Venable’s IP News & Comment

AUGUST 2007

Members of Venable’s 80-plus Technology Division are pleased to present this edition of IP News & Comment, covering topics generating the greatest interest in the areas of patents, trademarks, copyrights, and IP litigation. We welcome your comments and look forward to being of service.

Patent Law Reform (Update) ...... 1 USPTO Proposes New Rules of Ex Parte Practice Before the Board of Appeals and Interferences...... 3 OMB Approves USPTO's New Rules Restricting Continuation Applications and Patent Claims...... 4 A One-Two Punch Hits Biotech ...... 5 Is Fact Checking FairUse? ...... 6 A Preview of Michael Gollin's New Book...... 7 Venable’s Baltimore Office Adds Five Biotech and Business Attorneys From Saul Ewing...... 9 Venable Expands into Delaware ...... 10

Patent Law Reform (Update) By Catherine Bennett, Partner, Venable LLP

HOUSE

On Wednesday, July 18th, the House Judiciary Committee reported HR 1908, the Patent Law Reform Act of 2007. The bill approved was a substitute measure offered by IP Subcommittee Chair, Howard Berman (D-CA), to which 7 amendments were adopted.

The bill approved has evolved substantially since first introduced with a companion Senate (S.1045) measure last April. For example, the Berman substitute’s post grant opposition procedures no longer contain the so-called “second window” for challenging patent validity. Instead, the bill expands upon the existing patent reexamination procedures available for the first year after patent issues. The second window has been one of the more controversial points of contention between PhRMA/BIO companies and the “high tech” community.

Berman’s amendment also made clarifications to the “first-to-file” provisions, largely in response to concerns expressed by the university community. Universities were concerned about academic publications about an invention might jeopardize patent rights under a first to file system. He also delayed the effective date of the change until major trading partners (EU and Japan) adopted comparable “grace period” protections, independently or in the context of patent harmonization talks. Apparently, this change was requested by the Administration so as to not lose leverage in patent harmonization negotiations.

Another core provision to which changes were made related to the apportionment of damages. This was another key point of difference between the high tech community and the universities and drug makers. The earlier bill’s requirement for an apportionment of damages that reflects the economic value attributable to the patented product’s contribution over prior art was modified. Such a calculation would not be required where the parties have competing products. The bill also recognizes that the value of a combination of two elements of prior art might exceed their separate value and establishes circumstances where the entire market value calculation might apply. A committee amendment affirmed the discretion of judges to decide the apportionment analysis.

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Other modifications included in the approved bill:

• Inequitable conduct – requires that this defense be pled with “particularity” and separates proof of intent from proof of materiality. An amendment to eliminate the defense was rejected.

• Best mode – maintains the requirement that the patent application disclose the “best mode” for carrying out the invention, but eliminates the failure of the applicant to fulfill the best mode requirement as a defense against patent infringement.

• Studies – requires studies on the impact of the first to file and damage apportionment provisions every seven years.

• Venue – further tightens the venue provisions to require patent actions to be brought where either party resides or where the defendant has committed acts of infringement and has a regular place of business.

• Tax planning methods – makes tax planning methods (a plan, strategy, technique or scheme that is designed to reduce, minimize, or defer tax liability) unpatentable.

While Chairman Conyers (D-MI) announced at the close of the mark-up his intention to move the bill to the House floor before the August recess, this is not likely to happen. In addition, Chairman Conyers did not rule out further changes in the legislation, most likely in the form of an additional manager’s amendment, when the bill moves to floor.

SENATE

The Senate Judiciary Committee reported its patent laws reform measure on July 19, 2007 by a vote of 13-5. During Committee consideration, Chairman Leahy (D-VT) set forth another substitute bill and manager’s amendment to which five additional amendments were adopted.

As reported by the committee, the Leahy substitute also made changes in the post-grant review process. For both the first and second window, the bill raises the standard to grant such a review to a “substantial new question of patentability as to at least one claim”. It also requires pleading with particularity and prohibits filing a post-grant review petition if the party has already filed an action on validity in district court. With respect to the second window, the bill provides for the presumption of validity of the patent. It also requires that the post-grant petition for review be filed within 12 months of notice of infringement. Finally and curiously, it limits the second window to patents filed after November 29, 1999. As noted above, the House jettisoned the second window in its post-grant opposition provisions.

