IDEA Blog

Welcome to the IDEA Volume 57 Blog!

In this Blog, we want to showcase our Associate Editors’ notes.  If you are interested in any of these notes, we encourage all of you to attend the annual Student Note Symposium on April 21, 2017.  At this event, you can hear a short presentation from each Associate Editor and talk with them about their research and the nuances of each area.  Thank you, and enjoy!

Table of Contents
The Future of Patenting Antibodies after Amgen v. Sanofi
The Patentee’s Patent Right Gives the Patentee the Right to Exclude Infringers when there is Divided Infringement, However, no Direct Infringer
Contemporary Art and its Predisposition to Clash with Copyright Law
How Patent No. 9,095,554 is Changing Everything in the Marijuana Industry

The Future of Patenting Antibodies after Amgen v. Sanofi
 


    By Anna Lukacher JD '18

The research and development costs to produce a single antibody sequence is very high compared to the much lower costs of producing another, yet slightly structurally different antibody with the same function. How can a pharmaceutical company best protect its drugs, in which the active ingredient is an anti-antigen-antibody? Should biological antibody patents claim an antibody by its amino acid sequences or functionally by the sequence of its target epitope? 

An antibody is a protein that is part of the body’s adaptive immune system, made up of two immunoglobulin proteins formed in a Y-shaped structure, the heavy chain and the light chain. The constant region of the antibody, mostly the “tail” of the Y shape, forms the receptor binding region that binds to the surface of host cells. The constant region of the antibody determines the antibody’s immunoglobulin class: IgA, IgD, IgE, IgM, and IgG. With only five classes of antibody constant regions, patent applicants tend not to describe the sequence of an antibody by its constant region because this region does not distinguish the claimed invention from other antibodies. Instead, the specificity of an antibody comes from the antibody’s variable region.  The variable region of the antibody, the top of the “hands” of the Y shape, form an antigen binding region that binds to epitopes (amino acid residues) on a target antigen. The variable region is made up of complementary determining regions, three on the light chain and three on the heavy chain. The complementary determining regions are described by its amino acid sequence, which vary based on the antibody’s target antigen. While there are possibly infinite antibodies within a given antibody genus, there is a limited number of epitopes on a target antigen.  

In 2008, the United States Patent and Trademark Office [hereinafter USPTO] revised its Written Description Training Materials to include an antibody exception to the standard written description requirement. The standard written description requirement requires that the applicant sufficiently and particularly disclosure her invention to prove that she actually possess her claimed invention at the time of filing. At such time, it is impossible to know all possible antibody variants against a particular antigen. The standard written description requirement would dis-incentivize antibody patent applicants from filing until they knew all possible variants, which is actually still impossible. So, the USPTO included an antibody exception to this written description requirement which allows an applicant to claim a genus of antibodies without providing multiple antibody disclosures, so long as one of ordinary skill in the art would know the scope of the claimed antibody genus.  

In 2014, the Federal Circuit interpreted the USPTO’s antibody exception in Abbvie Deutschland Gmbh & Co. v. Janssen Biotech. Inc., by holding that AbbVie’s patent genus claim towards “a neutralizing isolated human antibody, or antigen-binding portion thereof that binds to human IL-12…” was invalid for lack of written description because AbbVie did not disclose the structure of every possible antibody variant within this genus. This seems to be reverting back towards the standard written description requirement. 

Though, in January 2017 the U.S. District Court of Delaware in Amgen Inc., et al. v. Sanofi, et al. held that Amgen’s patent genus claim towards “an isolated monoclonal antibody that binds to PCSK9, wherein the isolated monoclonal antibody binds an epitope on PCKS9 comprising at least one of residues 237 or 238…” was valid under the written description requirement. The biggest difference between AbbVie and Amgen’s patents was that while AbbVie disclosed more heavy and light chain sequences of its claimed antibody genus than Amgen, Amgen additionally disclosed sequences for the amino acid residues (epitopes) on PCSK9, the target antigen to Amgen’s claimed antibody. The District Court issued a permanent injunction against Sanofi’s drug, Praulent, even though Sanofi already had FDA approval and spent billions in research, development, and marketing costs. 

Claiming an antibody by the antibody’s target epitope without disclosing many structural antibodies leads to a very broad claim scope with a narrow disclosure. Granting and validating these patents may provide a pharmaceutical company with a monopoly on a particular drug market, as this seems to be happening in Amgen. Though, this broad functional claim may be the only way to effectively claim a genus of antibodies since the Federal Circuit in Abbvie stated that to structurally claim a genus of antibodies one must provide a structural representative of every possible antibody species within that genus.  I would submit that Amgen’s method of functionally claiming an antibody by structural disclosure of target epitopes may be the future of antibody patents. 


The Patentee’s Patent Right Gives the Patentee the Right to Exclude Infringers when there is Divided Infringement, However, no Direct Infringer

  By Jenna E. Dean JD '18

Currently in indirect infringement cases the patent law system does not afford a patentee an adequate remedy wherethere is no direct infringer, albeit, there are two or more entities acting in concert to perform each and every step of the claim.  Specifically, this is because the Federal Circuit and Supreme Court cases have interpreted 35 U.S.C. § 271, infringement of a patent, to hold that 35 U.S.C. § 271(a) defined infringement.  As a result, there must be a direct infringer in order for a patentee to assert a claim of indirect infringement under § 271(b).  In consequence, a patentee may have no remedial action against an indirect infringer even when there has been obvious infringement of the patentee’s claim, if there is no single entity whom directly infringes the claim such that there is infringement meeting the requirements of § 271(a). 

