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Friday, September 2, 2022

Biopharma Needs to Protect more than Crown Jewel IP to Stay Competitive

 The problem of intellectual property theft is greater than most biopharma executives realize, but the real issue is that companies are protecting only a fraction of their IP.

“Companies, especially in biopharma, are used to protecting their crown jewels – their secret formulas and manufacturing expertise,” Anne Elise Herold Li, a partner in Crowell & Moring’s life sciences’ litigation, intellectual property and trade secrets group told BioSpace. What they’re not protecting is the foundational IP required to start a rival company. “That’s what’s at risk right now. A lot of new companies are trying to enter the market and they’re trying to get the basics right,” Li said.

Anne Elise Herold Li_Crowell & Moring“Standard operating procedures (SOPs), the steps to get from point A to point B and how R&D is conducted or managed are all competitive advantages that are, largely, not protected,” she elaborated. “Companies have developed this expertise over decades of trial and error, and it may not be guarded as closely (as how to make the molecule, for example), but it’s just as valuable to copycat companies.”

Trade secrets are kept in a safe, but SOPs and processes may be in the lab or on the manufacturing floor...or in email. “Because the company doesn’t treat it as secret, employees often don’t know that it is a secret thing,” Li said.

Foundational know-how can differ greatly among companies. Consider manufacturing patents. They outline the (often proprietary) growth media, tests and tools needed to create a specific product and are unique to certain platforms and types of indications. “You need to keep that under lock and key,” Li said. “If you design a way to cut one step from the manufacturing process or shorten it by a day or two, that could represent hundreds of millions of dollars for certain products.”

When people think of IP theft, Cold War-style industrial espionage and cyber hacking may come to mind, but theft more often is personal.

Monitor Competitors’ Job Postings

"Often, companies recruit away employees because of their very specific knowledge,” Li said. They may have knowledge relating to how a particular molecule is made, a particular process or what has been tried and failed. Therefore, she recommended monitoring competitors’ job postings to see if they are tailored to certain employees who have access to your proprietary information. These postings are designed to attract very specific individuals within a company and will closely mirror those individuals’ resumes. Mirroring an employee’s job description and expertise is a way to lure them to another company without ringing any alarm bells.

“Often, you can reach out to the competitor and ask them to show that the person they just hired from your company isn’t working in an area that would use their proprietary knowledge,” Li assured. “Competitors are much more engaged in this kind of conversation because it goes both ways.”

Some degree of insider knowledge can also be gained by hiring a spouse or family member. “Companies are very careful about tracking where employees go next, but nobody really tracks where the spouse or next of kin goes. That’s often a vector for inadvertent disclosure,” she added.

Knowledge Dispersed by Remote Work

With so many people working from home during the COVID-19 pandemic, both asset and foundational knowledge has been dispersed. According to the 2022 Ponemon Cost of Insider Threats Global Report, “Sixty-five percent of respondents say email is where employees store their organizations’ most sensitive data, such as…IP.” For all industries surveyed, it noted that incidents stemming from insiders increased 44 percent in the past two years. For example, 74 percent of those responding said malicious insiders had emailed sensitive data to outsiders, and 60 percent reported people accessing sensitive data that was not associated with their job functions. The report interviewed 1,004 individuals from 278 organizations, six percent of which were in health and pharmaceuticals.

“Now that people are coming back into the office, companies need to gather up those crumbs that have been put in the diaspora and get them back where they need to be, within the confines of the building,” Li said. Simply raising awareness of the risk is a good step.

Aside from a few high-profile cases that are referred to the U.S. Department of Justice, instances of IP theft tend to be settled privately, Li added. “Neither the one from whom the IP was stolen or those who did this want their names associated with IP theft.” Therefore, it’s hard to associate a dollar value with IP theft, she noted.

SEC Disclosure Guidance

“IP theft is more common than anyone realizes, but companies are very reluctant to talk about it because of the potential implications,” Amy Fix, partner at Barnes & Thornburg, told BioSpace.

Amy Fix_Barnes & ThornburgThe SEC, which could be expected to have data, is rather canny on the subject.

“There is no specific line-item requirement under the federal securities laws to disclose information related to the compromise (or potential compromise) of technology, data or intellectual property,” according to the SEC. Yet, the guidance continued, “The company has certain disclosure obligations for IP and technology risks and some existing rules or regulations could require disclosure regarding the actual theft or compromise of…IP if it pertains to assets or intangibles that are material to a company’s business prospects.”

