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With seven years' experience as in-house counsel for a Fortune 500 company, Anneliese approaches her clients' legal projects with the end business goal in mind. Her patent prosecution experience includes working with inventors from around the world on pre-drafting strategy through appeals before the Board of Patent Appeals and Interferences and opposition strategy before the European Patent Office. She has facilitated multimillion-dollar license agreements, as well as confidentiality and development agreements.

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Anneliese’s litigation experience includes working on patent, trademark, and trade secret litigation teams at various stages of the litigation process from pre-filing due diligence through trial. She has also advised clients on overall IP strategy, best practices and education, freedom to operate, infringement and invalidity opinions, and due diligence and patent portfolio analyses for acquisitions and licensing opportunities.&nbsp;

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She has worked in a wide range of technical areas, including chemical, mechanical, biological, food science, and software and business methods.

Anneliese serves as a volunteer attorney for the Children's Law Center of Minnesota. She enjoys hiking with her family, cooking, and listening to music.&nbsp;

Marquette University Law School, J.D., 2002

College of St. Benedict, B.A. Chemistry, 1999

Anneliese Mayer, Intellectual Property Attorney

she / her / hers

Industrial Chemistry

Manufacturing

Pharmaceuticals

Minneapolis

Merchant &amp; Gould promoted five attorneys in three of its offices around the country &#8212; a great way to launch the New Year.&nbsp; The promotions include Eric R. Chad, Mark L. Gleason and Anneliese S. Mayer in Minneapolis; Ryan J. Fletcher, Ph.D., in Denver; and Steven F. Owens in Knoxville.



“We are excited to expand our leadership and embrace Merchant &amp; Gould’s growth in 2019.&nbsp; These promotions bring greater depth to our practice groups in innovative industries across the country,” said Christopher J. Leonard, Managing Director of Merchant &amp; Gould.



Eric Chad counsels clients on issues relating to privacy and data security, including the development and implementation of security and privacy policies and compliance with applicable privacy laws and regulations. He also practices general intellectual property law with an emphasis on all forms of litigation and contested proceedings before the Trademark Trial and Appeal Board.&nbsp; He represents clients through all stages of complex intellectual property disputes from pre-filing investigations through post-trial briefing and appeal.&nbsp; Eric has litigated cases involving a wide range of technologies, including HVAC equipment, sporting goods, pharmaceuticals, cosmetics, infection prevention, and lubrication technologies.



Mark Gleason focuses on general IP strategy and counseling and patent prosecution in the mechanical and electrical arts.&nbsp; He has written and prosecuted patent applications associated with a wide range of computer and software technologies, including financial services, website layout and information analysis and display. Mark is experienced with electrical and mechanical technologies including printers, industrial instrumentation and controls, and power and hand tools, as well as semiconductor technologies including microprocessor architecture, memory devices, wafer processing and testing, and circuit layout.



Anneliese Mayer works in a wide range of technical areas, such as chemical, mechanical, biological, food science, and software and business methods.&nbsp; Her litigation experience includes patent, trademark, and trade secret litigation.&nbsp; Anneliese also has an agreement and patent prosecution practice and advises clients on overall IP strategy, best practices and education, freedom to operate, infringement and invalidity opinions, and due diligence and patent portfolio analyses for acquisitions and licensing opportunities.&nbsp;



Ryan Fletcher, promoted to partner in Denver, has a Ph.D. in Biochemistry and Molecular Genetics, which brings a deep understanding of technology, a tireless attention to detail, and strong analytical thinking to his clients’ needs.&nbsp; His patent litigation experience covers the technology spectrum and includes medical devices, pharmaceutical compositions and laboratory testing techniques, computer software, window hardware, and container technology. Ryan has also successfully represented clients in litigation over disputes arising from allegations of copyright infringement, trademark infringement, unfair business practices, trade secret misappropriation, and breach of contract.&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;



Steven Owens, promoted to partner in Knoxville, focuses on patent prosecution and management. He counsels client companies of all sizes on their intellectual property rights and goals, including advising on the acquisition, defense, and licensing of their intellectual property. Steven has experience in patent and trademark litigation, including developing and implementing litigation strategies, preparing motions and pleadings, and coordinating discovery and e-discovery.



