Patent Law’s Enablement Requirement and Genus Claims: What Will SCOTUS Have to Say in Amgen v. Sanofi?  

This blog discusses a patent law case which SCOTUS has decided hear on the enablement requirement as it applies to genus claims.  The anticipated decision will have ramifications in particular in the life sciences industry which includes the biotech and pharmaceutical industries.


Even if the invention described in a patent application meets the subject matter eligibility (35 U.S.C § 101), novelty (35 U.S.C. § 102), and non-obviousness requirements (35 U.S.C. § 103) for patentability, the applicant must still describe the invention with enough particularity such that those skilled in the art will be able to make, use, and understand the “parameters” of the invention disclosed and claimed.  Under 35 U.S.C. § 112, this requirement involves 2 major factors: 1) the enablement requirement; and 2) the written description requirement.   The statute states:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.

Granted patent claims can later be invalidated on the basis of non-enablement or an inadequate written prescription in an inter partes proceeding before the Patent Trial & Appeal Board or during patent infringement litigation.  In long-time patent infringement litigation involving the biopharmaceutical firms Amgen and Sanofi, the enablement requirement issue has become intertwined with civil procedure issues:  is the determination of whether the patent description meets the enable requirements a question of law (to be decided by the presiding judge(s)) or fact (to be determined by a jury)?  In 2021, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed the District of Delaware’s invalidation of Amgen’s patent claims asserted against Sanofi as a matter of law in a post-verdict motion.  These very same invalidated claims had previously survived Sanofi’s “lack of enablement” allegations in two separate jury verdicts which the District Court ignored by ruling in favor of Sanofi. Amgen, Inc. v. Sanofi, 987 F.3d 1080 (Fed. Circ. 2021).

In Nov. 2021, Amgen filed a petition for writ of certiorari requesting the Supreme Court to grant the writ for the purpose of addressing two patent enablement questions raised by the CAFC’s opinion.  The first question pertained to whether enablement determinations are a question of law or fact.   The second question pertained to what level of experimentation is required to make Amgen’s invention enabled under 35 U.S.C. § 112(a) for its genus claims.  The Court invited the U.S. Solicitor General to file a brief; the resultant brief counseled against granting the writ.

Amgen filed a reply, arguing that the government’s own brief created a “disagreement with everyone” that further supports SCOTUS’s review. In support of the writ, Amgen emphasized that the Supreme Court’s “a question of fact” standard for enablement extends back to the pre-Civil war era in the 1847 case of Wood v. Underhill.  Amgen also argued that the Solicitor General’s brief failed to respond to arguments that the Seventh Amendment prohibits reexaminations of jury verdicts except under common law standards, which should have precluded the CAFC from reviewing the jury’s enablement finding de novo.   Finally, Amgen argued that the government never explained why a claim should be invalidated based on the cumulative effort to make all embodiments where, as with Amgen’s invention, such efforts would not require undue experimentation for those skilled in the art.  Indeed, the CAFC, in finding non-enablement, had opined that the the enablement standard for a genus claim may be raised if “substantial time and effort would be required to reach the full scope of the claimed embodiments.”

On Nov. 4, 2022, SCOTUS granted Amgen’s writ on Question 2 only: Whether enablement is governed by the statutory requirement [35 U.S.C. § 112(a)] that the specification teach those skilled in the art to “make and use” the claimed invention or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation – i.e., to cumulative identify and make [the invention] or nearly all [of its] embodiments.”

The Public Policy Behind the Enablement Requirement 

Patent protection lasts for about 20 years from the application’s filing date.  Through the government’s grant of this limited monopoly, the patentee has the right to exclusively use and exploit the invention.  After a patent expires, anyone can use, or sell, or import the invention covered by the patent. As such, the enablement requirement is intended to ensure that the public can actually derive benefit after the granted monopoly period is finished by making and using the invention.  Accordingly, the patent disclosure must provide sufficient information for allowing such persons to make the invention after the patent has expired.

Another aspect of the enablement requirement is to prevent the introduction of new matter during prosecution of the patent application.   MPEP 2164.05(a). Accordingly, the patent application is not to be “adjusted” to include new matter during prosecution.  This requirement is intended to help ensure that the patent application is thorough and complete at the time of filing.