Among the amendments approved were proposals to prohibit the diversion of patent fees, to permit PTO to accept late filing filings in certain circumstances and to limit damages with respect to check imaging and other financial archiving methods. The latter two were constituent driven changes. During the mark-up, Senator Kyl offered amendments to strike the post-grant opposition provisions and modify the damage apportionment language. The first lost by a vote of 7-11 and the second was defeated 7-10. The Committee also defeated amendments by Senator Specter to give the Federal Circuit more discretion regarding interlocutory appeals and to scale back the best mode requirements. Senator Specter also offered an amendment to require, in an inequitable conduct defense, clear and convincing evidence of misconduct and proof that the patent would not have been granted “but for” the misconduct. Chairman Leahy succeeded in striking the materiality portion of the amendment.

In approving the legislation, it was made clear that additional modifications to the legislation would likely be made before it was considered on the Senate floor. Staff has indicated that the bill is unlikely to reach the Senate floor before the Fall. In the interim, it is assumed that key stakeholders will continue to try to find more common ground.

While the high tech community has indicated that they support the Senate bill in current form, they know that BIO/PhRMA companies do not support it and would try to kill the legislation on the Senate floor unless there are additional modifications. In an environment in which any controversial bill requires 60 votes, it would not be that

VALUE ADDED, VALUES DRIVEN.® VENABLE’S IP NEWS & COMMENT AUGUST 2007 3 difficult to defeat. Recognizing this, Majority Leader Reid is unlikely to give the bill floor time until greater consensus is achieved. One staffer observed that it was highly doubtful this bill would go to the Senate floor and be opened for amendment. The more likely scenario is that it will be negotiated out in an Unanimous Consent Agreement off the floor.

As has been the case during most of the deliberative process, the key issues in contention are post-grant opposition and the apportionment of damages. Lesser tier issues include the inequitable conduct defense and best mode. After the considerable amount of work that has gone into the patent law reform process, it is difficult to believe that the legislation will not go forward. At the same time, given the differing business models and billions of dollars at stake on both sides of the current fight, that could very well happen.

USPTO Proposes New Rules of Ex Parte Practice Before the Board of Appeals and Interferences By Joan Ellis, Ph.D., Partner, Venable LLP

On July 30, 2007, the United States Patent and Trademark Office (USPTO) published proposed rule changes for ex parte practice before the Board of Appeals and Interferences (the Board) in the Federal Register. Although presented as proposed rule changes, the changes have already been reviewed and approved by the Office of Management and Budget (OMB). The USPTO characterizes the proposed rules as being merely procedural (involving changes to interpretive rules or rules of agency procedure under 5 U.S.C. § 553(b)(A)) and therefore, requiring no public comment. Nevertheless, written comments will be permitted on certain issues until September 28, 2007.

The goals of the proposed rules include: (1) decrease pendency by providing a means for the Board to handle the increased number of appeals in a timely manner; (2) provide both Examiners and other USPTO reviewers; e.g., Administrative Patent Judges (APJs), a more clear and complete statement of the appellant’s position; and (3) improve the likelihood that appealed claims will be allowed. While the proposed rules contain 17 changes to the current rules of practice for ex parte appeals, the most significant changes in the proposed rules for practitioners are the new requirements for the appeal briefs. The proposed changes in the format and content of the main appeal brief and the appendix will now be similar to what have been required for many years by the Trial Section of the Board in interference proceedings.

In addition, appeal briefs will be limited to 25 pages excluding the statement of the real party in interest, the statement of related cases, table of contents, appendix, and the signature block. Reply briefs and supplemental reply briefs will be limited to 15 and 10 pages, respectively. Briefs will not be permitted to circumvent the page limitations by incorporating by reference arguments from other papers in the evidence section or any other source. However, requests to exceed the page limits can be made by petition to the Chief Administrative Patent Judge (CAPJ) under Bd. R. 41.3 provided the petition is filed at least ten days before the brief is due.

