Author: TSA Press

By some accounts, 2020 represents something of a lull in terms of drugs expected to lose patent protection.

A 2017 report by Evaluate Pharma estimated that this year, $17 billion in worldwide sales are at risk due to patent expirations. By contrast, last year, $41 billion in sales were at risk, and companies were anticipated to lose $19 billion.

Nevertheless, the year will see its fair share of U.S. patents on drugs and biologics expiring, and some of those drugs will see generic or biosimilar versions launched this year and next.

The list of 12 pharmaceutical drugs going off patent in 2020 came from National Pharmaceutical Services. These were cross-referenced with the Food and Drug Administration’s Orange Book, which lists approved pharmaceutical drugs’ patents, patent expiration dates and in many cases summarizes what those patents cover. The agency’s Drugs@FDA site was then searched for information such as when the drugs were approved and whether any generic versions had received approval. If they hadn’t, OptumRx’s latest quarterly RxOutlook report was examined to find whether a possible near-term generic launch was anticipated. Company earnings reports were used to find the latest annual sales figures.

But there are a few caveats to bear in mind. For one, the expiration of a patent this year does not mean there are not additional patents that may be protecting a branded drug, let alone that a generic will become available in 2020. Another confusing factor is that under the provisions of the Hatch-Waxman Act, the 1984 law that created an abbreviated approval pathway for generics, it’s common for generic companies to launch ahead of patent expiration under deals with brand-name drugs’ manufacturers. Sales figures for some drugs were also unavailable because they are made by private companies or are not included in financial filings because they don’t generate enough revenue.

For biologics, finding patent data is much less straightforward than with pharmaceutical drugs. The NPS’ list doesn’t list any biologics facing patent expiration in 2020, but a 2019 article in the Generics and Biosimilars Initiative Journal lists six. However, because the FDA Orange Book does not include information for biologics, it is much more difficult to cross-reference its entries, some of which appear to be inaccurate – notably the entry for Novartis’ autoimmune disease drug Cosentyx. In addition, the list states that they are losing patent protection or exclusivity, but does not specify which is the case for each individual drug. The entries in GaBI’s list were checked against multiple sources like company reports and DrugPatentWatch.com, although the latter requires a subscription.

Only one of the biologics listed, Roche and Royalty Pharma’s Mircera, is anticipated to face biosimilar competition, according to OptumRx’s report, and not until late next year. However, other information, like sales numbers, was readily available.

Pharmaceuticals

(Source: NPS)

Atrovent HFA (ipratropium hfa)
Company: Boehringer Ingelheim
Approved: 2004
Indication(s): chronic obstructive pulmonary disease
Sales: N/A
Generic(s) approved? No
Patent expiration date in 2020: May 26

Bydureon (exenatide)
Company: AstraZeneca
Approved: 2012
Indication(s): Type 2 diabetes
Sales: $584 million (2018)
Generic(s) approved? No
Patent expiration dates in 2020: Jan. 14; May 25; Oct. 4 (treatment of Type 2 diabetes, treatment in combination with exenatide)
Note: OptumRx’s report does not include Bydureon, but does state a generic version of Byetta – a formulation of exenatide with more frequent dosing – may be launched this year.

Chantix (varenicline)
Company: Pfizer
Approved: 2006
Indication(s): smoking cessation
Sales: $282 million (2019)
Generic(s) approved? No
Patent expiration dates in 2020: May 10 (aid to smoking cessation); Nov. 10
Possible generic launch date: December 2021

Dexilant (dexlansoprazole)
Company: Takeda
Approved: 2009
Indication(s): gastroesophageal reflux disease
Sales: $688 million (FY2017)
Generic(s) approved? Yes (1)
Patent expiration dates in 2020: June 15 (healing of esophagitis, treatment of GERD); Dec. 15 (pediatric use)
Possible generic launch date: June 2020

Inlyta (axitinib)
Company: Pfizer
Approved: 2012
Indication(s): kidney cancer
Sales: $161 million (2019)
Generic(s) approved? No
Patent expiration date in 2020: June 30 (treatment of renal cell carcinoma)