What Does It Mean for an Invention to Enabled?

An enabled invention is one which is sufficiently instructive such that who is skilled in the art could make and use the invention without undue experimentation.  This requirement is not as straight forward as it may seem because all inventions are not equal with respect to their complexity or subject matter.   Storer v. Clark, 860 F.3d, 1340, 1350 (Fed. Circ. 2017).   New and more complex inventions may require more description and “directions” to meet the enablement requirement.   Also, for all claims to be approved under the enable requirement, the disclosure must sufficiently enable all of the claims.  In re Borkowski, 422 F.2d 904, 909 (CCPA 1970).

On the other hand, the enablement requirements does not require that the patent disclosure explain how to make a perfected, commercially viable embodiment of the invention.  See Christianson v. Colt Indus. Operating Corp., 822 F.2d 1544, 1562 (Fed. Cir. 1987).  Also, any invention may be associated with know-how and trade secrets (e.g., a raw material with desirable purity specifications to improve invented-product yields) which need not be revealed providing the trade secrets are not critical to the patentability of the invention.

The relevant factors courts have used in determining if the enablement requirement is met may “include (1) the quantity of experimentation necessary; (2) the amount of direction or guidance presented; (3) the presence or absence of working examples; (4) the nature of the invention; (5) the state of the prior art; (6) the relative skill of those in the art; (6) the unpredictability of the art; and (8) the breadth of the claims.”   In re Wands, 858 F.2d 731, 738 (Fed. Cir. 1988) (reversing the USPTO’s refusal to approve the patent applicant’s claims on non-enablement grounds and stating “[c]onsidering all of the factors, we conclude that it would not require undue experimentation to obtain antibodies needed to practice the claimed invention.”).  The commentator notes that this decision was at a time when biotechnology patents were in favor thanks to SCOTUS’s 1980 decision in Diamond v. Chakrabarty, 447 U.S. 303 (1980).  That decision is credited with paving the way for the rapid growth of the then-new biotechnology industry.  And now 40 years later SCOTUS is widely viewed as stifling innovation in today’s related technologies.

The subject patents the CAFC invalidated in Amgen v. Sanofi are directed to a genus of antibodies defined not by their structure (e.g., their amino acid sequence) but by their function, i.e., the ability of the monoclonal antibodies to bind a certain part of the PCSK9 antigen.  PCSK9 is a target for treating levels of LDL (the particularly “dangerous” form of cholesterol).   Accordingly, monoclonal antibodies directed against PCSK9 may still work with various sequence changes.   Patentees in the life sciences have had a difficult time defending claims directed to discovery of a novel biological therapeutic which often involve a functional genus claim.  Narrowly drawn claims to only the patent’s disclosed variations of the invention do not always “appreciate” the full scope of the invention, giving potential infringers wiggle room.

Amgen’s petition for writ emphasized that the CAFC wrongly applied a “special test” for its genus claims after gutting the juries’ findings.  “This approach will have devastating ramifications for biotech and pharmaceutical innovations because “significant breakthroughs [in these industries] often involve the mechanism for producing a desired effect and making a working embodiment . . . [where] the mechanism . . .may have the same effect when implemented in any number of structurally similar compounds.”  Amgen Pet. at 3, 29-30.  Hence a functional genus claim is one where structurally similar biochemical structures may be able to achieve at least some of level of the claimed function or mechanism.  The CAFC’s opinion indicated that the enablement standard for a genus claim could be raised if “substantial time and effort would be required to reach the full scope of the claimed embodiments.”

In its reply to the Solicitor General’s brief, Amgen argued that the Solicitor General had also wrongly extended the scope of Section 112’s enablement requirement to require a skilled artisan to “reach the full scope of claimed embodiments” without “substantial time and effort.”  Amgen’s position is that  “[o]nce inventors teach skilled artisans how to make and use the individual embodiments across the scope of the claim, there is no reason why they should lose their patent because it would take a lot of work to make them all [consecutively].”  Amgen countered that this standard does not comport with the statutory language of Section 112 which has no language connecting enablement with the amount of time and effort required to practice all embodiments of the claimed invention.  Nor did the government explain “why a claim should be invalidated based on the cumulative effort to make all claimed embodiments where as here, it would not require undue experimentation to make and use any individual embodiment.”  Substantial time and effort is not necessarily undue experimentation.


