2017 Top Cases & Deals of the Year

Top 10 Deals of the Year: F&T

Agios $287 million Public Offerings—WilmerHale

In May 2017, WilmerHale's Steven Singer represented Agios Pharmaceuticals, a developer of small-molecule anti-cancer therapeutics targeting cancer cell metabolism, in a $287 million public offering, while also counseling the company in a $172.5 million public offering in September 2016. This year, Agios submitted its first cancer drug (enasidenib) to the FDA, which is one of the first to target the metabolism of cancer cells.

Arrowhead Pharmaceutical's $670 million licensing & collaboration agreement with Amgen—Gibson Dunn & Crutcher

Gibson Dunn & Crutcher attorney Ryan Murr represented Arrowhead Pharmaceuticals in the $670 million license and collaboration agreements with Amgen to develop RNA interference therapies for cardiovascular disease. This was coupled with an equity investment by Amgen in Arrowhead. Announced on September 29, 2016, the deal represents one of the largest collaborations in the RNAi (gene therapy) space and follows Gibson Dunn's representation of Arrowhead earlier in 2016 in gaining the rights to Novartis' RNAi platform technology that is particularly focused on cardiovascular disease. Amgen will make an upfront payment of $35 million and an equity investment of $21.5 million in Arrowhead and potentially $617 million in option payments and milestones. "It was a large complicated transaction, so there was a long list of issues that come up that are sometimes meddlesome and difficult to resolve," said one Gibson Dunn partner involved. "We pulled that together working with the in-house counsel at Arrowhead and fairly quickly were able to draft definitive documents both for a license and joint venture as well as an equity venture."

Biotechnology Value Fund—Gibson Dunn & Crutcher

Gibson Dunn attorney Ryan Murr advised Biotechnology Value Fund, an investor in small-cap biotechnology companies, on several transactions including a $165 million senior secured note financing with Orexigen Therapeutics, multiple registered financings with CTI Biopharma (formerly Cell Therapeutics) raising a total of $105 million, a novel two-tranche $45 million financing Anthera Pharmaceuticals, and investments in XOMA and the France-based Inventiva IPO.

Of particular note was the Anthera financing; Murr navigated a situation in which the timing of the investment preceded the company's announcement of the clinical data. This led to a tricky situation in which BVF had to hedge its risk. The Gibson Dunn team developed a novel two-tranche equity investment with a price reset so that the company could sell two slices of newly designated preferred stock convertible into common stock at a fixed price dependent on the market. The second tranche had similar price fixing. Ultimately, BVF had the option for either a price reset or purchase option for second tranche. "A distinguishing feature of Gibson Dunn's life sciences practice is the breadth of our interdisciplinary expertise, and creative approach to solving our client's most challenging problems," said one involved Gibson Dunn partner. "We are able to offer insights and creative solutions that help thread the needle and get positive results for our clients."

Editas Medicine research & development collaboration with Allergan Pharmaceuticals—WilmerHale

In March 2017, WilmerHale attorneys Steven Barrett and Rosemary Reilly represented Editas Medicine, a CRISPR genome editing company, in a strategic research and development alliance with Allergan Pharmaceuticals. Allergan received exclusive access and the option to license up to five experimental eye-disease treatments, including one for Leber Congenital Amaurosis (LCA10), a rare retinal degenerative disease. Editas received $90 million up front and undisclosed milestone payments. In December 2016, WilmerHale also represented Editas in exclusively licensing intellectual property related to new CRISPR technologies that include intellectual property owned by MIT, Harvard, and the University of Tokyo.

Grail's $900 million Series B financing—Dechert/Fenwick & West

GRAIL, Inc., a life sciences company specializing in early cancer detection represented by Fenwick & West, announced in March 2017 one of the largest Series B financings in life sciences of $900 million. ARCH Venture Partners led the financing accompanied by the largest investor Johnson & Johnson Innovation. Dechert led by Kristopher Brown advised Johnson & Johnson Innovation and led all negotiations. GRAIL will use the financing for product development and validation of blood tests for early-stage cancer detection. This includes the Circulating Cell-Free Genome Atlas (CCGA) study and other clinical trials. CCGA uses GRAIL's high-intensity sequencing approach to understand DNA profiles of cancer patients.

Novan's $11 million license agreement with Sato Pharmaceuticals—Latham & Watkins

Latham & Watkin led by Judith Hasko represented pharmaceutical company Novan, Inc, in an exclusive license agreement with Sato Pharmaceutical Co., Ltd. Sato will pay Novan approximately $11.0 million up front for exclusive rights to develop and commercialize in Japan Novan's topical nitric oxide-releasing product candidate SB204. Novan will receive development and commercialization milestone payments from Sato. This deal allowed Novan to retain rights to products in the US, while also reaching into the Japanese market.

Novan and Sato were both relatively inexperienced in cross-border licensing, so the deal was a learning curve for both.

"There was a need to navigate some discrepancies in each party's experience." A involved partner noted. "Sato was picked as an ideal partner in connection with the particular product because they had some synergistic experience and market share."

