Amy Lenhert is our Latest Featured Speaker!

Our latest featured speaker is Amy Lenhert from Stone Grzegorek & Gonzalez!

Amy will be speaking at our upcoming Immigration Law Certified Legal Specialist Exam Prep course in Los Angeles on September 12th and 13th. This will be her first time speaking with us, and we’re looking forward to her presentation!

Amy Prokop Lenhert has expertise in a broad range of immigration matters and is a Certified Specialist in Immigration and Nationality Law, State Bar of California Board of Legal Specialization. She has successfully litigated cases before the U.S. Court of Appeals for the Ninth Circuit, and the U.S. District Courts of California, Nebraska, and Washington, D.C.

In addition to her federal court practice, Amy has represented clients in removal proceedings throughout the United States; assisting her clients in obtaining cancellation of removal for lawful permanent residents, cancellation of removal for nonresidents, waivers for fraud and criminal convictions, and applications for asylum. She has successfully represented clients with administrative appeals to both the Board of Immigration Appeals and the USCIS Administrative Appeals Office.

Amy also regularly represents individuals in connection with family-based visa petitions, unlawful presence waivers, applications for naturalization, and complex citizenship claims.

Amy believes strongly in the importance of giving back, and regularly provides pro bono legal services through a variety of organizations. She serves on the advisory committee for the Los Angeles office of Kids in Need of Defense (KIND), an organization dedicated to ensuring that no child appears in immigration court without legal representation.

Amy received her Juris Doctorate from Loyola Law School Los Angeles in 2003.

She is a member of the American Immigration Lawyers Association (AILA), the Los Angeles Bar Association, and the Federal Bar Association.

Nikki Mehrpoo Jacobson is our Latest Featured Speaker!

Our latest featured speaker is Nikki Mehrpoo Jacobson from The Jacobson Law Firm!

Nikki will be speaking at our upcoming Workers’ Compensation Law Certified Legal Specialist Exam Prep course in Los Angeles on September 19th and 20th. We’re looking forward to your first presentation with us, Nikki!

Nikki Mehrpoo Jacobson has achieved dual certification by the California State Bar Board of Legal Specialization as a legal specialist in Workers’ Compensation and Immigration & Nationality Law. This achievement makes attorney Jacobson the only lawyer with this dual certification in the state of California.

Ms. Jacobson is a nationally and internationally recognized speaker, legal analyst, media commentator, expert witness, lobbyist and legal consultant in immigration and workers’ compensation law. She regularly shares her valuable insight in France on France 5, in Iran on KIRN 670 AM, and in Denmark on Ekstra Bladet, as well as Business Insurance, WCAuthority.com and WorkersCompensation.com, analyzing high-profile cases, court decisions and legal issues. She currently represents clients assisting the Department of Homeland Security and the Federal Bureau of Investigations with matters of national security.

As a dual-certified specialist, attorney Jacobson is uniquely qualified to handle catastrophic orthopedic and neurological work-injury cases, and complex employment and family-based immigration matters. She has developed a special niche in the cases where her clients’ immigration status and employment matters intersect. For example, these cases can involve workers who are victims of a crime at work, or who are undocumented and have suffered work injuries.

Ms. Jacobson is a Commissioner on the California State Bar Workers’ Compensation Law Advisory Commission, on the Board of Directors for the California Applicants’ Attorneys Association (CAAA) and an active member of the American Immigration Lawyer’s Association (AILA). Ms. Jacobson is also Professor of Law at West Los Angeles College, published academic, and a distinguished lecturer on the rights of injured workers and immigrants. Attorney Jacobson is an editor and contributing author of several legal publications, including Navigating The Fundamentals of Immigration Law (2016–17 Ed.) and Immigration Practice Toolbox, Third and Fourth Editions.

As a refugee from Iran, she understands the issues and hardships her clients face every day. Ms. Jacobson is committed to giving voice to the voiceless and to insure that people are heard. She is a dedicated LGBTQ ally and is committed to representing members of the LGBTQ community with their asylum claims.