Put another way, the question SCOTUS will be addressing in 2023 is the following:  under the enablement requirement, must an invention like Amgen’s disclose every single potential embodiment of the claimed functional invention and how to make it to meet the enablement requirement and thereby minimize time required for making the embodiments by future users who are skilled in the art?  The commentator adds that the question is related to the actual disclosure’s quality.  Is there sufficient disclosure to meet the enablement requirement for the disclosed embodiments which will allow future users having the requisite skill in the art to proceed in making the disclosed and additional embodiments of a genus claim even if considerable time is involved? Under the enablement requirement, future users should not have to reinvent the wheel to make the patented invention and its various embodiments.  But time and effort are not necessarily undue experimentation.  Even the seminal Wands case’s “enablement” factors do not refer to time and effort but the quantity of experimentation.   Experimentation is itself subjective – and could range from optimization experiments (e.g., to maximize the yield of a claimed process’s product) to experimentation directed to filling in a critical missing or vague step not disclosed in the original application.

In sum, the issue in Amgen v. Sanofi is whether a precise roadmap for making all embodiments of a genus claim must be disclosed to meet the enablement requirement.  Does “time and effort” refer to the “time and effort” for making a limited number of the patent’s discussed embodiments or the “time and effort” for cumulatively making all possible embodiments which of course will result require more time and effort.   Amgen Pet. at 2 (quoting Amgen, 987, F.3d at 1088).  The commentator notes that the methodology for making and growing monoclonal antibodies was first developed last century and is routinely used by biotech companies who rely on the quicker technologies which have been developed over the years to support the biotech and pharmaceutical industries.

In Jan. 2021, SCOTUS denied a cert petition filed by Idenix Pharmaceuticals for nearly identical issues of enablement of functionally defined genus claims after it lost its appeal.  Idenix Pharmaceuticals, LLC v. Gilead Sciences, Inc., 941 F.3d 1149 (Fed. Cir. 2019).  The Amgen case will be closely watched by the patent bar and the life sciences industries now that SCOTUS is finally involved. After many decisions which have invalidated patent claims and negatively impacted patent portfolios in the life sciences industry, there is optimism that patent owners will see a shift in the pendulum in favor of genus claims which are common in this industry given the nature of the beast.  Of interest is the fact that three amicus briefs have been filed in favor in Amgen, including one by highly respected Professor Mark Lemley of Stanford Law School on behalf of a group of intellectual property professors.  This commentator is rooting for Amgen.

Stay tuned for a blog on SCOTUS’s opinion.


© 2022 by Troy & Schwartz, LLC


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Posted in Intellectual Property Law, Patent Law - Current Issues on November 15,2022 12:11 PM




On June 6, 2022 a copyright infringement lawsuit was filed in the U.S. District Court for the Central District of California over the new blockbuster film Top Gun Maverick by the heirs of deceased Israeli author Ehud Yonay.  The lawsuit involves a relatively unknown area of copyright law – the recapture doctrine – codified in § 203 of the Copyright Act.  This law gives authors and their heirs the right to recapture ownership of valuable copyrights by “terminating” past assignments and licenses of copyrighted works starting at the end of the 35th year from the date of the grant and for five years thereafter.  The process is complex and requires a notice to the copyright holder as well as the filing of documents with the U.S. Copyright Office.   Recapture is available even if the original grant was for the entire life of the copyright.  The doctrine is attended to provide the copyright owner and heirs with the right to seek new opportunities to receive financial compensation for their copyrighted works.  Such an option is particularly desirable where the copyrighted work’s value has increased over time as is the case here.  The Top Gun Maverick plaintiffs are seeking an injunction and compensation.

Paramount, the movie’s producer and distributor, allegedly secured the exclusive motion picture rights to the author’s copyrighted story which resulted in the release of the first Top Gun film in 1986.  The plaintiffs assert that Paramount knowingly failed to re-acquire the rights to the requisite film and ancillary rights to the author’s copyrighted story prior to the completion and release of the 2022 sequel as a derivative work.  That is, Paramount knew it didn’t have the rights to the sequel but moved ahead with production and distribution anyway.