There are two additional changes in the proposed rules which are noteworthy. Currently, all oral arguments at the Board are transcribed by a court reporter. To improve the accuracy of the transcripts, proposed Bd.R. 41.47(g) requires the appellant, when confirming attendance at oral hearing, to submit a list of technical terms and other unusual words which would have to be transcribed during the hearing. In addition, the authority and extent to which the Board may issue sanctions have never been clear in ex parte appeals proceedings. Proposed Bd. R. 41.56 puts ex parte appeals in line with interference practice (Bd. R. 41.128) and sets forth for the first time the type of attorney conduct which can result in sanctions as well as the type of sanctions an ex parte APJ may enter.

The proposed rule changes will unquestionably add to the preparation time of an ex parte appeal brief, and thus to the cost of the appeals process, especially with applications which are rejected on multiple grounds and/or have numerous claims which are separately argued. Preparing a brief in the proposed format will be onerous given the amount of newly required detail, but not complex. Counsel would be well advised to carefully review the discussion section accompanying the proposed rules and devise a comprehensive checklist to ensure compliance and to avoid the pitfalls which could result in abandonment of the application or dismissal of the appeal.

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One troublesome aspect of the proposed rules is that they are inconsistent in, on the one hand, attempting to improve quality by requiring a more comprehensive and detailed appeal brief and, on the other, imposing draconian page restrictions (Proposed Bd. Rules 41.37(v)(5), 41.41(d) and 41.44(d)). It is understandable that the Board would prefer to review shorter briefs, but it is during prosecution before the USPTO that the record should be fully developed and all the issues regarding patentability rigorously explored. Only when all the issues have been fully investigated should those which are key, yet still unresolved, be appealed to a district court or the Court of Appeals for the Federal Circuit (CAFC). By the time a case reaches the appellate level the issues have crystallized and become more focused, thus making page limits [for a brief] a more reasonable requirement. While the Board is the appellant panel for purposes of the examining corps, it is still a part of the record building process as evidenced by the Bd. R. 41.50(d) which permits the Board to make a new ground of rejection, Bd. R. 41.50(e) which permits the Board to make recommendations; and Bd. R. 41.50(f) which permits the Board to request briefing or additional information on certain matters. The implementation of any rule limiting the number of pages in an appeal brief could potentially result in either a decrease in the quality and accuracy of the record or a large increase in the number of petitions to the CAPJ.

OMB Approves USPTO’s New Rules Restricting Continuation Applications and Patent Claims By Michael A. Gollin, Partner, Venable LLP

The Office of Management and Budget (OMB) approved two new patent rules proposed by the U.S. Patent and Trademark Office (USPTO) limiting the number of continuation applications that may be filed (RIN 0651-AB93), and the number of claims in a patent application (RIN 0651-AB94). A July 12, 2007 OMB notice (available at www.reginfo.gov) shows that the rules were approved July 9, with changes. The OMB process was quite active, including meetings with BIO, Cantor Fitzgerald, and others objecting to the rules.

Despite the laudable intention of the rules – to streamline patent examination – this is the least popular reform of patent rules in recent history.

The proposed continuation rules would limit applicants to one continuation application absent good and sufficient reason. Comments by USPTO officials and blog reports suggest that the final rule may allow one RCE (request for continued examination) plus two continuations for new cases, or three continuations for cases that have received an office action, but exact details are unavailable.

The proposed rules on claims would require applicants to provide a patentability report for any application containing more than 10 claims (most applications), and would limit examination to representative claims. Comments suggest that the final rule may permit 25 claims in all, with five independent claims, but again the details are not publicly available.

Under federal administrative procedures, the final rules will be published in the Federal Register soon. The publication date depends on USPTO efforts, and could be days to months after the OMB approval. The effective date for the final rules will likely be the default of 30 days from publication, but there is a slight possibility that the rules might be effective immediately upon an appropriate showing by the USPTO, for example that the delay would encourage applicants to “game” the system by filing new continuations. A later effective date is also possible. Thus, the effective date may be as early as July, but will most likely be in late August or early September. Trade associations are likely to challenge the final rules in court.