Congratulations to these five attorneys!

Merchant & Gould Promotes Five Attorneys to Partners  in Three Office Locations

<h2 class="wp-block-heading">Location:</h2>



Hyatt Regency Cleveland At The Arcade 420 Superior Ave Cleveland, OH 44114



<h2 class="wp-block-heading">Overview</h2>



3-Minute Case Summaries:&nbsp;A fast-paced and energetic update on recent case law developments important to patent litigation from ten select cases.



Brand Protection Update:&nbsp;Hear an update on trends and cases related to online brand protection, including updates on copyright laws, trademark strategies, and anti-counterfeiting strategies. We will also provide an update regarding new programs put in place by online marketplaces to manage counterfeits and unauthorized product sales.



Data Privacy Developments:&nbsp;The laws and regulations relating to the collection, use, processing, and storage of consumer data and consumer privacy are constantly evolving. Eric will discuss two of the more significant developments in this area from the last few years: The EU’s General Data Privacy Regulation (GDPR) and the California Consumer Privacy Act (CCPA). Specifically, Eric will discuss what we’ve learned in the 13 months since GDPR went into force and what we can expect from the CCPA, which goes into force on January 1, 2020.



Panel Discussion: Agreements &amp; Innovation Due Diligence:&nbsp;M&amp;G attorneys share their experience helping their clients navigate technology, data, and IoT-driven projects. &nbsp;Agreement drafting, due diligence, litigation, data security, and client counseling will be discussed.



<figure class="wp-block-table"><table><tbody><tr><td>2:00 – 2:30</td><td>Registration</td></tr><tr><td>2:30 – 3:00</td><td>3-Minute Case Summaries: What Every Patent Lawyer Needs to Know &nbsp;</td></tr><tr><td>3:00 – 3:30</td><td>Brand Protection Update: Relevant Cases and Trends&nbsp;</td></tr><tr><td>3:30 – 3:50</td><td>Data Privacy Developments: GDPR at One Year and the California Consumer Privacy Act&nbsp;</td></tr><tr><td>3:50 – 4:00</td><td>Break</td></tr><tr><td>4:00 – 4:45</td><td>Panel Discussion: Agreements &amp; Innovation Due Diligence</td></tr></tbody></table></figure>



Followed by a cocktail &amp; networking reception



<a href="http://emailcc.com/cv/52439ec4097be55d3d6868fedcfda34fc8efe17a" target="_blank" rel="noopener">RSVP</a>

On the Cutting Edge: Updates on Patent Law, Data Privacy, and E-Commerce

Merchant &amp; Gould was honored by the Children’s Law Center of Minnesota (CLC) with the Distinguished Service Award at its 26th Anniversary Virtual Benefit on Oct. 7.



The Distinguished Service Award is presented annually to one law firm or corporation whose work on behalf of CLC’s clients exemplifies the commitment and dedication to pro bono representation that is the foundation of CLC’s mission. &nbsp;According to Amanda Finman-Palmer, Development Director, and the CLC team, Merchant &amp; Gould was especially recognized for its “dedication and commitment to representing children and youth in foster care,” as well as the firm’s “immense impact on Minnesota children in need.”



Over the years, Merchant &amp; Gould attorneys and staff have engaged with CLC in many ways, including CLC board and committee leadership; philanthropy by employees and volunteers; sponsorship support for CLC’s Annual benefit; in-kind donations for CLC clients and operation; and hundreds of pro bono hours representing children and youth in foster care.



Minneapolis partner Tony Zeuli, CLC board member, accepted the Distinguished Service Award on behalf of Merchant &amp; Gould in a video while applauding the firm’s robust team of pro bono volunteers, including Karen Beckman, Eric Chad, Julie Daulton, Lindsay Hartman, Rachel Hughey, Bradley Kuxhausen, Anneliese Mayer, Elisabeth “Bette” Muirhead, Ryan Smith, Rachel Zimmerman Scobie, and Tracey Skjeveland.