Mr. Yonay owned the original copyright in the story “Top Guns” which was published in a 1983 issue of California magazine.   The magazine piece described the high-adrenaline world of jet pilots at the US Navy’s “Top Gun” fighter training school. Yonay also later wrote a book, “NO MARGIN FOR ERROR: The Making of the Israeli Air Force.”

Paramount acquired the copyright to Yonay’s story immediately following its 1983 publication which resulted in the release of the 1986 film.  The copyright’s termination of the copyright became effective on January 24, 2020 or within the 5-year window from 2018, the 35th year following the story’s publication.  The copyright claimant for Yonay’s story was not, however, the author himself but “California Magazine.”  The registration listed in the complaint is for a copyright in a “serial publication,” with California Magazine seemingly claiming authorship under the work-made-for-hire doctrine according to the registration.  See copyright registration no. TX0001213463.

It is unclear whether this underlying registration helps the plaintiffs.  Copyright laws are applied according to the territory in which the lawsuit is filed.  Registration of a work in the U.S. is a prerequisite for the commencement of a copyright infringement lawsuit since the U.S. Supreme’s decision in Fourth Estate Pub. Ben. Corp. v.  Plaintiffs, who are not U.S citizens, may argue that U.S. registration of Mr. Yonay’s underlying story which resulted in the California article is not necessary for foreign nationals and the lawsuit should proceed.  Even if this assertion is found to be a valid basis for proceeding with the lawsuit without registration, the Plaintiff’s will likely need to allege as such under U.S. law.

Also, many of the complaint’s allegations appear to involve the expression of ideas that would fully be expect to be present in any story or film about combat military pilots, in this case navy pilots.  Copyright law does not protect common themes which appear across different works, e.g., romantic themes, works involving detectives, love songs, impressionism in art, etc.  Thus, even if the Plaintiffs pass the “copyright registration” threshold issue, they may have a very difficult time proving actual copyright infringement.

One of the more interesting allegations in the Complaint suggests that the famous scene in the original Top Gun movie where Maverick and Goose’s F14 plane is inverted over a Russian MiG was the author’s original expression. The 1983 California magazine article does reportedly show a photograph with one F-14 plane inverted atop another plane but the article credits a C.J. Heatley as the photographer.  The Complaint makes no mention of Heatley or the photograph and it is not clear from the story whether the “inverted plane orientation” is the author’s original expression and the photograph is a secondary expression which captures the literary expression to add “color” to the story.

This case will either be thrown out early on due to the registration issue without addressing “copying” issues or it will be drawn out.   Dates will be critical since Paramount is maintaining that the sequel was “sufficiently completed” prior to the copyright termination date of January 24, 2020.  Work on the sequel began in 2018.  The plaintiffs allege that the movie was completed in 2021 or well after the copyright’s 2020 termination date. “Big screen” release was postponed until May 27, 2022 after the movie was completed in 2021 because of the pandemic. Mr. Yonay passed away in 2021 or after termination of the copyright.

Plaintiffs contend that they originally sent Paramount a “termination of rights notice” in 2018 based on the 1983 magazine’s publication date.  However, Paramount allegedly ignored the letter apparently believing that the termination was ineffective because they had acquired the rights from the California magazine and not Mr. Yonay himself.  Instead, Paramount moved ahead with the very lucrative sequel.  It’s not clear who advised Paramount on the potential seriousness of this matter in 2018 but that this lawsuit has now been filed should have come as no big surprise.  The heirs now surprisingly are seeking to share in the financial bounty of a terrific movie which may owe its existence to a story written by their loved one almost 40 years ago under a legal doctrine that allows such redress.  Whether or not their claim of copyright infringement will pass muster remains to be seen.

The lawsuit will also likely call into question the underlying contracts between Paramount and California Magazine and California Magazine and Mr. Yonay.  It is noted that if a contract includes a waiver of termination rights by the copyright owner, such a waiver is generally unenforceable.

Stay tuned for periodic updates as the case progresses.