Many patent applicants are reviewing their pending applications to determine whether it is desirable to file continuation applications before the new rules take effect. For example, it may be advisable to file a continuation application in a patent family in which there have already been three or more continuations, on the assumption that no more would be allowed under the new rules. Also, in situations where there is already an intention to file a continuation application, it may be advisable to do so now rather than later. As to the claim number limitations, one option would be to add more claims now rather than after the effective date. After the transitional period, it is likely that patent prosecution will become yet more complex and, unfortunately, more expensive.

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A One-Two Punch Hits Biotech By Steven R. Ludwig, Ph.D., Partner, Venable LLP

The U.S. Board of Patent Appeals and Interferences recently gave practitioners three precedential opinions illustrating the board’s view on obviousness in view of the U.S. Supreme Court’s decision in KSR v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007). See, Ex parte Kubin, Appeal No. 2007-0819 (BPAI 2007), Ex parte Catan, Appeal No. 2007- 0820 (BPAI 2007), and Ex parte Smith, Appeal No. 2007-1925 (BPAI 2007). The three opinions each separately concern three technology areas – biotechnology, electronics, and mechanical inventions (Ex parte Kubin, Ex parte Catan, and Ex parte Smith, respectively).

The biotech opinion, Ex parte Kubin, in addition to finding that the claimed invention was obvious, also held that the applicant had not met the written description requirement – a significant one-two punch for certain biotech inventions in general.

The claims in Kubin were drawn to nucleic acid molecules encoding NAIL (natural killer cell activation inducing ligand) polypeptides. The appellants did not separately argue the claims separately (a potential mistake) and thus, claim 73 was cited as the representative claim:

73. An isolated nucleic acid molecule comprising a polynucleotide encoding a polypeptide at least 80% identical to amino acids 22-221 of SEQ ID NO:2, wherein the polypeptide binds CD48.

The prior art patent, Valente, disclosed the corresponding human protein, p38, and taught a prophetic example of how to isolate the cDNA clone. The prior art did not disclose the nucleic acid sequence of human p38. Another piece of prior art cited, Matthews, disclosed the mouse version of p38 and the mouse nucleotide sequence.

Appellants argued that In re Deuel, 51 F.3d 1552, 34 USPQ2d 1210 (Fed. Cir. 1995), was controlling. However, the Board held that “given the increased level of skill in the art and the factual difference,” Deuel was not controlling. The Board stated:

“To the extent Deuel is considered relevant to this case, we note the Supreme Court recently cast doubt on the viability of Deuel to the extent the Federal Circuit rejected an ’obvious to try‘ test. See KSR Int’l Co. v. Teleflex Inc . . . Under KSR, it’s now apparent ’obvious to try‘ may be an appropriate test in more situations than we previously contemplated.”

Appellants also argued that the cited references did not render the claimed invention obvious because the cited references did not provide an adequate written description of the claimed nucleic acid sequences. However, the Board held that “an obvious method of obtaining a single nucleic acid molecule encoding NAIL may be all that is required to show that the presently claimed genus of nucleic acid molecules is unpatentable under §103.”

Next, while the Board held the claims enabled, the Board found that the written description requirement was not met. The applicants did not disclose any variants in which the nucleotide sequence encoding amino acids 22-221 of SEQ ID NO:2. Therefore, the Board reasoned that under University of California v. Eli Lilly Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) and its progeny, the specification did not show possession of a sufficient number of sequences falling within their genus to establish possession of their claimed genus. Citing Lilly again the board held that “without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement.”

What does this case mean for biotech practitioners?

It will be much more difficult going forward to convince the USPTO that certain inventions are non-obvious and have an adequate written description.

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What is a practitioner to do?

In addition to assisting the Federal Circuit to overturn Kubin by submitting an amicus brief assuming Kubin is appealed, applicants have a few other possibilities.

With regard to the obviousness of specific sequences, applicants should present a narrow claim to the specific sequence and argue that their specific sequence is patentable over the prior art. Assuming that a claim to the specific sequence is not obvious, one could additionally argue that 99% identity, 98% identity, 97% identity, etc., is not obvious.

With regard to written description, applicants should disclose in their applications actual or prophetic variants of the specifically defined sequence present in the claim.

Applicants should also, when possible, expressly describe which residues can be changed in order to maintain biological function of the molecule.

Finally, in an ideal situation, applicants should disclose a correlation between function and structure.