Assisting on the deal was consultant Mark Palmer, of Triad Securities Group, who has business expertise in the Japanese market, and former Novan president Nathan Stasko.

"We needed these areas of expertise to get across the finish line," a involved partner said. "It was a good team because we brought a lot of deal making expertise and knowledge of carving out rights to the table."

Pamplona Capital's $5 billion acquisition of Parexel International—Goodwin Procter

Goodwin Procter, led by Stuart Cable, represented Parexel International in complicated transaction to be acquired by Pamplona Capital Management at a purchase price representing a 27.9% premium to Parexel's closing stock price in May. Parexel is a contract research organization (CRO) that sells services to pharmaceutical and biotechnology companies.

"Parexel is a big deal and representative of how private equity has come to understand that doing outsourced services for the biotech and pharma industry is a growth and scale industry," noted one involved partner.

Of Pamplona's strategy, an attorney involved said, "Pamplona waited in the wings and then bidded very aggressively in the end game. Their bidding strategy was brilliant."

Pfizer's $14 billion Acquisition of Medivation—Ropes & Gray

Ropes & Gray's key M&A attorney Christopher Comeau represented Pfizer Inc. in its acquisition of Medivation, Inc., a biopharmaceutical company developing and commercializing small molecules for oncology. Pfizer made an all-cash tender offer to purchase outstanding shares of Medivation common stock for $81.50 a share in cash yielding a total enterprise value of approximately $14 billion. About 80% of Medivation's shares outstanding were validly tendered or guaranteed delivery. Pfizer completed the acquisition through a two-step merger that will allow Pfizer to expand its offerings with novel drugs such as the prostate cancer drug XTANDI.

St. Jude Medical $30.7 billion Sale to Abbot Laboratories—Gibson Dunn & Crutcher

In January 2017, Gibson Dunn & Crutcher represented St. Jude Medical a medical device manufacturer, in its $30.7 billion sale to Abbott Laboratories, a global healthcare company. This makes Abbott a leading maker of medical devices in cardiovascular, diabetes, and vision care. Deal makers hope that the combined company will result in a $500 million pretax boost by 2020. Joseph Barbeau, of Gibson Dunn, led the deal against Abbott Pharmaceuticals represented by Wachtell Lipton Rosen & Katz. One attorney on the deal noted that "Wachtell was a very constructive part of getting the deal done." Just prior to this deal, Abbott had entered into an agreement to acquire Alere in a $6 billion transaction, which fell through after Alere received DoJ subpoenas. Abbott spent roughly a year in a lawsuit to get out of the deal, ultimately agreeing to a closing with a $500 million haircut. The mammoth St. Jude Medical deal followed fast on the heels of Alere deal. "Our deal was five times bigger," said a partner involved. "And so we were all looking over our shoulders [at the Alere deal]. This was the atmosphere in which the deal took place and it showed in countless ways, but it took real maturity on the part of everybody to rise above the situation and say 'we've got to make this deal work. We don't need to be generals fighting the last battle.'"

Verily's Venture with GSK to form Galvani Bioelectronics Limited—Hogan Lovells

In Hogan Lovell's fourth major transaction for Verily, Asher Rubin advised Verily in a ground breaking joint venture with GlaxoSmithKline to form Galvani Bioelectronics Limited, which has plans to develop miniaturized, implantable devices for trating chronic diseases such as arthritis, diabetes and asthma.

GSK contributed its bioelectronics business and employees, and Verily and GSK contributed certain intellectual property rights to Galvani. The shareholders have agreed to invest up to £540 million in Galvani over an initial seven-year period. "Merging a global pharmaceutical company with the iconoclastic culture of a cutting edge Northern California company makes for an interesting combination of cultures," one involved partner said.

Hogan Lovell's mobilized a large multi-faceted life sciences team to handle the deal, advising on all aspects of corporate, commercial, employment and pensions, anti-trust, regulatory, IP, and tax matters.

Verily mobilized a legal team called by one involved partner "possibly the hardest working legal department I've ever come across," adding, "they really do have that culture instilled from being a startup and being agile."



Top 10 Cases of the Year: IP



AbbVie Inc et al v Amgen Inc et al

Competitors' efforts to enter the market alongside blockbuster biologic HUMIRA come as no surprise, and the ongoing dispute in the District Court of Delaware between Amgen and AbbVie over a proposed biosimilar is one of the more closely-watched examples. Amjevita, Amgen's version of top-selling AbbVie drug HUMIRA received FDA approval in September 2016, triggering a patent infringement suit from the biologics innovator which claims the biosimilar encroaches on 61 of its patents surrounding the product. Under the Biologics Price Competition and Innovation Act (BPCIA) rules, the number of infringed patents was reduced to a mutually agreed list of ten.

