Use-Based Trademark Application vs. Intent-to-Use (ITU) Trademark Applications

Use-Based Trademark Application vs. Intent-to-Use (ITU) Trademark Applications

A very common question that we receive is, “What is the difference between a use-based trademark application and an intent-to-use trademark application?” In fact, we get this question so often that I have decided to write up this blog post highlighting the differences between the two, and some pros and cons for each.

When are Two Trademarks too Similar? – A Likelihood of Confusion

When are Two Trademarks too Similar? – A Likelihood of Confusion

While this seems like a simple question that should have a straightforward answer, the true analysis involved a multi-factor test where each factor must be evaluated separately, and then after each factor-specific analysis is performed, those analyses must be viewed collectively, or “in the totality of the circumstances.” After the collective analysis, a determination as to whether a “likelihood of confusion exists” can be made. 

What is Transformative for Fair Use?

What is Transformative for Fair Use?

There may be significant changes coming to fair use law. The 2nd Circuit is very influential in the field of copyright law, and this case is no exception. That the Supreme Court has chosen to weigh in on where the lines are drawn with respect to the nature of transformative use suggests that changes are on the way for fair use.

Is Section 2(c) of the Lanham Act Facially Unconstitutional?

Is Section 2(c) of the Lanham Act Facially Unconstitutional?

Context: We have an interesting free speech/trademark case this time. Steve Elster attempted to register the phrase “TRUMP TOO SMALL” under IC25 at the USPTO. Apparently, according to Elster, this phrase was taken from the 2016 presidential debate, from a particular exchange between Donald Trump and Marco Rubio. The intention of this phrase was to thus “convey[] that some features of President Trump and his policies are diminutive.”

More on Skinny Labels and Induced Infringement for Generics

GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 18-1976 (Fed. Cir. 2022)

 

Context: This is a case I have been personally following for a while because of its potentially substantial impacts on the pharmaceutical industry, particularly involving generics. In short, the drug cardevilol was unpatented, except for GSK’s patent for one particular use of the drug (treatment of congestive heart failure or “CHF”) under U.S. Patent Reissue No. 40,000 (“the ‘000 Reissue”). In 2002, Teva sought to release a generic version of cardevilol with a so-called “skinny label” which carved out GSK’s patented use of the drug. This version of the generic launched in 2007, but by 2011, the FDA required that Teva amend the skinny label to add back the patented use of the drug (“full label”).

 

Procedural History: GSK sued Teva for infringement of their patent, not only during the full label period, but even before 2011, during the skinny label period. GSK asserted an induced infringement theory in the lower court, and the jury found for GSK. However, Judge Stark reversed the jury decision, finding judgement as a matter of law for Teva. Judge Stark indicated that, despite evidence that physicians were prescribing the Teva generic for CHF, GSK failed to prove that Teva actually caused the physicians to do so.

GSK proceeded to appeal to the Federal Circuit, which reversed the lower court’s decision and found that substantial evidence supported the jury’s finding of induced infringement. Teva then requested en banc rehearing, arguing that this decision could be read to impose liability broadly on producers of generics, and defeat the purposes of skinny labels, in direct opposition to the purposes of the Hatch-Waxman Act. The Federal Circuit interpreted this request to also be a request for a panel rehearing, and this panel also found for GSK, indicating that GSK had provided substantial evidence that even the skinny label had directly encouraged the method of use of cardevilol for CHF in GSK’s patent. Teva now requests a full en banc hearing.

 

Claim 1 of the ‘000 Reissue is the representative claim here. It reads:

1.     A method of decreasing mortality caused by congestive heart failure in a patient in need thereof which comprises administering a therapeutically acceptable amount of carvedilol in conjunction with one or more other therapeutic agents, said agents being selected from the group consisting of an angiotensin converting enzyme inhibitor (ACE), a diuretic, and digoxin,

wherein the administering comprises administering to said patient daily maintenance dosages for a maintenance period to decrease a risk of mortality caused by congestive heart failure, and said maintenance period is greater than six months.