CLC provides free legal advocacy for foster care youth in Minnesota. &nbsp;The organization advocates for foster children through systemic reform and provides free legal representation services to foster children. &nbsp;CLC also trains volunteer attorneys to represent foster children in court. &nbsp;Currently, CLC represents over 800 children per year. &nbsp;

Merchant & Gould Receives Distinguished Service Award from Children’s Law Center of Minnesota

Merchant &amp; Gould partner Tony Zeuli says volunteering with Children’s Law Center (CLC) to represent foster children in court is a rewarding experience for him and Minneapolis colleagues.



Zeuli, a CLC board member, accepted the nonprofit’s Distinguished Service Award on the firm’s behalf earlier this month.



Read the rest of the article <a href="https://minnlawyer.com/2021/10/21/breaking-the-ice-ip-attorney-colleagues-earn-pro-bono-recognition/">here.</a>

Breaking the Ice: IP attorney, colleagues earn pro bono recognition

Other Attorneys Recognized for Pro Bono Hours and CLC Distinction



Merchant &amp; Gould’s Pro Bono Committee announced the firm’s 2021 Pro Bono Awards to attorneys who have dedicated their time to helping their communities through pro bono legal services and their deep commitment.&nbsp;



A special congratulations goes to Sheila Niaz (Minneapolis) who performed more than 300 hours of pro bono legal work this year. &nbsp;Sheila’s pro bono work included preparing several patent applications in connection with LegalCORPS and assisting on the appeal of a criminal conviction. &nbsp;She is the sole recipient of Merchant &amp; Gould’s 2021 Pro Bono Award.



In addition, we want to recognize Rachel Hughey (Minneapolis) who has since been appointed as a District Court Judge in Minnesota’s Fourth Judicial District; Bill Hughet (D.C.); Mike Erbele (Minneapolis); Joe Gess (D.C.); Rachel Scobie (Minneapolis); and Ben Tramm (Minneapolis) for dedicating more than 40 hours of pro bono work this year.



We also want to applaud our Minneapolis team of attorneys who received Children’s Law Center (CLC) of Minnesota’s “Distinguished Service Award” this year: &nbsp; Karen Beckman, Eric Chad, Julie Daulton, Lindsay Hartman, Rachel Hughey, Bradley Kuxhausen, Anneliese Mayer, Elisabeth “Bette” Muirhead, Ryan Smith and Rachel Zimmerman Scobie, Tracey Skjeveland and Tony Zeuli (CLC board member). &nbsp;Merchant &amp; Gould was recognized for its “dedication and commitment to representing children and youth in foster care,” as well as the firm’s “immense impact on Minnesota children in need.”



Congratulations to Sheila and all the attorneys who continue to help make our communities even better!

Merchant & Gould Congratulates Sheila Niaz as the Firm’s Pro Bono Award Winner

Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in<a href="http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/19-1787.OPINION.6-25-2020_1609483.pdf" target="_blank" rel="noopener"> Adidas, AG v. Nike, Inc.</a>, No. 19-1787 (June 25, 2020). The Court held the prior art cited by Adidas in two inter partes review (IPR) proceedings did not render any claims in Nike’s 7,814,598 and 8,266,749 patents obvious.



Adidas initiated two IPRs to invalidate claims of the ʼ598 and ʼ749 patents. The Patent Trial and Appeal Board considered two grounds for obviousness involving combinations of the following prior art references: (1) Reed and Nishida; and (2) Nishida, Castello, and Fujiwara. The Board held, as to both grounds, that a person of ordinary skill would not be motivated to combine the references. Adidas appealed.&nbsp;



On appeal, the Federal Circuit first considered whether Adidas had standing. Nike asserted Adidas lacked standing because Nike had not sued or threatened to sue Adidas for infringement and, therefore, Adidas had not suffered any injury. The Court disagreed. The Court explained that the requisite injury in fact could be shown by demonstrating that Adidas engaged in activity likely to give rise to an infringement suit. The Court concluded that sufficient injury was shown because Nike and Adidas are direct competitors, Nike already accused Adidas of infringing a similar patent, Nike asserted the ʼ749 patent against another entity selling a similar product, and Nike refused to grant Adidas a covenant not to sue.