In AbbVie's initial complaint, the drug maker cited Amgen as trying to reap the benefits of AbbVie's efforts involved in developing the biologic. "Whereas AbbVie has spent decades of research and vast resources on the development of HUMIRA, Amgen seeks to copy AbbVie's work and ignore AbbVie's patents," AbbVie stated in its complaint to the District Court of Delaware. "But while the BPCIA gives Amgen an abbreviated regulatory pathway for its biosimilar version of HUMIRA, it does not give Amgen license to infringe AbbVie's patents." The plaintiffs further added that they seek an injunction, stopping Amgen from moving forward with its biosimilar version.

The litigation is still young, but if it results in Amgen being enjoined by a district court judge, the case may take on a similar course to the concurrent biologic dispute Amgen v Sanofi, also on this list of top cases. This case flips the script with Amgen seeking to protect its innovation Repatha from biologic competitor Praluent, marketed by Sanofi and Regeneron.

AbbVie v Amgen is one example of the ever-increasing trend of brand versus brand disputes, demonstrating the shifting paradigms in the life sciences market. Of the five currently FDA-approved biosimilars and their biologic counterparts, Amgen is represented twice on the innovator side as biologic manufacturer, and once on the opposing biosimilar side for its proposed Amjevita.

On the litigation team for AbbVie is Benjamin Schladweiler of Ross Aronstam & Moritz as lead attorney and LMG Life Sciences star Amy Wigmore of WIlmerHale. Amgen is represented by LMG Life Sciences star Kevin Flowers of Marshall Gerstein & Borun.

Amgen Inc et al v Sanofi et al

On appeal at the Federal Circuit, this case displays the changing dynamics in the pharmaceutical space as the biologics market continues to grow, pitting innovator companies against other innovators. Sanofi and related parties continue to litigate the infringement verdict and rare permanent injunction issued against its marketed Praluent, a cholesterol-lowering product that is claimed by Amgen to infringe patents related to its drug Repatha.

The permanent injunction was issued in January by Judge Sue Robinson in the District Court of Delaware in response to a jury's finding that Amgen's patents were valid. Judge Robinson referenced the 2006 Supreme Court decision from eBay Inc v MercExchange LLC, which overturned a longstanding rule that dictates courts should generally issue injunctions when a party has infringed, and instead now holds that the action should be taken on a case-by-case basis. Of the four criteria a plaintiff must usually meet to qualify a permanent injunction, the judge found two favored Amgen's argument, one was neutral to both parties, and another favored the defendants.

The last item, which favored Sanofi and company, asks whether a permanent injunction would be in the public's best interest. To that point, Judge Sue Robinson stated in her decision, "The public generally is better served by having a choice of available treatments. Therefore, the court finds itself between a rock and a hard place, i.e., being a patent holder and a verdict winner should be a meaningful factor in the balancing test, but taking an independently developed, helpful drug off the market does not benefit the public."

In the pending appeal, counsel for Sanofi and the other appellants Paul Clement argued that Amgen's patent broadly claims ownership of varying species of antibodies, and that in the district court trial, their side was barred from presenting evidence meant to show meaningful differences between the antibodies. Appellee counsel Daryl Joseffer argued that if Amgen's scope of protection was limited to one type of antibody, that any manufacturer could later use the disclosures from the patent to make its own slightly different version with the same function, bypassing the two-billion-dollar development effort put forth by Amgen.

While the appraisal of Amgen's arguments in the initial district court decision certainly leans towards the plaintiffs' side, spectators of the pending Federal Circuit appeal will have to wait and see if there is enough in the defendants' arguments to support reversing the injunction.

CardiAQ Valve Technologies, Inc. v. Neovasc Inc et al

This much-watched case ended with a significant verdict for plaintiff CardiAQ Valve Technologies, a transcatheter valve manufacturer that sued medical device company Neovasc Inc for trade secret misappropriation, alleging it used CardiAQ-developed technology in one of its products. A jury in the federal court in Boston found that Neovasc violated a non-disclosure agreement between the two companies, and awarded CardiAQ $70 million in damages for the breach. In a later proceeding, the court awarded a further $21 million in enhanced damages, and gave CardiAQ founders Arshad Quadri and J Brent Ratz co-inventorship of the misappropriated mitral valve replacement. Shortly before the verdict, CardiAQ was acquired by medical device giant Edwards Lifesciences for a sum of $400 million.

Knobbe Martens Olson & Bear partners and LMG Life Sciences stars Christy Lea and John Sganga co-led the trial team for CardiAQ, along with litigators Brian Horne and Joshua Stowell.

Co-founder J Brent Ratz said in a press release following the verdict: "Through many years of dedicated work with Dr. Quadri, we were able to develop an extensive base of knowledge, make important advancements and create the CardiAQ transcatheter mitral valve to help patients in need who are not well-served by therapies available today. We are proud of this foundational work and grateful that the jury recognized these contributions to the developing field of transcatheter mitral valve replacement."

Following the 2016 judgment, Neovasc filed an appeal before the Federal Circuit, seeking to reevaluate the initial damages award and the accumulated interest payments ordered by the court.

