Biogen fends off Mylan’s challenge to patent on top-selling multiple sclerosis drug – MedCity News

Shares of Biogen soared Wednesday afternoon following a decision by a special court under the U.S. Patent and Trademark Office upholding its patent on a multiple sclerosis drug.

In a 56-page decision, the Patent Trial and Appeal Board ruled against Pittsburgh-based generic drugmaker Mylan’s effort to overturn the patent covering the 480mg dose of Cambridge, Massachusetts-based Biogen’s drug Tecfidera (dimethyl fumarate). Mylan had filed an inter partes review, or IPR, in 2018. Mylan had argued that claims in a key patent covering the drug, U.S. Patent No. 8,399,514 – also known as the ‘514 patent – were “obvious” and thus not patentable.

Biogen’s shares rose 25% on the Nasdaq immediately following the court’s decision and were still more than 20% higher than their Wednesday closing price late Thursday morning. Tecfidera’s patent expires in February 2028. The drug had sales of more than $4.4 billion in 2019, according to the company’s earnings report.

“Mylan strongly disagrees with the decision and plans to pursue all available options for appeal,” an emailed statement from Mylan read, noting that the company is challenging Tecfidera’s patent protection in the District Court of West Virginia, while other generic drugmakers are doing the same in Delaware.

In a note to investors Wednesday, Cowen analyst Phil Nadeau called the PTAB’s decision a “major positive” for Biogen that greatly increased the chances that Tecfidera would not face generic competition until late in the decade. On the other hand, he noted, the other cases in Delaware and West Virginia district courts challenging the drug’s exclusivity and patent are ongoing. However, it seemed based on the IPR that Mylan would not likely be able to reverse the PTAB decision, which could also bolster Biogen’s chances in the district courts.

BTIG analyst Thomas Shrader wrote that the PTAB’s decision was as one might expect, and his firm had forecast with an 80% likelihood that the court would rule in Biogen’s favor. Baird analyst Brian Skorney called the PTAB’s decision a “clear positive” for Biogen and concurred that it would bolster the biotech company’s chances in the district courts.

With the IPR out of the way, Skorney wrote that investors’ focus will shift to Biogen’s investigational Alzheimer’s disease drug, aducanumab. Biogen is seeking Food and Drug Administration approval for the drug, which targets amyloid beta, after a review of clinical data indicated it was able to treat the disease despite an earlier decision to halt the drug’s Phase III studies for futility.

Photo: Getty Images

Product Counsel In 2020

Join Axiom and Above the Law for our webinar, Product Counsel in 2020. Our panel of product counsel leaders from WhatsApp, PayPal, and Axiom will weigh in on what it means to be product counsel in the technology industry in 2020, hottest issues in the field, and practical career advice for breaking in or continuing to develop.

Webinar
Date: February 26th, 2020
Time: 2 p.m. ET / 11 a.m. PT

We will tackle questions such as:

  • What does it mean to be a product counsel in the technology industry?
  • What are the major issues you face in your job, and dos and don’ts of navigating these issues?
  • How does product counsel think?
  • What certifications and technical skills should you focus on?
  • How do hiring managers think about the necessary skills for product counsel?

Moderator:
– Dave Feldman, Director, Product Offerings at Axiom
Panelists:
– Tina Hwang, Legal Director & Associate General Counsel, WhatsApp
– Mark Schneider, Axiom Lawyer, Tech Industry
– Ben Adams, Vice President, Legal at PayPal

Can’t make the live event? Register anyway and webcast will be available on-demand 24 hours after the live event.

Make Money Mondays, Superbowl Edition: Always Bring Your Best Game No Matter Who’s Watching

Though I’ve never been much of a sports fan, football least of all, I feel compelled to turn on the Superbowl (if not watch it) just so that I can participate in Monday morning conversations. For that reason, I am probably the last person on earth to have learned about Katie Sowers, an assistant coach for the San Francisco 49’rs who made history as the first woman to coach an NFL team in the Superbowl.  