In summary, while the patenting of certain biotech inventions undoubtedly became more difficult in view of Kubin, savvy practitioners clearly still have options to pursue to convince the USPTO of the patentability of their inventions.

Is Fact Checking Fair Use? By Seth Shaifer, Associate, Venable LLP

What happens when someone is the subject of a forthcoming book? If the individual makes a copy of the book to check the facts – is there copyright infringement liability? These are important potential questions that this article attempts to answer by providing a framework for legal analysis.

All works produced after January 1, 1978, receive federal statutory copyright protection upon fixation in a tangible form. One of the rights granted to a copyright owner is the right of reproduction. 17 U.S.C. § 106(1) (2007). (“Copyright Act”). When someone other than the copyright owner makes an unauthorized copy of a work, that act may infringe the copyright owner’s right, even without a distribution by sale or lease. 17 U.S.C. § 106(3) (2007).

Because the reproduction of a work (even in its entirety) in connection with a judicial proceeding serves a different function and is not designed to “satisfy the reader demand for the original,” the use may be eligible to be a “fair use.” 4 MELVILLE B. NIMMER & DAVID NIMMER, NIMMER ON COPYRIGHT, § 13.05[D][2], at 13-230.11 (2006). Any potential infringer can assert the affirmative defense of “fair use.” Section 107 of the Copyright Act of 1976 has established a four-factor test to apply the defense of fair use: (1) the purpose and character of the use (commercial or non- commercial as well as transformative1 or superseding); (2) the nature of the copyrighted work; (3) the amount and substantiality of the copyrighted work used; (4) effect of the use on the potential market or value of the copyrighted work. See 17 U.S.C. § 107 (2007). Those factors seem to indicate that a use in fact checking may very well be a defensible fair use of the copyrighted work. First, it would be a transformative copy and not-for-profit, as the reason for the copy would be to check the work for accuracy, not to supplant it in the marketplace.2 This tends to favor fair use. Second, nature of the original work is creative, which falls against fair use. Third, copying the entire book tends not to indicate fair use; however, the copy was only of what was actually needed to perform the necessary research, which

1 Nimmer defines a transformative work as something that “adds something new, with a further purpose or different character, altering the first [work] with new expression, meaning, or message.” 4 NIMMER ON COPYRIGHT, § 13.05[A][1][b] (2006). 2 It should be noted that a court could find that there was a profit motive in a potential tort suit, but this seems to be a remote possibility.

VALUE ADDED, VALUES DRIVEN.® VENABLE’S IP NEWS & COMMENT AUGUST 2007 7 happens to be the entire work. This should be neutral, as no more was copied than necessary. Fourth, without the intent to commercially distribute the book, there is no effect on the marketplace for the original. The balances of the factors seem to lean towards fair use, as there are two in favor (purpose/character of use, effect on the marketplace), one essentially neutral (amount of the copyrighted work used) and one against (nature of the copyrighted work).

More specifically, copying for actual use in litigation has been allowed for various types of cases, including obscenity and defamation. Nimmer has indicated that it would “seem inconceivable that any court would hold such reproduction to constitute infringement either by the government or by the individual parties responsible for offering the work in evidence.” 4 NIMMER ON COPYRIGHT, § 13.05[D][2], at 13-230.11 (2006). For example, the Ninth Circuit has held that when defendants copied and transferred stolen documents to the defendants’ expert witnesses for the purpose of preparing testimony, it was considered fair use and not infringement. Religious Tech. Ctr. v. Wollersheim, 971 F.2d 364, 367 (9th Cir. 1992). This is true despite the fact that the documents were never actually offered into evidence. Id. Therefore, it would seem that copying a book before it is released to check facts would fall within the same general allowance.

A Preview of Michael Gollin’s New Book

“Driving Innovation; Intellectual property strategies for a dynamic world” presents intellectual property’s fundamental concepts with practical legal and business strategies that apply broadly to all innovation communities throughout the world, including industry, nonprofit institutions, and developing countries. Topics include the innovation cycle, the rise of IP, and other dynamics of the IP system; basics for managing IP in organizations; steps to strategic management; and how these strategies play out on a global stage. Examples are drawn from current news, personal experience, and recent and older lawsuits relating to patents, trademarks, copyright, and trade secrets, from biotechnology to the open source movement. The book’s comprehensive approach brings the dynamics of intellectual property to life for anyone involved with innovation. Students can thus gain an overview of this complex topic, while more knowledgeable practitioners can learn new skills and approaches for putting ideas to work, and navigating within or changing the global IP system.

