MUNCHIES FOR THE STONE AGE

If you're like me, you love a good salty or sweet snack, right?  And, no judgment here, but there are those who also enjoy "recreational" products as well.  Up to now, if you wanted to have your snacks combined with your recreational products, you had to make the combination yourself.  

But what if you could have "two great tastes that taste great together" prepared for you that you could simply buy at the store or even better, online?

Lucky for you, you live now, in the "stone age" where you can purchase cannabis-laced snacks.  And, just in time of Halloween, cannabis-laced candy is available that gives a new meaning to "fun size" candy.  As a result, states are warning parents to be on the lookout for knock-off candy such as Sour Patch Kids candy (labeled "STONEY PATCH" shown above) and Oreo cookies (e.g. "Double Stuf STONEO" shown on the right).

To be very clear, these cannabis-laced snacks and candy are unauthorized, knock-off products, and in no way associated with the respective famous products' manufacturers.  The makers of these cannabis-laced products are violating numerous laws and regulations.  Accordingly, multiple states' attorneys general are actively perusing the manufacturers of these cannabis-laced products.  

In addition, these cannabis-laced product manufacturers and distributers are infringing the better known (original) products manufacturers' valuable intellectual property rights which include but not limited to trademark infringement, tarnishment, dilution, unfair competition, passing off, etc.

Finally, I'd be remiss if I didn't acknowledge the fact that I have been away from blogging for a while.  But in the timeless words of Frank Costanza, I'm back baby!

© Stephen J. Weyer 2021

Send email feedback- sweyer@stites.com

Precision/personalized medicine and intellectual property: Balancing Public Health and Innovation

Precision / personalized Medicine and Intellectual Property: Balancing Public Health and Innovation

Summary

Medical technology, diagnostics and treatment, are becoming increasingly personalized or individualized.  “Precision medicine” (aka personalize medicine) is the term used to describe the revolution in biotechnology in which precision is used to identify not only a disease condition and general treatment but a specific abnormality or predisposition and a narrowly tailored treatment for the specific abnormality of that individual based on the individual’s biological makeup, genes or condition.  Often this involves identification of specific biological markers, proteins or genes, correlated to an identified health condition, and treating the identified condition with a biological / pharmaceutical agent specifically tailored to the specific individual and condition. 

At the 2019 ITechLaw World Conference in Boston (May 15-17), I gave a presentation and led a discussion on intellectual property issues pertaining to precision medicine.  First, we discussed this revolutionary new tool in medical diagnostics and treatment.  Next, we reflected on current intellectual laws with a foundation in the industrial age for historical context.  Finally, we discussed current intellectual property laws' applicability to precision medicine to explore whether existing intellectual property laws are a benefit to public health and innovation or a hindrance.

My PowerPoint slides from the presentation are available for download and the following discussion summarizes the presentation: 

•             Abridged presentation (minus some embedded video clips, but with hyperlinks to them) (7 meg)
•             Unabridged presentation (125 meg)

Discussion

Precision medicine by definition is specific to an individual.  For any particular condition, the diagnostic may need to be adjusted to specifically identify the abnormality in the individual.  Likewise, the specific treatment of the abnormality in an individual may need to be specifically tailored to that particular individual.  Conceivably, a different diagnostic and a different therapeutic treatment may be required for each individual to be treated.  As a result, pharmaceutical companies and diagnostic laboratories may not be able to mass produce broad spectrum diagnostics and broad spectrum treatments.  Instead, the future of biotechnology almost certainly suggests that this will not be the case.  Further, the traditional financial incentives in which biotechnology companies can recoup research and development costs of diagnostics and treatments by mass producing a diagnostic and treatment likely will need to change.  

Current intellectual property rights that are in place to provide limited monopolies in exchange for public disclosure of new technology may not be appropriate for the new precision medicine paradigm.  For example, use of the patent system may not be applicable since a virtual infinite number of diagnostics and/or infinite number of therapeutic treatments may need to be individually developed and hence patented to cover the physical diagnostic tool and/or therapeutic agent.  

Further, while one might consider that a method of treatment or method of diagnostic may be patentable, patent eligibility of such subject matter has been highly scrutinized and even ineligible for patenting under some countries’ patent laws.  Many countries’ patent laws have limitations on the patenting of subject matter relating to diagnostic methods and treatments based on correlation of natural physical conditions and products of natural.  