Concerning obviousness, the Court rejected Adidas’s contention that the Board erred in determining that Reed and Nishida were incompatible. The Court emphasized that the obviousness inquiry does not ask whether a skilled artisan could possibly combine references, but whether they would have been motivated to combine them. Nike’s patents recite a process of forming a cylindrical textile structure of yarn with different textures that are not joined together by seams. The Court agreed with the Board that Reed’s teaching of pre-seaming is incompatible with Nike’s claims, and with the teachings of Nishida, thus eliminating any motivation to combine. The Court also rejected Adidas’s contention that the Board erred in determining that a person of ordinary skill would not have been motivated to combine Nishida, Castello, and Fujiwara. The Court explained the Board did not err in finding a person of ordinary skill would not have been motivated to combine the identified references in view of fundamental differences between and among them.



This blog post was co-authored by Annelise Mayer and Samuel Scholz

CAFC Upholds Nike’s Patents; No Motivation to Combine References

Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in Best Medical International, Inc. v. Elekta Inc., No. 2021-2099 (Fed. Cir. Aug. 26, 2022), affirming-in-part and dismissing-in-part an appeal from two IPRs involving U.S. Patent No. 6,393,096. The Court held that the Board’s obviousness determination was supported by substantial evidence.



The ʼ096 patent was the subject of two IPRs and a parallel reexamination proceeding. In the IPRs, the Board determined a person having ordinary skill in the art would have had formal computer programming experience, which BMI’s expert lacked. The Board discounted BMI’s expert testimony and credited the testimony of Elekta’s expert, who possessed the relevant experience. The Board determined that challenged claims 1, 43, 44, and 46 were unpatentable as obvious. While the IPRs were pending, BMI canceled claim 1 in the reexamination proceeding “without prejudice or disclaimer.” In its final written decision in the IPRs, the Board acknowledged the cancelation of claim 1 but determined it had “not yet been cancelled by any final action” because BMI had “not filed a statutory disclaimer.” BMI’s cancelation of claim 1 became final after the Board’s final written decision. BMI appealed.



The CAFC rejected BMI’s argument that the Board lacked authority to issue a final written decision regarding claim 1. At the time the Board issued its decision, claim 1 had not been finally canceled, and it properly remained in the IPRs. The Court held that the Supreme Court’s Munsingwear decision was inapplicable—Munsingwear addressed appeals that became moot during their pendency, but here the “mooting” event occurred before BMI filed its notice of appeal. The Court determined there was no case or controversy regarding claim 1’s patentability once the cancelation became final, and accordingly, that BMI lacked standing to appeal the Board’s patentability determination for claim 1. The Court dismissed the appeal as to that claim.



For the remaining claims, the Court held that substantial evidence supported the Board’s findings regarding the level of skill in the art. BMI challenged the Board’s findings that a person skilled in the art would have had “formal computer programming experience” and that BMI’s expert did not have this experience, resulting in the Board’s discounting of BMI’s expert’s testimony. Applying the Graham factors, the Court affirmed the Board’s obviousness determination, relying on testimony from Elekta’s expert and the Board’s analysis of “the entire trial record.”&nbsp;

CAFC Affirms PTAB Decision on Patents in Parallel IPR and Reexamination Proceedings

Last week, the U.S Court of Appeals for the Federal Circuit issued an opinion in <a href="http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/19-1071.Opinion.1-10-2020.pdf" target="_blank" rel="noopener">Molon Motor and Coil Corp. v. Nidec Motor Corp., No. 2019-1071 </a>(Jan. 10, 2020), affirming the district court’s grant of summary judgment that Molon’s suit for patent infringement against Nidec is barred by a covenant not to sue previously provided by Molon.



