Volume 1

Index of Articles

Letter from the Chair, March 2009
An Introduction to Pharma Trademarks
Pleading and proving defamation in an online world - roadmap by the Court of Appeals
The Case of the Appropriation Artist
Notes from Editor
Members in the News and on the Move
Upcoming Events

“ Beginning with the next bar year (7/1/09 – 6/30/10), our Section will become a dues paying section, with annual dues of $20 ”

Letter from the Chair, March 2009

Greetings Section Members:

Since achieving Section status from the MSBA in June 2007, the Intellectual Property Section has grown from approximately 150 members to 588 members in February 2009. This tremendous growth in membership is attributable to the dedication, hard work and vision of our committees, which do the work of the Section to fulfill its mission and further the goals of our members.

Over the past two years, our Section has been funded by the MSBA. Beginning with the next bar year (7/1/09 – 6/30/10), our Section will become a dues paying section, with annual dues of $20. There are many benefits of membership, including the following:

Access to Section publications, including the new Section newsletter and the Annual IP Law Update, which is published at the time of the MSBA Annual Meeting.

Opportunities to learn and exchange knowledge and ideas at the Section’s educational programs and webinars held throughout the year and at the MSBA Annual Meeting.

Opportunities to publish in the Maryland Bar Bulletin and the Maryland Bar Journal.

Access to content and podcasts from the Section’s educational programs and publications available for download by members at the Section’s website.

Registration on the searchable database at the Section’s website, which gives visitors an opportunity to locate member-attorneys by geographic area and practice area.

Our Section’s website at www.msbaips.org, which provides information regarding registered Section members, Section officers and council members, notice of upcoming programs, meetings and events and access to Section publications and content from educational programs.

We hope you will continue your membership and encourage others to join our Section. I invite you to become more involved in the Section by joining one of the Section’s committees, as follows:

Publications Committee Sherry H. Flax, Chair 410.332.8784 sflax@saul.com	Communications Committee Michael D. Oliver, Chair 410.583.2400 oliver@bowie-jensen.com
Programs Committee Vasilios Peros, Chair 443.927.2118 vperos@tandllaw.com	Membership Committee Kathryn Miller Goldman, Chair 410.783.7575 kgoldman@charmcitylegal.com

Your support and participation drive our Section and yield personal rewards in the form of networking, learning and opportunities to speak and publish on intellectual property matters. Please join us in advancing the development and understanding of intellectual property law in the State of Maryland.

Sincerely,

Donna M.D. Thomas, Chair
Intellectual Property Section of the MSBA
410.783.3522
dthomas@agtlawyers.com

An Introduction to Pharma Trademarks

By: Sherry Flax

    Pharmaceuticals are big business, and pharmaceutical brand names can translate into big profits. Viagra, by any other name, might not generate over $1 billion in annual sales.

   Registering a trademark for a pharmaceutical product involves clearance from the U.S. Food and Drug Administration (FDA) as well as the United States Patent and Trademark Office (USPTO). Trademark clearance for pharmaceutical brands begins with the usual clearance principles of mere descriptiveness and likelihood of consumer confusion to determine if a trademark is available. For pharmaceuticals, however, consumer confusion has another aspect – safety. Pharmaceutical mistakes result from trademarks for brands and generics that look alike or sound alike and carelessness, lack of knowledge of drug names, poor handwriting, or human error. For example, a physician prescribed Zyrtec, an allergy drug, but the pharmacist filled the prescription with Zantac, for ulcers.

FDA Regulatory Process

    A pharmaceutical product has three names associated with it: a chemical name (e.g., acetylsalicylic acid); a generic name (e.g., aspirin); and a trademark or brand name (e.g., BAYER®). The chemical name application is in the form of a Chemical Abstracts Service (CAS) Registry number. The CAS number is a unique identifier that differentiates a chemical compound from millions of other compounds, each of which may be designated by other chemical names.

