Gleason IP Testimony Supports Client’s Successful Case
Gleason IP provided expert testimony on behalf of Teva Pharmaceuticals to establish that the asserted patent claims allegedly covering Adapt Pharma’s opioid overdose drug were invalid due to obviousness, and that the marketplace performance of Narcan® was attributable to features already known in the prior art, among other extrinsic factors unrelated to the Patents-in-Suit.
Engagement
In a Hatch-Waxman pharmaceutical patent infringement matter, Ivan Hofmann and the team at Gleason IP analyzed commercial success as a potential secondary consideration of non-obviousness on behalf of Teva Pharmaceuticals to assist the trier of fact in assessing the validity of the Patents-in-Suit that allegedly covered Narcan®.
Gleason IP analyzed and responded to the Plaintiffs’ claims that Narcan® was a marketplace success and that there was a nexus between such alleged success and the asserted claims of the Patents-in-Suit by focusing on non-patented features that drove the performance of Narcan®.
Gleason IP’s Role and Result
Gleason IP performed an analysis of the marketplace performance of Narcan® and determined that the marketplace performance of Narcan® failed to provide objective indicia of nonobviousness of the asserted claims of the Patents-in-Suit. Ivan Hofmann, Vice President and Managing Director at Gleason IP, testified at trial in the District Court of New Jersey before Judge Martinotti, offering testimony related to the marketplace performance of Narcan® and whether a nexus existed between the marketplace performance of Narcan® and the asserted claims, as well as an assessment of purported third-party praise.
Mr. Hofmann testified that the purported benefits of the asserted claims of the Patents-in-Suit were already known in the prior art, that the marketplace performance of Narcan® was attributable to extrinsic factors unrelated to the asserted claims of the Patents-in-Suit, and that evidence demonstrated that there was a lack of economic incentive for a Person of Ordinary Skill in the Art to develop a naloxone product that practiced the alleged patent claims.
Mr. Hofmann also addressed the Plaintiffs’ expert’s assertion of third-party praise for Narcan®, and argued that the alleged praise was simply information about features that were previously known and not novel to the asserted claims.
In June 2020, the District Court Opinion ruled in favor of Teva Pharmaceuticals and invalidated the asserted claims of the Patents-in-Suit due to obviousness. Specifically, the District Court found that no nexus existed between the purported secondary considerations of nonobviousness and the asserted claims of the Patents-in-Suit.
Judge Martinotti credited the testimony of Mr. Hofmann that the marketplace performance of Narcan® was attributable to features already known in the prior art, Adapt Pharma’s marketing strategies, and Adapt Pharma’s strategic pricing of Narcan®, rather than the alleged novel features of the Patents-in-Suit. In addition, the District Court found the Plaintiffs’ contention of substantial commercial incentive to develop the claimed invention to be “tenuous.”
The District Court found Mr. Hofmann to be a more credible witness than the Plaintiffs’ economic expert and technical expert on the issues, stating:
“Overall, the Court found Mr. Hofmann to be a highly credible and persuasive witness, and credited his testimony over that offered by Dr. Vigil and Dr. Majumdar.”
This was an exciting win for our client and Gleason IP was able to provide meaningful independent and objective expert analyses and opinions that contributed to our client’s success.
The case is ADAPT PHARMA OPERATIONS LIMITED, et al., v. TEVA PHARMACEUTICALS USA, INC., et al. C.A. No. 2:16-cv-7721 (BRM) (JAD)
(Opinion)
Aaryn Hogue August 3rd, 2020
Posted In: Gleason IP
Remote Depositions in Response to COVID-19
The COVID-19 pandemic and related stay-at-home directives have led to an increase in remote depositions. Historically, attorneys have been reluctant to conduct remote depositions, but there can be certain advantages to be gained from their adoption. On several occasions, Gleason Managing Directors have been deposed virtually and are providing insight for consideration to aid in the efficient execution of this discovery tool.
The COVID-19 pandemic and related stay-at-home directives have led to an increase in remote depositions. Under Federal Rules of Civil Procedure, a deposition may be conducted by remote means should the parties so stipulate or by court order. Since the beginning of the outbreak, many courtrooms have been closed, but some have encouraged (or ordered) the use of available technology to move forward with case discovery, including the use of remote depositions.