Foreword, by the Honorable Birch Bayh, Partner, Venable LLP

Innovation is the creative lifeblood of every country. One of my proudest accomplishments as a United States Senator was to help promote innovation in my country, by bringing about the passage of the Bayh-Dole Act of 1980. The Bayh- Dole Act gave universities ownership and control of government-funded inventions, balanced by restrictions to ensure that the public would benefit from the research. The resulting system has borne fruit beyond my dreams over the past 25 years. The law tapped into a basic truth – that society can benefit from creativity only if a properly balanced legal and institutional framework is in place to drive innovation forward. In particular, a special framework is required to bring publicly funded innovations out into the commercial marketplace so they are broadly accessible. Without such a framework, government-owned inventions gathered dust. With the right system, the benefits of academic creativity have washed across the globe in the form of new medicines, foods, materials, and information technology.

In this book, Michael Gollin explores the same fundamental concept. The process by which individual creativity leads to social progress is one that requires careful balancing of private control with public access, within an elaborate infrastructure of intellectual property. The intellectual property system has grown and changed over the centuries, through legal reforms as well as business and technical innovation. Moreover, globalization has brought us to a time when creativity and innovation impact everyone, rich and poor, in every nation. Intellectual property affects that process in important and complex ways, and we need a guide to help us understand it. This book fills that need. The book outlines the rise of intellectual property into a system that drives innovation in corporations and universities, in artists’ studios and farmers’ fields, around the world. It also offers practical strategies for working within the system to foster innovation, and some guidance on standards for reforming the system to maintain the balance so crucial to society, between private control and public access.

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This book can help us follow such strategies, to keep the engine of innovation going, the orchard growing, so individuals can work together in creative communities to find new ideas, develop them into products, and bring them out into the marketplace, until they are broadly available. Without the necessary knowledge and skills, we fail, the brakes go on, and the trees come down.

Those of us who care about innovation know that we need to keep an eye on the big picture – including international and national intellectual property laws and public funding – while also working to support the individual creative and entrepreneurial acts that, together, lead to the benefits of innovation. I am pleased to introduce you to this book because it will help you do both. It is also a good read, with many stories that simplify the complex topic with clear examples and illustrations, based on the author’s extensive practical experience. Enjoy it.

A Word from the Author

I wrote this book with the goal of helping people understand our intellectual property system as a human endeavor, a social and economic force that drives innovation, a manifestation of creativity and trade, a sometimes crude balance between exclusivity and access, and a topic worthy of study, teaching, learning, and practice. My hope is that such understanding can lead people from rough generalities about what’s good or bad about the system, toward more productive pursuits like how to make it work better.

Writing the book has also helped me understand the larger significance of my work as a patent attorney, in a global context along the long arc of history. Since finishing law school in 1984, my career has involved helping clients put their ideas to work, mainly pharmaceutical, biotechnological, and helping other industrial companies and universities from the U.S., Europe and Japan, in obtaining patents, registering trademarks, licensing rights, and arguing about them in court. I learned to see intellectual property law as the invisible infrastructure of innovation, underlying most of modern society. I also spent a few years practicing environmental law and saw first hand how the promise at the leading edge of innovation can lead to problems at the trailing edge, and I have long been disturbed by that contradiction.

Since about 1990, I have had the opportunity to see how intellectual property affects widely different communities around the world – participating in negotiations about biodiversity between Fijian villagers and a pharmaceutical company, cross-legged on straw mats drinking kava kava with tribal officials; waiting for the generator to kick on each time there was a power outage during a presentation to plant breeders and other agricultural researchers in Nigeria; working with researchers in developing countries suffering from malaria and subject to military unrest, authoritarian oversight, and lack of funds; witnessing the contrast between technology haves and have nots, side by side in India; marveling at how the most modern genomic sequencing technology can help traditional herdsmen in Kenya cure their livestock.

