information necessary to support a claim sentence submitted after the deadline expired.  Without this missing technical information, the related applications filed after the expired deadline are therefore invalid and non-enforceable.[4]

© 2022 Adrienne B. Naumann, Esq. All rights reserved. Ms. Naumann does not sponsor or endorse the advertisements at adriennebnaumann.wordpress.com.

[1] There are also documents known as design patents. Design patents protect ornamental features upon a manufactured article. 35 U.S.C. section 171(a).

[2] Manual of Patent Examination Procedure section 601[Ninth Ed. Rev. June 2020] [hereinafter MPEP]; 35 U.S.C. sections 111(b), 112(a) and 113 However, provisional applications do not require a claim sentence as do utility patent applications.

[3] MPEP section 601; 35 U.S.C. section 111(b)(5).

[4] An early submission date may also be necessary to predate earlier existing devices which may result in the invention being anticipated or obvious. However, a provisional application is not entitled to the priority date of another application. 35 U.S.C. section 111(b)(7).owebH


November 2, 2022

A very important benefit of copyright registration is that computer programs are copyright eligible as written works.[1] Copyright eligible computer programs comprise source code or object code although source code is preferred.[2] Executable code as well as non-executing comments within source code are each copyright eligible if they comprise sufficient originality and creativity.[3] Generally a computer program and resulting screen display comprises the same copyright eligible work and an ‘app‘ is also considered a computer program.[4] Copyright eligible source code is written by a natural person(s) using computer programming language such as Java or C++.[5]

With this very basic information in mind, one should be aware of considerable controversy surrounding patent eligibility of computer programs as computer related inventions.[6] Computer related inventions fall into two separate groups with respect to patent eligibility (i) those which improve the function of a computer, and (ii) abstract ideas implemented by generic computers with no improvements to those computers. For the first group sufficient knowledge of computer programming and software/object code drafting should prevent the rejection of a U.S. utility patent application based upon patent ineligibility. For the second group, there is simply no manner by which to draft an application for patent eligibility because abstract ideas in and of themselves are never patent eligible under U.S. patent law.  In this second group, without improvements to the computer or computer system, there is no inventive concept to salvage the purported invention.

But here is great news.  The computer program containing the abstract idea may be protected assuming sufficient originality, creativity, and other computer programing requirements in the U.S. copyright office. The copyright office is a separate agency under a different law with different requirements for registration. For these reasons the applicant should submit a registration application to the copyright office for a computer program which is not patent eligible under U.S. patent law.

There are other significant advantages to submitting a copyright registration for the computer program. To begin the initial preparation of the application requires significantly lesser, and fewer, attorney and government fees than a patent utility application. Secondly, time elapsing between application submission and a copyright office registration decision is also significant less than that for a patent application. There is also no first to file an application requirement or non-extendable deadlines for a copyright registration initial submissions. Finally, but very importantly, there is a copyright office procedure for redacting trade secrets from a submitted computer program.

©2022 Adrienne B. Naumann, Esq. All rights reserved. Ms. Naumann does not sponsor or endorse the advertisements at adriennebnaumann.wordpress.com.

[1] A computer program comprises instructions to be used in a computer for producing a certain result. U. S. Copyright Office, Compendium of U.S. Copyright Office Practices section 721.1 (3d Ed. 2021) [hereinafter Compendium]; 17 U.S.C. section 101. A computer program comprises a literary work.

[2] Compendium section 721.5.

[3] Id.  section 721.9(F).

[4] Id. sections 721.10(A) and 722.

[5] Id. section 721.3.

[6] See 35 U.S.C. 101.