Intellectual property law is a complex area of the law.  Contact us at 305-279-4740 for a complimentary consultation on protecting your inventions, creative works, brands, and proprietary information through patents, copyrights, trademarks and trade secrets or our litigation services involving intellectual property disputes.   We represent both individuals and business entities.  Our mission is to serve innovators and creators in protecting the fruits of their hard work and ingenuity through our Client Services Creed:  Conscientious, Rigorous, Energic, Empathetic, and Diligent legal services. 

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Take Home Points

  1. File at least a provisional patent application before taking steps to commercialize and sell an invention.
  2. Understand the ramifications of the on-sale bar to patentability.
  3. If engaging in experimentation with others prior to filing a patent application, ensure that contracts are very clear concerning the experimentation purpose.
  4. Be very careful about making an offer for sale of the invention prior to filing a patent application. An offer for sale can take many forms including a contract, proposal and/or invoice.

Section 102(b) of the Patent Act involves the on-sale bar to patentability.  The America Invents Act (“AIA”) amended § 102(b).  Any patent issuing from an application filed before May 16, 2013 which is later subjected to an on-sale bar analysis in a patent infringement analysis will be analyzed under pre-AIA § 102(b). This section states that a patent claim is invalid under 35 U.S.C. § 102(b) if “the invention was  . . .  on sale in this country more than one year prior to the date of the application for patent in the United States.”

This commentator recently published a blog on the CAFC’s February 2022 opinion in Junker v. Medical Corp., Inc where the Court held that the patentee had not timely filed a patent application under § 102(b) of the Patent Act.  Also see that blog for a comparison of the pre-AIA § 102(b) and the post AIA statute.  In Junker, the patent owner’s damages for patent infringement awarded by the district court were negated.  Now we have another decision in just over two months where the patent owner has had patent claim rights adversely affected because of failure to timely file a patent application.

On April 29, 2022, in Sunoco Partners Marketing v. U.S. Venture, Inc., the CAFC again addressed the on-sale bar to patentability.  The patent at issue involved an application filed on February 9, 2001.  Accordingly, based on 35 U.S.C. § 102(b), the critical date (the latest date on which the patentee could have made an offer for sale without violating the on-sale bar) was Feb. 9, 2000.  Here, the patentee’s offer for sale was Feb. 7, 2000.  Put another way, once the offer for sale was made, the patent applicant had exactly one year to file the patent application or until Feb. 7, 2001.

In Sunoco, the defendant asserted an on-sale bar defense to invalidate claims in two of Sunoco’s patents. To prevail, the defendant needed to demonstrate by clear and convincing evidence that the patented invention was both: (1) “the subject of a commercial offer for sale”; and (2) “ready for patenting.”  Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 57 (1998).

A factor which may allow the patent owner to negate an on-sale bar invalidation is whether the offer for sale occurred primarily for purposes of experimentation.  The “experimentation” exception to the on-sale bar was first articulated by the U.S. Supreme Court in City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877):  [E]xperimental use allows inventors to delay patenting to engage in “bona fide effort[s] to bring his invention to perfection or to ascertain whether it will answer the purpose intended.”  At the same time, “[a]ny attempt to use [the invention] for a profit and not by way of experiment” before the critical date will “deprive the inventor of his right to a patent.”  Ultimately, as the City of Elizabeth court explained, the on-sale bar is related to the monopoly afforded to a patentee – to have the government-granted right to seek legal recourse for the unauthorized use of the patented invention for a statutory period of time.   The on-sale bar prevents a subsequent patentee from “acquiring an undue advantage over the public by “preserv[ing] their monopoly . . .  for a longer period than is allowed.”

Sunoco, the current owner of the patents at issue, argued the on-sale bar was not violated because the inventor’s company, MCE Blending (“MCE”) offer to sell the invention to Equilon Enterprise, LLC (“Equilon”) was primarily for experimentation purposes.  The district court agreed and held found that the defendant’s on-sale bar defense was negated by the experimental use doctrine.

The CAFC disagreed on the basis of the terms of a contract between the inventor’s company and MCE.  The opinion is instructive because it demonstrates how a contract’s terms can play a critical role in upholding or defeating patent rights.  Whether such a transaction was for primarily for experimental or commercial purposes is a “question of law to be analyzed based on the totality of the surrounding circumstances.”   The Sunoco court assessed the transaction “under contract law as generally understood, focusing on those activities that would be understood to be commercial offers for sale in the commercial community.”