My broad interest in the impacts of innovation on our global community led me into writing, teaching, and public service. I developed an intellectual property curriculum for professionals in developing countries, and have used it in India, Kenya, Tanzania, C ôte d’Ivoire, Nigeria, Syria, and elsewhere. Since 2000, I have taught IP management to MBA students at Georgetown University, and am no longer surprised at who quickly they go from not knowing a trademark from a copyright, to producing a comprehensive report on the intellectual property of a selected major corporation, giving sound management advice that may not even have occurred to executives within the company. I continue to learn concepts and strategies from established masters as well as from students.

The global need for practical assistance with intellectual property matters has led me to take on pro bono projects. In 2002, to fill that need, I founded a non-profit organization that helps developing country organizations find IP professionals who can represent them on a volunteer basis. That organization, Public Interest Intellectual Property Advisors (PIIPA, www.piipa.org), is based on the conviction that all people, regardless of their sophistication and financial means, should have the benefit of good counsel on how IP issues affect them, and how they can use IP principles to help them meet their own goals.

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This book, then, is a logical extension of such activities, a way to extract fundamental concepts and dynamics of intellectual property, to outline practical strategies that organizations can use in managing it, and to convey the stakes involved in the ongoing policy debates about reforming the IP system around the world.

Venable’s Baltimore Office Adds Five Biotech and Business Attorneys From Saul Ewing

Venable LLP announced that it has added two new partners -- Herbert D. Frerichs and George F. Ritchie -- to its Baltimore office, as well as Bernard Rhee, of counsel, and associates Aida M. Lebbos and Guido J. Galvez. All five attorneys join from the firm of Saul Ewing LLP.

Mr. Frerichs is an experienced business lawyer with added tenure as an in-house corporate counsel. Mr. Ritchie is a litigator with an extensive background in products liability and commercial litigation.

Both Frerichs and Ritchie bring established practices and longtime client relationships to Venable. Mr. Frerichs advises businesses on corporate transactions, including mergers and acquisitions, as well as joint ventures, private equity and debt financings. Since 1996, he has served as counsel for international food processor Perdue Incorporated. Mr. Frerichs had previously been corporate counsel for UNC, Inc., a publicly traded aerospace company.

Mr. Frerichs has overseen all of Perdue's recent acquisitions, including its investments in ethanol production and other emerging areas of agribusiness. "As Perdue continues to focus on renewable fuels and other agricultural sectors, I can draw from Venable's strong resources in that area, not least of which is the firm's Agriculture and Food Group, which includes former General Counsel of the U.S. Department of Agriculture, Nancy Bryson," said Mr. Frerichs.

A versatile litigator, Mr. Ritchie will largely focus on product, pharmaceutical and medical device defense work at Venable. Among his notable past wins, he helped spearhead a successful motion for summary judgment in Estate of White v. R.J. Reynolds Tobacco Co. That decision was cited by the U.S. Court of Appeals (4th Cir.) in affirming the trial court's grant of summary judgment in a subsequent individual smoking and health case in federal court in Maryland, curtailing the likelihood of future similar suits in the state.

Mr. Ritchie brings expertise in a wide range of other areas, including complex commercial and class action litigation arising out of mergers and acquisitions, corporate governance and shareholder claims, as well as life sciences. He also plans to expand his patent litigation practice. "I enjoy learning about and working within many different business areas," he explained. "Litigation is just the point of departure."

Messrs. Rhee and Galvez focus their practices on intellectual property and business issues, assisting a number of life sciences and technology companies to develop and commercialize the intellectual property assets. Ms. Lebbos regularly counsels clients on patent and software licensing, trademark registration and protection, and advertising issues. She is experienced in representing life sciences and other technology companies formed around the intellectual property that results from university and federal laboratory research efforts.

Thomas Washburne, chair of Venable's Business Transactions Practice Group, and Geoffrey Garinther, head of the firm's Litigation Division, joined in welcoming the group to the firm.

"These experienced attorneys add even more muscle to two already powerful core practices," Mr. Washburne said. "Herb's experience in both the legal and practical business aspects of commercial transactions - including his ten-plus years working with one of the country's best-known food brands - will be invaluable to our corporate clients as they strive constantly to retain their competitive edge. Aida, Bernie and Guido bring a high level of intellectual property and technology transfer expertise that will allow Venable to better serve Baltimore's growing life sciences industry."