The previous cases in this line of cases were met with great skepticism from the generic pharmaceuticals industry. In particular, amici raised serious issues with these rulings regarding when generics producers could be held liable for their products and the potential to “nullify” the Hatch-Waxman Act. In response, the Federal Circuit in its panel rehearing appeared to have attempted to narrow the impact of the ruling by focusing on what it deems to have been Teva’s failure to correctly exclude the patented use from its skinny label.

The en banc petition, along with the panel rehearing, raised an interesting issue, however. GSK was involved in the FDA process for issuing the skinny label, and GSK failed to name an indication (post-MI LVD) as being an infringing use. However, during trial, GSK asserted that post-MI LVD was, in fact, equivalent to the CHF that was recited in the ‘000 Reissue. The Court thus raised the issue of equitable estoppel, namely that GSK’s failure to prevent post-MI LVD from appearing on the skinny label resulted in the induced infringement, and thus GSK should be estopped on fairness principles from suing for this use.

Although Teva’s en banc hearing was denied here by the Federal Circuit, it appears that each of the Judges here have indicated some amount of support for this equitable estoppel position. Interestingly enough, the en banc hearing was denied at least in part because the concurrence asserts that Teva did not raise the equitable estoppel argument at the Federal Circuit – instead, these equitable estoppel issues are credited to the dissenting opinions[1]. Chief Judge Moore, however, states in the concurring opinion that “I too am concerned that GSK’s representations to the FDA are at odds with its enforcement efforts in this case. It would be troubling to hold Teva liable for relying on GSK’s representations to the FDA.” Chief Judge Moore notes that “[t]he dissents’ fairness concerns – which are limited to the [skinny] label period – track [the] three-element framework [for equitable estoppel] precisely.”

The dissent, written by Judge Prost, goes even further, indicating that not only does this case reveal an underlying conflict between the FDA regulatory framework and patent law, but that the Court here is abdicating its responsibilities by refusing to hear it. The dissent, in fact, refuses the equitable estoppel framework by stating that the facts are directed towards the issue of inducement of infringement, although it endorses the underlying argument itself.

There are two interesting takeaways from this decision. The first is that Teva, despite losing in its en banc petition, may ultimately win this case after all (at least on the issue of its skinny label). As noted in the concurrence, this equitable estoppel issue must now go back to the lower court for a decision, and each of the Judges here indicated support for the argument. The second is that producers of generics may indeed have some protection under the FDA framework for skinny labels. The persistent fear from generics has been that a producer like Teva could follow the FDA’s rules to attempt to not induce infringement through a skinny label and still be found liable in the end. If Teva ultimately wins this case on equitable estoppel, this should provide at least some relief to generics producers.

 

 

 



[1] Strangely enough, however, the majority opinion in the panel rehearing, which included Judge Moore, indicated that Teva had indeed raised an equitable estoppel issue at oral hearings, and expressed some amount of doubt about the success of such an argument

A Key Ruling on COVID-19 Vaccine Technology

A Key Ruling on COVID-19 Vaccine Technology

As part of its COVID-19 vaccine, Moderna has used a number of lipid particle technologies to encase and help deliver the mRNA vaccine payload into the body. Arbutus owns patents, including U.S. Patent 8,058,069 (the ‘069 patent), directed towards the lipid particle technology used by Moderna. Moderna thus brought the above case in anticipation that Arbutus would sue for infringement of the ‘069 patent.

The Principal vs. Supplemental Register

The difference between the Principal Register and the Supplemental Register is one of the most initially confusing aspects of Intellectual Property (IP) to non-IP law attorneys. To understand the fundamental differences between both registers, each register is comprised of, and its strengths and shortcomings should be considered prior to choosing a registration alternative.  

The Federal Trademark Register in the United States consists of two separate registers, the Principal Register and the Supplemental Register. The principal register grants protection for distinctive marks or marks that have an associated secondary meaning. On the other hand, the Supplemental Register provides protection for non-distinctive marks that have the potential of acquiring distinctiveness. For more information about the spectrum of distinctiveness, visit this article.  