Namenda (memantine)
Company: Allergan
Approved: 2003
Indication(s): Alzheimer’s-type dementia
Sales: $71 million (2018)
Generic(s) approved? Yes (19)
U.S. patent expiration date: N/A
An oral solution is also available, but without generic equivalents

Safyral (drospirenone, ethinyl estradiol, levomefolate)
Company: Bayer
Approved: 2010
Indication(s): Birth control
Sales: N/A
Generic(s) approved? Yes (2)
Patent expiration date in 2020: April 17, 2020
Note: Patent covering prevention of pregnancy expires March 3, 2022.

Saphris (asenapine)
Company: Allergan
Approved: 2009
Indication(s): schizophrenia, bipolar disorder
Sales: $139.7 million (2018)
Generic(s) approved? No
Patent expiration dates in 2020: June 9 (treatment of schizophrenia and bipolar disorder); Dec. 9 (pediatric use)
Possible generic launch date: 1H 2020

Silenor (doxepin)
Company: Currax
Approved: 2010
Indication(s): insomnia
Sales: N/A
Generic(s) approved? Yes (1)
Patent expiration date in 2020: Feb. 17 (treatment of insomnia)
Possible generic launch date: January 2020
Note: Additional patents covering treatment of insomnia expire throughout the decade and into 2030.

Sprycel (dasatinib)
Company: Bristol-Myers Squibb
Approved: 2006
Indication(s): Philadelphia chromosome-positive chronic myeloid leukemia and acute lymphoblastic leukemia
Sales: $2 billion (2018)
Generic(s) approved? No
Patent expiration dates in 2020: April 13 (treatment of CML); June 28 (treatment of protein tyrosine kinase-associated disorder and cancer); Oct. 13 (pediatric use); Dec. 28 (pediatric use)

Tykerb (lapatinib)
Company: Novartis
Approved: 2007
Indication(s): HER2-positive metastatic breast cancer
Sales: N/A
Generic(s) approved? No
Patent expiration date in 2020: Sept. 29 (treatment of HER2-positive metastatic breast cancer)
Possible generic launch date: September 2020

Vigamox (moxifloxacin)
Company: Novartis
Approved: 2003
Indication(s): bacterial conjunctivitis
Sales: N/A
Generic(s) approved? Yes (6)
Patent expiration date in 2020: March 29 (pediatric use)

Biologics

(Source: GaBI Journal)

Simulect (basiliximab)
Company: Novartis
Approved: 1998
Indication(s): organ transplant
Sales: N/A
Biosimilar approved? No
Estimated patent/exclusivity expiration date: 2020 (Source: Novartis)

Cosentyx (secukinumab)
Company: Novartis
Approved: 2015
Indication(s): plaque psoriasis, psoriatic arthritis, ankylosing spondylitis
Sales: $3.6 billion (2019)
Biosimilar approved? No
Estimated patent/exclusivity expiration: 2028 (Source: Novartis)
Note: Given that Cosentyx was approved only five years ago, and no information could be found corroborating its inclusion among biologics losing patent protection in 2020, it may have been included in the GaBI Journal list in error.

Lucentis (ranibizumab)
Companies: Roche, Novartis
Approved: 2006
Indication(s): age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, myopic choroidal neovascularization
Sales: $4 billion (2019)
Biosimilar approved? No
Estimated patent/exclusivity expiration: Unclear for U.S. (Japan, E.U. patents to expire 2020-2022) (Source: Novartis)

Vectibix (panitumumab)
Company: Amgen
Approved: 2006
Indication(s): wild-type RAS metastatic colorectal cancer
Sales: $744 million (2019)
Biosimilar approved? No
Estimated patent/exclusivity expiration date: April 8, 2020 (Source: Amgen)

