buchanan's life sciences team

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Food and Drug Administration Antitrust and Trade Regulation Buchanan’s Life Sciences Team brings together focused experience of four practice areas. With a depth of talent in strategic locations, we have the resources to tailor a team specific to your needs. From discovery to market, Buchanan’s Life Sciences Team will help you express your potential. Buchanan’s Life Sciences Team 4 Complementary Bases That Express Your Potential ©2015 Buchanan Ingersoll & Rooney PC Donald V. Scaltrito, Ph.D. Patent Agent Alexandria, Virginia 703 838 7571 [email protected] Howard D. Scher Philadelphia, Pennsylvania 215 665 3920 [email protected] Stephany G. Small, Ph.D. Patent Agent Wilmington, Delaware 302 552 4247 [email protected] Aaron L. J. Pereira New York, New York 212 440 4468 [email protected] Michael S. Powers Princeton, New Jersey 609 987 6804 [email protected] Linda Pissott Reig Newark, New Jersey 973 424 5618 [email protected] Richard G. Salazar Tampa, Florida 813 222 1142 [email protected] Duane A. Stewart, III Pittsburgh, Pennsylvania 412 562 1622 [email protected] Theodore M. Sullivan Washington, D.C. 202 452 7992 [email protected] Carla J. Vrsansky Pittsburgh, Pennsylvania 412 562 1639 [email protected] Todd R. Walters Alexandria, Virginia 703 838 6556 [email protected] Mark M. Yacura Washington, D.C. 202 452 7949 [email protected] Alfred W. Zaher Philadelphia, Pennsylvania 215 665 3880 [email protected] Genevieve M. Spires Newark, New Jersey 973 424 5612 [email protected] S. Lloyd Smith Alexandria, Virginia 703 838 6514 [email protected] Samantha L. Southall Philadelphia, Pennsylvania 215 665 3884 [email protected] Christopher L. North, Ph.D. Alexandria, Virginia 703 838 6511 [email protected] Shantanu C. Pathak, Ph.D. Philadelphia, Pennsylvania 215 665 3939 [email protected]

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Buchanan’s Life Sciences Team brings together focused experience of four practice areas. With a depth of talent in strategic locations, we have the resources to tailor a team specific to your needs. From discovery to market, Buchanan’s Life Sciences Team will help you express your potential.

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• Intellecual Property Procurement • Intellectual Property Enforcement • Food and Drug Administration • Antitrust and Trade Regulation

Buchanan’s Life Sciences Team brings together focused experience of four practice areas. With a depth of talent in strategic locations, we have the resources to tailor a team speci� c to your needs.

From discovery to market, Buchanan’s Life Sciences Team will help you express your potential.

Buchanan’s Life Sciences Team4 Complementary Bases That Express Your Potential

Intellectual Property Procurement

Buchanan offers a full-service IP Section, the cornerstone of which is

the intellectual property procurement group. Whether you need a patent,

trademark or copyright, Buchanan will ably assist you at every turn.

PatentsBuchanan boasts over 50 practitioners registered to practice before the United States Patent and Trademark Offi ce. In 2014, we prosecuted over 2,100 applications and helped our clients obtain 1,682 U.S. patents. Calling upon our network of foreign counterparts, we helped our clients prosecute over 550 foreign applications and obtain 342 patents in 2014.

Application Drafting An invention’s value often turns on the quality of the patent embodying it. Because our team members are versed in life sciences, we can readily understand an inventor’s contribution to the art, and we work directly with inventors to capture and claim the full invention. We follow case law developments in the Life Sciences area and draft applications that satisfy current standards yet leave options open should shifts occur.

Prosecution Buchanan’s IP Section prides itself on cross-training. Our patent prosecutors have litigation experience and realize that every word in a fi le history is carefully analyzed. As a result, our patent prosecutors draft accurate and effi cient responses. Should an Examiner fail to appreciate a given invention based upon written responses, Buchanan frequently takes advantage of its location and conducts in-person interviews with Examiners. Buchanan’s fl agship IP offi ce is in Alexandria, Virginia, just blocks away from the Patent Offi ce.

Opinions Key business decisions rest upon analyses not only of your IP, but also that of your competitors. Whether the issue is validity/invalidity, infringement/non-infringement or both, we can help you determine whether to stay the course or modify your tentative plan so as to minimize risk.

Diligence InvestigationsWhether you seek to acquire a patent portfolio or seek to transfer your patent portfolio, diligence investigations involve a detail-oriented process. From verifying that the “owner” truly owns the property to determining whether the risks in the transaction outweigh the potential rewards, Buchanan’s Life Sciences Team can assist with every step.

Licensing A key reason to have patents is to monetize them. We have experience with issues encountered in life sciences licensing transactions, including those associated with inter-institutional agreements, federal funding, cooperative research and development agreements, the Bayh-Dole Act, F/RAND and export control.

©2015 Buchanan Ingersoll & Rooney PC

Donald V. Scaltrito, Ph.D. •Patent AgentAlexandria, Virginia703 838 [email protected]

Howard D. Scher •Philadelphia, Pennsylvania215 665 [email protected]

Stephany G. Small, Ph.D. •Patent AgentWilmington, Delaware302 552 [email protected]

Aaron L. J. Pereira ••New York, New York212 440 [email protected]

Michael S. Powers •Princeton, New Jersey609 987 [email protected]

Linda Pissott Reig •Newark, New Jersey973 424 [email protected]

Richard G. Salazar •Tampa, Florida813 222 [email protected]

Duane A. Stewart, III •Pittsburgh, Pennsylvania412 562 [email protected]

Theodore M. Sullivan •Washington, D.C.202 452 [email protected]

Carla J. Vrsansky •Pittsburgh, Pennsylvania412 562 [email protected]

Todd R. Walters ••Alexandria, Virginia703 838 [email protected]

Mark M. Yacura •Washington, D.C.202 452 [email protected]

Alfred W. Zaher ••Philadelphia, Pennsylvania215 665 [email protected]

Genevieve M. Spires •Newark, New Jersey973 424 [email protected]

S. Lloyd Smith •Alexandria, Virginia703 838 [email protected]

Samantha L. Southall •Philadelphia, Pennsylvania215 665 [email protected]

Christopher L. North, Ph.D. ••Alexandria, Virginia703 838 6511 [email protected]

Shantanu C. Pathak, Ph.D. •Philadelphia, Pennsylvania215 665 [email protected]

www.bipc.com

California | Colorado | Delaware | Florida | New Jersey | New York | North Carolina | Pennsylvania | Virginia | Washington, DC

• Intellecual Property Procurement • Intellectual Property Enforcement • Food and Drug Administration • Antitrust and Trade Regulation

Buchanan’s Life Sciences Team brings together focused experience of four practice areas. With a depth of talent in strategic locations, we have the resources to tailor a team speci� c to your needs.

From discovery to market, Buchanan’s Life Sciences Team will help you express your potential.

Buchanan’s Life Sciences Team4 Complementary Bases That Express Your Potential

Intellectual Property Procurement

Buchanan offers a full-service IP Section, the cornerstone of which is

the intellectual property procurement group. Whether you need a patent,

trademark or copyright, Buchanan will ably assist you at every turn.

PatentsBuchanan boasts over 50 practitioners registered to practice before the United States Patent and Trademark Offi ce. In 2014, we prosecuted over 2,100 applications and helped our clients obtain 1,682 U.S. patents. Calling upon our network of foreign counterparts, we helped our clients prosecute over 550 foreign applications and obtain 342 patents in 2014.

Application Drafting An invention’s value often turns on the quality of the patent embodying it. Because our team members are versed in life sciences, we can readily understand an inventor’s contribution to the art, and we work directly with inventors to capture and claim the full invention. We follow case law developments in the Life Sciences area and draft applications that satisfy current standards yet leave options open should shifts occur.