    The generic name is assigned by the United States Adopted Name (USAN) Council, composed of representatives of United States Pharmacopeial Convention, the American Medical Association, and the American Pharmaceutical Association, with the FDA as a liaison member. The purpose of the USAN Council is to serve health professions by selecting simple, informative, and unique nonproprietary names for drugs. The USAN Council has established logical nomenclature classifications based on pharmacological and/or chemical relationships. The following are some of the criteria for generic name assignment: appropriateness for the drug; adherence to nomenclature rules; suitable for routine use both in the United States and internationally; not misleading or confusing or imply efficacy or application to particular anatomical parts; and distinctive from other drug names.

    A USAN generic name is required before a new drug application may be filed with the FDA. Typically, a company will apply for a USAN during the Phase I or II clinical trials of an investigative new drug application process. The company must provide a proposed name as well as chemical information about the drug and an explanation of its indications. After approval by the USAN Council, the name is sent to the World Health Organization International Non-proprietary Name Committee for final approval and entry in the US Pharmacopeia Dictionary of USAN and International Drug Names and the CAS database.

    The final step in the regulatory approval process, the FDA review, involves a series of subjective tests to determine if the proposed brand name can be approved. A panel compares the name against standard compendia and references and compiles a list of names that are potentially confusing. Handwriting comparisons are conducted to determine whether there is a risk of prescription or dispensing error. The panel also evaluates treatment indications, patient populations, dosage amounts, and risk of harm if the wrong drug is taken.

        The subjective nature of the FDA’s hypothesis generation method of review leads to inconsistent results. A Pilot Project for Proprietary Name Review under the recent Prescription Drug User Fee Act would allow pharma companies to conduct their own trademark evaluations consistent with “best practices” and to submit the data generated from those evaluations to the FDA for review. This project is designed to facilitate a comparison of this model for name submissions with the existing model of FDA review of proposed name.

        On Feb. 17, 2009, the FDA announced the availability to the public of the source code and supporting technical documentation for its Phonetic Orthographic Computer Analysis (POCA) software program, an analytic tool designed to help identify drug and biologic names and medical terminology that look and sound alike. POCA is one analytic tool that the FDA uses in its review of proposed proprietary drug and biologic names to help the FDA identify proprietary names that look alike or sound alike. Using POCA in the trademark clearance process will permit trademark attorneys to be more objective in their analysis of existing names and to predict with greater success whether the FDA will approve a proposed drug name.

    The FDA rejects about one-third of the 400 or so brand names it reviews each year. The FDA prohibits trade names associated with the product's intended use and will not approve names that imply efficacy. For example, ROGAINE was substituted when the FDA rejected REGAINE, which was approved and is used in the United Kingdom. Regulatory action can occur even after a name is approved and in use if there is evidence of actual confusion.
USPTO

    Because the development of a prescription pharmaceutical can take more than 4 years, a trademark should be registered for the research and development services as well as for the drug itself. To avoid a likelihood of confusion refusal to register, the drug name should be chosen with a eye towards avoiding confusion not only with existing trademarks, but also with USANs and generic chemical names. Pursuant to the doctrine of Greater Care, the USPTO often requires a lesser degree of likelihood of confusion in order to reject a pharmaceutical mark based on consumer safety considerations.

    The actual use requirement is different for a pharmaceutical product because these products cannot be commercialized without regulatory approval. The courts have recognized that shipping a drug to an investigator for use in clinical trials during the FDA approval process can constitute use in commerce sufficient to obtain a registration. See G.D. Searle & Co. v. Nutrapharm, Inc., No 98-6890, 1999 US Dist LEXIS 16862, 1999 WL 988533 (SDNY Oct. 29, 1999). Although a drug might take years to be approved, an intent to use application may be maintained for approximately 4 years and a Statement of Use may be filed based on use of the mark in clinical trials.