Coherus BioSciences Inc v AbbVie Biotechnology Ltd

In a series of significant wins before the Patent Trial and Appeal Board (PTAB), legal counsel for Coherus BioSciences convinced the board that three dosing patents related to AbbVie's HUMIRA biologic were obvious due to prior art, the first successful challenge against the blockbuster drug.

A team of Fish & Richardson lawyers led by partner and post-grant co-chair Dorothy Whelan took on the inter partes reviews on behalf of the biosimilar maker, whose resulting wins will now carve out a path for other challengers to dispute the HUMIRA patent portfolio. The US Patents at issue are numbered 8,889,135; 9,073,987; and 9,017,680, touted as "cornerstone patents" in the HUMIRA group.

"You're not going to file IPRs for the whole portfolio. You'll bankrupt yourself," Whelan said about the trial team's targeted approach. "We thought, 'What are the chinks in the armor here?'" She explained that the team put its focus on the dosing claims for rheumatoid arthritis, a primary indication for the biologic, since they showed to be the biggest vulnerabilities for the patent family.

The board gave final written decisions for all three patents, the '135 patent declared invalid in May, and the '987 and '680 patents in June. Rounding out Fish's litigation bench in the patent dispute were partners John Adkisson, Michael Kane, Jonathan Singer, Elizabeth Flanagan and Chad Shear.

Whelan, now recognized as an LMG Life Sciences star, described some of her team's strategy in putting forth a convincing argument for the client: "Our real challenge was to try and present enough evidence," she said. "We did it in the way we formed our arguments and the expert declarations we submitted. We wanted to put all those arguments in a new light, to show the examiner did not have all the relevant information."

Recently, the life sciences industry has seen a slight increase in IPRs as a viable route for patent strategy, though not as high as the tech space. Whelan said use of this proceeding has to be strategic, and in this case she viewed it as the best option to clear the patents. Soon after the initial IPR filing for Coherus, pharmaceutical innovator Boehringer Ingelheim sought to challenge the same HUMIRA patents at the PTAB. Whelan said in a case like this there are typically multiple challengers, and one party has to decide whether they want to take the risk and be the primary actor, which, of course, she and the Fish team were.

While the team was successful in invalidating the three patents, Whelan said it wasn't without difficulty, given the strength of the HUMIRA portfolio and the complex nature of biologic claims. "I really think that our biggest challenge is that the references had been extensively considered with prosecution," she said. With that, Whelan's job in the courtroom was "not just a matter of presentation, but raising a new question of patentability."

Gilead Sciences Inc. v Merck & Co, Inc. et al

Gilead v Merck resulted in one of the most stunning outcomes out of the many patent cases from the past year. In the dispute over patents related to Gilead-marketed Hepatitis C drugs Harvoni and Sovaldi, a jury in the District Court of Northern California upheld the validity of Merck's patents for the drugs' active ingredient and awarded the company $200 million in damages, but after a malfeasance was discovered involving false testimony from an expert witness for Merck, the verdict was reversed and the award waived under the unclean hands doctrine.

"After a thorough review of the evidence submitted at trial and in post-trial submissions, the Court finds Gilead has not shown that Merck waived its right to enforce the '499 and '712 Patents against Gilead," a court order addressing the malfeasance reads. "The record, however, reflects a pervasive pattern of misconduct by Merck and its agents constituting unclean hands, which renders Merck's '499 and '712 Patents unenforceable against Gilead."

In a bench trial following the initial eight-day jury trial, a Fish & Richardson team made the convincing argument for Gilead's defense that Merck had knowingly used confidential information about the developing drugs to draft its own patents, and later attempted to cover it up at trial by delivering false testimony from a witness about the events at issue. Leading the charge in the series of trial stages were attorneys Juanita Brooks and Jonathan Singer.

"We really scoured the case law, and not limited to patent disputes," Fish partner and trial team member Elizabeth Flanagan said about the team's work in proving unclean hands. "We took a very broad view to try to give the district court a picture of the type of conduct that could lead [the district judge] to find that misconduct was in place."

The Gilead side further argued that this misconduct bars Merck's right to enforce the patents related to the drugs, even after the initial ruling declaring them not invalid. "The judge found both testimonies to be untruthful, and she found it more disturbing because it was an officer of the court," Fish partner and trial team member John Farrell said, adding, "It was nice to see a judge keep control of how things go in a courtroom." Farrell deposed the Merck witness who was central to the false testimony matter.

Adding to the trial team's success in arguing for Gilead's defense at the bench trial, the team was also able to reduce the initial award of over $2 billion sought by Merck to a fraction of the sum at $200 million, which of course still ended up being discarded.

"I think that this is a cautionary tale for companies who are developing the next blockbuster drug, who are perhaps the small company like Pharmasset who is looking to big pharma or a partner," Flanagan said. "It's a good reminder for them to be very careful and diligent about protecting their compounds, and making sure they have adequate protection in place."

Gilead was also represented by Fish & Richardson attorneys Douglas McCann, Gregory Booker, Bob Oakes, Michael Florey and Joseph Warden.