Prosecution Buchanan’s IP Section prides itself on cross-training. Our patent prosecutors have litigation experience and realize that every word in a fi le history is carefully analyzed. As a result, our patent prosecutors draft accurate and effi cient responses. Should an Examiner fail to appreciate a given invention based upon written responses, Buchanan frequently takes advantage of its location and conducts in-person interviews with Examiners. Buchanan’s fl agship IP offi ce is in Alexandria, Virginia, just blocks away from the Patent Offi ce.

Opinions Key business decisions rest upon analyses not only of your IP, but also that of your competitors. Whether the issue is validity/invalidity, infringement/non-infringement or both, we can help you determine whether to stay the course or modify your tentative plan so as to minimize risk.

Diligence InvestigationsWhether you seek to acquire a patent portfolio or seek to transfer your patent portfolio, diligence investigations involve a detail-oriented process. From verifying that the “owner” truly owns the property to determining whether the risks in the transaction outweigh the potential rewards, Buchanan’s Life Sciences Team can assist with every step.

Licensing A key reason to have patents is to monetize them. We have experience with issues encountered in life sciences licensing transactions, including those associated with inter-institutional agreements, federal funding, cooperative research and development agreements, the Bayh-Dole Act, F/RAND and export control.

©2015 Buchanan Ingersoll & Rooney PC

Donald V. Scaltrito, Ph.D. •Patent AgentAlexandria, Virginia703 838 [email protected]

Howard D. Scher •Philadelphia, Pennsylvania215 665 [email protected]

Stephany G. Small, Ph.D. •Patent AgentWilmington, Delaware302 552 [email protected]

Aaron L. J. Pereira ••New York, New York212 440 [email protected]

Michael S. Powers •Princeton, New Jersey609 987 [email protected]

Linda Pissott Reig •Newark, New Jersey973 424 [email protected]

Richard G. Salazar •Tampa, Florida813 222 [email protected]

Duane A. Stewart, III •Pittsburgh, Pennsylvania412 562 [email protected]

Theodore M. Sullivan •Washington, D.C.202 452 [email protected]

Carla J. Vrsansky •Pittsburgh, Pennsylvania412 562 [email protected]

Todd R. Walters ••Alexandria, Virginia703 838 [email protected]

Mark M. Yacura •Washington, D.C.202 452 [email protected]

Alfred W. Zaher ••Philadelphia, Pennsylvania215 665 [email protected]

Genevieve M. Spires •Newark, New Jersey973 424 [email protected]

S. Lloyd Smith •Alexandria, Virginia703 838 [email protected]

Samantha L. Southall •Philadelphia, Pennsylvania215 665 [email protected]

Christopher L. North, Ph.D. ••Alexandria, Virginia703 838 6511 [email protected]

Shantanu C. Pathak, Ph.D. •Philadelphia, Pennsylvania215 665 [email protected]

• Intellecual Property Procurement • Intellectual Property Enforcement • Food and Drug Administration • Antitrust and Trade Regulation

Buchanan’s Life Sciences Team brings together focused experience of four practice areas. With a depth of talent in strategic locations, we have the resources to tailor a team speci� c to your needs.

From discovery to market, Buchanan’s Life Sciences Team will help you express your potential.

Buchanan’s Life Sciences Team4 Complementary Bases That Express Your Potential

Intellectual Property Procurement

Buchanan offers a full-service IP Section, the cornerstone of which is

the intellectual property procurement group. Whether you need a patent,

trademark or copyright, Buchanan will ably assist you at every turn.

PatentsBuchanan boasts over 50 practitioners registered to practice before the United States Patent and Trademark Offi ce. In 2014, we prosecuted over 2,100 applications and helped our clients obtain 1,682 U.S. patents. Calling upon our network of foreign counterparts, we helped our clients prosecute over 550 foreign applications and obtain 342 patents in 2014.

Application Drafting An invention’s value often turns on the quality of the patent embodying it. Because our team members are versed in life sciences, we can readily understand an inventor’s contribution to the art, and we work directly with inventors to capture and claim the full invention. We follow case law developments in the Life Sciences area and draft applications that satisfy current standards yet leave options open should shifts occur.

Prosecution Buchanan’s IP Section prides itself on cross-training. Our patent prosecutors have litigation experience and realize that every word in a fi le history is carefully analyzed. As a result, our patent prosecutors draft accurate and effi cient responses. Should an Examiner fail to appreciate a given invention based upon written responses, Buchanan frequently takes advantage of its location and conducts in-person interviews with Examiners. Buchanan’s fl agship IP offi ce is in Alexandria, Virginia, just blocks away from the Patent Offi ce.

Opinions Key business decisions rest upon analyses not only of your IP, but also that of your competitors. Whether the issue is validity/invalidity, infringement/non-infringement or both, we can help you determine whether to stay the course or modify your tentative plan so as to minimize risk.

Diligence InvestigationsWhether you seek to acquire a patent portfolio or seek to transfer your patent portfolio, diligence investigations involve a detail-oriented process. From verifying that the “owner” truly owns the property to determining whether the risks in the transaction outweigh the potential rewards, Buchanan’s Life Sciences Team can assist with every step.

Licensing A key reason to have patents is to monetize them. We have experience with issues encountered in life sciences licensing transactions, including those associated with inter-institutional agreements, federal funding, cooperative research and development agreements, the Bayh-Dole Act, F/RAND and export control.

©2015 Buchanan Ingersoll & Rooney PC

Donald V. Scaltrito, Ph.D. •Patent AgentAlexandria, Virginia703 838 [email protected]

Howard D. Scher •Philadelphia, Pennsylvania215 665 [email protected]

Stephany G. Small, Ph.D. •Patent AgentWilmington, Delaware302 552 [email protected]

Aaron L. J. Pereira ••New York, New York212 440 [email protected]

Michael S. Powers •Princeton, New Jersey609 987 [email protected]

Linda Pissott Reig •Newark, New Jersey973 424 [email protected]

Richard G. Salazar •Tampa, Florida813 222 [email protected]

Duane A. Stewart, III •Pittsburgh, Pennsylvania412 562 [email protected]

Theodore M. Sullivan •Washington, D.C.202 452 [email protected]

Carla J. Vrsansky •Pittsburgh, Pennsylvania412 562 [email protected]

Todd R. Walters ••Alexandria, Virginia703 838 [email protected]

Mark M. Yacura •Washington, D.C.202 452 [email protected]

Alfred W. Zaher ••Philadelphia, Pennsylvania215 665 [email protected]

Genevieve M. Spires •Newark, New Jersey973 424 [email protected]

S. Lloyd Smith •Alexandria, Virginia703 838 [email protected]

Samantha L. Southall •Philadelphia, Pennsylvania215 665 [email protected]

Christopher L. North, Ph.D. ••Alexandria, Virginia703 838 6511 [email protected]

Shantanu C. Pathak, Ph.D. •Philadelphia, Pennsylvania215 665 [email protected]

Portfolio ManagementObtaining a patent is just one hurdle along the life cycle of an invention. Buchanan’s Life Sciences Team will help you chart out how best to fully protect an invention, be it with one or many patents. Buchanan offers institutional knowledge of the invention from its inception, and we use that knowledge to assist you in deciding what assets to retain and enforce.

Patent Term Adjustment Every day of patent term matters, especially in the life sciences world. Due to our familiarity with PTA-triggering events, our patent prosecutors work with you to maximize valuable term. In addition, Buchanan’s team can verify PTA calculations performed by the PTO and can challenge erroneous calculations.

Patent Term Extension Applying for PTE is a seemingly straight-forward task but one that brings with it important consequences. From helping to analyze which patent in the portfolio should be extended to shepherding the application through the regulatory channels, Buchanan can advise you at every turn.