Molon sued Nidec for infringement of Molon’s U.S. Patent 6,465,915. Molon and Nidec’s predecessor had entered into a settlement agreement in 2007, which granted the predecessor a license to use the ‘915 patent, and other Molon patents, in a certain market. In the present suit, Molon asserted Nidec was operating outside the licensed market, and thereby was liable for infringement of the ’915 patent. Nidec moved for summary judgment, asserting a 2006 covenant not to sue for infringement of the ‘915 patent granted by Molon to Nidec’s predecessor prevented Molon from enforcing the ‘915 patent against Nidec in the present action. The district court agreed with Nidec, and granted summary judgment against Molon. Molon appealed.



At the Federal Circuit, Molon relied on a merger clause in the 2007 settlement agreement, which stated “[a]ll prior and contemporaneous conversations, negotiations, possible and alleged agreements, representations and covenants concerning the subject matter hereof, are merged herein and shall be of no further force or effect.”&nbsp; Molon asserted the merger clause extinguished the 2006 covenant not to sue.&nbsp; The Federal Circuit disagreed.&nbsp; In assessing whether the 2006 covenant “concern[ed] the same subject matter” as the 2007 agreement, the Court, applying Illinois contract law, explained that the determination of the “subject matter” of the agreement, is made by examining the agreement language.&nbsp; Comparing and contrasting the 2006 and 2007 agreements, the Court identified “important substantive differences” between them. The Court noted that the merger doctrine in contract law traditionally refers to the rule that once an agreement is reduced to writing, all prior negotiations are merged into that writing and parol evidence is not admissible to interpret the agreement.&nbsp; The Court explained that the 2006 covenant was not part of the negotiations for the 2007 settlement agreement – it was its own separate agreement and therefore outside the scope of what a merger clause is intended to cover. Having concluded that the 2006 covenant was not extinguished by the merger clause of the 2007 agreement, the Court affirmed the district court’s grant of summary judgment against Molon.

CAFC Holds Merger Clause in Later Agreement Does Not Extinguish Earlier Covenant

Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in <a href="https://cafc.uscourts.gov/opinions-orders/21-2369.OPINION.2-8-2022_1904898.pdf">Nippon Shinyaku Co., Ltd. v. Sarepta Therapeutics, Inc., No. 2021-2369 (Feb. 8, 2022)</a>, reversing the district court’s denial of preliminary injunction and holding that parties to a contract may use a forum selection clause to preclude the filing of inter partes review (“IPR”) petitions. &nbsp;



The Federal Circuit considered the Mutual Confidentiality Agreement (“MCA”) executed by Nippon Shinyaku, Co. (“Shinyaku”) and Sarepta Therapeutics, Inc. (“Sarepta”) in June 2020, which contained two provisions restricting future litigation – a mutual covenant not to sue and a two-year forum selection clause.



Under the covenant, which specifically covered patent validity challenges before the U.S. Patent and Trademark Office, each party agreed not to pursue any cause of action against the other before June 21, 2021. The forum selection clause required that “all Potential Actions arising under U.S. law relating to patent infringement or invalidity,” including intellectual property disputes before a court or administrative agency, must be filed in the U.S. District Court for the District of Delaware.



The day the covenant expired, Sarepta filed seven petitions for IPR with the Patent Trial and Appeal Board. Shinyaku filed a suit for breach of contract in the District of Delaware and moved for a preliminary injunction to block Sarepta’s IPR petitions. The district court denied Shinyaku’s motion, relying on a perceived “tension” between the terms of the covenant not to sue and the forum selection clause and a perception that the forum selection clause, in context, applies only to cases filed in federal court.



The Federal Circuit disagreed. Applying Delaware law, the Court determined the plain language of the forum selection clause unambiguously requires Sarepta to bring all invalidity disputes related to Shinyaku’s patents, including the allegations and contentions in Sarepta’s IPR petitions, in the District of Delaware. The Court reasoned that the MCA provisions were not in conflict merely because they provided different time frames for similar restrictions. The MCA provisions also did not leave the parties without recourse for patent-related claims, which might still be brought in Delaware. The Court ultimately concluded that the public interest does not prevent parties from “bargain[ing] away their rights to file IPR petitions, including through the use of forum selection clauses” as Sarepta did under the MCA. Accordingly, the Court reversed the district court’s judgment and remanded for entry of a preliminary injunction.