Although the technology to perform remote depositions has existed for years, attorneys have been reluctant to implement such technology. Common criticisms of remote depositions include (but are not limited to):
- The potential for internet/network disruptions
- Poor audio quality
- Difficulty in handling and coordinating deposition exhibits
- Difficulty reading the deponent’s body language or other non-verbal communication
- The potential for remote coaching of the witness
- Network security
Despite these concerns, the practice of conducting depositions in a remote environment may provide several benefits to the litigation. Perhaps most importantly, given the nature of these unprecedented times, parties will maintain compliance with local government restrictions and/or health and safety protocols (e.g., social distancing, travel restrictions, etc.) One significant advantage of remote depositions is in the form of cost and time savings through a reduction in travel. Furthermore, counsel may have the ability to participate in a greater number of depositions than if traveling between locations for physical attendance.
Several Gleason Managing Directors have participated in remote depositions in the wake of the pandemic and have developed a list of considerations to enhance the virtual experience.
- Ensure all parties have adequate technology – including a webcam, microphone with clear audio, and dual monitors (to allow on-screen video on one screen and exhibits on the other screen).
- Ensure the deponent has a quiet environment free of interruption for the duration of the deposition and that the background view is clean and appropriate.
- Familiarize oneself with the deposition software (e.g., Zoom) in advance of the deposition to improve efficiency. Provide a tutorial the day before if necessary.
- Deposition exhibits should be provided to the court reporter in advance and to the deponent in a sealed envelope or box to be opened upon the start of the deposition.
- The deponent should take an extended pause before responding to a question to provide the defending attorney time to issue an objection and allow the court reporter time to receive the testimony clean without overlap.
- Careful planning should be performed to ensure the deposition stays on track and makes effective use of the allotted time.
Remote depositions may require additional preparation, communication, and coordination, but will likely be an essential skill to master as remote depositions are likely to become more commonly utilized in the future.
As court systems continue to cope with the impact of COVID-19 and transitioning to a virtual environment for depositions, the logical next step is an increase in remote trials. In July 2020, the Southern District of New York conducted a remote bench trial in a patent infringement case. Direct testimony was submitted in writing and cross-examination occurred live via Zoom. In the current environment, it is likely for patent infringement cases to be tried either partially or completely via remote testimony.
Aaryn Hogue August 3rd, 2020
Posted In: Gleason IP
Pricing in the Pharmaceutical Industry
Drug pricing in the United States has been a political hot topic in recent years. On July 24, 2020, President Trump signed four executive orders on lowering drug prices. This multifaceted issue has numerous stakeholders with far reaching financial impacts. The backdrop of the current global pandemic creates additional complications for pharmaceutical companies seeking to bring COVID-19 treatments and vaccines to market, as these companies could be judged harshly if pricing of their products is not seen as reasonable by the public.
The pharmaceutical industry in the United States is structured to provide companies and investors economic incentives to engage in product development in exchange for fruitful returns throughout product launch. In recent years, drug pricing in the United States has been heavily scrutinized, with many arguing that companies are abusing regulated monopolistic periods and marketing drugs at unjustified prices.
An analysis published in 2018 by the America’s Health Insurance Plans (AHIP) association stated that on average, approximately 700 drugs had increased their price by 10 percent or more annually during the past five years. In 2019, the Senate Finance Committee held a congressional hearing with seven pharmaceutical executives to discuss increases to drug pricing, and H.R.3, a bill known as the Lower Drug Costs Now Act, is awaiting Senate review after being passed by the House of Representatives in late 2019.
The COVID-19 pandemic has pharmaceutical companies under a microscope due to the world-wide demand for drugs to treat the disease. The non-partisan organization, Institute for Clinical and Economic Review (ICER), known as an independent watchdog on drug pricing, is closely following the pricing developments for COVID-19 treatments and vaccines.
On May 1, 2020, Gilead’s remdesivir received an emergency approval from the United States Food and Drug Administration for hospitalized patients with severe COVID-19 symptoms. Acknowledging the speculation regarding the potential pricing of remdesivir, Gilead published an open letter from its Chairman and CEO. The letter announced that in the United States, remdesivir would be listed at $3,120 for a 5-day treatment and discounted to $2,340 for certain government programs. Gilead also stated that by the end of 2020, it expected its investment in remdesivir to exceed $1 billion and that it felt the price set for remdesivir was well below its value.
In response to Gilead’s announcement, ICER stated that Gilead’s price was largely in line with its analysis of a reasonable price, given certain assumptions. However, some felt the pricing was too high given the pandemic and noting that Gilead received funding from the government for the development of remdesivir.