Biosimilars/BiologicsThe Biologics Price Competition and Innovation Act (BPCIA) became law almost fi ve years ago, and the import of the Act is now emerging. Our team can help you navigate the biosimilars world —from pre-litigation considerations to discovery mechanisms to actual litigation.

Trademarks and CopyrightsBuchanan’s Trademark and Copyright Group includes attorneys and paralegals who handle all aspects of trademark and copyright matters, including investigation and clearance, registration and maintenance, opposition and cancellation proceedings at the Trademark and Trial and Appeal Board (TTAB), federal and state court litigation involving the protection and enforcement of trademarks and copyrights, and administrative litigation at the International Trade Commission (ITC). The fi rm has experience in remedies against trademark and service mark counterfeiting on the Internet. We also handle preparing and fi ling copyright applications and have experience in all aspects of copyright litigation, including notice and takedown demands and safe harbor defenses under the Digital Millennium Copyright Act.

Product Naming Our trademark lawyers represent life sciences companies in selecting and obtaining approval of product names for prescription and over-the-counter drugs. We research, review and vet possible trademarks with our clients and guide them through each phase of the naming process.

Counterfeit Products Because the value of a product can be undermined by harmful or ineffective counterfeits, our Trademark Group develops strategies to uncover and combat counterfeit goods in the markets. Buchanan’s trademark lawyers are prepared to work aggressively to obtain injunctions and seizure orders and to take other steps to minimize the harm to our clients a the public.

1

Patents, trademarks and copyrights permit the holder to exclude others from encroaching upon the protected area. Buchanan’s Life Sciences Team helps patent, trademark and copyright holders decide whether their rights are being threatened and, if so, when and how to take action. Our team also helps alleged infringers determine whether the infringement allegations are well-founded and whether the underlying intellectual property is valid. We are sensitive to the invasive nature of litigation, as well as the costs associated with enforcement. Drawing upon the technical knowledge of our deep bench, we tailor each litigation team to your

particular needs.

Intellectual Property Enforcement

Traditional LitigationBuchanan’s IP Litigation Group offers the resources and experience of a general practice fi rm but with the focus of an IP boutique. We handle patent, trademark, copyright, trade secret, unfair trade/competition, ITC and arbitration matters from the initial tribunal through the highest appellate court.

PatentPatent litigation is complex, and the amount in controversy in the life sciences space is often very high. Our litigators roll up their sleeves and truly learn the technology, which enables them to develop effi cient litigation strategies. We have handled many life sciences cases involving chemicals, pharmaceuticals, genetically-modifi ed organisms and medical devices.

TrademarkBuchanan’s trademark litigators handle a wide range of trademark disputes, including all types of trademark infringement and dilution claims, counterfeiting, gray-market goods, domain name claims and licensing disputes. We also assist our life sciences clients in disputes before non-judicial forums, including ex parte and inter partes registration and cancellation disputes before the TTAB and anti-counterfeiting enforcement through the United States Customs & Border Protection Service.

CopyrightOur copyright litigators understand and work through key issues in copyright disputes, including originality, fair use, work-for-hire agreements and ownership, public domain, the Digital Millennium Copyright Act, Orphan Works and database protection.

Trade SecretTrade secrets can be among a life science company’s most valuable assets. In today’s competitive global marketplace, it is all too easy for a trade secret to be revealed, especially in light of the mobility within the life sciences sector. Our litigation team handles a broad spectrum of scientifi c, factual, legal and procedural issues in all state and federal courts, and we are prepared to proceed under all state and federal statutes and regulations, the Uniform Trade Secrets Act, the Federal Economic Espionage Act and state business tort laws.

2

• Intellecual Property Procurement • Intellectual Property Enforcement • Food and Drug Administration • Antitrust and Trade Regulation

Buchanan’s Life Sciences Team brings together focused experience of four practice areas. With a depth of talent in strategic locations, we have the resources to tailor a team speci� c to your needs.

From discovery to market, Buchanan’s Life Sciences Team will help you express your potential.

Buchanan’s Life Sciences Team4 Complementary Bases That Express Your Potential

Intellectual Property Procurement

Buchanan offers a full-service IP Section, the cornerstone of which is

the intellectual property procurement group. Whether you need a patent,

trademark or copyright, Buchanan will ably assist you at every turn.

PatentsBuchanan boasts over 50 practitioners registered to practice before the United States Patent and Trademark Offi ce. In 2014, we prosecuted over 2,100 applications and helped our clients obtain 1,682 U.S. patents. Calling upon our network of foreign counterparts, we helped our clients prosecute over 550 foreign applications and obtain 342 patents in 2014.

Application Drafting An invention’s value often turns on the quality of the patent embodying it. Because our team members are versed in life sciences, we can readily understand an inventor’s contribution to the art, and we work directly with inventors to capture and claim the full invention. We follow case law developments in the Life Sciences area and draft applications that satisfy current standards yet leave options open should shifts occur.

Prosecution Buchanan’s IP Section prides itself on cross-training. Our patent prosecutors have litigation experience and realize that every word in a fi le history is carefully analyzed. As a result, our patent prosecutors draft accurate and effi cient responses. Should an Examiner fail to appreciate a given invention based upon written responses, Buchanan frequently takes advantage of its location and conducts in-person interviews with Examiners. Buchanan’s fl agship IP offi ce is in Alexandria, Virginia, just blocks away from the Patent Offi ce.

Opinions Key business decisions rest upon analyses not only of your IP, but also that of your competitors. Whether the issue is validity/invalidity, infringement/non-infringement or both, we can help you determine whether to stay the course or modify your tentative plan so as to minimize risk.

Diligence InvestigationsWhether you seek to acquire a patent portfolio or seek to transfer your patent portfolio, diligence investigations involve a detail-oriented process. From verifying that the “owner” truly owns the property to determining whether the risks in the transaction outweigh the potential rewards, Buchanan’s Life Sciences Team can assist with every step.

Licensing A key reason to have patents is to monetize them. We have experience with issues encountered in life sciences licensing transactions, including those associated with inter-institutional agreements, federal funding, cooperative research and development agreements, the Bayh-Dole Act, F/RAND and export control.

©2015 Buchanan Ingersoll & Rooney PC

Donald V. Scaltrito, Ph.D. •Patent AgentAlexandria, Virginia703 838 [email protected]

Howard D. Scher •Philadelphia, Pennsylvania215 665 [email protected]

Stephany G. Small, Ph.D. •Patent AgentWilmington, Delaware302 552 [email protected]

Aaron L. J. Pereira ••New York, New York212 440 [email protected]

Michael S. Powers •Princeton, New Jersey609 987 [email protected]

Linda Pissott Reig •Newark, New Jersey973 424 [email protected]

Richard G. Salazar •Tampa, Florida813 222 [email protected]

Duane A. Stewart, III •Pittsburgh, Pennsylvania412 562 [email protected]

Theodore M. Sullivan •Washington, D.C.202 452 [email protected]

Carla J. Vrsansky •Pittsburgh, Pennsylvania412 562 [email protected]

Todd R. Walters ••Alexandria, Virginia703 838 [email protected]

Mark M. Yacura •Washington, D.C.202 452 [email protected]

Alfred W. Zaher ••Philadelphia, Pennsylvania215 665 [email protected]

Genevieve M. Spires •Newark, New Jersey973 424 [email protected]

S. Lloyd Smith •Alexandria, Virginia703 838 [email protected]

Samantha L. Southall •Philadelphia, Pennsylvania215 665 [email protected]

Christopher L. North, Ph.D. ••Alexandria, Virginia703 838 6511 [email protected]

Shantanu C. Pathak, Ph.D. •Philadelphia, Pennsylvania215 665 [email protected]

Unfair Trade and Unfair CompetitionBuchanan’s litigators are familiar with the substantial body of federal and state law directed to unfair trade practices and unfair competition, including laws that prohibit false advertising. False advertising can be especially harmful in the life sciences area. We develop creative strategies using the Lanham Act and other tools to protect our clients against unfair competition in various forms, including false product comparisons and scientifi c claims made without proper testing and verifi cation.