Her adherence to legal ethics and superior skills has earned her the highest rating of AV Preeminent from Martindale-Hubbell. In 2015 through 2019, she was designated a “Top Rated Immigration and Workers’ Compensation Attorney in Los Angeles” by Super Lawyer and in 2009 through 2012 she was named Super Lawyers’ Southern California Rising Star, an honor bestowed on attorneys in California who excel in the practice of law. She is also rated “Superb” by AVVO.

Beyond Writing: The Foundations of an Effective Brief

Honey Kessler Amado recently shared her expertise with us in our How to Write a Better Appellate Brief webinar. In this article, she shares some more expertise on the subject!

Our adversarial system is based on the belief that “the fairest results and the best rules of law are discovered by the vigorous presentation of opposing viewpoints.” In trial and appellate advocacy the primary presentation is done through written briefs, which are only as effective as they are helpful. The effective brief requires outlining, writing, and editing, and is grounded in thorough research.

Research identifies the essential elements of the case, which dictate what facts need to be developed in the trial court and emphasized in the appellate brief. Research also identifies the relevant case law, both those cases most factually relevant, which likely will become the core authorities for the arguments, and those directly adverse to the case, which must be discussed and distinguished. And research identifies any “magic language” of an issue which appears repeatedly in published opinions and which, for persuasive advocacy, should appear in the briefs.

This legal foundation helps to frame the core question being presented to the court. Bryan Garner calls the core issue, the “deep issue.” He explains that the deep issue is concrete: it “sums up a case in a nutshell.” Determining the core issue leads to tighter, more cogent writing because it establishes the context for the facts and the arguments. It is especially important to spend time thinking about and crafting a statement of the issue because the one who controls the issue generally prevails! The importance of properly stating the issue raised on appeal cannot be overemphasized. Indeed, some would say that they would take either side of any case as long as they could pick the issues.

The Outline

After the research and conceptualization, the actual writing begins with an outline.

The outline is the blueprint for each section of the brief or memorandum of points and authorities. Writing “off the top of one’s head” leads to circular arguments and redundancy because the writing has begun before the thinking is completed. Justice Thomas Hollenhorst of the California Court of Appeal speaks of some briefs as “whirly-bird briefs” which seem to start in the middle of the story and go in circles or disconnected tangents, giving the court no guidance or direction. An outline prevents such a brief.

The outline should begin with listing the key facts for the Statement of Facts and legal authorities for the Argument – without regard for organization. After this free-floating list is completed, then the order in which to address each point can be determined. The informal listing of the facts and arguments allows for developing ideas from a broad perspective. Related themes and ideas become apparent and enable critical analysis: which cases should be cited for which idea, which ideas are weak or flawed or need further development, and which progression of the facts or arguments would be most persuasive.

The outlining process is where the struggle with the facts and the law is engaged. The outline directs how to tell the story of the case effectively. Which facts should be highlighted, which go first, which must be understood before other facts will make sense, which are irrelevant. For appellate briefs, California Rules of Court require that all factual statements be supported by references to the record. This rule serves two important functions: it enables the court and opposing counsel to verify the factual statements easily, and it “protects the court and opposing counsel from unfounded assertions of fact.” In preparing the outline, counsel should work closely with the record to be scrupulously certain that the factual statements are correct. For pleadings in the trial court, the commitment to stating the facts correctly should be no less scrupulous.

As to the legal argument, the outlining phase is where inconsistent cases can be reconciled and troublesome cases can be distinguished. The outline is where ideas are expanded, such as borrowing from other areas of law to resolve an issue or to suggest how the law might be developed. The outline is where the holes in reasoning are exposed and resolved.

Beware the temptation to take language out of context to make a point. On this, Justice Arthur Gilbert of the California Court of Appeal is compelling. Quoting William Shakespeare, “‘[e]ven ‘[t]he devil can cite scripture for his purpose…,’” Justice Gilbert cautions against misconstruing an opinion to make it applicable to the client’s case. “[S]ome misimpressions are created by the reader or critic who takes a sentence or paragraph from an opinion, sometimes out of context, and analyzes it as a Shakespeare scholar would, or as though it were a verse from Holy Writ, discovering hidden meanings, innuendoes, and subtleties never intended.” As to extending the holding of a case to fit an argument, alluding to the Cheshire Cat of Alice in Wonderland, Justice Gilbert noted, “The reader who distinguishes between facts germane to the holding, and those that are not, can assess the reasonable extensions of the holding. A reader must realistically appraise what he or she reads and resist the temptation to see a grin without a cat. Ultimately this approach is more effective to advance a client’s cause and the cause of justice.”