GlaxoSmithKline LLC et al v Teva Pharmaceuticals USA Inc

A federal jury in the District Court of Delaware delivered a verdict which found that Teva Pharmaceuticals willfully infringed on GlaxoSmithKline's patent for blood pressure drug Coreg, resulting in a stunning $235 million damages award for the branded drug manufacturer. Teva had been producing a generic version of GlaxoSmithKline's product, carvedilol, after receiving FDA approval for indications solely related to expired patents connected to Coreg. But in 2011, Teva changed its label to indicate treatment for chronic heart failure, which was still protected under patent's licensed to GSK. With this added indication, providers then started prescribing Teva's product as a substitute for Coreg. GSK's suit involved claims of lost profits while the generic was being marketed for its added indication, which resulted in the large multimillion-dollar verdict. The two parties are currently engaged in post-trial motions following the June verdict. Fish & Richardson attorneys secured the win for client GlaxoSmithKline, including Juanita Brooks, Jonathan Singer, Douglas McCann, Elizabeth Flanagan, Michael Amon, Craig Countryman, Michael Kane and William Woodford.

Idenix Pharmaceuticals Inc et al v Gilead Sciences Inc

An obvious choice for this list, Idenix Pharmaceuticals v Gilead Sciences resulted in the biggest patent infringement verdict in history with $2.54 billion in damages awarded to Merck subsidiary Idenix and other entities, a complete victory for the plaintiff side. The dispute was related to sofosbuvir, the ingredient in blockbuster Hepatitis C drugs Harvoni and Sovaldi under the Gilead brand.

The patent at issue was filed by Idenix in 2000, claiming a method for treatment of a Hepatitis C infection with a nucleoside composition, the method the plaintiffs claim was misappropriated by the defendants through the use of confidential information prior to the patent's issuance. That information allegedly used by Gilead-acquired company Pharmasset Inc led to the development of the marketed drugs Harvoni and Sovaldi. Because District of Delaware Judge Leonard Stark found the defendants to have "willfully" infringed the patent, the already staggering damages amount could multiply.

Jones Day partners and LMG Life Sciences stars Anthony Insogna, Stephanie Parker and Calvin Griffith were some of the leading attorneys on the plaintiff side. Insogna served as lead trial strategist and Parker argued the case before the district court judge and jury, her first ever intellectual property case according to a press statement released by Jones Day. Insogna has been counsel to the drug maker Idenix since related disputes arose in 2012. Additional leads for the plaintiffs were Steven J Balick, John G Day, and Andrew Mayo of firm Ashby & Geddes.

Naturally with stakes of this magnitude, the case is currently under appeal by Gilead at the Federal Circuit. Reports question whether the massive award will stand, but still, such a victory is notable as far as any litigation goes, and a prospective settlement would still likely be substantial given the determination from the district court. The next largest damages sum in recent patent history was found in the life sciences dispute from 2009, Centocor v Abbott, which resulted in a $1.67 billion award eventually overturned on appeal.

Phigenix Inc v ImmunoGen Inc

Phigenix v ImmunoGen resulted in a precedential decision from a panel at the Federal Circuit, which declared that non-practicing entities (NPE) do not have standing to appeal a decision for damages because they did not receive harm. This dispute originated at the Patent Trial and Appeal Board, where Phigenix, an NPE with no competing products, moved to challenge ImmunoGen's patent covering breast cancer drug Kadcyla. The challenge was denied, and Phigenix filed an appeal of the decision, kicking off the arguments at the Federal Circuit.

"It was an interesting decision," lead attorney representing ImmunoGen Eldora Ellison said. "They said in the 35 years since the court was formed that was the first time they had to deal with standing from a federal agency decision." Ellison is a partner at Sterne Kessler Goldstein & Fox and its resident inter partes review expert, as well as an LMG Life Sciences star. She managed the case together with partner Eric Steffe, who debuted this year as an LMG Life Sciences star.

Upon moving to the Federal Circuit, Ellison said it immediately became clear that the central argument would revolve around Phigenix's standing to appeal, framing it in the context of the similar Consumer Watchdog decision from 2014. Ellison and the ImmunoGen side moved to dismiss on the basis that Phigenix did not receive harm as a non-practicing entity, which proved successful. "That for us was absolutely the right strategic move, and it showed that the appellant had failed to demonstrate any injury that they suffered," she said.

Since the appellate court made the ruling precedential in January, Ellison said she has seen other cases reference the decision, including a biosimilar dispute between NPE Momenta and Bristol-Myers Squibb which involves an appeal of an IPR.

"It's very rewarding, and I speak on behalf of the team, it's rewarding to have brought this issue to light at the Federal Circuit," Ellison said on her involvement in achieving the precedential ruling. "We feel it was absolutely the right decision. There are nuances about where the boundaries are drawn for future cases."

In a new development since the Phigenix appeal concluded, a Federal Circuit case in the tech space Personal Audio v Electronic Frontier Foundation resulted in a ruling that further clarified January's precedential decision. The court concluded that Personal Audio, an NPE that succeeded in nullifying a patent in IPR, was not obliged to meet standing requirements when the patent owner appealed to the Federal Circuit.