CAFC Finds Forum Selection Clause Precludes Filing of IPR Petitions

Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in <a href="https://cafc.uscourts.gov/opinions-orders/20-2257.OPINION.1-27-2022_1899316.pdf">Nature Simulation Systems Inc., v. Autodesk, Inc., No. 2020-2257 (January 27, 2022)</a>, reversing the district court’s decision of invalidity on the grounds of indefiniteness.



Nature Simulation Systems (NSS) sued Autodesk for infringement of two patents directed to computer algorithms for building 3D geometric models. The district court held a Markman hearing to construe the claims. Claim construction is a matter of law. The district court ruled after claim construction that two claim terms were indefinite and the claims invalid because there were “unanswered questions” about the terms. Citing Autodesk’s expert, the district court concluded that, even if the questions were answered in the specification, the claims were invalid if the questions were not answered in the claims. NSS appealed. &nbsp;&nbsp;



The Federal Circuit reversed on the grounds that the district court’s “unanswered questions” standard is the wrong indefiniteness standard. Citing 35 U.S.C. § 112, Ariad, Nautilus, and Phillips, the CAFC stated that the district court failed to construe the claims, review the intrinsic and extrinsic evidence, or resolve the meaning and scope of the claims. The Court then walked through the specification, prosecution history, and prior art. In analyzing the specification, the Court said “the function of the claims is not to duplicate the specification” but to (a) distinguish the prior art and (b) define the scope of protection. In reviewing the prosecution history, the Court found it significant that the patent claims had been amended to address an indefiniteness rejection and the rejection was withdrawn, stating, “[a]ctions by PTO examiners are entitled to appropriate deference . . .”&nbsp; Finally, the Court noted that the claimed invention represented an improvement over well-established prior art methods that were referenced in the patent. The well-established nature of the prior art supported the definiteness of the claims.



Judge Dyk dissented. Though the patent examiner introduced the disputed claim language, Judge Dyk noted that: (1) the claims must meet the requirements of 35 U.S.C. § 112, even if they are submitted by an examiner; (2) the claim terms at issue did not have an ordinary and customary meaning; and (3) the definition of the claim term was inconsistent with the claim language itself and not sufficiently defined in the specification.

District Court’s Indefiniteness Determination Based on “Unanswered Questions” Reversed by CAFC

Last week, the U.S. Court of Appeals for the Fifth Circuit issued an opinion in <a href="https://www.govinfo.gov/content/pkg/USCOURTS-ca5-20-50323/pdf/USCOURTS-ca5-20-50323-0.pdf" target="_blank" rel="noopener">Future Proof Brands, LLC v. Molson Coors Bev. Co.</a>, No. 20-50323 (Dec. 3, 2020), affirming the district court’s refusal to grant a preliminary injunction.



Future Proof sells hard seltzer products under its registered trademark BRIZZY. Coors began offering its own hard seltzer products under the brand VIZZY, which it asserted was an amalgamation of the product’s “two most prominent attributes: Vitamin C and fizzy.” Future Proof sued Coors for trademark infringement and moved for a preliminary injunction. The district court denied the motion, and Future Proof appealed.&nbsp;



The Fifth Circuit affirmed, agreeing with the district court that Future Proof failed to satisfy the first factor of the preliminary injunction test—substantial likelihood of success on the merits. The Court explained that the determination of likelihood of success in a trademark infringement case requires consideration of the eight “digits of confusion”: (1) the type of mark infringed, (2) the similarity of the marks, (3) the similarity of the products, (4) the identity of the retail outlets and purchasers, (5)&nbsp;the identity of the advertising media used, (6) the defendant’s intent, (7) evidence of actual confusion, and (8) the degree of care exercised by potential purchasers.