Conclusion

Pharmaceutical trademarks merit special considerations. Trademark clearance searches must be conducted in light of USAN and generic names as well as the likelihood of FDA approval. Secrecy must be maintained because marks are not protected until they are filed in the USPTO. An intent to use application should be filed with a description of goods that is broad enough to cover the goods and services as the scope may be narrowed but not broadened during the registration process. Finally, FDA approval should be sought at the late Phase 2 to early Phase 3 period. The FDA allows two marks to be submitted at one time, expediting the process by increasing the likelihood of approval.

Sherry Flax is the Chair of the Publications Committee and Chair-Elect of the Intellectual Property Section, and a partner at Saul Ewing.

Pleading and proving defamation in an online world - roadmap by the Court of Appeals

By Mike Oliver

In late February 2009 the Court of Appeals decided Independent Newspapers, Inc. v. Brodie.

In Brodie, the plaintiff discovered that several users of a forum on a newspaper internet site had made disparaging remarks about his business and property. He sued the newspaper, and three "john doe" posters, seeking the true identities of the posters. Unfortunately for the plaintiff, he mis-identified the true posters of the allegedly defamatory comments, and so the Court determined he was not entitled to discover the names of the posters. The Court, however, took the opportunity to expound at length on how to deal with claims of defamation in the internet context. The court laid down the following rule:

"Thus, when a trial court is confronted with a defamation action in which anonymous speakers or pseudonyms are involved, it should, (1) require the plaintiff to undertake efforts to notify the anonymous posters that they are the subject of a subpoena or application for an order of disclosure, including posting a message of notification of the identity discovery request on the message board; (2) withhold action to afford the anonymous posters a reasonable opportunity to file and serve opposition to the application; (3) require the plaintiff to identify and set forth the exact statements purportedly made by each anonymous poster, alleged to constitute actionable speech; (4) determine whether the complaint has set forth a prima facie defamation per se or per quod action against the anonymous posters; and (5), if all else is satisfied, balance the anonymous poster’s First Amendment right of free speech against the strength of the prima facie case of defamation presented by the plaintiff and the necessity for disclosure of the anonymous defendant’s identity, prior to ordering disclosure."

Three judges concurred but believed that the fifth element (balancing) was not necessary.

While the decision is welcome guidance (the Court notes that only one other case has addressed this issue in the civil context), it is unfortunate that almost the entire decision is dicta, as the plaintiff simply blew it and failed to sue the correct user names because he apparently did not understand basic internet forum threading. Additionally, while the Court is trying to offer guidance and reduce uncertainty, by introducing the fifth element in an action to discover the identities of anonymous internet posters, this will introduce ambiguity and probably result in decisions based on a judge's particular biases in determining the importance of anonymous speech.

The case is also a great example of why it is virtually never a good idea to sue anonymous posters - by filing the suit, the plaintiff has undoubtedly brought way more attention to the allegedly defamatory posts than the original posts probably ever did.

Mike Oliver is the Chair of the Communications Committee of the IPS, and a member of Bowie & Jensen, LLC.

The Case of the Appropriation Artist

By: Jim Astrachan

I was in Palm Springs speaking before a group of advertising agencies and a question came from the audience. She was a creative director with a large L.A. agency, but she was also a fine artist and had a good following in the galleries of Southern California. “I like to find a provacative photo in a magazine. It could be a still life, or it might be an animal. Whatever. Then, I like to copy that photo but add my own zest to it and use it in something I am creating. You know.”

I didn’t know and asked if she could elaborate on what she might do to the original photo, the copyright for which we assumed belonged to someone else. “Well, let’s see,” she replied. “I might colorize a black and white photo. I might enlarge one of the objects or subjects depicted in the photo, well out of proportion to the original, add it to a collage. Things like that.”

“I think that what you are asking is whether using another person’s photo as a basis or a part of your art, is copyright infringement,” I said.

“Uh huh, that’s what I’m asking.”

“Let’s narrow the question to whether your use of someone else’s photo for this purpose a fair use under the Copyright Act? If ‘yes’, you are not an infringer.”

“Uh huh. Isn’t that what I asked?” she questioned.