Now, again – as a non-football fan, what Sowers actually does as a coach on a day to day basis doesn’t hold much interest for me. But I was captivated by the story of how Sowers as a woman ascended to the top of the game in football – and it’s a story that holds valuable lessons for any struggling solo or small firm lawyer — male or female — stumbling along the Sisyphysian path to greatness. 

According to this New York Times profile, Sower found her path to the NFL in the most unlikely of places: as a coach for a fifth-grade basketball team in Kansas City, Missouri.  But Sower took her role seriously and soon caught the eye of Scott Pioli who had been General Manager of the Kansas City Chiefs and whose daughter played on Sower’s team.  Pioli saw that Sower took coaching seriously and as the two became friendly, Pioli also learned of Sowers’ interest in coaching football. She just needed an opportunity which came in the form of the Bill Walsh Diversity Coaching fellowship program for which Pioli recommended Sowers. After the fellowship, Sowers was offered a 10-month NFL internship that paid $10 an hour.  So Pioli stepped in to pay Sowers’ rent so she could take the position and afford the mortgage. Once Sowers secured those opportunities, she worked to prove herself, eventually catching the eye of 49’rs coach Kyle Shanahan who hired her.

So what does all of this have to do with running a solo or small practice? First, you never know where you may find an opportunity that will catapult you forward in your career – so it’s important to always be on.  For example, if you agree to give a CLE presentation or speak at a bar association, don’t just roll in the day of with a canned powerpoint. Instead, if you’re going to do it, do it right: practice your presentation and supplement it with case law summaries and other useful materials so that a participant has an opportunity to experience the quality of your work.  When you show up for even a routine court hearing, be prepared and present yourself so that everyone in the courtroom takes notice and you come to mind for a future case.

Second, like Sowers, recognize that the path to opportunity isn’t always obvious or a direct line. When I started my career, I threw my heart into pro bono work for the Washington Legal Clinic for the Homeless, eventually winning a service award. Turned out that a partner at a prominent energy law firm served on the Board and the awards event gave me an opportunity to introduce myself which resulted in an of counsel position.  Likewise, if you serve on a PTA committee or coach a sports team, you could wind up impressing a corporate CEO or a small business client or a dad who needs a family law attorney with your organizational or marketing or leadership skills just by doing a kickass job of running an email list or persuading local vendors to sponsor events.  

Of course, serendipity can find you even outside of an organized event, when you’re simply out in the world.  A decade ago, I shared this great story of how a chatty lawyer who walked into Staples to buy a fax machine struck up a conversation with a clerk and wound up helping him  reconnect with his energy-tycoon father and secure his rights to the Duke Trust.

Whether online or offline, connection is powerful and can transform every day into an opportunity. But to use a sports analogy, opportunities arise only when you treat every day like game day, rather than a time out on the sidelines. What will you do to bring your best game today?

Fund Manager Got Pre-Approval For All That Alleged Fraud And Self-Dealing, Fund Manager Says

Law School Reverse Discrimination Lawsuit Alleges Bonkers Details About The School

Richard Faulkner is a former professor at Chapman University School of Law. He worked there from 2007 through 2018, and piloted the academic achievement program. In November, he filed a lawsuit against the school alleging breach of express employment agreement, discrimination on the basis of gender and political affiliation, wrongful constructive discharge, and breach of the covenant of good faith and fair dealing.

According to the complaint, Faulkner’s employment at the law school took a turn for the worse after Matt Parlow became dean in 2016. The complaint alleges Parlow demanded Faulkner work over the summer — despite a 10-month academic employment contract — that Faulkner was micromanaged and harassed; that his role was moved to an administrative one; and that he was relieved of teaching responsibilities. Faulker further alleges that his gender and political believes (as a socialist) were factors in his treatment at the law school.