And beware the temptation to omit an unfavorable case. Counsel have an obligation to cite decisions that are “directly adverse” to any proposition of law that counsel advocates or which would be “reasonably important” to a judge deciding the case. To omit such holdings is a misrepresentation of the law, “tantamount to making a false statement of the law.” The duty to cite adverse authority is part of the attorney’s duty of candor. Candor includes the obligation to disclose legal authorities that the court should consider when making a decision “even when these authorities are adverse to the lawyer’s position.”

Some say that writing is organic. Outlining is a substantial part of that process, perhaps the most creative part; but surely the part that prevents the paralysis induced by the blank page! Writing may be organic, but well-organized, persuasive briefs do not spring up from the pages without careful thinking and planning.

The Drafting

The act of writing – the drafting– begins only when the brainstorming and outlining is complete. The brief or memorandum of points and authorities generally should contain an Introduction, a Statement of Facts, a Legal Argument, and a Conclusion. (An appellate brief should also include a Statement of Issues.) The introduction is a summary of the position presented. It serves to focus the reader. A good introduction should include a very short summary of the critical facts; the core issue, stated explicitly in terms of the pertinent legal rule or requirement, and the answer, applying the relevant rule or rules with a stated reason. The introduction can be a few sentences, but should not be longer than a few paragraphs. A long introduction is likely to contain too much information and will have no context. In effect, the court will be reading in a vacuum, which will squander the court’s attention and patience!

The Statement of Facts should tell “the story” of the case. Everyone enjoys and remembers stories. In telling the story, do not simply string facts together or recite the dry testimony of each witness. Weave a coherent story from the facts, perhaps taking bits from different testimony or evidence. In an appellate brief, barring a specific reason to the contrary, the order in which the facts were presented in the trial need not dictate the way the story is told. Similarly, in preparing legal memoranda for the trial court, the facts can be gleaned from the supporting declarations or deposition transcripts, but need not be told through dry references to each source.

When referencing the parties, first identify them by their positions in the litigation (for example, “plaintiff” in the trial court, “appellant” in the review court) and thereafter use a name or title which is helpful to telling the story. If using an abbreviation, it should be defined in its first use. And use only well-known initial abbreviations, such as BofA for Bank of America or CEO for Chief Executive Officer. Beware of a false economy of abbreviations. Few things are more irritating to a reader or distracting to the story than getting lost in a haze of meaningless abbreviations. If the plaintiff is ABC Hardware Store, which subleased space to XYZ Landscaping, and the defendant is Able Suppliers, it will not take long before ABC is confused with XYZ or with Able and the reading slows as the reader pauses – a second or two – to recall who is who or which is which. It would be clearer and reinforces the parties to use shortened names like “Hardware Store,” “Landscaping,” and “Suppliers.” As the reader of the brief is the court, the reader is the last one who should be distracted, lost, or annoyed!

The Statement of Facts should be objective. Compelling facts should carry the story without vilifying or denigrating the opposition or the lower court. Therefore, avoid “screaming” adjectives and adverbs intended to convey an intensity of feelings or indignation. Such adjectives and adverbs are not persuasive. “[O]verheated rhetoric is unpersuasive and ill-advised. Righteous indignation is no substitute for a well-reasoned argument.” Indeed, courts generally dislike the tenor of such pleadings. “Counsel violates the cardinal rule of effective appellate legal writing when he or she disparages the lower court. Even in zealous advocacy, attorneys are required to maintain respect to the courts of justice.” Similarly, refrain from disparaging opposing counsel or the opposing party. If the facts or challenged rulings are bad, the trial or review court will see that without the colorful adjectives or adverbs pointing the way.

In the declarations or Statement of Facts, use headings to indicate the relevant topic. Headings signal that the topic has changed. When the reader is looking for that point again, the reader can easily find it. Also, headings provide natural white space on the page, giving the reader some relief from what otherwise appears to be dense text.