For example, recent U.S. Supreme Court decisions have limited the subject matter eligible for patent protection for inventions relating to natural products and correlations.  See, e.g.:

  

–     Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013)

–     Mayo v. Prometheus, 566 U.S. 66 (2012)

However, often precision medicine involves diagnostics and identification of a “natural” biologically occurring abnormality (i.e. a naturally phenomenon) correlated to a health or disease condition and treatment involves administering a naturally occurring biological or chemical product (i.e. a product of nature) to address the abnormality.  Therefore, patent protection may not be available for precision medicine diagnostics and treatments.

In addition, other forms of IP protection may not be applicable for precision medicine.  While data exclusivity and/or trade secret protection have been used for prior technologies, relying exclusively on trade secret protection may thwart the public interest in having the full disclosure of the diagnostic tool and/or treatment so that other companies can build on the technology.  Instead, relying on trade secret protection may hinder the advancement of precision medicine such that it does not realize its full potential.

It is important to reflect on the purpose of an intellectual property system such as the patent system and data exclusivity for biologics, which is quid pro quo in which the public receives the benefit of the new technology in exchange for exclusivity by the developer of the technology.  As a result, the limited monopoly provides exclusivity so that the company investing in the technology can recoup its investment.  Without the ability to recoup investment costs, companies may not develop new diagnostics and new treatments to advance precision medicine.  Up to this point, much of the research and development of precision medicine not surprisingly has been done by non‑profit universities and research facilities funded by grant money and government subsidies so these institutions do not have the same pressures to recoup investment costs as the public sector.  As research dollars become tighter and governments which fund research have limited resources, relying exclusively on universities and government research funding may not be the best way to advance precision medicine.

  

As always, a counterargument can be made that strong intellectual property will benefit only a small number of companies resulting in high costs of the precision medicine to individuals (i.e. patients) and as a result will prevent some individuals from access to the precision medicine.  Opponents to this theory will say that however, without strong intellectual property rights, the precision medicine would not be developed for anyone as without strong intellectual property rights which provide for recouping investments costs, companies would not take the time and invest money to develop the precision medicine in the first place.

  

I invite all to post your comments here on this topic to keep the discussion going.  Please provide your thoughts and remarks on whether current intellectual property rights are a benefit or a hindrance to the development and deployment of precision medicine.

© Stephen J. Weyer 2019

Send email feedback- sweyer@stites.com

Locast's attempt to sneak re-broadcast streaming live television under non-profit copyright exemption

Locast's Attempt to Sneak Re-broadcast Streaming Live Television Under Non-profit Copyright Exemption

Stop if you have heard this before....  A start-up company takes a television antenna (commonly referred to as an over-the-air (OTA) antenna), attaches it to an HDTV receiver, connects the receiver to a computer server, invites the public (one device at a time) to log into the server, and then streams live television from the server to the device.  Sound familiar?  Hint, Aereo tried this in the early part of the decade only to have the U.S. Supreme Court find Aereo liable for copyright infringement for unauthorized rebroadcast of the broadcasters' content.  See Supreme Court finds Aereo's Emerging Online Streaming Technology Hits Copyright Infringement Bullseye. 

Start-up company, Locast, has a new twist on streaming live television by capturing broadcasters’ television signals and streaming their content.

So what is Locast’s strategy for avoiding the same fate as Aereo and being found liable for copyright infringement?

First, let’s look at the technology that Locast is using.  Locast’s technology is basically unremarkable: a single antenna, a single receive, a single server, and multiple users.  This is completely different than Aereo’s novel and unique technology aimed at a futile attempt to avoid copyright restrictions on public performance / re-transmission of broadcasters’ content, by using a separate antenna for each transmission, and assert that the transmission is not “public” but private transmission, albeit multiple, single transmissions.

However, unlike the "for profit" company, Aereo, Locast aims low as a "non-profit" organization.  As a non-profit, Locast hopes to slide under the non-profit exemption that allows non-profit companies to “secondary transmission of broadcast programing by cable.”  17 U.S.C. § 111 (a) (5) (emphasis added).

For argument sake, let’s assume that Locast is really a non-profit and in keeping with the statutory requirements of § 111 (a)(5), it does not have direct or indirect commercial benefit or advantage in the service. 

Seems like, so far, so good for Locast.  But, wait...  Not so fast….

Subsequent to Aereo being found liable for copyright infringement for separately streaming broadcasts’ content to respective subscribers (viewers), Aereo applied for a license with the U.S. Copyright Office to be an authorized re-broadcaster/distributor or cable provider under the compulsory licensing provisions of the U.S. Copyright Act, 17 U.S.C. § 111 (§111), “secondary transmission of broadcast programing by cable.” 