The invention was for an automated butane-blending system to maximize a desirable property of combining butane and similar gasoline components.

Based on the following contractual words and terms, the transaction was deemed to be a commercial offer for sale for the following reasons:

  1. The contract expressly described the transaction as a sale without any mention of any experimental purpose.
  2. The contract stated that MCE already developed the relevant technology and equipment, that Equilon wanted to purchase it, and that MCE was willing to sell it, install it, and supply butane for it in return for Equilon’s agreement to purchase several hundred barrels of butane from it over a period of five years.
  3. The contract stated that MCE is willing to install the blending Equipment and to supply the butane required for such blending to Equilon.
  4. The contract stated that the ownership and title to the Equipment shall be conveyed to Equilon by MCE upon completion of the installation and training. MCE was to execute a bill of sale to effectuate the conveyance of ownership of the Equipment to Equilon.
  5. The contract referred to Equipment Testing and not Experimental Evaluation.

The district court concluded that there had been no offer of sale of the invention because the contract “did not require Equilon to pay MCE anything in exchange for the system which incorporated the invention.  In contrast, the CAFC opined that Equilon purchased MCE’s equipment by committing to buy MCE’s butane.  In other words, it incurred a real if indirect cost.   Had the contract not intertwined the equipment’s required installation with Equilon’s obligation to buy butane, the CAFC indicated that it would not have characterized the transaction as a sale.

The CAFC further emphasized that the concept of experimental use can be difficult to establish.  For example, the contract had a section entitled “Equipment Testing” with two sets of testing:  pre-installation testing and post-installation testing.  Sunoco argued that MCE wanted “to experiment at the actual tank farm and determine whether their inventive idea was capable of performing its intended purpose in its intended environment.” MCE therefore would need access to Equilon’s facility to test under action conditions.  However, testimony revealed that the testing, which focused on determining whether that system could communicate with one of the equipment’s components was not done at Equilon, after all but by a third party.  Additionally, the testing could have been done at any time prior to entering into the offer for sale with Equilon.   This was not a situation involving, e.g., street pavement, which cannot be experimented upon satisfactorily except on a highway.  Sunoco court quoting City of Elizabeth, 97 U.S.C. 134.

The commentator adds that large, expensive equipment is often set up and qualify assurance tests conducted by the seller’s employees.  However, these are not “experimental purpose” activities because the buyer is expecting the equipment to work.  A good example is medical diagnostics equipment.

The inventor’s subjective intent concerning experimentation is of minimal importance.  The courts have generally looked to objective evidence to show that a precritical date sale was primarily for experimentation.   The opinion includes a useful list of objective indicia relied on by the courts in footnote 5.  In this case: 1) the terms of the sale agreement itself constituted objective evidence; and 2) the nature of the experimentation was such that it could have been done prior to the sales offer.

In conclusion, the CAFC held that the Equilon agreement was an offer for sale to commercially exploit the invention rather than primarily for experimentation purposes. Equipment which incorporated the invention was ready for use at the time the contract was entered into and ready for patenting based on objective evidence.   The district court’s experimental-use determination was reversed and its infringement determination with respect to the pertinent claims was vacated.   The decision involved some other issues which are separate from the 102(b) discussion of this blog for those interested.


If you have any questions about when you should file a patent application to preserve your rights, contact Susan at 305-279-4740.





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Opinion Background & Discussion – In re Dare Foods, Inc.

Trademark blogs often focus on detailing decisions by the Trademark Trial & Appeal Board (“TTAB”) and the courts over whether a mark should be approved for registration or not based on the likelihood confusion with an existing registered mark.  However, trademark law provides a mechanism through which two registered marks having different owners can co-exist.  How is this possible? Because the mechanism involves a co-existence or consent agreement between a registered mark owner and an applicant.  As the Federal Circuit Court of Appeal’s predecessor court stated in the 1973 seminal Dupont case,

[W]hen those most familiar with use in the marketplace and most interested in precluding confusion enter agreements designed to avoid it, the scales of [likelihood of confusion] evidence are clearly tilted.  It is at least difficult to maintain a subjective view that confusion will occur when those directly concerned say it won’t.  A mere assumption confusion is likely will rarely prevail against uncontroverted evidence from those on the firing line that it is not.