Similarly, in the Legal Argument, use headnotes to separate the various points in the argument. Good headnotes and sub-headings serve a number of purposes: first, they give the reader cues that aid comprehension. The reader immediately knows the subject or point of the section. Second, headnotes help make a long brief or argument digestible. The reader is not overwhelmed with pages of text, with no visual breaks and no markers indicating a new point.

Third, headnotes assist the writer by exposing organizational weaknesses in the Argument section and by exposing where sections have mixed ideas which need to be treated separately. (Be certain that the argument under the headnote relates to that headnote only, and use sub-sections within a headnote to underscore a discrete point or to signal a sub-topic.) Fourth, headnotes serve as a useful summary of the arguments when set out in the Table of Contents. The reader can quickly and easily see the direction and key elements of the argument from the headnotes and sub-topic headlines.

When addressing a complex topic that has its own jargon, always define the terms and always assume that the reader does not know the subject. Defining terms helps the reader understand the discussion. A simple explanation of the language, concepts, or theories of the topic will add substance to the written discussion.

The Conclusion should state the major points – in a phrase or two – and should state the ruling or relief being sought. For example, “For the reasons stated, that the motion is untimely, that it fails to meet the requirements of the statutes, and that the relief requested is unwarranted, Petitioner requests that Respondent’s motion for reconsideration be denied in entirety.” Or, “For the reasons stated, that the evidence supports the factual findings of the court, that the court considered the required, statutory factors for granting spousal support, and that the amount awarded for spousal support was not an abuse of discretion, Respondent requests that the Order be affirmed in entirety.”

The Editing

The final component of clear, concise writing is editing. This part, like the outlining, can take almost as long as the initial writing! Edit for clarity and organization: do the central points stand out? Does the Statement of Facts tell a coherent story? Does it include unnecessary, extraneous information? If so, eliminate the non-essential points. To paraphrase Anton Checkhov: If the rifle on the wall is not the murder weapon, don’t discuss the rifle. It makes little sense to ask the reader to retain useless information.   Does the Legal Argument present consistent arguments? Do they follow a reasoned progression? Are key points buried in words or presented too late in the brief?

Edit for grammar and word usage. Mistakes in this area are irritating and can distract from the effectiveness of the brief.   Edit for length. Consider that “[e]ye fatigue and irritability set in well before page 50.” Indeed they do!

The purpose of a brief is to enlighten the court and elucidate the issues. The well-written brief can be the difference between winning and losing. It leans towards winning when it is a pleasure to read.

Judge Mary Thornton House is our Latest Featured Speaker!

Our latest featured speaker is Judge Mary Thornton House (Ret.) from Alternative Resolution Centers!

Judge House will be speaking at our upcoming Estate Planning, Trust and Probate Law Certified Legal Specialist Exam Prep course in Los Angeles on September 19th and 20th. Most recently, she spoke at our Trusts and Estates 101 seminar where she received rave reviews from our attendees. Welcome back, Judge House!

Judge House recently retired after 22 years on the Los Angeles Superior Court, where she presided over countless jury and court trials in the Civil and Probate departments. With experience serving as the Supervising Judge of the Northeast and North Central districts, Hub Operations and Assistant Supervising Judge of Civil countywide, Judge House brings a unique and in-depth understanding of all aspects of civil case processing and case values.

Judge House was the first Municipal Court Judge to become a Supervising Judge for the Superior Court in the Northeast District. Elevated in 2000, she presided over mandatory settlement conferences in both limited and general civil matters, reducing the civil caseloads throughout the Northeast and North Central Districts.

In 2004, she moved to a Civil direct calendar court at the Mosk Courthouse, handling civil matters including personal injury, contract, employment, professional malpractice, asbestos and products liability. She routinely conducted successful settlement conferences for her colleagues and her own matters. She returned to Pasadena in 2010, presiding over Probate and Family/Civil harassment cases. In 2016, she returned to a downtown Probate Department for two years before retiring in 2018.