BACK TO BASICS (of copyright)! Part 3

November 1, 2022

In this installment I address (i) use of another’s copyright registered work and (ii) international copyright protection. With the defense of fair use[1] a third person without authorization (i) copies a portion of another’s work, or (ii) changes the original work into another version of the original work, but without infringing.[2] Whether use of another’s work comprises fair use requires evaluation of: (i) purpose and nature (transformation) of the copying person’s work, (ii) nature of original work, (iii) amount and substantive nature of the copied portion,  and (iv) the effect of this use upon the potential market for, or value of, the copyright registered work.[3]

Unfortunately, each judicial region of the country may promote a different judicial interpretation of this defense. Moreover, these different regions (that is, for each U.S.  federal circuit court of appeals) may agree, for example, on fair use for literary works, but they may interpret this defense differently for visual or and/or musical works. Is there a cost-effective manner by which to avoid a litigated fair use debacle? Actually, the best practice is to obtain the written permission of the copyright owner(s).  If the identity and contact information for the copyright owner(s) is not apparent, then authorizing a search within the U.S. copyright office is a satisfactory option.  The copyright office charges an hourly fee for this search, although there is no guarantee that the search will provide the sought-after results.  However, this approach is significantly less expensive than (i) responding to a cease-and-desist letter or (ii) undertaking defensive litigation in court for infringement.[4] Other options include obtaining licenses from organizations such as American Society of Composers, Authors and Publishers at ASCAP.com for public performance music licenses.

The person who receives a permission should always provide an appropriate value in exchange for permission. Why? Because under U.S. law each party should provide value to the other party for the contract to be enforceable. [5]  The value provided, which is generally comprises a financial amount, should also be properly documented.

Finally, how does one protect U.S. copyright registered works internationally? Generally, a U. S. work is protected in another country if that country is a party to a treaty with the United States for copyright protection. However, there may be preconditions to protection under another country’s copyright law, assuming they have one.  The copyright owner should also remember that a U.S. work only receives the protection which that other county’s law provides its own citizens. ©2022 Adrienne B. Naumann, Esq. All rights reserved. Ms. Naumann does not endorse or sponsor the advertisements at adriennebnaumann.wordpress.com.

[1] 17 U.S.C. section 108.

[2]  Whether there is sufficient transformation of an original photograph to vindicate creation of Warhol’s paintings depicting the identical subject matter is Andy Warhol Foundation for the Visual Arts v. Goldsmith, 992 F.3d 99 (2d Cir. 2021). This case is currently pending before the U.S. Supreme Court. There are other exceptions for some organizations: For example, libraries and archives may create limited number of complete copies under specific conditions.

[3] 17 U.S.C. 107. That a work is unpublished does not prevent a fair use defense if all four statutory factors are considered.

[4]  This letter generally identifies the work, how it is being infringed, and a deadline for a response prior to commencing infringement litigation.

[5] A permission is one kind of contract.


October 10, 2022

Every work which is eligible for U.S. copyright protection comprises copyright at the moment of its creation. However, a copyright owner cannot enforce rights in the United States except after registration, or after refusal thereof, in the United States copyright office. There are different U.S. registration requirements depending in large part upon whether subject matter is published.[1]

In addition to enforcement, why should content creators invest in U. S. copyright registration? First, registration is necessary to access the administrative procedure to prevent infringing imported products from entering the U. S. Secondly, after a specific time interval registration also provides a rebuttable presumption of the validity of statements in a copyright registration certificate. Thirdly, if registration occurs at the appropriate time, then after copyright infringement litigation a prevailing copyright owner may obtain statutory damages, attorneys fees and costs. [2]

A common misapprehension is that a copy of a work transfers copyright ownership of a work; this misapprehension includes works which are registered or unregistered, published or unpublished. As an example, suppose a customer pays a photographer to take her photograph. She also pays for ten copies of the photograph. The customer subsequently places the photograph on her commercially distributed book jacket without the photographer’s permission. Unfortunately, this activity comprises copyright infringement, because the customer did not pay for the right to display or distribute the photograph. This is the outcome even though the photograph comprises her own likeness, because public display and/or distribution are exclusive rights from the U.S. copyright ‘bundle.’

The good news is that a person may own copyright to a work which appears identical to a second work if both works were created independently. This means that unlike trademark or patent submission, there is no need to file ahead of third persons. However, under U. S. law more than one person may register the identical work as another person if the works were each independently created.