The Court analyzed the district court’s determination that digits 1, 2, 6, 7, and 8 favored denial of the injunction. As to the type of mark, the Court disagreed with the district court’s classification of the BRIZZY mark as “descriptive,” but concluded that as a “suggestive” mark BRIZZY is nevertheless “comparatively weak.” The Court further noted the significant third party usage of other “-IZZY” marks supported the district court’s conclusion that BRIZZY is a weak mark. The Court also agreed with the district court’s conclusion on lack of similarity, emphasizing the visual differences in product packaging. The Court further concluded that (1) mere awareness of another mark does not prove bad intent, and Future Proof had not presented evidence that Coors sought to derive benefit from the reputation of the BRIZZY mark; (2) while wholesalers could be considered consumers for purposes of confusion, one instance of a “fleeting mix-up” that ultimately did not sway the purchase decision does not amount to actual confusion; and (3) Future Proof’s evidence on the degree of care exercised by potential purchasers, consisting only of reference to its low price, was insufficient.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

Fifth Circuit Affirms Denial of Preliminary Injunction in Hard Seltzer Trademark Battle

Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in <a href="https://cafc.uscourts.gov/opinions-orders/22-1889.OPINION.11-6-2023_2217732.pdf">Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., 22-1889 (Nov. 6, 2023)</a>, vacating and remanding the district court’s judgment of patent infringement.



Actelion owns two patents for epoprostenol formulations, which are used to treat cardiovascular disease. The patents describe epoprostenol solutions with a high pH having improved stability compared to an earlier product called Flolan. At the center of the case was the district court’s construction of the claim term “a pH of 13 or higher”.



Actelion and Mylan both argued the claim term should be given its “plain and ordinary meaning”. Actelion argued that plain and ordinary meaning includes numbers as low as 12.5 because those numbers round to 13. According to Actelion, if a “pH of 13 or higher” was not meant to include lower numbers that round to 13, it would have been written as “13.0.” Mylan argued that the plain and ordinary meaning is limited to pHs of 13 or higher and does not include lower numbers that round to 13. Actelion cited to numerous textbooks, and both parties made arguments that the textbooks supported their respective positions. The district court did not address the extrinsic evidence, and instead decided the issue in favor of Actelion based on intrinsic evidence alone. The district court explained that “under its conventional significant figure meaning, the term ‘a pH of 13’ would ordinarily encompass those values that round up or down to 13, 12.5 to 13.4” and that the specification did not indicate an intention by Actelion to import any higher degree of precision. Under that construction of the term, the parties stipulated to judgment of infringement and Mylan appealed.



The Federal Circuit reviewed the construction of the term “pH of 13 or higher” de novo. The Court first noted that the absence of the modifier “about” was insufficient to resolve the dispute. The Court next determined that the specifications and prosecution histories of the Actelion patents did not resolve the dispute either. Rather, the Court concluded, consideration of extrinsic evidence was necessary and “the district court should have considered, at a minimum, the textbook excerpts offered and addressed by the parties.” Accordingly, the Court vacated and remanded to the district court with instructions to consider the extrinsic evidence and its impact on the proper construction of the disputed claim term.

CAFC Vacates and Remands Claim Construction for Consideration of Extrinsic Evidence

Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in <a href="http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1937.OPINION.5-28-2021_1784040.pdf" target="_blank" rel="noopener">Becton, Dickinson and Co. v. Baxter Corp. Englewood</a>, No. 20-1937 (May 28, 2021), reversing the decision of the Patent Trial and Appeal Board finding Baxter’s telepharmacy patent not invalid.&nbsp;



Baxter’s U.S. Patent No. 8,554,579 is directed to a computer system that allows a pharmacist to remotely review and verify that drug preparation steps were preformed properly before a prescription is released to a patient.&nbsp;Becton petitioned for inter partes review (IPR) asserting that Baxter’s patent claims were invalid as obvious over a combination of three prior art references:&nbsp;Alexander, Liff, and Morrison.&nbsp;In the IPR, although the Board found that a person of ordinary skill in the art (POSA) would have been motivated to combine the references and that Baxter’s evidence of secondary considerations was weak, the Board ultimately concluded that the prior art did not render obvious the “verification” and “highlighting” limitations of the challenged claims.&nbsp;Becton appealed.