Prior to her appointment to the bench, Judge House was an Assistant City Attorney for the City of Los Angeles. Initially, she was a criminal prosecutor, but transferred to the civil branch to defend lawsuits against the City and its employees. Her last five years included advising the Los Angeles City Council, Police Commission and Fire Commission. She successfully defended the City’s Police and Fire departments in highdollar-value and high-profile cases in both federal and state courts.

Elizabeth Roberson is our Latest Featured Speaker!

Our latest featured speaker is Elizabeth Roberson!

Elizabeth will be speaking at our upcoming Tax Law Certified Legal Specialist Exam Prep course in Los Angeles on August 22nd and 23rd. We’re so excited for her to join us!

Prior to starting her own firm, Elizabeth worked with a financial services company where she represented the company’s clients before the Internal Revenue Service and several of the state taxing authorities throughout the nation. Elizabeth successfully negotiated Offer in Compromise settlements on behalf of her clients, and she has also obtained successful results through audit representation, audit reconsideration, innocent spouse relief, partial pay installment agreements, installment agreements, and penalty abatement for her clients. Elizabeth also has experience in Real Estate Contracts, Mortgage, Collections, Bankruptcy, and Criminal Defense.

Elizabeth obtained her undergraduate degree in Psychology from California State University, Northridge with honors. She received her Juris Doctorate degree from the University of West Los Angeles, School of Law cum laude. While in law school, she received eight Witkin Legal Institute Awards for academic achievement in various subjects, and she also received a Scholarship for her excellent academic achievement in the subject of Evidence. Elizabeth was admitted to the California State Bar in June of 2012. She is also admitted to practice before the United States Tax Court and the United States District Court, Central District of California.

It’s Complicated, Part 2: Life Technologies Corporation v. Promega Corporation

Adrienne Naumann recently spoke for our United States Federal Intellectual Property Developments 2018-2019 Webinar, offering her expertise for both the webinar and the corresponding E-Book. She established her own practice in 1996, exclusively focusing on intellectual property law. We’re glad to share the second article in her series here!

In Life Technologies Corporation et al. v. Promega Corporation, 137 S. Ct. 732 (2017) [hereinafter ‘Life Technologies’ and ‘Promega’] the U.S. Supreme Court [hereinafter ‘the Court’] held that U.S. patent infringement liability does not result from (i) a single non-innovative component that (ii) originates from the United States for assembly abroad. The statutory provision was 35 U.S.C. section 271(f)(1) which states that patent infringement liability exists where all or a substantial number of components of a patented technology originate from the United States for assembly in another country. In contrast, section 271(f)(2) provides liability resulting from a newly designed single U.S. component without significant non-infringing uses. Because of its potential economic consequences, all U.S. based manufacturers with international facilities should be aware of this case prior to assembly and production related business decisions.

Promega is an exclusive licensee of a U.S. patented technology for genetic testing kits. Life Technologies sublicensed this patented technology from Promega for specified limited utilities of genetic testing kits. Life Technologies manufactured one kit component in the U.S. (a previously existing widely used enzyme) and sent this component abroad for assembly with remaining components. Life Technologies then sold these kits abroad for utilities which were not authorized under Promega’s sublicensing agreement. Promega filed a patent infringement lawsuit against Life Technologies, based upon sales of kits that included this single component enzyme from the United States. The trial court granted judgment to Life Technologies, because (i) only one component of Promega’s multi-component patented technology originated from the U. S., but (ii) all or a substantial number of components must originate from the U.S for liability under section 271(f)(1). The court also stated that subsection 271(f)(2) does not apply, because the single U.S. component enzyme was a previously existing ‘commodity’ item.

However, the Federal Court of Appeals for the Federal Circuit [hereinafter ‘the Federal Circuit’] reversed the trial court and concluded that ‘all or a substantial portion’ could be either of (i) a qualitatively important component or (ii) a quantitative number of components. The court concluded that in this case the single enzyme originating from the U.S. was qualitatively a substantial potion because (i) it was important to the utility of the entire invention, and (ii) even though this enzyme was a ‘commodity’ component with numerous non-infringing uses.