Kineret (anakinra)
Company: Sobi
Approved: 2001
Indication(s): rheumatoid arthritis, cryopyrin-associated periodic syndromes
Sales: $118.6 million (2017)
Biosimilar approved? No
Estimated patent/exclusivity expiration date: July 29, 2020 (Source: DrugPatentWatch.com)

Mircera (methoxy polyethylete glycol, epoetin alfa)
Company: Roche, Royalty Pharma
Approved: 2007
Indication(s): anemia associated with chronic kidney disease
Sales: $610 million (2019)
Biosimilar approved? No
Estimated patent/exclusivity expiration date: Unclear
Possible biosimilar launch date: November 2021

Photo: gerenme, Getty Images

In West Virginia State Board of Ed. v. Barnette, the Court ruled in favor of Jehovah’s Witness students who declined to recite the Pledge of Allegiance, noting in the opinion that the Parent and Teachers Association, the Boy and Girl Scouts, the Red Cross, and the Federation of Women’s Clubs had all objected to the Pledge statute as well, and that their concerns were heeded while the Jehovah’s Witnesses were ignored. What were all those groups complaining about?

Hint: Given the timing of the suit, this was a pretty big deal.

See the answer on the next page.

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Olga V. Mack is the CEO of Parley Pro, a next-generation contract management company that has pioneered online negotiation technology. Olga embraces legal innovation and had dedicated her career to improving and shaping the future of law. She is convinced that the legal profession will emerge even stronger, more resilient, and more inclusive than before by embracing technology. Olga is also an award-winning general counsel, operations professional, startup advisor, public speaker, adjunct professor, and entrepreneur. Olga founded the Women Serve on Boards movement that advocates for women to participate on corporate boards of Fortune 500 companies. Olga also co-founded SunLaw, an organization dedicated to preparing women in-house attorneys to become general counsels and legal leaders, and WISE to help female law firm partners become rainmakers. She authored Get on Board: Earning Your Ticket to a Corporate Board Seat and Fundamentals of Smart Contract Security. You can email Olga at olga@olgamack.com or follow her on Twitter @olgavmack. 

Over the past decade, Lateral Link has become the prominent player in the legal recruiting industry. As we continue to grow our global footprint, we are looking to add recruiters to our San Francisco, Chicago, Washington D.C., and New York offices.

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Lateral Link has made thousands of placements with almost every Am Law 200 law firm in the nation. Not only do we have personal relationships with decision-makers at the biggest and best firms in the nation, but our exclusives with — and insider information about — some of the most desirable law firms separates us from ALL of our competitors in the field.  We are a market mover, not a follower.

Moreover, we only hire the best and almost all of our recruiters are law school graduates with extensive Biglaw experience. Here are a few of the law schools we represent.

Highest Compensation in Our Industry

We understand that hiring and retaining the best legal recruiters requires spreading the wealth.  Not only do you deserve it, but you should demand it.  Lateral Link’s recruiters earn 50-85 percent ABOVE the market.  Also, our Principals partake in real profit sharing. Our compensation formula also favors hard workers and high earners, and the more you make, the more you keep. Here’s a preview below of our compensation structure, not including bonuses and profit sharing.

Teamwork & Culture

If you have to define the legal recruiting industry, you would probably say it is a “dog eat dog world.” At Lateral Link, our recruiters find working together and collaborating on searches gives us an edge over our regional or national competition.  If you don’t have access to decision-makers and your brand isn’t opening the door in a meaningful way, why are you bringing more to a platform than what you are giving?  We encourage you to look at the contributions you make.  Is your platform really helping you?

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We know the business aspect is important, but we also like to have a bit of fun at Lateral Link. We believe it is important to bring all of our colleagues together, from across the nation, annually at our company retreats.

If you are interested in working for us please email hiring@laterallink.com or click here to apply.

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Lateral Link is one of the top-rated international legal recruiting firms. With over 14 offices world-wide, Lateral Link specializes in placing attorneys at the most prestigious law firms and companies in the world. Managed by former practicing attorneys from top law schools, Lateral Link has a tradition of hiring lawyers to execute the lateral leaps of practicing attorneys. Click ::here:: to find out more about us.