The cited wording pertains to Dupont factor #10 in a likelihood of analysis determination which was referred by the Dupont court as the “market interface” factor.

On March 29, 2022, the TTAB recently reversed the examining attorney’s refusal to register the mark RAINCOAST DIP for “snack food dips” in view of the registered mark RAINCOAST TRADING for seafood products on likelihood of confusion grounds.  Note that the USPTO routinely finds likelihood of confusion problems with a registered mark and an applied-for mark where both marks have the same word as the first word (the aspect of the mark consumers are most apt to focus on) when the same or related goods/services are involved.  For example, the TTAB itself found that the involved goods were related because “it is not uncommon for snack food dips as well as seafood and seafood snacks to emanate from the same source.”    It was thus not surprising that the examining attorney found likelihood of confusion because the marks are more similar than dissimilar in appearance, and sounds, and “particularly connotation and commercial impression.”  The TTAB agreed.

However, the TTAB found that the examining attorney had failed to give proper credence to a 2013 agreement between the parties’ predecessors.  That agreement was detailed and covered the typical factors the TTAB will look at in determining whether the agreement meets at least the following requirements:

  1. Shows agreement between both parties;
  2. Whether the agreement includes a clear indication that the goods or services travel in separate trade channels;
  3. Whether the parties agree to restrict their fields of use;
  4. Whether the parties will make efforts to prevent confusion and cooperate and take steps to avoid any confusion that may arise in the future;
  5. And whether the marks have been used for a period of time without evidence of actual confusion.

Simple agreements, which some sarcastically refer to as “naked agreements”, will not qualify as suitable co-existence/consent agreements.  Here, the TTAB concluded that the parties had entered into a detailed agreement with sufficient parameters for allowing the existence of the two registered marks.

This commentator has drafted detailed co-existence/consent agreements resulting in registration of an applied-for mark.  One fact that can be helpful is when the goods/services are provided in a different geographical market.  For example, this type of agreement was entered into between a Florida eatery (the commentator’s client) and an Oregon eatery. Obviously, the registered mark owner must be willing to enter into such an agreement.  Had the Oregon eatery instead been a Georgia-based company owned by a franchisor who planned to open franchise restaurants in Florida and across the Southeast, the possibility of obtaining a “USPTO-acceptable” co-existence/consent agreement would likely have been more difficult because of the stronger possibility of overlapping trade channels.

Take Home Point

A properly-drafted, accurate co-existence/consent agreement with appropriate provisions may allow an applied-for mark to be registered by the USPTO even where the applied-for mark would not otherwise be registered on the basis of its likelihood of confusion with the registered mark.

In Need of Legal Counsel on Trademark Matters?

Contact Susan at 305-279-4740 if you have any questions about co-existence/consent agreements or any other matter related to trademark law.




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On Feb. 24, 2022 in a 6 to 3 decision, the U.S. Supreme Court held that mistakes of law – and not only mistakes of fact – could protect copyright infringement lawsuit plaintiffs from losing their copyrights on grounds of inaccurate registrations.  The decision is a win for creators who own registered copyrights.  Remember, since 2019, copyright registration is an absolute requirement for commencing a copyright infringement lawsuit as the result of the Supreme Court’s decision in Fourth Estate Public Benefit Corp. v, LLC.

Background of the Lawsuit

In 2020 Unicolor, a fabric design company, sued fashion giant Hennes & Mauritz, LP (H&M) for copyright infringement of Unicolor’ copyrighted 2-dimensional fabric designs.  Unicolor’ registered copyright stemmed from its copyright registration for 31 separate designs allegedly included in the same unit of publication.  The Copyright Office’s regulations governing the submission of applications provides that a single application may cover multiple works only if they were “included in the same unit of publication.” The opportunity to submit multiple works in one application can save the applicant considerable filing fees.  H&M argued that Unicolor had failed this requirement by making some of the designs exclusively available to certain customers while offering the rest to the general public.  That is, the designs were not included in the same unit of publication.