Concluding that the Board’s prior art analysis lacked substantial evidence, the Federal Circuit reversed. For the “verification” step, the Court disagreed with the Board’s determination that Alexander’s use of the word “may” instead of “must” taught an optional, but not mandatory, review step.&nbsp;Applying the Board’s claim construction, the Court determined that Alexander’s use of the word “may” (in the phrase: “a remote pharmacist may verify each step. . .&nbsp; may provide an indication to a non-pharmacist…that the step was preformed correctly. . . may provide verification feedback. . .”) did not mean “occasionally,” but rather that a pharmacist may choose to systematically check each step of a non-pharmacist.&nbsp;With respect to the “highlighting” limitation, the Court determined that the Board erred by considering only what was disclosed within the four corners of Liff and failing to consider other information about what a person of ordinary creativity would have understood.&nbsp;

CAFC Reverses Board’s Prior Art Interpretation as Lacking Substantial Evidence

Chemical & Life Sciences

Licensing

Trade Secret

IP Due Diligence

Kristy N. Self

Partner

Represented a prison inmate pro bono against a prison guard for violation of 42 U.S.C. § 1983.  Part of the trial team in a three day jury trial in the Western District of Wisconsin.
Represented industrial chemical Fortune 500 company in patent litigation against competitor. Resolved case with an injunction against the competitor’s future use and admission of patent validity and enforceability.
Represented generic pharmaceutical companies in Hatch-Waxman litigation as a member of the trial team in bench trials in the District of Delaware and the District of New Jersey. The patents were either invalidated or not infringed.
Represented a Fortune 500 company in trade secret litigation against former employees. Obtained a jury verdict of willful and malicious trade secret misappropriation and breach of the employment agreements.
Represented a Fortune 500 company in patent litigation against a competitor for infection prevention technology. The case settled favorably immediately before trial.

Anneliese  S. Mayer

Negotiated technology transfer and license agreements granting rights of newly acquired sensor IP to a number of start-up and smaller organizations.
Negotiated long-term development agreements with international chemical and biological raw material suppliers.
Negotiated project-specific development agreements with global machine and packaging companies.
Drafted intercompany agreements moving intellectual property to one corporate entity and licensing the use of the intellectual property to the operating entities of the organization around the world.

Representative Projects

American Intellectual Property Law Association 
Minnesota Intellectual Property Law Association 
Licensing Executives Society

Professional Affiliations

<h3>Presentations</h3>
Presenter, IP Law for Non-IP Attorneys: Four Hot Takes On What Your Clients Need You to Know, CLE, March 12, 2020
Instructor, IP Management 7: Biotechnological/Pharmaceutical Licensing, CASRIP Patent and Intellectual Property Law and Practice Summer Institute, July 27, 2016
Panelist, IP Provisions in Employment: Contracts Protecting the Company’s Best Assets on the Front End, December 16, 2015
Panelist, Fundamental Intellectual Property Law and Related Restrictive Covenants, ABA 8th Annual Labor and Employment Law Conference, Los Angeles, CA, November 6, 2014
Panelist, IP Provisions in Employment Contracts, Midwest IP Institute, Minnesota CLE, September 26, 2013
Panelist, IP Issues in Contracts, Minnesota CLE, June 12, 2013
Panelist, IP Issues in Employment Contracts: Protecting the Company&#8217;s Best Assets on the Front End, Minnesota CLE, 2013
Presenter, Collaboration Agreements to Support Open Innovation, LES Minnesota Chapter meeting, February 19, 2013
Presenter, Practical Considerations for Development Agreements, LES Minnesota Chapter Meeting, February 9, 2010
Presenter, Your IP Portfolio, MHTA CEO Roundtable, February 5, 2010
<h3>Quoted</h3>
Quoted, Selling overseas? Know your intellectual property rights, Minnesota Business, October 2018

Anneliese S. Mayer

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