The Court concluded that the quantitative interpretation of section 271(f)(1) is the exclusive meaning of section 271(f)(1), and thereby reversed the Federal Circuit’s holding. To reach its decision the Court reviewed the statutory words such as ‘all’ and ‘portion’, and concluded that the statute exclusively conveyed a quantitative meaning. The Court reasoned that under the quantitative approach, a single component cannot constitute a ‘substantial portion,’ because section 271(f)(1) consistently refers to plural components, and thereby indicates that multiple components comprise a substantial portion. The Court also observed that interpreting section 271(f)(1) to include any single component results in section 271(f) (2) becoming superfluous. The Court further stated that requiring a fact finder to resolve infringement under either a qualitative or quantitative approach would compound any ambiguity of section 271(f)(1). Finally, the Court found that it was Congress’ intent to hold a supplier liable for sending U.S. components to another country for assembly, but only under the explicit conditions of section 271(f). In sum, for the present case where only a single commodity enzyme originated from the United Sates, Life Technologies’ activity is outside the scope of section 271(f).

Dorian Peters is our Latest Featured Speaker!

Our latest featured speaker is Dorian Peters!

Dorian will be speaking at our upcoming Criminal Law Certified Legal Specialist Exam Prep course in Oakland on August 8th and 9th. This will be Dorian’s first time speaking with us, and we’re looking forward to it!

Dorian A. Peters is an East Bay native, born and raised in Berkeley. He began his education at Diablo Valley College in Pleasant Hill, and then transferred to UC Berkeley, where he double majored in political science and mass communications. Go Bears! Through UC Berkeley, he was able to serve as a press and policy intern in Congresswoman Barbara Lee’s office in Washington, D.C.

Dorian then traveled to Nashville, Tennessee, to attend Vanderbilt Law School, where he participated in the moot court and mock trial programs. He had the opportunity to intern in the chambers of U.S. District Court Judge Kenneth Hoyt in Houston, Texas, and he also worked as a law clerk for the Metropolitan Nashville Public Defender’s Office, the U.S. Attorney’s Office in Nashville and the Contra Costa County District Attorney’s Office. Upon graduation, he became a prosecutor in the CCC District Attorney’s Office, where he tried about 35 cases to a jury and worked in several units.

One of the highlights of his career was a brief stint at the California Department of Corrections and Rehabilitation as part of the Employment Advocacy and Prosecution Team, where he investigated and litigated employee misconduct matters in front of the State Personnel Board. After that, he went into private practice, focusing mostly on criminal defense work.

He is active in many different parts of the Contra Costa County Bar Association. Currently, he serves as a committee member and a panelist on the Criminal Conflict Program, a volunteer fee arbitrator for both the CCCBA and the State Bar, and a CCCBA delegate to the California Conference of Bar Associations. Dorian participates in the Robert G. McGrath American Inn of Court and also served as a board member of the Barristers Section, where he assisted in the drafting of the current bylaws.

Outside of the CCCBA, he is a member of the Leadership Council for the nonprofit Center for Youth Development through Law, a pipeline program focused on exposing under-privileged youth to the legal system, and encouraging them to attend college and pursue careers as attorneys.

Edgar Saenz is our Latest Featured Speaker!

Our latest featured speaker is Edgar Saenz!

Edgar will be speaking at our upcoming Estate Planning, Trust and Probate Law Certified Legal Specialist Exam Prep course in Los Angeles on September 19th and 20th. He has spoken for us several times, including at this year’s Trusts and Estates 101 course. Welcome back, Edgar!

Edgar Saenz is a California Certified Specialist in Estate Planning, Trust & Probate Law practicing in Westchester, Los Angeles. He is a graduate of Stanford Law School (JD ’86) and St. Mary’s University (BA ’83, magna cum laude).

He serves on numerous community and professional boards, including past president of the Westchester Rotary Club (2013-2014) and board member of the LAX Area Chamber of Commerce. Edgar is rated AV by Martindale Hubbell.

Edgar has performed pro bono legal services for the Los Angeles Center for Law and Justice and other nonprofits, and has been a judge pro tem with the Los Angeles County Superior Court.

It’s Complicated, Part 1: Amgen v. Sandoz

Adrienne Naumann recently spoke for our United States Federal Intellectual Property Developments 2018-2019 Webinar, offering her expertise for both the webinar and the corresponding E-Book. She established her own practice in 1996, exclusively focusing on intellectual property law. We’re so glad to be able to share her article here!