Catalyst Capital Advisors told its investors that it had a dedicated risk manager. It told them that this dedicated risk manager monitored its risk metrics daily. It said that it had safeguards to prevent losses in excess of 8%. So when it lost 20% over the course of three months, it was either because that risk manager and those safeguards weren’t very good, or because they didn’t exist. Care to guess which one?

Catalyst Capital Advisors LLC (CCA) and its President and Chief Executive Officer, Jerry Szilagyi, agreed to pay a combined $10.5 million to settle the charges. The SEC also filed a complaint in federal district court in Madison, Wisconsin, against Senior Portfolio Manager, Edward Walczak, for fraudulently misrepresenting how he would manage risk for the fund.

Trials like, treasure hunts, need to be pursued with the utmost care. One anecdote particularly reminds me of the challenges of trial work: the story of Forrest Fenn’s treasure.

Forrest Fenn, an art dealer, former Vietnam fighter pilot, and self-taught archaeologist was diagnosed with cancer in 1988. He proceeded to fill a chest with emeralds, rubies, gold coins, and diamonds he had collected during his explorations of the American Southwest prior to his diagnosis. He intended to drag it into the Rocky Mountains and die beside it. In a twist of fate, Fenn survived the cancer and, sometime around 2010, he buried the chest in the Rockies and offered clues to its location in a cryptic 24-line poem he included in his autobiographical, self-published memoir, The Thrill of the Hunt. Since then, thousands have gone searching for the treasure, and four have perished in their pursuit.

Treasure hunting and trials have many parallels. Success at trial and finding Fenn’s treasure both require dedication, effort, and will. Reasonable opinions may vary when determining which experience is more intimidating: traversing the expanses of the Rockies looking for a small box or marching into a federal court on the first day of a multiple-week trial. But there would likely be a consensus that both require grit and determination.

Both trial work and finding Fenn’s treasure also require interpreting cryptic texts. Fenn left a 24-line poem, attorneys got the Federal Rules of Civil Procedure and a web of federal and state statutes. Of course, a misstep in pursuit of the treasure could cost you your life. To my knowledge, no one has died from putting a foot wrong with the FRCP. That said, you may wish you were dead if you ever have a judge chastise you for a rule-related flub.

Like treasure hunting, litigation is local. Venue matters and so does knowing the local rules. Having appeared before a certain judge previously can be a great advantage for a litigator. Knowing how and when to utilize local procedure and insights into the personality of a jurist is knowledge that takes a career to develop. Thankfully, I am fortunate enough to work with seasoned litigators who impart their wisdom and experience on a daily basis. Their presence and insight make deciphering the matrix of litigation within which we wrestle every day a more navigable journey. Another part of my good fortune lies in the team that surrounds me. As has been noted by wiser minds than mine, litigation is a team sport. Our firm has procedures in place to deal with the most complex of issues, and those processes makes the marathon of intellect that litigation demands more feasible and, quite frankly, fun. Surely, if the individuals seeking Fenn’s treasure teamed-up their efforts, the chest would have been discovered by now. After all, humans have landed themselves on the moon. Finding a piece of luggage in a mountain range is a comparatively small feat.

This spring promises to be a busy one for the firm, with several matters on the verge of trial. The right mix of experience, grit, determination, effort, and will shall carry us to the proverbial box of Fenn’s gold and gems. Of course, there is no penultimate promised land in a career of law, and the whole thing is an exercise in a daily pursuit of betterment and enjoying the process. But that’s a topic for another day.

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Timothy M. Lupinek is an attorney at Balestriere Fariello who represents companies and individuals in state, appellate, and administrative courts of Maryland. He focuses his practice on complex commercial litigation with thousands of hours of civil, criminal, and regulatory trial experience. You can reach Timothy at timothy.m.lupinek @balestrierefariello.com.