The Relevant Statute

The Copyright Act includes the following statements under section § 411(b):

(1)  A certificate of registration satisfies the requirements of this section and section 412, regardless of whether the certificate contains any inaccurate information, unless—

(A) the inaccurate information was included on the application for copyright registration with knowledge that it was inaccurate; and

(B) the inaccuracy of the information, if known, would have caused the Register of Copyrights to refuse registration.

(2) In any case in which inaccurate information described under paragraph (1) is alleged, the court shall request the Register of Copyrights to advise the court whether the inaccurate information, if known, would have caused the Register of Copyrights to refuse registration.

The Decision

The Unicolor case involves interpretation of § 411(b)(1)(A), commonly referred to as a safe harbor provision.  The District Court determined that because Unicolor did not know when it filed its application that it had failed to satisfy the “single unit of publication” requirement, Unicolor copyright registration remained valid by operation of the safe harbor provision.  The Ninth Circuit disagreed and instead opined that the safe harbor provision only applied to good-faith mistakes of fact, not law.  Unicolor had known the relevant facts surrounding publication of the designs; its knowledge of the law (or lack   thereof) was irrelevant

The U.S. Supreme Court sided with the District Court by holding that 411(b)(1)(A) is applicable to both mistake of law and mistake of fact.  As such, lack of either factual or legal knowledge can be the basis for the application of the statute’s safe harbor provision.

In finding for Unicolor, the Court found that cases decided before § 411(b) was enacted “overwhelmingly” found that inadvertent mistakes in copyright registration did not invalidate copyrights.  The court also referred to the legislative history which suggested that § 411(b) was enacted to make it easier, not more difficult, for nonlawyers to obtain valid copyright registrations.  One of the goals behind the new section was to “improve intellectual property enforcement in the United States and abroad.” H. R. Rep. No. 110–617, p. 20 (2008).  Section 411(b) did so in part by “eliminating loopholes” that could be exploited to block otherwise valid copyrights.

H&R had argued that copyright owners would be allowed to avoid the consequences of an inaccurate application by claiming lack of knowledge.   The Court emphasized that courts need not accept the copyright owner’s claim that it was unaware of the relevant legal requirements.  For example, willful blindness may support a finding of actual knowledge on either the issue of law or fact, triggering the application of 411(b)(1)(B).

The Court’s opinion did not address section 411(b)(1)(B) which states: “the inaccuracy of the information, if known, would have caused the Register of Copyrights to refuse registration.  Section 411(b)(2) makes it clear that any decision concerning the validity of a registered copyright is not made by the court but by the Register of Copyrights.  This step is generally commenced upon the court’s grant of a defendant’s motion to Submit the Matter to the Register of Copyright and then submitting the matter to the Register of Copyrights. Based on Unicolor, the Register of Copyrights should only be involved if the court finds that the copyright registrant had knowledge of the facts and/or law associated with registration’s error(s).    In contrast to registered trademarks and patents, a federal court has no right to invalidate a registered copyright.  It’s up to the Register of Copyrights to determine what impact, if any, the misinformation had on the Copyright Office’s decision to register the copyright to the designated owner in the first place.

Take-Home Points

The decision helps bolster the validity of copyright registrations involving errors made by the applicant.  In the commentator’s opinion, applicants should not automatically assume that all errors are “excusable.”  Nevertheless, it’s still a good idea to ensure that all information presented in copyright registration applications is accurate to start with to prevent a situation where the defendant draws out the case by asserting the registration is invalid.  Also, where an attorney files the application on behalf of the applicant, will the attorney’s error be “excused” for errors of law?

On the other hand, defendants who think they can get away with infringement by trying to invalidate the plaintiff’s registered copyright in a future infringement lawsuit should think twice.  This approach is akin to a shoplifter blaming the retailer for not having shoplifting preventive measures in place.




Intellectual property law is a complex area of the law.  Contact us at 305-279-4740 for a complimentary strategy session on protecting your inventions, creative works, brands, and proprietary information through patents, copyrights, trademarks and trade secrets or our litigation services involving intellectual property disputes.   We represent both individuals and business entities.  Our mission is to serve innovators and creators in protecting the fruits of their hard work and ingenuity through our Client Services Creed:  Conscientious, Rigorous, Energic, Empathetic, and Diligent legal services. 


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