There exist three subcategories within the category of a strong mark. These include fanciful or coined marks, arbitrary marks, and suggestive marks. Coined marks are invented terms, arbitrary marks are ones consisting of ordinary words with no relation to the product they are in reference to, and suggestive marks are those which do not describe the product sold and thus require imagination to relate them to the respective product they represent. Marks outside of these categories are considered descriptive or generic, implying that they would make weak marks and hard to protect.  

Generic terms are not registrable on either of the Registers because no one should be given exclusive right to use terms that refer to generic goods or services (For example, KLEENEX and BAND-AID. Though these were once trademarks, these brands are victims of genericide.) 

 A descriptive mark, though, can become trademarkable if it obtains a secondary meaning, also known as “acquired distinctiveness” by becoming an identifier for a good when a company has gained recognition for their goods and services by using a descriptive trademark for over five years. According to the United States Patent and Trademark Office (USPTO), sometimes trademark applications get denied under the Principal Register as they are not deemed distinctive meaning the trademark lacks secondary meaning. The USPTO's Principal Register is limited to marks that have acquired distinctiveness. Trademarks that lack acquired distinctiveness can only be placed on the Supplemental Register. 

The Supplemental Register can be considered as an alternative when the Examiner from the Principal Register rejects registration of the trademark under the premise that it is a weak, descriptive mark but that it can acquire distinctiveness on the Supplemental Register.  The applicant can then obtain a Supplemental Registration. If the trademark becomes distinctive in the future through acquired distinctiveness, then it is possible to obtain a registration on the Principal Register. 

The Supplemental Registry offers limited protection when compared to the Principal Registry in that it includes no right to stop the importation of infringing goods/services and that it does not allow owners to record the filing with the US (United States) customs services to prevent the import of items violating the mark. Although holding certain limitations, the Supplemental Register also has several advantages which include the registrant’s ability to use the registration symbol ®, protection against registration of a similar mark and the ability of bringing a lawsuit for infringement of the mark to federal court.  

So, if your mark is denied on the Principal Register, do not get discouraged! Run, do not walk to the Supplemental Registry, and aim for acquired distinctiveness.  

Genericide

Popularity is inherently attributed to be a positive thing. However, when it comes to trademarks, attaining a certain level of popularity for your trademark can result in negative repercussions. More specifically, a trademark gaining too much popularity can lead to the trademark losing some rights and becoming generic.  

A trademark gives its owner the right to stop others from the making, using, selling, offer to sell, and import of something they own a trademark over. However, not all trademarks are created equally. A trademark has an associated strength to it which determines whether the trademark is considered to be strong or weak.   

In general, a rule of thumb to follow when it comes to the strength of a trademark is that the more descriptive it is, the weaker the trademark is. Trademarks are generally grouped into one of four categories of distinctiveness: coined, arbitrary, suggestive and descriptive, from most to least distinctive.  

Descriptive marks, marks which are the most difficult to enforce and are words or designs that unimaginatively describe the product or service they reference, are not registrable either even though they can eventually become registrable after five years. Suggestive marks are marks that hint at what the product or service trademarked does or looks like but require more imagination to figure it out. Coined marks are made-up words which did not exist prior to the trademark on them. Arbitrary marks are marks that involve a word with a dictionary definition that applies to the function or design of the product or service trademarked. Coined marks are generally preferred as they are the easiest to enforce and register while also being the most distinct. Any of these four categories of trademarks are at risk of falling into a fifth trademark category: generic marks.  

Generic trademarks are not eligible for trademark protection. What makes this dangerous is that is a trademark can become the generic term for a product, due to that product’s popularity. This is known as “Genericide”. Put another way, genericide is when a name becomes so popular that it becomes the generic term for that thing in the public’s mind, putting the owner of that trademark at risk of losing their mark.   

This type of situation is more common than you might think. The following is a compiled list of twenty well-known companies owning a trademark on their product or service’s name who are in danger of, or have already suffered, genericide. 