A formidable defense to copyright infringement is the legal concept of fair use. Fair use comprises  factors to determine whether a third person (i) has properly incorporated a portion of another’s work into his or her own subject matter, and (ii) therefore does not infringe.[3]  Currently the most prominent factors are (i) a commercial purpose for the third person’s work, and (ii) whether there is sufficient transformation of the original work by the third person.[4]

© 2022 Adrienne B. Naumann, Esq., all rights reserved. Ms. Naumann does not sponsor or endorse the advertisements at adriennebnaumann.wordpress.com

[1] Publication comprises the distribution of copies to the public by sale or other transfer of ownership, or by rental, lease or lending. Offering to distribute copies to a group for further distribution, public performance or public display also comprises publication.  17 U.S.C. 101.

[2] 17 U.S.C section 504; 17 U.S.C. section 412. Publication of a registered work is a factor when assessing availability  of statutory damage, costs and attorney fees under section 412. The best practice for clients with subject matter to protect will always be submission of a registration application as soon as possible.

[3] 17 U.S.C. section 107.

[4] The transformative use prong of the fair use defense is before the U.S. Supreme Court this term in Andy Warhol Foundation for the Visual Arts Inc. v. Goldsmith, 11 F4th 26 (2d Cir. 2021).


October 7, 2022

In my last article I reviewed several initial basics of United States (U.S.) copyright law, so we now move to equally important topics. Copyright ownership in a work is clearly important, i.e., ownership of the rights designated in my previous article.  As an initial matter it is important to understand the difference between an author and a copyright owner.  Under U.S. copyright law, the word ‘author’ is a term of art which generally designates the individual who creates the work.  In many instances the author and the owner of the right are one and the same, because the general rule is that the person who actually created the work, the author, owns these rights.

However, there are at least two gaping exceptions to this general result. The first is that anyone who creates a work within the scope of his or her employment is not the owner or author of this work.  Instead, the employer is considered both and this result automatically exists without a contract or other agreement.

The second exception occurs whenever a person engages an independent third party to create a work on a per project basis.  Whenever this person engages this third party there should be a contract transferring that party’s copyright in the work to the engaging person. Otherwise, the engaging person pays for the services but has no rights to use, modify, sell or even duplicate the work! This contract also requires a payment from the retaining person for the transfer, and this payment is separate and apart from the services fee.

If the subject matter by the third party falls within one of several statutory categories for this purpose, then with the appropriate contract and payment, the retaining party becomes the author as well as copyright owner.  If the retaining person becomes author, then the original owners are not entitled to return of the copyright which they transferred to that retaining person; this possible return is known as a reversion of rights. As a famous example, the reversion of rights was extensively litigated by the original authors and heirs of the comic book characters SUPERMAN® and SUPERBOY®.  

Because copyright is considered property, legatees and heirs may obtain these rights through a deceased’s estate. Someone may also obtain a transfer of copyright ownership from a person or entity; the transfer of rights from a third party to the engaging person is an example in this category. For the rights transfer to be exclusive the contract is written, but for a non-exclusive transfer a written agreement is not necessary. In either instance, the right of reversion could be exercised by the original copyright owner if the current owner does not also qualify as an author.

On or after January 1, 1978, registered and non-registered copyright in a particular work exists for the author’s natural life plus seventy years. For works under employment or a retainer agreement copyright endures 95 years from publication[1] or 120 years from creation, whichever is shorter.[2]  

© 2022 Adrienne B. Naumann, Esq. Ms. Naumann does not endorse or sponsor the advertisements at adriennebnaumann@wordpress.com.

[1] There is a special definition for ‘publication’ in copyright law which is much narrower than that of normal English language discourse.

[2] For works created prior to January 1, 1978 as well as non -U.S. works the rules for copyright duration prove significantly more complicated.  Anonymous and pseudonymous works have the same duration as works within the scope of employment.