The fights involving Home Owners Associations (HOAs) are so legendary and stereotyped that they’ve even been a minor plot point in Seinfeld. The general stereotype is that HOAs involve insane political power struggles, significantly out of proportion to the actual issues at hand. It is often an example of Sayre’s law, in that the stakes are so little, yet the disputes are much more vicious and out of control than elsewhere. I’m thankful I don’t live in a place with an HOA, but for many years I did (as a renter, not an owner) and remember receiving a long (7 pages typed, I believe) letter from an owner complaining about HOA battles and claiming that he was afraid to go to the next HOA meeting for fear of being shot by another HOA member, and going on and on about threats of violence.

In other words, petty squabbles in HOAs all too frequently get blown way out of proportion, and people take them way too seriously. So, it’s perhaps of little surprise that an HOA in Gilbert, Arizona, is taking things so far as to violate the 1st Amendment, and is threatening to sue residents over social media posts. Perhaps not surprisingly, the community in question has the type of name that would fit in well with Seinfeld’s Del Boca Vista. In this case, it’s Val Vista Lakes (VVL).

Following elections, the board proposed a social media policy restricting opinions about the board on Facebook. It was vehemently opposed by the community and quickly tabled.

Then a letter from a law office representing the board showed up at Nardecchia’s home.

“They are threatening if I don’t remove any content that frames certain members of the board in a negative light,” said Nardecchia.

Threatening her with $250 daily fines as well as taking away her access to community amenities.

The letter was sent from a law firm paid for by HOA fees to at least eleven residents.

Other HOA members received similar letters:

The letter demands posts that are disparaging, speculative or defaming to board members be removed immediately. It also cites past incidents including posts that said that board members altered or manipulated votes in annual elections and that board members purposefully retaliated against members in the association. Opinions that now come with consequences.

“I really do believe in that freedom of speech. We are a diverse community with diverse opinions and views, and we should be able to share that and have a discussion about that.” said Nardecchia.

That last line of the first paragraph above is quite incredible: “opinions that now come with consequences.” While it’s not quoted, it sounds like something that may have been said in the letter, as it’s a line we all too frequently hear from those filing or supporting bogus SLAPP-style lawsuits over free speech, that “speech has consequences.” Of course, they are misunderstanding what that means. Speech has social consequences in terms of how others in the community view you, and on your reputation and trustworthiness. What opinionated speech cannot have under the 1st Amendment of the constitution, is legal consequences that chill and intimidate free speech.

The article discussing all of this, from the local ABC affiliate in Arizona, concludes with a fairly understated comment reflecting what actual 1st Amendment lawyers told the news station:

At least two attorneys focused on constitutional law, told ABC15 the board is over stepping their authority and may want to take a closer look at the protection found under the first amendment.

May want to take a look? Uh, yeah. You can’t sue people for stating opinions about you on social media. That’s kind of a core aspect of the 1st Amendment.

Home Owners Association Threatens Residents With Lawsuit For Online Criticism

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AT&T, Comcast Dramatically Cut Network Spending Despite Net Neutrality Repeal
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History is rhyming hard today! As Republican Senators prepared to close out the only impeachment trial ever without witnesses, President Donald Trump was served with a demand to turn over a DNA sample in a sexual assault defamation case.

Elle advice columnist E. Jean Carroll, who says she was raped by Trump 24 years ago in a Bergdorf Goodman’s dressing room on Fifth Avenue (of course), has scheduled a March 2 cheek swab for the president at the LabCorp closest to the White House. The appointment is at 9 a.m., but if this cuts into his Executive TeeVee-n-Twitter Time, “another location convenient for Defendant” will suffice.

Carroll, who told acquaintances about the rape at the time, is one of at least 25 women who have accused the president of sexual misconduct. Trump has denied the allegations, saying Carroll is “not my type” and claiming he “never met this person in my life,” despite a photograph of them laughing together at a party. She then filed a defamation suit, claiming Trump had smeared her by calling her a liar who was just trying to gin up publicity for her book.