In general, to avoid genericide regardless of the category within which the trademarked brand lies, one must protect trademark rights by monitoring the use of the trademark, educating the public about the public use of the trademark, presenting the style of the trademark in proper form in terms of font and style and never use the trademark in a generic manner. Consumers should also be discouraged from using the trademark in a generic manner to avoid massive popularity becoming your trademark’s ruin.  

gen1.jpeg

A company who has successfully avoided genericide thus far, Xerox, did so by taking multiple preventative steps when the threat of genericide arose. Xerox manufactures printing and photocopying machines and its name, “xerox” is often used as a verb to indicate the act of photocopying something.  

To avoid losing its trademark due to genericide, Xerox took to educating the public and asking that they not use their trademarked name as a verb to prevent them from losing their trademark. They did this by running advertisements that informed the public about their trademark concerns. One of these advertisements featured a vest with a zip in it and conveyed the message that “Zipper” was once a trademark and that if people continued to misuse Xerox as they did Zipper, Xerox may be in danger of losing their trademark. Another advertisement’s message was that “When you use ‘Xerox’ the way you use ‘Aspirin,’ we get a headache” alluding to Aspirin which was once a trademark owned by pharmaceutical company Bayer until 1919. 

gen2.jpg

 In addition to designing advertisements to get the public’s help in avoiding genericide, Xerox also worked in conjunction with dictionary publishers to include in the definition of “Xerox” that while it may be used to mean “to copy” it is a registered trademark which is commonly misused. Xerox also worked with organizations such as Wikipedia to add the latter fact to their content featuring the word.  

While the public’s use of a trademark as a generic term for a product or service may seem enviable at a first glance, genericide ultimately results in damage to the owner of the trademark. In the case of Xerox, for example, were they to lose their trademark, rival companies could use the name “Xerox” in their operations and the original Xerox’s right to litigate this in federal court may be taken away, as they have lost ownership of their mark.  

So next time you “xerox” something or borrow a “scrunchie” you may want to keep the concept of and consequences that come with genericide. 

Before you are tempted to say you are “Xerox”-ing something, you may want to check that the printer you are using is Xerox brand. Your best bet, either way, is sticking to “printing” over “xerox”-ing, for genericide-avoidance purposes.

Spectrum of Distinctiveness for Trademarks

Spectrum of Distinctiveness for Trademarks

Choosing a brand name can be hard! With so many names that are already in-use, finding a name that is available can pose as a genuine challenge to new companies. Understanding the “Spectrum of Distinctiveness" can help!

The DuPont Factors – Analysis under Section 2(d) of The Lanham Act (Trademark Act of 1946)

The DuPont Factors – Analysis under Section 2(d) of The Lanham Act (Trademark Act of 1946)

When comparing whether a “likelihood of confusion” exists between two trademarks, a multi-factor test is employed. While each jurisdiction has a specific set of factors that get used, the United States Patent and Trademark Office (USPTO) uses the factors set forth in In re E.I. du Pont de Nemours & Co so these “likelihood of confusion” factors are commonly referred to as the “DuPont Factors.”

Copyright 101 - Tips for Every Startup, Entrepreneur, and Artist

Copyright 101 - Tips for Every Startup, Entrepreneur, and Artist

This introduction to copyright law is aimed at helping people, startups, artists, and other creative entrepreneurs improve their understanding of this vital component of Intellectual Property Law. As you set out on your innovative and creative endeavors, it is important to know how to not only own your ideas but to protect your creations as well.

Oracle v. Google: A Battle Over Fair Use

Oracle v. Google: A Battle Over Fair Use

The extremely important case of Oracle v. Google, which will undoubtedly impact the future of many software companies, is set to be heard by the Supreme Court later this year.

4 Intellectual Property Strategies Every Cannabis Company Should Be Using

4 Intellectual Property Strategies Every Cannabis Company Should Be Using

Your one-stop guide for protecting your cannabis company’s intellectual property. With all of these tools at your disposal, you can strengthen your company’s presence in the cannabis space.