Outside of the United States, Gilead entered into non-exclusive licensing agreements with nine companies to manufacture and distribute remdesivir at a lower cost for developing countries and countries with substantial healthcare obstacles. Each licensee is able to set the price for its generic remdesivir product and the licenses are royalty-free until the World Health Organization ends the Public Health Emergency of International Concern or another drug is approved for the treatment or prevention of COVID-19.
The current pricing approach in the U.S. relating to COVID-19 treatments and vaccines continues to provide opportunities for companies and investors to engage in further product development. As a result, companies may be able to set higher prices in the U.S. and lower prices in developing countries. However, as seen with Gilead’s remdesivir, the pricing decisions made by pharmaceutical companies marketing COVID-19 treatments will be analyzed and scrutinized extensively.
Aaryn Hogue August 3rd, 2020
Posted In: Gleason IP
Patent-Thickets in the News
Recently the practice of establishing so called patent-thickets for biologic products has been questioned as a potentially abusive way of preventing biosimilar competition. In June 2020, the Honorable Judge Manish S. Shah in the United States District Court for the Northern District of Illinois Eastern Division issued a Memorandum Opinion and Order dismissing a class action lawsuit against AbbVie. The Memorandum Opinion and Order dismissed claims against AbbVie for allegedly violating federal and state antitrust laws and consumer protection laws regarding AbbVie’s “patent thicket” covering the world’s best-selling pharmaceutical product, Humira® (adalimumab).
Humira® (adalimumab), an anti-inflammatory biologic product, is the world’s top selling prescription product. Humira® has generated over $130 billion in total sales since its launch in 2003. In 2019 alone, the global and U.S. sales of Humira® were approximately $19.1 billion and $14.9 billion, respectively. AbbVie has obtained well over 100 patents covering Humira® which has been commonly referred to as a “patent thicket.” As of May 2019, AbbVie had entered into settlements with eight pharmaceutical companies over Humira® biosimilars. Humira® biosimilar competitors in the U.S. are expected to launch in 2023.
In a 2019 class action lawsuit, AbbVie was accused of violating federal antitrust laws, state antitrust laws, and consumer protection laws regarding Humira®. The Plaintiffs, who were indirect purchasers of Humira®, alleged that AbbVie cornered the market for Humira® through allegedly anticompetitive conduct.
According to Judge Shah’s Order, the Plaintiffs alleged that AbbVie obtained and asserted patents to gain power in order to elbow its competitors out of and maintain its position in the U.S. Humira® market. Plaintiffs further alleged that AbbVie repeatedly and aggressively asserted “swaths of invalid, unenforceable, or non-infringed patents without regard to the patents’ merits.”
Judge Shah’s Order states the alleged anticompetitive conduct described by Plaintiffs was not an antitrust violation. “AbbVie has exploited advantages conferred on it through lawful practices and to the extent this has kept prices high for Humira® [adalimumab], existing antitrust doctrine does not prohibit it.”
AbbVie claimed there was nothing illegal about amassing a broad portfolio of legitimate patents, even if a few were issued erroneously. Furthermore, the Order stated that the legal and regulatory backdrop for patented biologic drugs, together with a well-resourced litigation strategy, gave AbbVie the ability to maintain control over Humira®.
“The allegations-even when considered broadly and together for their potential to restrain trade –fall short of alleging the kind of competitive harm remedied by antitrust law.”
AbbVie anticipates biosimilar competition for Humira® in the U.S. starting in 2023. AbbVie continues to pursue strategies to differentiate Humira® from competing products and add to Humira®’s sustainability.
Sources:
- AbbVie Inc. Form 10-K for the fiscal year ended December 31, 2019
- Memorandum Opinion and Order, In Re: Humira (Adalimumab) Antitrust Litigation, No. 19 CV 1873, Judge Manish S. Shah, dated June 8, 2020
- Class Action Complaint, UFCW Local 1500 Welfare Fund, on behalf of itself and all others similarly situated v. AbbVie Inc., AbbVie Biotechnology Ltd., Amgen Inc., Samsung Bioepis Co., Ltd., Mylan Inc., Mylan Pharmaceuticals, Inc., Sandoz, Inc., Fresenius Kabi USA, LLC, Pfizer Inc., and Momenta Pharmaceuticals, Inc. Civil Action No. 1:19-cv-01873, dated March 18, 2019
Matt Gleason August 3rd, 2020
Posted In: Gleason IP