October 7, 2022

In this article I explore basic concepts of United States (U.S.) copyright law. Copyright is a kind of property which is analogous to, but not the same as, those rights one would obtain when purchasing a house. Property rights which the copyright owner initially owns in a particular subject matter comprise:

(i) Reproduction;

(ii) Preparation of subsequent subject matter based upon the original;

(iii) Distribution of copies to the public by sale, rental lease, lending or other ownership transfers;

(iv) Public performance; and

(v) Public display

Furthermore, these rights may be transferred separately from each other. Although these rights  automatically exist within particular subject matter, copyright protection requires registration of the subject matter in a federal agency known as the U. S.  Copyright Office [copyright office). 

Which kinds of creative subject matter are eligible for U. S. copyright protection?  Clients often request protection for copyright eligible literary subject matter (otherwise known as ‘works’) such as hand written or typed manuscripts. However, computer related software and source code are also eligible for registration as literary works. Furthermore, copyright registration for computer related subject matter is significantly less expensive than patent protection, and there are generally no submission deadlines for these works.

Clients also often request copyright registration for visual art works such as two-dimensional designs, photographs and paintings. Other kinds of subject matter which are eligible for a copyright registration comprise:

  • Musical works, including lyrics;
  • Dramatic works, including music;
  • Pantomimes and choreographic words;
  • Motion pictures and other audiovisual works;
  • Sound recordings resulting from musical works or other sources; and
  • Architectural works.

To further qualify for U. S. copyright protection a work should (i) comprise sufficient originality and creativity, and (ii) be expressed upon a tangible medium.

Unfortunately, many persons mistakenly request protection for works which (i) do not comprise copyright, and (ii) therefore cannot be registered with the copyright office. This is particularly true for two-dimensional logos without enough design elements to fulfill creativity and originality requirements.

© 2022 Adrienne B. Naumann, Esq. Ms. Naumann does not endorse or sponsor the advertisements at adriennebnaumann.wordpress.com

A little less conversation, a little more action, please: [1] Blackberry Fallout Part 3

August 11, 2021

After the 2006 Blackberry settlement many states implemented laws referred to as anti-patent statutes.[2] States ostensibly enacted these statutes to curb patent owning companies which aggressively distributed bad faith patent infringement assertion letters to other businesses.  Although this intimidation did not occur in Blackberry[3], some contended that companies who did not ‘practice’ their patents would use patents to other businesses’ disadvantage.  Unfortunately, legitimate businesses have been entrapped by anti-patent statutes which implement liability for bad faith patent infringement assertion letters.

At least in federal courts, it appears there is no decision in which a truly predatory company was held accountable under an anti-patent statute.[4] In Summer Infant (USA) Inc. v.  Tomy International,

Inc.,[5] single alleged infringer Summer Infant contended that Tomy sent a bad faith patent infringement assertion letter under the state anti-patent statute. The court dismissed Summer Infant’s complaint with prejudice, where (i) Tomy sent a single cease and desist patent infringement letter to a single company, i.e.   Summer Infant, and (ii) none of threshold statutory criteria for liability under the anti-patent statute were present. Similarly, in Shoflo, LLC v. TSA Services, LLC[6], the single alleged infringer Shoflo counterclaimed under the state anti-patent statute that there was insufficient information in the patent infringement assertion letter. However, the district court concluded that there was sufficient information because the defendant and plaintiff had previously negotiated about the same patents. The court then dismissed the counterclaim with prejudice after holding that in any event the substantive content of a patent infringement assertion letter was pre-empted by federal patent law.

In another instance Prolacta Bioscience, Inc. sent a patent infringement assertion letter to single company Ni-Q, LLC and thereafter commenced a patent infringement lawsuit.[7] Ni-Q counterclaimed under Oregon’s anti-patent statute by alleging that Prolacta’s lawsuit was objectively baseless, because Prolacta knew this patent was invalid.  The court then denied summary judgment to Prolacta for an injunction and damages. In another case the court denied a bond to the single alleged infringer[8] after balancing the factors in the anti- patent statute.  In another bond request by a single alleged infringer under an anti-patent statute the court denied the motion because the patent owner’s complaint did not appear objectively baseless. [9]

These cases do not illustrate the alleged but widely publicized predatory behavior by which a patent owner distributes phony infringement assertion letters to hundreds of businesses.  Instead, these cases involved businesses who sent traditional cease and desist letters to corresponding single competitors.  Clearly the anti-patent statutes are overbroad and action is required to either repeal them or tailor them so legitimate businesses are not disadvantaged.