The complaint’s allegation of reverse gender discrimination revolves around Faulkner’s claim that Parlow systematically replaced experienced male staff with women, who the complaint disturbingly refers to as “pliant”:

In the summer of 2016, Dean Matt Parlow began is tenure as Dean of the Law School. Quickly, it became apparent that he would not tolerate any challenge to his authority either actual or perceived. Also, any staff member who appeared more experienced or knowledgeable than Parlow in any context was quickly marginalized and/or replaced by someone with less experience and a deferential or grateful attitude toward Parlow. If Parlow determined a staff or faculty member was a threat to him or his image in any way, they would be removed and replaced with a younger, pliant female employee unlikely to challenge Parlow.

The complaint also details an example of a woman associate dean being replaced by another woman, though there’s no explanation of how this fits into the alleged scheme of gender discrimination.

To further illustrate the alleged reverse gender discrimination at the law school, the complaint goes on to describe the treatment of two different professors, that plaintiff believes shows discriminatory intent. The complaint alleges a female professor is allowed to keep a photograph of a former student’s testicles on her desk:

The great disparity between the treatment of make and female employees at the law school is best illustrated by the following example. A female faculty member has, in pride of place [sic] on her desk, a picture of testicles of one of her former students. This is widely known among students, faculty and staff alike. At one point, due to a complaint made to the administration, she put the picture of the student’s testicles away in a drawer, but after some time she put the picture back on her desk. There, where she regularly meets with students and other faculty and staff members, sits the picture of a pair of her student’s testicles, and she suffers no consequences. In fact, Parlow gave her a large amount of donor money for her program the second year of his deanship.

There are so many unanswered questions about this. Is the picture an artistic shot? How do people know it was a former student’s testicles? Was the pic sent to the professor unsolicited? Was there a relationship between student and professor? Does the person behind the testicles know about/consent to the display of the photo? Why would anyone decorate with testicles?

The complaint then goes on to compare this situation with a male professor the complaint says was falsely accused of impropriety:

In stark contrast, a male faculty member was physically removed from the building under the supervision of two senior administrators, one of whom was Parlow, upon the receipt of unsubstantiated allegations against this male faculty member. This is worth restating: a female faculty member with brazen pictographic evidence of impropriety received donor funds to expand her program, and a male faculty member who was wrongfully accused and later exonerated was marched from the building like a criminal. Chapman’s general practice with unsubstantiated claims is to restrict the faculty member’s access to the person who made the claims until an investigation is complete. The person is not summarily removed from campus. He or she does not lose access privileges to campus buildings. However, under Parlow this male faculty member, was removed from the building, he lost key-card access to that building and the two young, pliant females who fabricated the allegations against him were given his job responsibilities.

Without knowing the nature of the allegations against the unnamed professor, it is hard to judge the school’s alleged reaction. Was there a difference in the severity of the allegations in this case? Were there multiple accusers in the other cases? And without those additional details the complaint reads like comparing apples and tablecloths. But its still a fascinating read into what is allegedly going on at Chapman.

Speaking of interesting tales to tell, the complaint also alleges that Dean Parlow has reason outside gender and political leanings to act against Faulkner. The complaint alleges Faulkner caught Parlow in a lie. No, it wasn’t some academic issue involved, but a dustup over a student-organized softball game:

In 2008, when Parlow was a Professor at Chapman Law, he and Plaintiff both participated in a student-organized softball tournament. During this tournament, Professor Parlow got into a verbal altercation with another faculty member playing on the opposing team. The altercation very nearly came to blows, and Plaintiff along with several students pulled these two faculty members apart. Plaintiff had anonymously recounted this story to the Dean’s Search Committee as an illustration of his and other faculty members’ concern that Parlow lacked the judgment and temperament to make a suitable dean. When the Dean’s Search Committee asked Parlow about the softball incident, he did not just try to minimize its importance, he flatly denied that it happened. He said that whoever told the story was a liar and suggested it was a false accusation politically motivated to keep him from becoming the dean. The Dean’s Search Committee then asked Plaintiff to publicly recount his story because the anonymous report would not carry the same weight as it would with his name attached to it. The Dean’s Search Committee also warned Plaintiff that if he did come forward and Parlow still became the dean that they believed Parlow would retaliate against him. Nevertheless, Plaintiff publicly told his story and another faculty member independently verified the softball incident by speaking with several people who corroborated Plaintiff’s version of the events. Marlow was ultimately recommended by the faculty as the first choice for the Dean by a two-vote margin in spite of lying about the incident.