“For starters, fair use is found in the Copyright Act as an exception to infringement, but it is not defined; instead non-exclusive factors are listed and a court can accord them the weight it sees fit. The idea behind copyright fair use, I said, is to allow some use of another’s copyrighted work to fulfill copyright’s very purpose – the promotion of the progress of science and the useful arts. You see, the monopoly given to an author under the copyright law is really intended to benefit the public. An absolute monopoly on the use of a work would actually stifle, and not advance, the law’s objective. People are allowed to draw on an earlier work to create a new work, but this right has limitations.

“Clearly, then, there is a real tension between the property rights granted to an author which, under the Copyright Act, is a virtual monopoly and the ability of artists like you to express themselves by referencing works owned by others. Fair use tries to bridge this gap.

“Ever hear of an appropriation artist named Jeff Koons?”, I said, hoping that this discussion was not going so far afield of advertising law so as to bore the audience. “He has been in court for copyright infringement several times. The most recent was federal court in New York for doing something very similar to what you just asked about.

“Koons was commissioned by Deutsche Bank to create an exhibition of paintings. Koons culled images from advertisements and scanned them into a computer, and superimposed the scanned images against pastoral backgrounds. Then he printed color images of the resulting collages. His assistants used the prints as templates for painting 10’ x 14’ canvases.

“One of these giant canvases was titled ‘Niagara’ and it consisted of fragmentary images against a pastoral background with four pairs of women’s feet and lower legs dangling prominently over images of brownies, donuts and apple pastries. The legs were placed side by side and together occupied the entire horizontal expanse of the 14 foot painting.

“Koons was sued over his use of the legs in this painting, and that,” I said, “is pretty much the sort of use you had in mind when you asked your question, wasn’t it?”

“Uh huh,” she said.

“The leg shots,” I said, “were the work of professional photographer Andrea Blanch who shoots for Vogue, Allure, Details and G.Q. She is the go-to photographer for advertisers like Revlon, Johnny Walker and the fashion house Valentino, and is the author of a photograph book called Italian Men: Love & Sex. The legs were part of a slick fashion ad shot in the posh cabin of a private jet.

“Koons,” I said, “was not about to confess Mia Culpa and pay the tariff. He defended the suit on the grounds that his use was fair. He testified that those legs represented a particular type of woman who is frequently depicted in fashion ads, and by using them in his painting he was commenting on the ‘commercial images in our consumer culture.”

“Koons,” I said, “did not use any of the background of the photos; just the legs and feet. And still, he got sued for infringement.”

I explained that the jumping-off point for a fair use analysis is the statutory factor that examined the purpose and character of Koons’ use. The central purpose of this inquiry is whether Koons’ work merely superseded Blanch’s photo, or did Koons’ painting add something new? Did Koons’ work change the purpose or character of Blanch’s photo?

In other words, did Koons use Blanch’s legs as raw material and transform them into something new when he created his painting? Were new insights and new aesthetics were added by Koons?

Koons asserted, and Blanch did not deny, that his reason for using Blanch’s leg shots was totally different than her purpose. She used the legs in a slick fashion ad to create an erotic sense; he wanted people to examine the legs and consider how like photos effect their lives. Koons used Blanch’s legs as fodder for social commentary relating to how the mass media enters our lives and affects us. He wasn’t repackaging Blanch’s photo or duplicating it and using it for the purpose Blanch created it.

“It used to be,” I said, “that all courts were of the mind that if the use was commercial, it could not be fair. But in 1994 the Supreme Court held that commercial use alone can not be dispositive. That was good for Koons because his painting was appraised at $1 million.”

“Blanch appealed the trial court’s ruling in Koons’ favor, and the appellate court affirmed. It cost a lot of money and although Koons might have been entitled to recover his legal fees he did not try. If you want to use another’s work in your work,” I continued, “you may be able to. But expect a challenge. If it comes, it won’t be cheap.”

James B. Astrachan is a partner at Astrachan, Gunst & Thomas, P.C. and is the author of The Law of Advertising, published by Matthew Bender-Lexis/Nexis.