[1] Recorded by Elvis Presley

[2] Representative state anti-patent statutes include: O.C.G.A. section 10-1-771 and R. I. Section 6-41.1-3.

[3]  NTP, Inc. v. Research in Motion, 418 F.3d 1283(Fed. Cir. 2005) cert denied 546 U.S. 1157(2006).

[4] See Vermont v. MPHJ Technology Investments, LLC, 803 F.3d 635 (Fed. Cir. 2015).

[5] 2020 U.S.P.Q2d (BNA) 10879 (D.R.I. August 3, 2020).

[6] 2017 U.S. District Lexis 224864 (M.D. Fla. July 12, 2017).

[7] Ni-Q, LLC v. Prolacta Bioscience, Inc., 129 U.S.P.Q.2d (BNA) 1422 (D. Oregon February 14, 2019).Prolacta  also used its patent to commercially produce human milk formula.

[8] Farmer v. Alpha Technologies, 2015 U.S. Dist. Lexis 196079 (N. D. Ga.  November 18, 2015).

[9] Ice Castles, LLC v. LaBelle Lake Ice Palace LLC et al., 2021 U.S. Dist. Lexis 137239 (D. Idaho July 21, 2021).

Food for thought: reminiscences on the Blackberry settlement

July 27, 2021

Many of you may recall the Blackberry settlement of 2006 after which NTP, Inc., a patent owning company received a settlement of over $600 million dollars for patent infringement by the Canadian company Research in Motion[1] [hereinafter RIM]. NTP, Inc. did not use or practice these patents at the time. Prior to settlement of this protracted litigation, the Federal Circuit held[2] that the jury had properly found infringement of most claims in the five patents, and subsequently the United States Supreme Court denied RIM’s petition for certiorari.[3]  Since that fateful decision a worrisome number of United States attorneys and companies have waged war relentlessly on companies which (i) own but do not necessarily practice patents and (ii) enforce their right to exclude others from infringing their  patented innovative products and methods.

According to these attorneys and their business allies, companies that own patents, but do not ‘practice’ them or create products, forfeit their statutory right to exclude others from unauthorized transactions with these patents.[4] Not only is this against the policy and letter of the United States patent statute, but this proposal conflicts with the very longstanding concept of property in the United States. As a very everyday example, think of a family owning a house and then deciding to take a vacation for several weeks. Even though the house is vacant for this duration, does anyone presume that without permission a stranger may enter the house and live there during the owner’s absence?

Now assume that the family returns and finds a stranger residing in the house. The owners proceed to court and ask the judge to issue an order so the sheriff can remove the strange from the house.  However, in defense of his occupancy the stranger states to the judge: “I have the right to stay in the house without permission and without paying rent, because the owners were not using the house for that time period. Furthermore, because they left the house I may legitimately remain indefinitely and without paying rent or any other fees.”

Most people, including the judge, will conclude that this stranger is delusional, because everyone’s everyday implicit understanding of property is that the owner has the right to exclude others (with limited exceptions such as fire access, covid emergencies, etc.) from a residence.  So, why should NTP, Inc.  forfeit its patent ownership rights, one of which is the right to exclude, and which is a statutory patent right as well as a traditional property right? Should there be a substantially lesser remedy or recourse because there is ownership of a house instead of ownership of a patent? Should there be a different outcome even with an immense economic scope of the infringement in RIM’s case? One should note that the enormity of the award to NTP, Inc. directly results from RIM’s business decision to (i) infringe (ii) undertake the risk that the patent owner will not fight, or that the patent owner will lose a lawsuit as well as (iii) assume the risk that the patents are not valid.