All in all, these are some inflammatory allegations that paint a real picture of the law school. Though, it should be noted, the litigation is still in the very early stages.

Chapman University was contacted for this story, but said they were unable to comment on ongoing litigation.

Read the full complaint below.


headshotKathryn Rubino is a Senior Editor at Above the Law, and host of The Jabot podcast. AtL tipsters are the best, so please connect with her. Feel free to email her with any tips, questions, or comments and follow her on Twitter (@Kathryn1).

UpCounsel to Shut Down; Was Marketplace for Freelance Lawyers | LawSites

Lawyer marketplace UpCounsel is shutting down.

The San Francisco based company, which has raised a total of $26 million, including a $12 million Series B in April 2018, notified customers by email this morning that it will shut down permanently on March 4.

The company served corporations by providing freelance lawyers for anything from a one-time consultation to staffing a legal department.

It was cofounded by Mason Blake, an engineer who was its CTO,  and Matt Faustman, its CEO and an attorney who previously represented startups in Silicon Valley.

Following is the email that went out today:

We want to thank you for your continued support since we first started UpCounsel in 2012. It has been a delight to work with each of you along the way, building innovative products to make the legal experience better. Pursuing our mission of creating a remarkable legal experience was made possible because of you. As founders we are humbled and honored that you came on this journey with us.

Pursuant to a decision approved by our board of directors and shareholders, the UpCounsel website will be shut down permanently on March 4, 2020. At that time you will no longer be able to login to your account. In connection with the site shutdown we will be deleting all account information and any data associated with your usage of UpCounsel in accordance with best data practices. If you wish to retrieve a copy of your data, please contact support@upcounsel.com.

We recommend and encourage you to continue working with your lawyers. This does not disrupt your attorney relationships or interfere with the progress of any legal project. Please reach out to your lawyer to discuss steps on managing this transition and feel free to contact us with questions as well.

It is with a heavy heart that we deliver this news and understand that this abrupt announcement will come as a shock to some of you that have come to rely on UpCounsel. Our team will be available as usual to answer any questions you may have leading up to the site’s shutdown on March 4th. We will share further details with you as they become available.

Best,

Mason Blake & Matthew Faustman

UpCounsel Co-founders

Bill Barr’s Not Letting A Little Thing Like Law Enforcement Interfere With Trump’s Reelection

(Photo by Jahi Chikwendiu/The Washington Post via Getty Images)

Bill Barr isn’t even bothering to hide it any more. Donald Trump’s Attorney General is locking down those U.S. Attorneys Offices to put the kibosh on any politically inconvenient investigations during this election season. Well, not of Republicans, anyway.

The New York Times reports that Barr announced new restrictions yesterday on Justice Department investigations during an election year. If a U.S. Attorney’s Office wants to investigation a candidate for president, vice president, or congress, the AG will have to sign off on it personally. Ditto for any federal political campaign or campaign donor.

No investigation into a presidential or vice-presidential candidate — or their senior campaign staff or advisers — can begin without written notification to the Justice Department and the written approval of Mr. Barr.

The F.B.I. must also notify and consult with the relevant leaders at the department — like the heads of the criminal division, the national security division or a United States attorney’s office — before investigating Senate or House candidates or their campaigns, or opening an inquiry related to “illegal contributions, donations or expenditures by foreign nationals to a presidential or congressional campaign.”

The part about donors being off limits is a really nice touch. Rudy Giuliani’s errand boys in the Ukraine smear campaign, Lev Parnas and Igor Fruman, are currently under indictment for lying about the source of $325,000 they contributed to Trump’s America First Action PAC. Parnas and Fruman claimed the money was earned by their company Global Energy Producers, which had no actual income. In fact, the $325,000 check was from another shell company, but Trump’s PAC was courteous enough to credit it to Global Energy Partners. Which is not a good look. Lucky thing Uncle Bill is making sure America First won’t be distracted by law enforcement during this important fundraising period!