The granting clause of 35 U.S.C § 154 grants exclusive patent rights to the patentee, i.e., “the right to exclude others from making, using, or selling.”  Accordingly, infringement would be a violation of those rights, specifically because infringement is inherently defined in § 154 as a violation of the patentee’s exclusive rights to exclude.  Moreover, the legislative history of § 271 made it clear that when an entity does something less than direct infringement, but nonetheless acts in concert with another such that there is obvious infringement, § 154 affords the patentee the exclusive right to enjoin an indirect infringer for infringement under § 271(b) indirect infringement.

Accordingly, there does not have to be direct infringement by a single entity under §271(a) in order to hold an indirect infringer liable under § 271(b).  Stated otherwise, when there is no direct infringer, but there is obvious infringement, § 154 will define the infringement as a violation of the patentee’s exclusive rights to exclude.


Contemporary Art and its Predisposition to Clash with Copyright Law

head shot   By Joseph Scott JD '18

In a renowned opinion, Justice Reed stated, “individual perception of the beautiful is too varied a power to permit a narrow or rigid conception of art.”

Everyone’s an art critic. Whether you want to or not, when looking at a work of art or hearing a song, you either like it, dislike it, appreciate its complexity, or wonder why on earth a blue canvas split vertically by a white line could fetch $43.8 Million at auction. Minimalism tends to be one of the more polarizing artistic movements, and it makes no exceptions in its interactions with the law of copyright. So, when it comes to copyright, and the bench is required to disregard a work’s artistic merit in determining whether a work is eligible for copyright protection, how do they do it? For a work to be worthy of copyright protection, it must be an original work of authorship fixed in a tangible form of expression. In other words, to benefit from copyright protection, a work need not be novel or radiate artistic merit so long as it is original. So why is it that belt buckles made from precious metals (which simply serve the inevitable function of fastening belts) obtain copyright protection, when minimalist art (which serves no other purpose than to express the creativity of an author) consistently struggles to gain protection?

Copyright law and modern art often clash, particularly in light of the minimalist movement. Minimalism, which emphasizes simplification and the scarcity of detail and reduction of elements to the bare essentials, struggles to fit into the copyright criteria. Although the dilemma of artistic merit is not unique to minimalism, the very nature of the movement does not forebode well for its protection under copyright. It will be interesting to look into the tensions between the law and art, and the wide reaching threshold of originality dilemma in this context.

Moreover, the threshold of originality does not reserve its squabbles solely for minimalism. On March 17, 2015, Anton Motolko took a picture of the Northern Lights shimmering behind the dark silhouette of an imposing tree. He published the photographs on his social media accounts where they attained substantial popularity. The next morning, he woke up to his work being used on a state-run television channel to which he had not given permission nor had he received any form of recognition. Seeking credit and compensation for his work, Motolko brought suit in Belarus in the hopes of receiving his due compensation. Unfortunately for him, the court determined that his photographs failed to demonstrate any signs of “creative freshness, originality, uniqueness, or exceptionality,” and denied him any recourse for the unauthorized use of his photographs. Motolko has since appealed to the World Intellectual Property Organization, in what could be a pivot point for copyright law across the globe.

The threshold of originality consistently manifests itself as an ominous shadow for artists reaching beyond the traditional forms of art. In 2008, the Tenth Circuit held that digital wire-frame models of Toyota vehicles were not eligible for copyright protection because the models were no more than digital depictions of actual Toyota vehicles and hence lacked creativity. Here, the court refused to consider the substantial efforts the plaintiff made to create the models, rejecting the sweat of the brow doctrine, and denying any protection.

If the bench is to refrain from assessing artistic merit or factoring in personal preference, why does copyright law favors certain traditional art forms over newer ones, notably traditional art over contemporary movements? Maybe it’s time for copyright law to take a stride away from its “rigid conception of art.”


How Patent No. 9,095,554 Is Changing Everything in the Marijuana Industry

   By Cecily Wilbanks JD '18

On August 4, 2015, the USPTO granted patent U.S. Patent No. 9,095,554, a patent for “specialty cannabis plants, compositions and methods for making and using said cannabis plants and compositions derived thereof.” The patent covers the methods of breeding, production, processing and use of specialty cannabis. Prior to patent 9,095,554 no specialty cannabis (or “strain”) had been patented. Further, most if not all potential patent holders believed that such a patent was impossible to get, due to cannabis’ placement as a schedule I drug by the DEA under the Controlled Substances Act (CSA). Patent 9,095,554 has opened up a new world of potential patents, innovation, and major complications in our current era of marijuana legalization.

In terms of intellectual property law, there are a multitude of questions and areas of concern surrounding marijuana patents, including patent registration roadblocks like “novelty” and “utility.” Numerous strains of marijuana were developed years ago and have been in use illegally, potentially creating a “novelty” issue if creators attempt to patent these strains. On the other hand, if an agricultural company independently develops a strain, it is unclear whether the strain’s prior illegal use would be considered invalidating prior art. “Utility” may also prove to be an issue, due to strong similarities between various marijuana strains along with the FDA’s current stance on marijuana as a schedule I drug. Developers both large and small will be under a great deal of pressure to find and create strains with different effects, the determination of which would likely be delayed by the FDA and the DEA.

Moreover, patenting marijuana strains could create a serious impact in the business world. For years small growers have been wary of larger companies like Monsanto getting in on the marijuana business. With the ever growing legality of both medicinal and recreational marijuana, the ability to patent strains will be an important part of a business’ portfolio, for both small and large growers. Many small scale growers have been in business for decades and the patenting (and ensuing legal fight over said patents) of various strains is likely to become a competitive business very soon.