In my next article I will examine legal and business events which have occurred since and in reaction to the Blackberry settlement.

©2021 Adrienne B. Naumann, Esq. All rights reserved. Ms. Naumann does not sponsor or endorse the advertisements at adriennebnaumann@wordpress.com.  

[1] Business News, page D2; March 4, 2006. St. John’s Telegram, a division of Transcontinental Media Group.

[2] NTP, Inc. v. Research in Motion, Ltd., 418 F.3d 1282 (2005), cert denied 546 U.S. 1157 (2006).

[3] Id.

[4] 35 U.S.C. section 154 (a)(1).

Once More with Feeling: Patent Eligible Subject Matter Part 2

July 23, 2021

For those fortunate enough to sit on the sidelines, there is the observation that many patents and patent applications have met their demise in the Federal Circuit because of patent ineligible subject matter. In my previous article I identified a large group of patents and patent applications which are foreseeably patent ineligible: that is, abstract ideas implemented by conventional computers. In this article I identify biomedical innovations that comprise patentable subject matter, while for other innovations no amount of application drafting expertise results in patent eligible subject matter.

Unlike computer related inventions comprising abstract ideas, for biomedical inventions the issue is generally whether the invention primarily comprises a (i) natural phenomenon, such as relationship between substances in a human body, or (ii) a natural law such as that for gravity.[1] The United States Supreme Court has held that naturally occurring subject matter is not patent eligible, in large part because private ownership would hinder medical innovation. Allowing patent eligibility would also prevent people from obtaining proper medical care because (i) their physician could not access the private owned natural medical subject matter, or (ii) it was prohibitively expensive to do so.

The Federal Circuit has held that diagnostic procedures which, without more only detect and quantify naturally occurring physiological events, are not patent eligible. However, the situation differs for medical treatment because these innovations (i) address a process which relies upon underlying natural human physiology, but (ii) sufficiently build upon naturally occurring events with new practical steps. For example, in Boehringer Ingelheim Pharmaceuticals et al. v. Mylan Pharmaceutical, Inc. et al.[2], the patent addressed treatment of diabetes mellitus with biochemical inhibitors metabolized by the liver instead of the kidneys. The Federal Circuit found the treatment was patent eligible, because it comprised a particular method with a specific biochemical inhibitor at quantified doses. Similarly, for a laboratory technique based upon naturally occurring cell free fetal DNA, the Federal Circuit held that the method of concentrating this fetal DNA, was patent eligible, although the natural correlation between DNA length and designation as fetal, was not.[3]

In sum, treatments and laboratory methods, but not diagnostic methods, are much more likely to be patent eligible if properly drafted. However, physicians and pharmaceutical companies should greatly appreciate these present criteria for biomedical subject matter eligibility and ‘weigh in’ to support its continued viability. Otherwise, if colleagues privately own patents for naturally occurring medical subject matter, physicians and other pharmaceutical companies could not (i) continue related research or (ii) diagnose their patents without high fees and permission of competitors.

© 2021 Adrienne B. Naumann. All rights reserved. Ms. Naumann does not sponsor or endorse the advertisements at adriennebnaumann@wordpress.com.

[1] Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012); Association for Molecular Pathology v. Myriad Genetics, 569 U. S. 576 (2013). In Mayo the Court held that a diagnostic method for detecting  thiopurine metabolite levels and toxicity of thiopurine was naturally occurring. Furthermore, there was nothing else to the claimed diagnosis method except observation and mental steps. According to Mayo, each patent subject matter eligibility requires a two-step inquiry:

  • Is a claim sentence as a whole directed to a natural event or natural law?
  • If so, is there an inventive concept within a claim sentence which transforms the naturally occurring event/law into patent eligible subject matter?

[2] 803 Fed. Appx. 397 (Fed. Cir. 2020) (non-precedential).

[3] Illumina, Inc. et al. v. Ariosa Diagnostics, Inc. et al., 952 F.3d 1367 (Fed. Cir. 2020) modified at 967 F.3d 1319,  petition for cert. dismissed, May 21, 2021.