The important word in the statute is “cable.”  The U.S. Copyright Office denied Aereo’s application based on a finding that Internet streaming does not meet the definition of cable under § 111.   Therefore, the Copyright Office denied Aereo's request to pay compulsory licensing fees to retransmit broadcast television signals over the Internet.  See Aereo's Online Streaming Broadcast TV Caught Between a Rock and a Hard Place.

Based on how the U.S. Copyright Office interpreted “cable” re-broadcast and streaming content to not be equivalent in the context of compulsory licensing broadcasters’ content under § 111, it looks like Locast may have a steep climb to get out of potential copyright infringement hole that it has dug.  Time will tell….

© Stephen J. Weyer 2019

Send email feedback- sweyer@stites.com

Give me a “C-O-P-Y-R-I-G-H-T-A-B-L-E” for Cheerleader Uniform Designs

Give me a “C-O-P-Y-R-I-G-H-T-A-B-L-E” spells Copyrightable Protection for Cheerleader Uniform Designs

“Six” cheers for copyright protection for cheerleader uniforms.  In a 6-2 decision, the U.S. Supreme Court in Star Athletica, L.L.C. v. VarsityBrands, Inc. proclaimed Varsity Brands’ cheerleader uniforms are entitled to copyright protection.  Varsity Brand’s victory over Star Athletica re-confirms copyright protection as a viable option for protecting the design of useful articles of manufacture.  Time will tell if U.S. copyrights will upset U.S. design patents as the champion of protection of designs of useful articles.

The subject at the heart of this epic copyright contest are cheerleader uniforms such as the ones reproduced in this article.

Many are aware that U.S. copyright protection is afforded to artistic works of authorship fixed in a tangible medium of expression such as works of fine, graphic, and applied art, photographs, prints and art.  What might surprise some is that the U.S. copyright law extends limited copyright protection for pictorial, graphic, or sculptural works incorporated into a “useful article” if the artistic features “can be identified separately from, and are capable of existing independently of, the utilitarian aspects of the article.” 17 U. S. C. §101.   In particular, the U.S. Copyright Act establishes a special rule for copyrighting a pictorial, graphic, or sculptural work incorporated into a “useful article,” which is defined as “an article having an intrinsic utilitarian function that is not merely to portray the appearance of the article or to convey information.” 

A design incorporated into a useful article qualifies for copyright protection only if the design features:

(1) can be perceived as a two- or three-dimensional work of art separate from the useful article and
(2) the design would qualify as a protectable pictorial, graphic, or sculptural work—either on its own or fixed in some other tangible medium of expression— if it were imagined separately from the useful article into which it is incorporated.

In this case, the Supreme Court held that the designs of the cheerleader uniforms (useful articles) are entitled to copyright protection since the designs (1) can be perceived as a two- or three-dimensional work of art separate from the useful article and (2) the designs qualify as protectable pictorial or graphic when imagined separately from the useful articles (cheerleader uniforms).  The Court determined that the arrangements of lines, chevrons, and colorful shapes appearing on the surface of the cheerleading uniforms are eligible for copyright protection as separable features of the design of those cheerleading uniforms.

The significance of this decision is the strengthening of intellectual property protection for artistic designs of useful articles.  Where, in the past, one may have relied solely on U.S. design patents to protect the intellectual property of the look or appearance of a useful article of manufacture, U.S. copyright protection may also be available to protect the intellectual property of the design of a useful article of manufacture.

© Stephen J. Weyer 2017

Send email feedback- sweyer@stites.com

“Stairway to Copyright Infringement”- Step Two in Spirit's uphill climb to prove Led Zeppelin's 'Stairway to Heaven' infringes its copyright

Followers of this blog and classic rock fans everywhere with a keen interest in the nuances of copyright infringement will recall that Led Zeppelin is being sued by the band Spirit for copyright infringement based on Zeppelin's immortal song which Spirit alleges lifted portions from its guitar instrumental, Taurus.  The judge in the infringement suit has just now cleared the way for the 'Stairway to Heaven' copyright case to proceed to trial next week (reported on WTOP.COM).  

This morning, I again listened to both the introduction of Zeppelin's Stairway to Heaven and Spirit's Tarsus instrumental (links to both at the bottom of this post).  While there are similarities, there are differences as well.  As one commentary to my original post put it, the Spirit instrumental is a standard chord progression whereas the introduction to Stairway to Heaven is much more than that.

The group, Axis of Awesome, very creatively demonstrated that a series of four chords makes up hundreds of popular songs, tens of which are featured in their song "Four Chords" (link below).  Yet most would agree that each of the songs featured are themselves unique creative works.