Notes from Editor

By Joseph G. Contrera

    Dear Colleagues, I would like to introduce you to the MSBA Intellectual Property Section newsletter, which we hope to publish 3-4 times per year. This newsletter is the result of the ideas of members of our fledgling section and the concerted efforts of the publications committee. We hope to be able to provide you with a newsletter that offers a timely and efficient means for keeping abreast of some of the more important happenings in the areas of intellectual property law and related practice areas.

    The present vision is for this newsletter to provide information regarding section happenings and events, as well as a calendar of intellectual property related seminars and meetings around the Baltimore-Washington metropolitan area.

    In addition, we hope to present you each month with articles and reports on recent happenings in various areas of intellectual property law. The reports are intended to be a focused summary of anything IP related, such as pending or newly enacted legislation, recent cases in the Federal District Courts, the Federal Circuit, International Trade Commission, or U.S. Supreme Court. We also hope to bring you an editorial opinion on intellectual property matters and decisions, from your editor, other members of the section or other IP practitioners.

    We want this to be your newsletter, and with that, we want your comments, suggestions and thoughts on what you want to see in the IP section newsletter. We also need content! Lots, and lots of content! So please think about an issue important to you and send us your ideas in an email or phone call, and we will try to get it in front of the members. You can email Joe at jcontrera@leydig.com.

Joseph Contrera is a member of the Publications Committee, Editor of the MSBA IP Section newsletter and counsel with the firm of Leydig, Voit & Mayer.

Members in the News and on the Move

J. Andrew McKinney is starting a new Maryland law firm on March 1, and opening an office in Severna Park (410) 518-6040. Mr. McKinney will continue his association with the firm, Jones, Tullar & Cooper, P.C., and their offices will remain in Arlington, Virginia.

Jeffrey I. Auerbach was the keynote speaker for the Project for the Strategic Development of Industry-University-Government Collaboration Training Program of the Japanese Ministry of Education, Culture, Sports, Science & Technology that was sponsored by the Tokyo University of Agriculture & Technology on January 28, 2009. The presentation focused on ways in which Japanese Universities could better position themselves to collaborate and partner with US Companies, and in particular, US biotechnology companies. Copies of the presentation (in English and Japanese) can be found at (www.usiplaw.com).

IPS Member Roberto N. Allen, Esq., formerly VP of Legal Affairs & Intellectual Property at Alba Therapeutics Corp., is now providing legal and business development consulting services to biotech companies and other startups and venture-backed firms. Mr. Allen can be reached at 410-456-7562 or rallen111@gmail.com

Sterne, Kessler, Goldstein & Fox P.L.L.C., an intellectual property law firm in Washington, DC, announced the election of Gaby L. Longsworth, Ph.D. to the directorship. Dr. Longsworth is a member of the Biotechnology/Chemical Group. Her practice encompasses domestic and foreign patent prosecution, patentability, freedom to operate, infringement, and design-around strategies, as well as issues related to pharmaceutical patent litigation brought under the Hatch-Waxman Act.

Mohammad S. Rahman, Esq. is pleased to announce the creation of his new intellectual property law firm, Rahman LLC, located in Columbia, Maryland. He can be reached at (443) 283-7000 or rahman@rahmanllc.com.

Mary Beth Tung, Ph.D. has joined the Howard County law firm of Davis, Agnor, Rapaport & Skalny, LLC. Representing individuals, businesses and associations, Tung works primarily in the area of intellectual property and patent management. Mary is a Registered Patent Agent and represents clients in the areas of plant and animal genetics and recombinant technologies, antibodies, chemistry, pharmaceuticals, engineering, and information technology.

Bruce Margulies, an attorney with Neifeld IP Law, PC, passed the Patent Bar in February 2009.

Upcoming Events

Wednesday September 08, 2010 12:00 PM (Type: Officers' Meeting) (Section Officers' Meeting)

Thursday September 16, 2010 12:00 PM (Type: Section Educational Event) (The Digital Millenium Copyright Act: An Update)