Remember when Donald Trump took to Twitter to excoriate then-AG Jeff Sessions for allowing the DOJ to prosecute Reps. Chris Collins and Duncan Hunter during an election year?

Looks like Rep. Pete Sessions, who also took hinky money from Parnas and Fruman, is in the clear. Phew!

Barr has consistently claimed that the investigation of Trump’s campaign for coordination with the Russian government was politically motivated, and he’s launched a criminal probe into its origins. The DOJ has tried, and apparently failed, to indict former FBI Deputy Director Andy McCabe for lying about it. Clearly Barr won’t be allowing that kind of slip up this time around!

Although an investigation of Joe Biden’s son for bog standard, totally legal sleaziness might be just what the doctor ordered.

In the end, Barr gives the whole game away. After the 2020 elections, the Department will revisit the issue to see whether the Attorney General really needs to bother himself with low-level corruption prosecutions. How tidy of him to include a sunset provision in his cover-up campaign.

Investigations Into 2020 Candidates Must Be Cleared by Top Justice Dept. Officials [NYT]


Elizabeth Dye lives in Baltimore where she writes about law and politics.

Prettylittlething Advertisement Banned in the UK for Being ‘Overly Sexualized’

The ad was “likely to cause serious offense and was irresponsible,” according to the Advertising Standards Authority.

Will One Of Trump’s Impeachment Defense Lawyers Become A Supreme Court Justice?

Jay Sekulow

He’s certainly qualified. He’d be a terrific Supreme Court justice.

John Dowd, one of Donald Trump’s former personal attorneys, in comments given about 63-year-old Jay Sekulow possibly being rewarded by the president with a lifetime appointment to the Supreme Court for his performance during the Senate impeachment trial. Joe diGenova, an informal Trump legal adviser, shared his thoughts about Sekulow after the trial: “For me, Jay belongs on the Supreme Court. I’ve always said that about him, and now it’s even more clear.”

After three years of working as one of Trump’s personal attorneys, Sekulow still hasn’t been fired, quit, or faced any legal troubles. For what it’s worth, Sekulow found the concept of a Supreme Court appointment quite laughable, saying, “Way too old. Not even in the cards at all.”


Staci ZaretskyStaci Zaretsky is a senior editor at Above the Law, where she’s worked since 2011. She’d love to hear from you, so please feel free to email her with any tips, questions, comments, or critiques. You can follow her on Twitter or connect with her on LinkedIn.

Short And Distort: How Companies Are ‘Bearing’ Down On Market-Shifting Disinformation

(Image via Getty)

Ed. note: Stock market manipulation schemes are coming to life on social media platforms and within inboxes of unsuspecting investors. This two-part series will discuss the problem and the tension between truth and tainted information. In part two, we will delve into what companies can do to get out in front of disinformation campaigns through attribution and other measures.

Disinformation is on track to disrupt Wall Street, and this growing trend is picking up steam. The Securities and Exchange Commission (SEC) initiated enforcement actions against 27 individuals and entities in 2017 for improper stock promotion schemes after uncovering deceptive scenarios in which communication firms hired to generate publicity for published positive articles promoting the stocks that “left investors with the impression they were reading independent, unbiased analyses on investing websites” when in fact they were reading paid advertisements propounded by investment research websites hired to pump the stock.

The SEC’s enforcement actions hammering back against company-initiated disinformation underscores the agency’s commitment to weeding out this deception when it relates to investments.

And while market manipulation is top of mind for the SEC, there is another disinformation-based scheme that is flummoxing companies and regulators alike — “short and distort” — a form of securities fraud wherein an investor takes a short position on a stock and then publicly berates the stock to influence it to drop. Inversely, the disinformation-based “pump and dump” scheme involves overpromotion of speculative stocks before selling out at the top. Pumping and dumping works best in a bullish market and shorting and distorting works best in a bear market.