Sandoz Inc v Amgen Inc

The 2017 Supreme Court decision was a landmark moment in the life sciences space, ultimately ruling in favor of biosimilar makers with regards to the question over the "patent dance." The unanimous judgment, and probably the first visible one for Justice Neil Gorsuch, determined that federal courts can't order a biosimilar applicant to announce its abbreviated Biologics License Application (aBLA) to the innovator or licensee of the related biologic patents, and that the applicant can begin its 180-day period of notice before FDA approval. Ultimately, the result of the much-watched case should bring a sigh of relief to biosimilar makers, as it will allow for a speedier path to marketing a competing product and limit instances where the petitioner is enjoined from moving the application forward.

The dispute originated after Sandoz applied to market a biosimilar version of Amgen's biologic NEUPOGEN in 2014, but failed to provide the requisite application and information. Sandoz also planned to market its version less than the required 180 days after FDA approval. Amgen sued the company on those two counts, and after much litigating in the lower courts remained the two large issues at play for the Supreme Court justices to adjudicate.

In his written opinion on behalf of the Court, Justice Clarence Thomas concluded that although an injunction will not be available under federal law, lower courts will have the opportunity to determine whether such actions are allowed under state law.

Morrison Foerster's Deanne Maynard, LMG Life Sciences star and lead counsel for the Sandoz side, argued before the Court in April, with supporting testimony from Assistant to the US Solicitor General Anthony A Yang as amicus curiae, and WilmerHale attorney Seth Waxman for his role as lead counsel in the linked case Amgen Inc v Sandoz Inc.

One patent attorney cites this case as testing the structure of the relatively young legislation which guides biosimilar proceedings. "This is early days for these litigations," he said. The Biologics Price Competition and Innovation Act (BPCIA) has been signed into law for less than a decade, and just roughly a dozen litigations have made way under the act. This question of the patent dance was already looming on the minds of attorneys operating in this space, and Sandoz v Amgen served as a vehicle to have that question answered.

"We're going to have the patent dance no matter what," another practitioner said. "In Sandoz v Amgen, the issue is how much information the biologic innovator and the biosimilar have to exchange, and whether or not they have to exchange that information."

TC Heartland LLC v Kraft Foods Group Brands LLC

Referred to as a "game changer" by patent attorneys, this Supreme Court case dealing with the issue of venue may be the most high-profile patent case from the past year from a statutory standpoint. It's because of the case's impact, despite not being a life sciences patent suit, that it makes this list.

The reaffirmation of the 1957 Supreme Court verdict in Fourco Glass Co v Transmirra Products Corp declares that a domestic corporation resides only in its state of incorporation, instead of the broader interpretation which defines venue as "any judicial district in which such defendant is subject to the court's personal jurisdiction with respect to the civil action in question."

This is certainly not a new issue, and not the first time venue has been litigated at a high level, but it is curious to see how this latest determination will close down on the trendiest patent venue in the US District Courts, the Eastern District of Texas. The favorite District Court for petitioners only became popular after the most recent major decision regarding venue in 1990. One attorney says the decision will result in cases being spread across the country, and a swelling of filings in the District Court of Delaware, the home of most corporations.

"I just read a brief to dismiss because of TC Heartland," another patent attorney said. "We're dealing with it now." He opined that over time the decision will have less impact than anticipated, but in the short term will have repercussions due to uncertainty in the market and costs driving up. Opinions may differ on the impact it has on the life sciences industry, but it seems clear to most that this Supreme Court decision sounds the death knell of the Eastern District of Texas as a litigation hub.

The Supreme Court trial team for TC Heartland was led by Hughes Hubbard & Reed attorneys James Dabney, John Duffy, Richard Koehl and Emma Baratta.


Top 10 Cases of the Year: Non-IP Litigation

USA ex rel. Kevin N. Colquitt, et al. v. Abbott Laboratories, et al.—Kirkland & Ellis

Kirkland & Ellis represented Abbott Laboratories in in a False Claims Act case that arose when a former Abbott sales representative filed an action as an alleged whistleblower and sought more than $1 billion for alleged Medicare fraud. The plaintiff's theory was that alleged "illegal" off-label marketing by Abbott drove FDA unapproved medical procedures. During the jury trial, rather than refuting each allegation about improper promotions, Kirkland shifted the jury's focus to the benefits of the devices themselves and the reasons doctors believed they were the best devices to use. This gave Kirkland an opening to call to the stand seven leading doctors from six states, who described tremendous patient benefits from the off-label use. Kirkland forced a conversation where doctors vividly described how they saved and improved patients' lives–a topic for which the plaintiff had no effective lines of cross-examination. In doing so, Kirkland effectively equated marketing issues with technical FDA and patient health with the relevant Medicare issue–a theme it drove home with most witnesses and also a simple and effective way to convince the jury to tune out any discussion of marketing practices and discount the plaintiff's core trial themes. In 2016, following a nearly three-week trial, a jury returned a verdict in favor of Abbott after only three hours of deliberation. In May 2017, the U.S. Court of Appeals for the Fifth Circuit affirmed Kirkland's trial win. Abbott was represented by Andrew Kassof, Mark Filip, James Hurst, Henry DePippo, John O'Quinn and Elizabeth Hess.