Carroll kept the black Donna Karan coat dress she was wearing the day of the alleged assault and recently sent it for forensic analysis at a lab in California. After Trump’s date with the lab tech, which will doubtless be delayed by several rounds of court filings, she hopes to match it with male DNA found on the sleeves and hem of the dress. Carroll says the only time she ever wore it after the assault was when she was photographed for New York Magazine’s story about her allegations. The participants in the photo shoot, whose names are redacted in the pleading, have also been tested for elimination purposes. The analysis does not suggest the presence of semen on her clothing, which is consistent with Carroll’s account of fighting Trump off and fleeing moments into the attack.

The echo of the infamous blue Gap dress worn by Monica Lewinsky in 1997 is inescapable. Independent Counsel Ken Starr, who argued this week that impeachment witnesses were a gross violation of the constitution, secured a blood sample from President Bill Clinton in 1998 and matched the DNA to the semen on the White House intern’s dress. But this time around, instead of a vicious manipulator like Linda Tripp, who told the 23-year-old Lewinsky that she shouldn’t wear the dress anymore because it made her look “really fat,” but that she should keep it unwashed “for your own ultimate protection,” Carroll has iconic civil rights lawyer Roberta Kaplan, a partner at Kaplan Hecker & Fink, to advise her.

Kaplan has already batted aside Trump’s pathetic efforts to duck the process server and then declare himself a Florida Man, immune to suit in New York’s court. Monica Lewinsky may have floundered with a California med-mal attorney, unused to the bare-knuckles cage match of DC and New York, but Kaplan is not new to this game. It might take her a minute, but she’ll get that cheek swab. But before that happens, look for Trump’s lawyers to assert any number of inane defenses.

Will they claim executive privilege over the president’s biological material? Call it national security risk to have his DNA analyzed? Assert absolute immunity to civil process under an OLC memo conveniently magicked up by Bill Barr?

Safe money is on ALL OF THE ABOVE.

PLAINTIFF’S FIRST NOTICE TO SUBMIT TO PHYSICAL EXAMINATION TO DEFENDANT DONALD J. TRUMP [via NYT]

We’re coming up on that time of the year when the legal tech community descends upon Chicago for ABA TECHSHOW because who doesn’t want to be on the shores of Lake Michigan in February?

On Wednesday, February 26, after the TECHSHOW welcome reception, join us at Centennial Chicago as Above the Law and ETL host our third annual networking reception so women leaders and allies can find and support each other in the tech community. Be sure to sign up here!

An opt-in attendee list will be shared with registrants so attendees can find, hire and buy from women and 100 percent of registration fees will be donated to the Domestic Violence Legal Clinic of Chicago.

Want to see pics from the event last year? Well, we’ve got ’em.

Hope to see you there.

During yesterday’s impeachment trial, Rand Paul tried to pull a fast one.

The senator from Kentucky has a hard-on to unmask the whistleblower who first sent a complaint to Senator Richard Burr and Congressman Adam Schiff over Donald Trump’s behavior vis-à-vis Ukraine foreign aid. Yes, of course there is a compelling public interest in keeping the identity of whistleblowers confidential. And yes, there’s a whole network of federal legislation build around the premise that confidentiality is essential to stem corruption. But all that just goes out the window when there’s a chance to own the libs.

So yeah, Rand submitted a question during the impeachment trial to the presiding officer, Chief Justice Roberts, naming the whistleblower. But Justice Roberts was having none of that ish, saying, “The presiding officer declines to read the question as submitted.” Rand reportedly stormed out of the chamber.

But unfortunately we live in the worst timeline, and Rand was not content to merely accept the rebuke. No, of course not. As HuffPost reports, he held a press conference throwing out names like it’s of no consequence:

Paul then stormed out of the chamber and held a press conference where he twice said the name of the alleged whistleblower ― whose identity has not been confirmed ― as well as another individual but insisted he was not outing anyone.

“I think this is an important question, one that deserves to be asked, and makes no reference to anybody who may or may not be a whistleblower,” Paul told reporters.

This farce of a trial is expected to reach its conclusion today, without calling any witnesses.

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Kathryn 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).