According to global law firm DLA Piper, once all of the elements have been successfully proven, both schemes are de facto securities fraud by merit of the following elements: (1) misrepresentation to the market through articles, blogs, and social media; (2) materiality, especially when false statements discuss a company’s financial condition or viability; (3) an intent to deceive through market manipulation; and (4) connection to the purchase or sale of securities. State securities, consumer protection statutes, and common law can all apply too.

The Wildfire Effect of the Internet

Online forums and social media channels — which allow disinformation to spread quickly and often anonymously — are here to stay. So wrongfully targeted companies are getting more proactive around identifying the bad actors who are playing in this space and working to shut them down through attribution and law enforcement referrals.

It’s still too soon to see what type of role the platform companies can play in helping identify fake news around targeted companies especially since these discussions can be nuanced and encompass a level of opinion that, while unfounded, may appear credible to a news tagger. And email is no better. In 2015, in what has been described as one of the biggest cybercrimes in history, the data of over 100 million people was stolen from a dozen companies’ computers and used by a vast global network of cybercriminal accomplices to turn it into hundreds of millions of dollars. The weapon of choice — email addresses and other customer information that was stolen from the likes of J.P. Morgan and used to spam those customers with false information that led cybercriminals to successfully short and distort various stocks. Similarly, fake press releases and fake news websites, when sent to or viewed by the right audience, can create the same effect.

In the face of these challenges, companies are not sitting idle, and success stories exist. For example, homebuilder Lennar Corp., which was the subject of a short-and-distort campaign conducted by a developer and his associate caused Lennar’s market cap to decline by nearly half a billion dollars, brought suit for extortion and defamation. Lennar was awarded a $1 billion judgment, with the defendant also convicted on criminal charges.

First Amendment Versus Falsehoods 

On the other hand, the courts are not inclined to deny investors an opinion about a company’s value or behaviors. In 2012, when SilverCorp, a Canadian silver producer listed on the New York and Toronto stock exchanges, sued a hedge fund and group of investors who had published two separate reports alleging that the company was engaging in fraud, the court dismissed the defamation case on the grounds the reports were composed of constitutionally protected opinions and therefore not actionable. Among the considerations that tipped the lawsuit in favor of the defendants were the court’s findings that the reports expressly disclosed that the reports were opinions and that the authors of the report were not disinterested because they held short positions in the company. Perhaps due to precedents of that nature, lawsuits against short sellers have been considered rare, given free speech protections and companies’ hesitancy to submit themselves to the distraction and exercise of regulatory review.

But there has been movement by the SEC to crack down on these exploits.  On September 12, 2018, the SEC filed a complaint alleging that George Lemelson and Lemelson Capital Management LLC issued false information about a company after Lemelson took a short position in the company on behalf of Amova Fund, a hedge fund he advised and partly owned. According to the SEC, as a result of Lemelson’s short and distort scheme, and through disseminating reports, conducting interviews, and using social media platforms, the company lost more than one third of its value. The case survived a motion to dismiss in 2019. If the SEC is successful, this case is thought to pose a significant deterrent to would-be market manipulators.

According to DLA Piper, by its actions, the SEC also further opens the door for defrauded companies and investors who have been, or may be, targeted by short and distort schemes to pursue civil litigation to recover their damages. The SEC’s involvement could help companies overcome prior difficulties in identifying the real person behind an online alias or obscure entity.  Companies and private investors may also be more willing to pursue such actions if they feel that the SEC or other regulators will back them up by taking bad actors to task in separate civil or criminal proceedings.

In the next part of this two-part series, we will address how companies have successfully deterred or strategically mitigated the fallout from short and distort campaigns.


Jennifer DeTrani is General Counsel and EVP of Nisos, a technology-enabled cybersecurity firm. She co-founded a secure messaging platform, Wickr, where she served as General Counsel for five years. You can connect with Jennifer on Wickr (dtrain), LinkedIn or by email at dtrain@nisos.com.