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Mr. Garinther noted of Mr. Ritchie: "George possesses unusual range and flexibility as a litigator. With his successes representing major manufacturers and retailers in so many different types of actions - ranging from personal injury and wrongful death to defective design, patent infringement, and breach of contract - we see him immediately becoming an integral part of our national litigation team."

Mr. Frerichs received his J.D., with honors, from the University of Maryland School of Law (1988); his Masters of Marine Affairs from the University of Rhode Island (1985); and his B.S. from the United States Naval Academy (1980). After graduating from the Naval Academy, he served for five years as a surface warfare officer. Mr. Frerichs remains active in alumni affairs at the Academy. He also serves on the boards of directors for The Hippodrome Foundation, which brings Broadway shows to Baltimore, as well as the USS Constellation Museum, Living Classrooms Foundation and Business Volunteers Unlimited of Maryland. An appointee to the Appellate Courts Judicial Nominating Commission, Mr. Frerichs was named one of "Maryland's Legal Elite" by Baltimore SmartCEO magazine in 2006.

Also named one of "Maryland's Legal Elite," Mr. Ritchie is a member of the Business Litigation and Drug & Medical Device Committees of the Defense Research Institute. He received his J.D. from Notre Dame (1992) and his B.A. from Middlebury College (1988). He serves on the board of the non-profit, Baltimore Shakespeare Festival, which both produces plays and has an educational arm that introduces the subject to school children.

A registered patent attorney, Mr. Rhee received his J.D. from the University of Baltimore School of Law (2000) and his B.S. in pharmacy from the University of Maryland School of Pharmacy (1991).

Mr. Galvez is also a registered patent attorney, and received his J.D. from The Catholic University of America Columbus School of Law (2001). He holds an M.S. in Applied Molecular Biology (1997) and a B.S. in Biology (1995), both from the University of Maryland Baltimore County.

Ms. Lebbos received her J.D., cum laude, from the University of Baltimore School of Law (2000) and her B.A. from Duke University (1988).

Venable Expands into Delaware

Venable recently expanded its practice into Delaware to better serve the needs of our national client base, especially those involved in Delaware bankruptcy proceedings. In the past, many clients were unable to take full advantage of Venable's bankruptcy attorneys because Delaware rules require local counsel participation at every hearing and deposition. Now Venable clients can take full advantage of the firm's nationally known bankruptcy and creditors' rights lawyers in Delaware proceedings, without the additional cost of retaining local Delaware counsel.

Lisa Tancredi, a partner based in Venable's Baltimore office, has been admitted to the Delaware bar and serves as local counsel in Delaware cases. We invite you to contact Lisa Tancredi for additional information.

VALUE ADDED, VALUES DRIVEN.® VENABLE’S IP NEWS & COMMENT AUGUST 2007 11

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Editor: Clifton McCann Associate Editor: Mary Ellen Himes Patent/Trade Secrets Contributing Editor: Catherine Voorhees Trademark Contributing Editor: Mark Harrison Copyright Contributing Editor: Josh Kaufman IP Litigation Contributing Editor: Peter Curtin

Questions and comments concerning material in this newsletter can be directed to Clifton McCann at [email protected] or Mary Ellen Himes at [email protected].

th Venable’s IP News & Comment is published by the Technology Division of the law firm, Venable LLP, 575 7 Street, NW, Washington, DC 20004. www.Venable.com. It is not intended to provide legal advice or opinion. Such advice may only be given when related to specific fact situations.

U.S. Treasury Circular 230 Notice: Any tax advice contained in this communication (including any attachments) was not intended or written to be used, and cannot be used, for the purpose of (a) avoiding penalties that may be imposed under the Internal Revenue Code or by any other applicable tax authority; or (b) promoting, marketing or recommending to another party any tax-related matter addressed herein. We provide this disclosure on all outbound e-mails to assure compliance with new standards of professional practice, pursuant to which certain tax advice must satisfy requirements as to form and substance.

VALUE ADDED, VALUES DRIVEN.®