LabMD petitions for review of privacy and data security-related FTC decision—Ropes & Gray

Ropes & Gray, and specifically Douglas Meal, represented medical laboratory LabMD in its petition to the Court of Appeals for the Eleventh Circuit for review of a privacy and data security-related FTC decision that held LabMD liable for allegedly having "unfair" data security practices in violation of Section 5 of the FTC Act. The case arose from the alleged theft from LabMD of a file containing patient information and resulted in a July 2016 decision by the agency that adopted several novel and controversial interpretations of its authority under the FTC Act. In November, the Eleventh Circuit granted LabMD's motion to stay the FTC's order pending appeal.

Sanofi wins consumer class action relating to epinephrine injection drug Auvi-Q—Weil Gotschal

Weil Gotshal star trial lawyer Diane Sullivan secured a significant victory for Sanofi when an Illinois federal court granted the dismissal, without prejudice, of all claims in a putative consumer class action relating to Sanofi's epinephrine injection product, Auvi-Q. The plaintiff filed her complaint following a global recall by Sanofi of its Auvi-Q product, which is used to treat life-threatening allergic reactions, because of certain reported device malfunctions. As part of its recall, Sanofi offered to reimburse any patient who had to incur out-of-pocket costs to replace their Auvi-Q device with another epinephrine injector. The plaintiff asserted that Sanofi's Auvi-Q recall was a deceptive act or trade practice and unjustly enriched Sanofi, in violation of the Illinois Consumer Fraud Act (ICFA). A judge granted Sanofi's motion to dismiss, finding that plaintiff failed to state a claim that Sanofi's recall was unfair, and that the plaintiff failed to even allege intent by Sanofi for her to rely on the allegedly unfair practice. Turning to the plaintiff's unjust enrichment claim, the judge granted this dismissal as well. Rather than file an amended complaint, Plaintiff filed a notice of voluntary dismissal, resolving the case with no monetary payment by Sanofi.

In re K-Dur Antitrust Litigation—Goldman Ismail

After 14 years of being represented by other major firms, in fall 2015, Merck hired Goldman Ismail to serve as lead trial counsel in a private antitrust "pay-for-delay" class action by direct purchasers of prescription potassium supplement K-Dur 20. Plaintiffs claim that in June 1997, Schering-Plough Corporation (now Merck) agreed to make a $60 million payment to generic manufacturer Upsher-Smith in order to delay entry of a generic version of K-Dur 20 until September 2001. Since joining the case, the Goldman Ismail team has been involved in all aspects of trial work up, including appearing at hearings, drafting key motions, and preparing trial witnesses and experts. In late 2016, Jennifer Greenblatt spearheaded a third round of summary judgment briefing based on a new Third Circuit case, and a few weeks before trial, the 15-year-old case came to a close in February 2017. Had the case proceeded to the jury trial set to begin in the US District of New Jersey in April 2017, Tarek Ismail would have served as lead trial counsel and Jennifer Greenblatt would have served as second-chair trial counsel for Merck.

Fosamax product liability litigation—Goldman Ismail

Goldman Ismail also serves as trial counsel in product liability litigation over Merck's osteoporosis medication, Fosamax. Ken Baum also is a leading member of Merck's national science and expert team identifying key expert witnesses, taking and defending expert and treater depositions, and developing the scientific defense theories. Tarek Ismail and Andy Goldman have been retained to lead several femur fracture trials. Andy Goldman was selected as lead trial counsel for the first Illinois Fosamax case set for trial in January 2016, which Jen Greenblatt had narrowed from a consolidated multi-plaintiff matter to one plaintiff after securing key admissions from treating physicians. That last plaintiff voluntarily dismissed her case to avoid trial. Tarek Ismail, Andy Goldman, Ken Baum, and Jennifer Greenblatt served as lead counsel in these various matters.

Swann v. Johnson & Johnson—Proskauer Rose

Proskauer Rose obtained a significant victory for client Johnson & Johnson (J&J) in March 2017, when a St. Louis jury returned a complete defense verdict in the widely publicized product liability trial relating to J&J's talc-based Baby Powder and Shower to Shower products and its alleged link to ovarian cancer. The result is particularly significant considering that in 2016, the company suffered three adverse jury verdicts in St. Louis state court totaling nearly $200 million. At trial, plaintiffs claimed that J&J failed to warn consumers that its talc-based products can cause or contribute to ovarian cancer, and that the individual plaintiffs in the cases contracted ovarian cancer as a result of their multi-year use of those products. Proskauer attorneys Bart Williams and Manuel Cachán argued that the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), the National Institute of Health (NIH), and the Occupational Safety and Health Administration (OSHA), among other cancer watchdog agencies, have reviewed the same scientific evidence upon which the plaintiffs relied and concluded that talc should not be listed as a cancer causer or contributor. Proskauer will also be trial counsel in an upcoming talc-related trial in California state court, the first of its kind in the state.