In Amgen, Inc. v. Sandoz, Inc., 137 S. Ct. 1664 (2017) the U.S. Supreme Court [hereinafter the Court] held that an applicant need not disclose certain technical information to another company under the federal abbreviated drug approval process. See 42 U.SC. sections 262(k) and 262(l). The Court also held that an injunction is not available to enforce compliance with this specific federal disclosure requirement. Under this abbreviated process an applicant may obtain a license for commercial marketing of its pharmaceutical product, if its pharmaceutical is (i) derived from living organisms and (ii) sufficiently similar to a licensed pharmaceutical that had undergone the traditional approval process. The traditional process requires numerous clinical tests and other technical data by a ‘sponsor,’ so there is a strong incentive for an applicant to ‘piggyback’ on the sponsor’s submissions under the abbreviated process. Also during the abbreviated process, the two companies may determine whether the sponsor’s patents would be infringed prior to the applicant’s pharmaceutical’s manufactured and sales. The statute expressly provides a remedy of an immediate declaratory judgment to the sponsor if the applicant does not disclose its FDA licensing application and manufacturing information to the sponsor.

In the instant case, Amgen was the sponsor with a traditionally licensed protein to stimulate white blood cell production. Sandoz submitted an abbreviated approval application for a biosimilar product, but it refused to disclose its application or manufacturing information to Amgen. Thereafter Amgen filed a lawsuit against Sandoz for patent infringement, conversion and unfair competition, but the trial court dismissed these counts. The U.S. Court of Appeals for the Federal Circuit [hereinafter the Federal Circuit] affirmed and held that Sandoz need not disclose the licensing application or manufacturing information to Amgen. It also held that there was no injunction available for compliance with this particular disclosure.

Before the Court, Amgen contended in part that the term “shall” of the statute conclusively demonstrates that disclosure of a licensing application and manufacturing information is mandatory. Amgen also contended that merely because the statute did not expressly include an injunction as a remedy did not preclude its use. However, Sandoz contended that non-disclosure was simply a conditional precedent that results in forfeiture of litigation rights to the sponsor. Sandoz further stated that injunctions were not explicitly included as a remedy for this non-disclosure, whereas in other statutory provisions an injunction was included as a remedy. The Court agreed with Sandoz on both these points. However, it also concluded that although an injunction was not an option under the federal statute, it may be a remedy under the state law count of unfair competition. The Court then remanded the case to the Federal Circuit to determine whether Sandoz’s non-disclosure constitutes unfair competition under state law, and it so whether an injunction was possible.

 

[1] Another issue before the Court was whether the applicant may provide the notice of initial commercial marketing to the sponsor prior to FDA licensing. The Court reversed the Federal Circuit which had previously held that notice must be provided only after the applicant actually receives its license. Instead the Court squarely held that notice may be provided either before or after actual receipt of the license.

Susan Han is our Latest Featured Speaker!

Our latest featured speaker is Susan Han from Han Law Group!

Susan will be speaking at our upcoming Immigration Law Certified Legal Specialist Exam Prep course in Los Angeles on September 12th and 13th. She has spoken for us several times, including at our Visa Processing seminar in 2017. We’re glad to have you with us again, Susan!

Ms. Han has extensive experience in Immigration Law and Criminal Law, and is a Certified Legal Specialist in Immigration & Nationality Law. Ms. Han has been practicing immigration law since 1998 and has successfully represented hundreds of clients before the U.S. Citizenship and Immigration Services (USCIS – formerly INS), the Immigration Court and the Appeals Board and Courts. She has vast experience in handling all aspects of immigration law including family-based petitions, business immigration, deportation and removal, asylum, citizenship and naturalization, and appeals at all levels. Ms. Han received her Bachelor of Arts degree in English Literature and Creative Writing from the University of California, Santa Barbara. She graduated with a Juris Doctor degree from Southwestern University School of Law where she earned the American Jurisprudence Award in Constitutional Law. In addition to her practice, Ms. Han had been an adjunct professor at California State University, Los Angeles, where she taught Immigration Law for the Paralegal Program.