Previously reported in my 2014 post entitled, “Stairway to Copyright Infringement”- Step One in Spirit's uphill climb to prove Led Zeppelin's 'Stairway to Heaven' infringes its copyright", Led Zeppelin was sued by the band Spirit for copyright infringement based on Zeppelin's immortal song which Spirit alleges lifted portions from its guitar instrumental, Taurus.  Spirit has now advanced past step two, convincing the judge that there is sufficient evidence to conduct a trial for copyright infringement.

Turning to substance of the debate, does "Stairway to Heaven" infringe Spirit's Taurus guitar instrumental?  In order to infringe an original work's copyright, the alleged infringing work must be deemed "substantially similar" to the original work and the alleged infringer has to have had "access" to the original work.  In this case, "access" would not appear to be an issue as Led Zeppelin and Spirit toured together in 1968 and 1969. 



Below are links to YouTube clips from Spirit's "Taurus" and  Led Zeppelin's "Stairway to Heaven."  See if you think that the opening notes in Stairway to Heaven are substantially similar to the middle guitar instrumental in Spirit's "Taurus" (e.g. starting around 0:43).  Since most are familiar with the iconic guitar progression in "Stairway to Heaven," I present Taurus first.  Please let OP-IP know what you think.

© Stephen J. Weyer 2016

Send email feedback- sweyer@stites.com

Bitter Truth Behind the Cadbury Chocolate Import Ban

United States' lovers of authentic, original British Cadbury chocolate will have to book a flight to the UK to enjoy the cherished confection.  Hershey's, manufacturing licensee of Cadbury's chocolate in the U.S., uses a different recipe than the one Cadbury uses in the UK.  Not surprising to many, the first ingredient to Hershey's made U.S. Cadbury chocolate is sugar, whereas milk is the first ingredient in Briton-made Cadbury.  Chocolate connoisseurs say that Briton-made Cadbury chocolate tastes creamer and is smother than U.S. Cadbury chocolate made by Hershey's.  These British chocolate aficionados argue that U.S. Cadbury chocolate is pure humbug.

Hershey's was concerned that if Briton-made Cadbury chocolate, made with a different recipe, were imported into the U.S., Americans would be confused and mislead by two different chocolate experiences.  As the U.S. trademark licensee of Cadbury, Hershey's believes that two different tasting chocolate would negatively affect its licensed intellectual property.

However, as a lover of chocolate, might there not be a middle ground betwixt unrestricted Briton-made Cadbury flooding into the U.S. and a complete abolition of the milky-sweet delight?  Can't we have our cake and eat it too?  Options include special labeling of U.S. imported Briton-made Cadbury chocolate so that unsuspecting U.S. consumers who like their current U.S. (Hershey's made) Cadbury chocolate will not be confused with Briton-made Cadbury chocolate.

© Stephen J. Weyer 2015

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Attempts to Register Intellectual Property Rights in the Slogan "JE SUIS CHARLIE" have Missed the Mark

At last count, over 120 trademark applications have been filed in the French trademark office for the phrase "JE SUIS CHARLIE."  Included is an application by Joachim Roncin who is a graphic designer in Paris who claims that he is the true creator of the now ubiquitous phrase and the graphic design (shown to the left) of JE SUIS (white) above CHARLIE (gray) on a square black background.

The French trademark office, the INPI, issued a press release (in French) saying that it has rejected over 50 registrations based on a "lack of distinctiveness" in the phrase.  Translation: (into both English and plain non-legalese language), the phrase, "JE SUIS CHARLIE", does not qualify for trademark protection since the phrase is "too general" and not associated with (or identify) a specific origin (originator, owner) of goods or services.  As reported by a colleague, Amy Cahill of a sister publication of OP-IP, Trademarkology, in her article "Lawyers Make Good Lovers", it is not always so easy to secure trademark protection for slogans and phrases.  Examples of registered trademark phrases/slogans which are associated with a good or service include "You deserve a break today" and "i'm lovin' it" both for McDonald's and "JUST DO IT" for Nike.

Although JE SUIS CHARLIE may miss the mark for trademark protection, Joachim Roncin has other intellectual property protection avenues to pursue.  For example, the JE SUIS CHARLIE logo (shown above) is entitled to copyright protection for the artistic expression of the layout, e.g. the white font JE SUIS over gray CHARLIE on black square background.  In addition, design registration (e.g. European design registration (OHIM) and U.S. design patent protection) may be available to cover the design if applied to a specific article of manufacture or product.

© Stephen J. Weyer 2015

Send email feedback- sweyer@stites.com