International Trade Commission The ITC provides a specialized, fast-paced venue for solving intellectual property disputes, including for life science companies. Whether you are a complainant or respondent, our litigators can assist with every step of the process from development of theories for domestic industry assertions to the full scope of invalidity attacks and defenses.

ArbitrationBecause the courts are not the only, best or most cost-effective forum for many disputes, our IP litigators are experienced in domestic and international arbitration of patent, trademark and copyright disputes. Our team members use this experience to counsel clients on the advantages of arbitration in certain IP disputes.

Hatch-Waxman (Paragraph IV) LitigationEver since its adoption, members of Buchanan’s Life Sciences Team have counseled companies with Paragraph IV litigation under the Hatch-Waxman Act. We staff our Paragraph IV teams in a manner that makes sense for the particular dispute. We endeavor to minimize invasive, expensive discovery that does not bear on the merits of the validity and infringement challenges. We work with our FDA and Antitrust groups to stay abreast of developments in these overlapping areas. Because members of our team are located in key Paragraph IV locations—Delaware (Wilmington), New Jersey (Trenton and Newark), New York (New York City), and Virginia (Alexandria, home of the “Rocket Docket”)—the expense of local counsel is obviated.

Concurrent ProceedingsGone are the days of single patent, single proceeding litigation. Life sciences companies increasingly face concurrent proceedings on several assets, which can drain precious resources. Due to our team’s familiarity with each type of concurrent proceeding, we can work with you to determine whether a multi-proceeding path is wise and can advise you on what to expect at each phase. For example, IPRs (detailed below) are now a complement to traditional Paragraph IV litigation. We counsel pharmaceutical companies about the pros and cons of using IPRs and on how best to navigate such proceedings. If you are faced with concurrent proceedings, we will quickly assemble a team to vigorously protect your assets.

(continued)

3

Intellectual Property Enforcement(continued from previous page)

InterferencesBuchanan offers an interference team that has handled hundreds of interferences before what is now the Patent Trial and Appeal Board (the Board). While interferences are being phased-out due to the transition to fi rst-inventor-to-fi le, many cases in the life sciences fi eld remain vulnerable to interference practice. Our interference practitioners can work with you to position your portfolio so as to provoke an interference and then assist you with every step of the process. Should you unexpectedly fi nd yourself in an interference, we can work with you to develop validity attacks on your opponent. Buchanan’s experience with all phases of interference practice and our familiarity with the Board removes what would otherwise be unknowns associated with an “arcane” practice.

Inter Partes Reviews (IPRs)The America Invents Act (AIA) brought about several new types of post-grant proceedings, including IPRs. IPRs are modeled closely after the motions phase of an interference, and Buchanan has effectively transitioned its interference experience to IPR practice. To date, we have assisted with over 35 IPRs, on behalf of both patent owners and petitioners. For petitioners, we help identify art, retain experts, formulate bases to effi ciently attack the targeted claims, and draft persuasive petitions. For patent owners, we develop a coherent strategy to protect the patent, retain experts, decide whether to fi le a preliminary response and whether to amend, and draft persuasive responses. Our versatility in these proceedings allows us to craft and execute an appropriate strategy, anticipate our opponent’s next move, and create an appropriate record should the matter proceed to appeal.

Post Grant Reviews (PGRs)Subject matter eligibility, written description and enablement issues are key concerns to our life sciences clients. While not appropriate for IPRs, which are limited to anticipation and obviousness attacks, these issues can be pursued using a PGR. Our team can help you determine if a PGR is the right way to challenge your competitor and can help defend you should your property face one of these new attacks. In time, a PGR will also become a possible alternative to traditional Paragraph IV litigation.

Reissue and ReexaminationOur patent reissues team has the in-depth knowledge our clients have come to expect, particularly when they are considering fi ling patent infringement litigation to enforce their intellectual property rights. Reissue proceedings are similar to standard patent prosecutions, but critical differences between the two can lead to a poor outcome if they are not handled correctly. Our experience in both broadening and narrowing reissue applications and in reissue protests provides our clients with full access to this sometimes critically valuable option. Many defendants and some plaintiffs in patent litigation are interested in reexamination requests, an option with both benefi ts and serious risks. We are ready to advise our clients about the complex strategic decisions presented by reexamination requests.

4

• Intellecual Property Procurement • Intellectual Property Enforcement • Food and Drug Administration • Antitrust and Trade Regulation

Buchanan’s Life Sciences Team brings together focused experience of four practice areas. With a depth of talent in strategic locations, we have the resources to tailor a team speci� c to your needs.

From discovery to market, Buchanan’s Life Sciences Team will help you express your potential.

Buchanan’s Life Sciences Team4 Complementary Bases That Express Your Potential

Intellectual Property Procurement

Buchanan offers a full-service IP Section, the cornerstone of which is

the intellectual property procurement group. Whether you need a patent,

trademark or copyright, Buchanan will ably assist you at every turn.

PatentsBuchanan boasts over 50 practitioners registered to practice before the United States Patent and Trademark Offi ce. In 2014, we prosecuted over 2,100 applications and helped our clients obtain 1,682 U.S. patents. Calling upon our network of foreign counterparts, we helped our clients prosecute over 550 foreign applications and obtain 342 patents in 2014.

Application Drafting An invention’s value often turns on the quality of the patent embodying it. Because our team members are versed in life sciences, we can readily understand an inventor’s contribution to the art, and we work directly with inventors to capture and claim the full invention. We follow case law developments in the Life Sciences area and draft applications that satisfy current standards yet leave options open should shifts occur.

Prosecution Buchanan’s IP Section prides itself on cross-training. Our patent prosecutors have litigation experience and realize that every word in a fi le history is carefully analyzed. As a result, our patent prosecutors draft accurate and effi cient responses. Should an Examiner fail to appreciate a given invention based upon written responses, Buchanan frequently takes advantage of its location and conducts in-person interviews with Examiners. Buchanan’s fl agship IP offi ce is in Alexandria, Virginia, just blocks away from the Patent Offi ce.

Opinions Key business decisions rest upon analyses not only of your IP, but also that of your competitors. Whether the issue is validity/invalidity, infringement/non-infringement or both, we can help you determine whether to stay the course or modify your tentative plan so as to minimize risk.

Diligence InvestigationsWhether you seek to acquire a patent portfolio or seek to transfer your patent portfolio, diligence investigations involve a detail-oriented process. From verifying that the “owner” truly owns the property to determining whether the risks in the transaction outweigh the potential rewards, Buchanan’s Life Sciences Team can assist with every step.

Licensing A key reason to have patents is to monetize them. We have experience with issues encountered in life sciences licensing transactions, including those associated with inter-institutional agreements, federal funding, cooperative research and development agreements, the Bayh-Dole Act, F/RAND and export control.