In re Nexium (Esomeprazole) Antitrust Litig.—Williams & Connolly

Williams & Connolly was lead trial counsel for AstraZeneca in what Bloomberg called a "landmark" class action antitrust litigation alleging that AstraZeneca and certain generic pharmaceutical companies violated federal and state antitrust laws when they settled Hatch-Waxman patent cases that AstraZeneca had brought to enforce its patents for Nexium, a widely prescribed proton-pump inhibitor with annual US sales in the billions of dollars. The case, involving issues of antitrust law, patent law, and food and drug law, was one of the first so-called "reverse-payment settlement" cases following the Supreme Court's ruling in FTC v. Actavis, 570 U.S. 756 (2013), in which the Court held that alleged "pay-for-delay" settlements may be challenged under federal antitrust laws. The case was tried before a Massachusetts federal jury starting in October and lasted six weeks. On December 5, 2014–after less than two days of deliberations–the jury returned a verdict in favor of AstraZeneca and its co-defendant, Ranbaxy Laboratories, on all counts. On appeal to the First Circuit, plaintiffs challenged a number of the district court's rulings, sought reversal and a retrial. The US Court of Appeals for the First Circuit rejected those arguments and affirmed the decision in our client's favor on November 21, 2016.

In re C.R. Bard Pelvic Repair Systems Products Liability Litigation—Williams & Connolly

Williams & Connolly is lead resolution counsel for Medtronic, one of the world's largest medical device makers, in connection with over 10,000 claims concerning pelvic surgical mesh products that the company inherited when it acquired Covidien in early 2015. The litigation consists of cases spread across a federal MDL in West Virginia, state coordinated proceedings in New Jersey, Massachusetts, and California, and multiple cases in other state courts. Over the past 18 months, the vast majority of the claims have been resolved. In 2016, the company was able to resolve virtually all of the remaining cases pending against it, leaving no active litigation.

Mylan Pharmaceuticals Inc., et al v. Warner Chilcott Public Limited, et al—White & Case

A White & Case antitrust team consisting of Mark Gidley, Peter Carney, Eileen Cole, Jack Pace and Michael Gallagher and Noah Brumfield represented Warner Chilcott/Actavis/Allergan in litigation concerning acne medication Doryx, securing a Third Circuit affirmance in September 2016 of the district court's April 2015 dismissal of all claims in the first ever summary judgment defense victory in the US in an antitrust case alleging "product hopping," a theory that challenges innovation in the life sciences sector. In its September 2016 ruling, the Third Circuit rejected plaintiff Mylan's contention that the relevant market for antitrust purposes was limited to Doryx and its generic equivalents only. The Third Circuit also held that that alleged "product hops" Mylan took issue with did not amount to exclusionary conduct because they did not prevent Mylan from competing. Mylan moved the US Supreme Court for an extension of the time to move for an appeal, but as of April 2017 Mylan declined to file a petition for a writ of certiorari, ending the Doryx antitrust litigation.

Partner Investments, L.P., et al v. Theranos, Inc., et al—Gibson Dunn & Crutcher

Elizabeth Holmes, CEO of Silicon Valley startup Theranos, claimed that she and her company had revolutionized the world of blood testing by figuring out how to take all common blood tests through a finger stick amount of blood alone, rather than through intrusive venous blood draws. Holmes's elaborate boasts enabled Theranos to attract an all-star Board of Directors and attracted investments from some of the US's elite investment funds. In 2005 Theranos' technology was eventually proven to be fraudulent, and the company proceeded to undergo a protracted implosion, with Holmes' public identity spiraling from celebrity to pariah. In 2016, one of the company's investors, Partner Fund Management (PFM), turned to Gibson Dunn & Crutcher's Reed Brodsky in search of a solution of recourse. While other investors decided to stay on the sidelines and await the results of ongoing investigations by federal prosecutors and SEC regulators, Gibson Dunn led by Reed Brosky investigated, developed viable claims to pursue, and then filed the first lawsuit by an investor against Theranos, Holmes, and the company's former COO, seeking to recover the lost investment of nearly $100 million and treble damages. Theranos's counsel attempted to launch a tender offer for certain investor classes, offering those investors, including PFM, additional shares in exchange for a release of all claims and a higher priority in any bankruptcy proceeding. That tender offer was a thinly veiled attempt to force PFM to choose between giving up its claims or continuing to proceed against Theranos at the risk of getting absolutely nothing in bankruptcy. The firm succeeded in stopping the tender offer from proceeding for weeks while it pursued discovery into Theranos's motives and communications. Eventually the parties were able to reach a satisfactory settlement of both lawsuits, extricating the client entirely, while many other investors remained at risk.