©2015 Buchanan Ingersoll & Rooney PC

Donald V. Scaltrito, Ph.D. •Patent AgentAlexandria, Virginia703 838 [email protected]

Howard D. Scher •Philadelphia, Pennsylvania215 665 [email protected]

Stephany G. Small, Ph.D. •Patent AgentWilmington, Delaware302 552 [email protected]

Aaron L. J. Pereira ••New York, New York212 440 [email protected]

Michael S. Powers •Princeton, New Jersey609 987 [email protected]

Linda Pissott Reig •Newark, New Jersey973 424 [email protected]

Richard G. Salazar •Tampa, Florida813 222 [email protected]

Duane A. Stewart, III •Pittsburgh, Pennsylvania412 562 [email protected]

Theodore M. Sullivan •Washington, D.C.202 452 [email protected]

Carla J. Vrsansky •Pittsburgh, Pennsylvania412 562 [email protected]

Todd R. Walters ••Alexandria, Virginia703 838 [email protected]

Mark M. Yacura •Washington, D.C.202 452 [email protected]

Alfred W. Zaher ••Philadelphia, Pennsylvania215 665 [email protected]

Genevieve M. Spires •Newark, New Jersey973 424 [email protected]

S. Lloyd Smith •Alexandria, Virginia703 838 [email protected]

Samantha L. Southall •Philadelphia, Pennsylvania215 665 [email protected]

Christopher L. North, Ph.D. ••Alexandria, Virginia703 838 6511 [email protected]

Shantanu C. Pathak, Ph.D. •Philadelphia, Pennsylvania215 665 [email protected]

Buchanan’s Life Sciences Team provides clients a robust and well-respected practice focusing on the Food and Drug Administration (FDA). The strength of our dedicated FDA Group, practicing out of Buchanan’s Washington, D.C.; Newark, New Jersey.; and Princeton, New Jersey offi ces, is based upon the seamless interaction amongst our group members, as well as our colleagues in Buchanan’s healthcare, government relations, intellectual property and litigation groups. Many of our team members have worked for the FDA, U.S. Congress or Drug Enforcement Administration (DEA). Other team members have worked for drug companies and research institutes as scientists or legal counsel. We are uniquely qualifi ed to provide a variety of services for manufacturers of pharmaceuticals, medical devices, foods, supplements, nutraceuticals and biologics.

Food and Drug Administration Group

Key Focus Areas Include:

New Products and Market ApprovalWe advise clients on the pharmacogenomic, preclinical, bench, animal, clinical testing, clinical trial and marketing application requirements to support approval or clearance of drug, biological, medical device and combination (drug-device-biologic) products. We work with our clients to prepare and submit NDAs and ANDAs; NADAs and ANADAs; BLAs and HCT/P registrations and listings; PMAs and 510(k) notifi cations; INDs and IDEs; combination product requests for designation (RFDs); product jurisdiction determinations; citizen petitions; appeals of agency action; food additive GRAS opinions and petitions; PDUFA and MDUFMA user fee waivers; and Pan-European drug, biological product, and medical device approvals and clearances.

Clinical TrialsOur team provides clients with legal strategies for developing biologics, medical devices and drug products that have the optimal chance of attaining passage through the FDA review process. With our experience, we are able to identify technologies and experts that assist companies not only in protecting their existing products but also in expanding the life cycle of their products through new technologies, patents, studies and more. For clients that have already developed a protocol, Buchanan can provide the legal advice and contract documents necessary during the execution of the clinical research process.

Advertising and PromotionWe handle all aspects of marketing of FDA-regulated products. We evaluate promotional materials for compliance with FDA requirements, as well as to reduce risks of product liability and Lanham Act claims. We counsel companies on lawful preapproval communications, including dossier development to obtain managed care approval. We participate in regularly scheduled promotional review committees and evaluate items, such as slim jims, master visual aids, websites, fi le cards, reprint carriers, journal advertisements and slide kits. We also address dissemination of medical journal articles, promotional speaker programs, scientifi c convention

(continued)5

participation, advisory board management and utilization of social media tools. We counsel on the state and federal laws on Sunshine Act/aggregate spend disclosure, spending limits and prohibitions and compliance program adherence.

Drug SafetyWe work to assess the various issues associated with drug safety, adverse event reporting and manufacturing. FDA’s increased regulation of manufacturing and drugs in gray regulatory areas has led us to work directly with the agency to try to ensure its actions are justifi ed. In many cases, we have been able to convince the agency that injunctions against clients were inappropriate, that seizures of goods were unnecessary and the recalls of the goods were unwarranted.

Regulatory Compliance and EnforcementWe apply our cross-functional knowledge to help our clients comply with regulatory requirements at every phase of a product’s lifecycle, from development and manufacturing through marketing and distribution. We also create highly effective plans for addressing compliance issues related to clinical trials and the manufacture, marketing and distribution of human and animal drugs, biological products, medical devices, combination products, tissue-based and gene therapy products, foods and cosmetics. We help our clients stay ahead of what is next by keeping our eyes on what is happening with the FDA, the Federal Trade Commission (FTC) and the Department of Justice (DOJ). We make sure our clients know what may be newly required in pre-approval and post-approval inspections, advertising and promotion, good manufacturing practice and quality system regulations, import-export, clinical trial monitoring, post-market surveillance and administrative and judicial enforcement actions.

Government InvestigationsOur multidisciplinary team is experienced in navigating the intricacies of government investigations. We frequently represent clients before the DOJ, the FTC, state attorneys general and various other federal and state regulatory agencies. In addition to representing clients facing antitrust or unfair trade practices allegations, we counsel individual clients who are subpoenaed to testify as third-party witnesses, as well as clients with an interest in such investigations. In addition, we have conducted internal investigations and advised clients with respect to compliance with antitrust regulations, as well as other state and federal laws governing business and commerce.

International MarketsWe have dealt with regulatory agencies in Canada, Europe, the Pacifi c Rim, the Middle East and South Africa. Conversely, we have helped companies from all over the world market their products in the United States. Product licensing and joint venture agreements are an important part of international business. Our group provides companies entering such agreements with economic and fi nancial analyses of the products and markets involved. We also analyze the

Food and Drug Administration Group(continued from previous page)

6

• Intellecual Property Procurement • Intellectual Property Enforcement • Food and Drug Administration • Antitrust and Trade Regulation

Buchanan’s Life Sciences Team brings together focused experience of four practice areas. With a depth of talent in strategic locations, we have the resources to tailor a team speci� c to your needs.

From discovery to market, Buchanan’s Life Sciences Team will help you express your potential.

Buchanan’s Life Sciences Team4 Complementary Bases That Express Your Potential

Intellectual Property Procurement

Buchanan offers a full-service IP Section, the cornerstone of which is

the intellectual property procurement group. Whether you need a patent,

trademark or copyright, Buchanan will ably assist you at every turn.

PatentsBuchanan boasts over 50 practitioners registered to practice before the United States Patent and Trademark Offi ce. In 2014, we prosecuted over 2,100 applications and helped our clients obtain 1,682 U.S. patents. Calling upon our network of foreign counterparts, we helped our clients prosecute over 550 foreign applications and obtain 342 patents in 2014.

Application Drafting An invention’s value often turns on the quality of the patent embodying it. Because our team members are versed in life sciences, we can readily understand an inventor’s contribution to the art, and we work directly with inventors to capture and claim the full invention. We follow case law developments in the Life Sciences area and draft applications that satisfy current standards yet leave options open should shifts occur.

Prosecution Buchanan’s IP Section prides itself on cross-training. Our patent prosecutors have litigation experience and realize that every word in a fi le history is carefully analyzed. As a result, our patent prosecutors draft accurate and effi cient responses. Should an Examiner fail to appreciate a given invention based upon written responses, Buchanan frequently takes advantage of its location and conducts in-person interviews with Examiners. Buchanan’s fl agship IP offi ce is in Alexandria, Virginia, just blocks away from the Patent Offi ce.

Opinions Key business decisions rest upon analyses not only of your IP, but also that of your competitors. Whether the issue is validity/invalidity, infringement/non-infringement or both, we can help you determine whether to stay the course or modify your tentative plan so as to minimize risk.

Diligence InvestigationsWhether you seek to acquire a patent portfolio or seek to transfer your patent portfolio, diligence investigations involve a detail-oriented process. From verifying that the “owner” truly owns the property to determining whether the risks in the transaction outweigh the potential rewards, Buchanan’s Life Sciences Team can assist with every step.

Licensing A key reason to have patents is to monetize them. We have experience with issues encountered in life sciences licensing transactions, including those associated with inter-institutional agreements, federal funding, cooperative research and development agreements, the Bayh-Dole Act, F/RAND and export control.

©2015 Buchanan Ingersoll & Rooney PC

Donald V. Scaltrito, Ph.D. •Patent AgentAlexandria, Virginia703 838 [email protected]

Howard D. Scher •Philadelphia, Pennsylvania215 665 [email protected]

Stephany G. Small, Ph.D. •Patent AgentWilmington, Delaware302 552 [email protected]

Aaron L. J. Pereira ••New York, New York212 440 [email protected]

Michael S. Powers •Princeton, New Jersey609 987 [email protected]

Linda Pissott Reig •Newark, New Jersey973 424 [email protected]

Richard G. Salazar •Tampa, Florida813 222 [email protected]

Duane A. Stewart, III •Pittsburgh, Pennsylvania412 562 [email protected]

Theodore M. Sullivan •Washington, D.C.202 452 [email protected]

Carla J. Vrsansky •Pittsburgh, Pennsylvania412 562 [email protected]

Todd R. Walters ••Alexandria, Virginia703 838 [email protected]

Mark M. Yacura •Washington, D.C.202 452 [email protected]

Alfred W. Zaher ••Philadelphia, Pennsylvania215 665 [email protected]

Genevieve M. Spires •Newark, New Jersey973 424 [email protected]

S. Lloyd Smith •Alexandria, Virginia703 838 [email protected]

Samantha L. Southall •Philadelphia, Pennsylvania215 665 [email protected]

Christopher L. North, Ph.D. ••Alexandria, Virginia703 838 6511 [email protected]

Shantanu C. Pathak, Ph.D. •Philadelphia, Pennsylvania215 665 [email protected]

regulatory framework of the United States and that of the foreign countries to determine the feasibility of the proposed agreement. Our lawyers review corporate licensing agreements and decipher the details of issues like taxes, patents, trademarks and other intellectual property rights. Some of the issues we deal with every day have to do with CE marks for medical devices, food ingredient listing and labeling, cosmetic marketing and drug clearances.

Reimbursement

We work on a daily basis with our Federal Government Relations Group to assist our efforts in the reimbursement realm. We have also assisted clients in dealing with Congressional Oversight investigations and hearings related to a variety of food and drug matters.

Our new product opportunities and market approval services include:

• Financing new development opportunities.

• Protecting products from unfair competition in the post-approval marketing period.

• Securing proper payment by third-party payers such as insurance companies, Medicare and Medicaid.

We work with clients to prepare and submit:

• NDAs, NADAs and ANDAs.

• BLAs and HCT/P registration and listing.

• PMAs and 510(k) notifi cations.

• INDs and IDEs.

• Combination product RFDs.

• Product jurisdiction determinations.

• Citizen petitions.

• Appeals of agency action.

• Food additive GRAS opinions and petitions.

• PDUFA and MDUFMA user fee waivers.

• Pan-European drug, biological product, and medical device approvals and clearances.

• Requests for administrative hearings Comments to FDA administrative proceedings Comments on guidance documents and proposed legislation.

(continued)

7

Food and Drug Administration Group(continued from previous page)

Our regulatory compliance and enforcement assistance includes:

• Administrative proceedings and hearings at both the FDA and DEA.

• Regulatory correspondence and compliance actions calling for client response and/or corrective action.

• Domestic and foreign inspections and audits.

• Import detentions.

• Administrative and judicial enforcement actions.

• Civil actions like product seizures, injunctive proceedings, consent decrees and civil monetary penalties.

• Criminal actions, both corporate and individual.

• Clinical trial and bioresearch monitoring actions, including disqualifi cation proceedings.

• Adverse event, counterfeiting and product deviation reports and actions.

• Product recalls.

• Product shortage issues.

• Government health fraud investigations.

• Congressional hearings and investigations.

• Court actions by the government or by private parties, such as actions involving trade practices, product advertising, patent enforcement or contract disputes.

We’re BookishBuchanan’s FDA Group has experience with Orange and Green Book issues and is working with clients on, as well as monitoring closely, developments with the new Purple Book for biologics.

Orange BookOur Orange Book experience includes creating unique listings for products and handling post-approval listing of patents. We guide clients on the nuances between ANDAs and Section 505(b)(2)/paper NDAs. We also have experience with fi rst-to-fi le ANDA refuse-to-receive issues.

Green BookOur team helped to establish the Green Book, and we have worked with the Center for Veterinary Medicine on its evolution. Our team has animal drug listing experience and can assist you through all phases of the process.

Purple BookWe have advised a number of clients on issues relating to listing biosimilar and interchangeable biological products licensed by FDA by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). We have worked with clients to obtain exclusivities for complex biologics and have obtained market exclusivity for orphan drugs and pediatric drugs.

8

• Intellecual Property Procurement • Intellectual Property Enforcement • Food and Drug Administration • Antitrust and Trade Regulation

Buchanan’s Life Sciences Team brings together focused experience of four practice areas. With a depth of talent in strategic locations, we have the resources to tailor a team speci� c to your needs.

From discovery to market, Buchanan’s Life Sciences Team will help you express your potential.

Buchanan’s Life Sciences Team4 Complementary Bases That Express Your Potential

Intellectual Property Procurement

Buchanan offers a full-service IP Section, the cornerstone of which is

the intellectual property procurement group. Whether you need a patent,

trademark or copyright, Buchanan will ably assist you at every turn.

PatentsBuchanan boasts over 50 practitioners registered to practice before the United States Patent and Trademark Offi ce. In 2014, we prosecuted over 2,100 applications and helped our clients obtain 1,682 U.S. patents. Calling upon our network of foreign counterparts, we helped our clients prosecute over 550 foreign applications and obtain 342 patents in 2014.

Application Drafting An invention’s value often turns on the quality of the patent embodying it. Because our team members are versed in life sciences, we can readily understand an inventor’s contribution to the art, and we work directly with inventors to capture and claim the full invention. We follow case law developments in the Life Sciences area and draft applications that satisfy current standards yet leave options open should shifts occur.

Prosecution Buchanan’s IP Section prides itself on cross-training. Our patent prosecutors have litigation experience and realize that every word in a fi le history is carefully analyzed. As a result, our patent prosecutors draft accurate and effi cient responses. Should an Examiner fail to appreciate a given invention based upon written responses, Buchanan frequently takes advantage of its location and conducts in-person interviews with Examiners. Buchanan’s fl agship IP offi ce is in Alexandria, Virginia, just blocks away from the Patent Offi ce.

Opinions Key business decisions rest upon analyses not only of your IP, but also that of your competitors. Whether the issue is validity/invalidity, infringement/non-infringement or both, we can help you determine whether to stay the course or modify your tentative plan so as to minimize risk.

Diligence InvestigationsWhether you seek to acquire a patent portfolio or seek to transfer your patent portfolio, diligence investigations involve a detail-oriented process. From verifying that the “owner” truly owns the property to determining whether the risks in the transaction outweigh the potential rewards, Buchanan’s Life Sciences Team can assist with every step.

Licensing A key reason to have patents is to monetize them. We have experience with issues encountered in life sciences licensing transactions, including those associated with inter-institutional agreements, federal funding, cooperative research and development agreements, the Bayh-Dole Act, F/RAND and export control.

©2015 Buchanan Ingersoll & Rooney PC

Donald V. Scaltrito, Ph.D. •Patent AgentAlexandria, Virginia703 838 [email protected]

Howard D. Scher •Philadelphia, Pennsylvania215 665 [email protected]

Stephany G. Small, Ph.D. •Patent AgentWilmington, Delaware302 552 [email protected]

Aaron L. J. Pereira ••New York, New York212 440 [email protected]

Michael S. Powers •Princeton, New Jersey609 987 [email protected]

Linda Pissott Reig •Newark, New Jersey973 424 [email protected]

Richard G. Salazar •Tampa, Florida813 222 [email protected]

Duane A. Stewart, III •Pittsburgh, Pennsylvania412 562 [email protected]

Theodore M. Sullivan •Washington, D.C.202 452 [email protected]

Carla J. Vrsansky •Pittsburgh, Pennsylvania412 562 [email protected]

Todd R. Walters ••Alexandria, Virginia703 838 [email protected]

Mark M. Yacura •Washington, D.C.202 452 [email protected]

Alfred W. Zaher ••Philadelphia, Pennsylvania215 665 [email protected]

Genevieve M. Spires •Newark, New Jersey973 424 [email protected]

S. Lloyd Smith •Alexandria, Virginia703 838 [email protected]

Samantha L. Southall •Philadelphia, Pennsylvania215 665 [email protected]

Christopher L. North, Ph.D. ••Alexandria, Virginia703 838 6511 [email protected]

Shantanu C. Pathak, Ph.D. •Philadelphia, Pennsylvania215 665 [email protected]

Buchanan’s Antitrust and Trade Regulation Group provides comprehensive legal services that help life sciences clients achieve their business goals in today’s challenging life sciences industry. We represent clients in nearly all types of antitrust matters, from antitrust compliance and counseling to antitrust issues in the merger, acquisition and collaboration contexts, to government and regulatory investigations, to complex antitrust jury trials with many millions of dollars at stake. Buchanan’s Antitrust and Trade Regulation Group complements Buchanan’s IP and FDA groups to advise life sciences companies on key antitrust-specifi c issues. Members of Buchanan’s Antitrust and Trade Regulation Group provide guidance with regard to Hatch-Waxman, settlement, pay-for-delay/reverse payment and sham litigation issues. We also assist clients in complying with the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the Hart-Scott-Rodino (HSR) Act.

Antitrust and Trade Regulation

Key Focus Areas Include:

Hatch-Waxman (Paragraph IV) Litigation AssistanceAs clients consider whether to initiate a Paragraph IV litigation, Buchanan advises on the benefi ts and drawbacks of fi ling the litigation from an antitrust perspective. Our attorneys also advise on non-litigation options, such as manufacturing or distribution agreements, which may offer a better resolution in certain contexts. After a Paragraph IV case begins, Buchanan can advise on how to settle cases given current antitrust-related decisions, if settlement is in the best interest and is desired by the client. Buchanan has experience in dealing with the FTC; the Antitrust Division of the DOJ; state attorneys general; and private parties, such as wholesalers, distributors, retailers, pharmacy benefi t managers and end consumers.

Traditional Litigation Buchanan’s Antitrust and Trade Regulation Group has experience in litigating antitrust claims or counter-claims and/or patent misuse affi rmative defenses in the life sciences area. As seasoned trial attorneys, we take an aggressive but strategic approach to handling complex class-action and individual litigant antitrust cases. For example, we have litigated national class-action conspiracy lawsuits brought by direct and indirect purchasers in the pharmaceutical industry, including acting as co-counsel in the defense of Caremark RX, Inc., a pharmacy benefi ts manager, named as a defendant in In re Pharmacy Benefi ts Managers Antitrust Litigation.Our attorneys also have experience in defending against patent misuse claims in ITC administrative hearings.

(continued)

9

Buchanan’s Life Sciences Team

Practice Area Key

Antitrust and Trade Regulation(continued from previous page)

Mergers, Acquisitions and Affi liationsWorking in conjunction with our team of FDA, IP and corporate attorneys, our Antitrust and Trade Regulation Group has signifi cant experience handling the range of antitrust issues that arise out of mergers and acquisitions, joint ventures, collaborations and other forms of affi liation, including purchasing/selling single drug products, NDAs or ANDAs, and entire companies. Buchanan’s Antitrust and Trade Regulation Group has experience advising on and fi ling these pre-merger notifi cations required by the HSR Act. We work with clients to determine if a fi ling is necessary and, if so, assist our clients in the fi ling.

10

• Intellecual Property Procurement • Intellectual Property Enforcement

Sarah Abshear •San Diego, California619 685 [email protected]

Edward John Allera •Washington, D.C.202 452 [email protected]

Carrie G. Amezcua •Washington, D.C.202 452 [email protected]

Mackenzie A. Baird •Pittsburgh, Pennsylvania412 562 [email protected]

James M. Becker •Philadelphia, Pennsylvania215 665 [email protected]

Barbara A. Binzak Blumenfeld, Ph.D. •Washington, D.C.202 452 [email protected]

Steven E. Bizar •Philadelphia, Pennsylvania215 665 [email protected]

Travis W. Bliss, Ph.D. ••Wilmington, Delaware302 552 [email protected]

• Intellecual Property Procurement • Intellectual Property Enforcement • Food and Drug Administration • Antitrust and Trade Regulation

Buchanan’s Life Sciences Team brings together focused experience of four practice areas. With a depth of talent in strategic locations, we have the resources to tailor a team speci� c to your needs.

From discovery to market, Buchanan’s Life Sciences Team will help you express your potential.

Buchanan’s Life Sciences Team4 Complementary Bases That Express Your Potential

Intellectual Property Procurement

Buchanan offers a full-service IP Section, the cornerstone of which is

the intellectual property procurement group. Whether you need a patent,

trademark or copyright, Buchanan will ably assist you at every turn.

PatentsBuchanan boasts over 50 practitioners registered to practice before the United States Patent and Trademark Offi ce. In 2014, we prosecuted over 2,100 applications and helped our clients obtain 1,682 U.S. patents. Calling upon our network of foreign counterparts, we helped our clients prosecute over 550 foreign applications and obtain 342 patents in 2014.

Application Drafting An invention’s value often turns on the quality of the patent embodying it. Because our team members are versed in life sciences, we can readily understand an inventor’s contribution to the art, and we work directly with inventors to capture and claim the full invention. We follow case law developments in the Life Sciences area and draft applications that satisfy current standards yet leave options open should shifts occur.

Prosecution Buchanan’s IP Section prides itself on cross-training. Our patent prosecutors have litigation experience and realize that every word in a fi le history is carefully analyzed. As a result, our patent prosecutors draft accurate and effi cient responses. Should an Examiner fail to appreciate a given invention based upon written responses, Buchanan frequently takes advantage of its location and conducts in-person interviews with Examiners. Buchanan’s fl agship IP offi ce is in Alexandria, Virginia, just blocks away from the Patent Offi ce.

Opinions Key business decisions rest upon analyses not only of your IP, but also that of your competitors. Whether the issue is validity/invalidity, infringement/non-infringement or both, we can help you determine whether to stay the course or modify your tentative plan so as to minimize risk.

Diligence InvestigationsWhether you seek to acquire a patent portfolio or seek to transfer your patent portfolio, diligence investigations involve a detail-oriented process. From verifying that the “owner” truly owns the property to determining whether the risks in the transaction outweigh the potential rewards, Buchanan’s Life Sciences Team can assist with every step.

Licensing A key reason to have patents is to monetize them. We have experience with issues encountered in life sciences licensing transactions, including those associated with inter-institutional agreements, federal funding, cooperative research and development agreements, the Bayh-Dole Act, F/RAND and export control.

©2015 Buchanan Ingersoll & Rooney PC

Donald V. Scaltrito, Ph.D. •Patent AgentAlexandria, Virginia703 838 [email protected]

Howard D. Scher •Philadelphia, Pennsylvania215 665 [email protected]

Stephany G. Small, Ph.D. •Patent AgentWilmington, Delaware302 552 [email protected]

Aaron L. J. Pereira ••New York, New York212 440 [email protected]

Michael S. Powers •Princeton, New Jersey609 987 [email protected]

Linda Pissott Reig •Newark, New Jersey973 424 [email protected]

Richard G. Salazar •Tampa, Florida813 222 [email protected]

Duane A. Stewart, III •Pittsburgh, Pennsylvania412 562 [email protected]

Theodore M. Sullivan •Washington, D.C.202 452 [email protected]

Carla J. Vrsansky •Pittsburgh, Pennsylvania412 562 [email protected]

Todd R. Walters ••Alexandria, Virginia703 838 [email protected]

Mark M. Yacura •Washington, D.C.202 452 [email protected]

Alfred W. Zaher ••Philadelphia, Pennsylvania215 665 [email protected]

Genevieve M. Spires •Newark, New Jersey973 424 [email protected]

S. Lloyd Smith •Alexandria, Virginia703 838 [email protected]

Samantha L. Southall •Philadelphia, Pennsylvania215 665 [email protected]

Christopher L. North, Ph.D. ••Alexandria, Virginia703 838 6511 [email protected]

Shantanu C. Pathak, Ph.D. •Philadelphia, Pennsylvania215 665 [email protected]

Counseling and Compliance ProgramsWe provide ongoing advice to our clients about trade associations, joint ventures, collaborations, and antitrust and life science compliance issues. Our antitrust assistance has also included advising clients on distribution, licensing, non-compete and exclusivity issues. Our approach of becoming fully knowledgeable of our clients’ business and industry leads Buchanan to be a trusted part of the client’s team, providing advice on both day-to-day and major antitrust-related business matters. Buchanan’s Antitrust and Trade Regulation Group’s knowledge of the intersection of life sciences and antitrust allows us to effi ciently provide advice that furthers the goals of our life sciences clients.

• Food and Drug Administration • Antitrust and Trade Regulation

11

Craig G. Cochenour, R.Ph. ••Pittsburgh, Pennsylvania412 562 [email protected]

Michael L. Dever ••Pittsburgh, Pennsylvania412 562 [email protected]

Erin M. Dunston ••Alexandria, Virginia703 838 [email protected]

Matthew J. Feeley •Miami, Florida305 347 [email protected]

Ralph G. Fischer ••Pittsburgh, Pennsylvania412 392 2121ralph.fi [email protected]

Travis D. Boone • Alexandria, Virginia703 299 [email protected]

Thomas G. Buchanan •Pittsburgh, Pennsylvania412 562 [email protected]

Nicholas Chidiac •Alexandria, Virginia703 838 [email protected]

Practice Area Key

Buchanan’s Life Sciences Team

12

• Intellecual Property Procurement • Intellectual Property Enforcement

Roger H. Lee ••Alexandria, Virginia703 838 [email protected]

Fang Liu, Ph.D. •Alexandria, Virginia703 838 [email protected]

Thomas P. Manning •Philadelphia, Pennsylvania215 665 [email protected]

Bryce J. Maynard •Alexandria, Virginia703 838 [email protected]

Benjamin F. McAnaney •Philadelphia, Pennsylvania215 665 [email protected]

Robert G. Mukai ••Alexandria, Virginia703 838 [email protected]

Wendelynne J. Newton •Pittsburgh, Pennsylvania412 562 [email protected]

Mythili Nadella, Ph.D. ••Alexandria, Virginia703 299 [email protected]

Shawn Li, Ph.D. ••Philadelphia, Pennsylvania215 665 [email protected]

Tina Hu-Rodgers •Washington, D.C.202 452 [email protected]

Bassam N. Ibrahim ••Alexandria, Virginia703 838 [email protected]

Gretchen L. Jankowski •Pittsburgh, Pennsylvania412 562 [email protected]

Victoria Bechtold Kush •Pittsburgh, Pennsylvania412 562 [email protected]

Rudolph Garcia •Philadelphia, Pennsylvania215 665 [email protected]

William A. Garvin •Washington, D.C.202 452 [email protected]

Christine M. Hansen ••Wilmington, Delaware302 552 [email protected]

Philip L. Hirschhorn •New York, New York212 440 [email protected]

Holly M. Ford •Alexandria, Virginia703 838 [email protected]

• Intellecual Property Procurement • Intellectual Property Enforcement • Food and Drug Administration • Antitrust and Trade Regulation

Buchanan’s Life Sciences Team brings together focused experience of four practice areas. With a depth of talent in strategic locations, we have the resources to tailor a team speci� c to your needs.

From discovery to market, Buchanan’s Life Sciences Team will help you express your potential.

Buchanan’s Life Sciences Team4 Complementary Bases That Express Your Potential

Intellectual Property Procurement

Buchanan offers a full-service IP Section, the cornerstone of which is

the intellectual property procurement group. Whether you need a patent,

trademark or copyright, Buchanan will ably assist you at every turn.

PatentsBuchanan boasts over 50 practitioners registered to practice before the United States Patent and Trademark Offi ce. In 2014, we prosecuted over 2,100 applications and helped our clients obtain 1,682 U.S. patents. Calling upon our network of foreign counterparts, we helped our clients prosecute over 550 foreign applications and obtain 342 patents in 2014.

Application Drafting An invention’s value often turns on the quality of the patent embodying it. Because our team members are versed in life sciences, we can readily understand an inventor’s contribution to the art, and we work directly with inventors to capture and claim the full invention. We follow case law developments in the Life Sciences area and draft applications that satisfy current standards yet leave options open should shifts occur.

Prosecution Buchanan’s IP Section prides itself on cross-training. Our patent prosecutors have litigation experience and realize that every word in a fi le history is carefully analyzed. As a result, our patent prosecutors draft accurate and effi cient responses. Should an Examiner fail to appreciate a given invention based upon written responses, Buchanan frequently takes advantage of its location and conducts in-person interviews with Examiners. Buchanan’s fl agship IP offi ce is in Alexandria, Virginia, just blocks away from the Patent Offi ce.

Opinions Key business decisions rest upon analyses not only of your IP, but also that of your competitors. Whether the issue is validity/invalidity, infringement/non-infringement or both, we can help you determine whether to stay the course or modify your tentative plan so as to minimize risk.

Diligence InvestigationsWhether you seek to acquire a patent portfolio or seek to transfer your patent portfolio, diligence investigations involve a detail-oriented process. From verifying that the “owner” truly owns the property to determining whether the risks in the transaction outweigh the potential rewards, Buchanan’s Life Sciences Team can assist with every step.

Licensing A key reason to have patents is to monetize them. We have experience with issues encountered in life sciences licensing transactions, including those associated with inter-institutional agreements, federal funding, cooperative research and development agreements, the Bayh-Dole Act, F/RAND and export control.

©2015 Buchanan Ingersoll & Rooney PC

Donald V. Scaltrito, Ph.D. •Patent AgentAlexandria, Virginia703 838 [email protected]

Howard D. Scher •Philadelphia, Pennsylvania215 665 [email protected]

Stephany G. Small, Ph.D. •Patent AgentWilmington, Delaware302 552 [email protected]

Aaron L. J. Pereira ••New York, New York212 440 [email protected]

Michael S. Powers •Princeton, New Jersey609 987 [email protected]

Linda Pissott Reig •Newark, New Jersey973 424 [email protected]

Richard G. Salazar •Tampa, Florida813 222 [email protected]

Duane A. Stewart, III •Pittsburgh, Pennsylvania412 562 [email protected]

Theodore M. Sullivan •Washington, D.C.202 452 [email protected]

Carla J. Vrsansky •Pittsburgh, Pennsylvania412 562 [email protected]

Todd R. Walters ••Alexandria, Virginia703 838 [email protected]

Mark M. Yacura •Washington, D.C.202 452 [email protected]

Alfred W. Zaher ••Philadelphia, Pennsylvania215 665 [email protected]

Genevieve M. Spires •Newark, New Jersey973 424 [email protected]

S. Lloyd Smith •Alexandria, Virginia703 838 [email protected]

Samantha L. Southall •Philadelphia, Pennsylvania215 665 [email protected]

Christopher L. North, Ph.D. ••Alexandria, Virginia703 838 6511 [email protected]

Shantanu C. Pathak, Ph.D. •Philadelphia, Pennsylvania215 665 [email protected]

www.bipc.com

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