For ‘crown jewels’ type IP theft, “The primary issue is the balance of risk versus reward,” Fix said. Because that information typically is well-protected, the thief tends to be more sophisticated than someone sharing foundational knowledge. For blockbuster products, the reward can be huge.

The chances of success also may be higher in biopharma than in other industries, she speculated. “I don’t think pharmaceutical organizations have invested in (mitigating) cyber risk as much as other areas of their companies. Because it’s such a highly regulated industry, even their IT components have to be reviewed and approved in terms of being audited…so they often don’t have the newest versions of everything…and that puts them at risk,” Fix explained.

Look Beyond the Crown Jewels

To safeguard IP, look beyond the crown jewels, Li advised, and identify what gives your company a competitive edge. “Implement the same sort of safeguards you use to protect the more specific product information,” such as restricting and monitoring access to that information.

Fix advocated segregating access to sensitive information, but with a caveat. “Take a step back and determine what really is sensitive and what isn’t. Don’t just mark everything confidential or proprietary." Doing so undermines protection for data that truly is sensitive. Instead, “Focus on data that actually needs encryption,” she said.

Going a step further, Li advised monitoring employee behavior. “For example, if someone suddenly works different or odd hours with no apparent reason, or tries to access information they don’t need for their job – even if it isn’t foundational SOP – find out why.

Also, conduct deep due diligence on collaborating companies and the individuals in that company. See if they’ve ever been involved in a trade secret or fraud case,” she said. The life sciences industry is more collaborative today than it was even three years ago, and far more so than 10 or 20 years ago. That collaboration strengthens companies and the industry, but also adds risks. As Fix said, “Every time you introduce a third party, you introduce IP risk.”

https://www.biospace.com/article/biopharma-needs-protect-more-than-crown-jewel-ip-to-maintain-a-competitive-edge-/

Pfizer, BioNTech seek to revoke CureVac's patent infringement claims

 Pfizer and its German partner BioNTech have filed proceedings at the High Court of England and Wales, seeking a judgment that their COVID-19 vaccine, based on mRNA technology, does not infringe on CureVac's European patents, according to a regulatory filing on Friday.

In July, CureVac had filed a patent lawsuit against BioNTech over its use of mRNA technology, seeking fair compensation from the company and two subsidiaries for infringement of its intellectual properly rights.

Pfizer and BioNTech later filed a complaint with a U.S. district court, seeking a judgment that they did not infringe U.S. patents held by CureVac.

Pfizer and BioNTech are also facing patent infringement lawsuits from other companies.

Last month, rival mRNA vaccine maker Moderna filed a patent lawsuit against the companies related to their COVID-19 shot.

https://finance.yahoo.com/news/1-pfizer-biontech-seek-revoke-140534027.html

Walgreens Sets Updated COVID-19 Pfizer and Moderna Boosters

 Walgreens now offers updated COVID-19 Pfizer and Moderna boosters to eligible individuals aged 12 years and older following authorization from the Food and Drug Administration (FDA) and new guidance from the Centers for Disease Control and Prevention (CDC). Scheduling an appointment is preferred and is available via the Walgreens app, 1-800-WALGREENS, or online at Walgreens.com/ScheduleVaccine starting today for vaccinations. Additional appointments will be added daily as select Walgreens stores begin to receive the updated COVID-19 boosters.

https://finance.yahoo.com/news/walgreens-now-offering-appointments-updated-151900706.html

Amylyx up for 2nd NDA meeting on ALS treatment

 Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) ("Amylyx or the "Company") today announced that the U.S. Food and Drug Administration (FDA) posted briefing documents for the reconvened Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) meeting to review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS).

The second meeting of the PCNSDAC for the AMX0035 NDA is scheduled for 12:00 p.m. ET on Wednesday, September 7, 2022. The briefing materials and webcast information can be accessed here. The Company is not responsible for the content of, nor the statements made in, the briefing materials that were prepared by the FDA.

The PCNSDAC previously met on March 30, 2022 to discuss the NDA for AMX0035 for the treatment of ALS. The Prescription Drug User Fee Act (PDUFA) target action date for the NDA is September 29, 2022, which was extended by the FDA to allow more time to review additional analyses of data from the Company’s clinical studies.

https://finance.yahoo.com/news/amylyx-pharmaceuticals-announces-posting-briefing-161500681.html

Liquidia: Options, analyst actions

 Liquidia Co. (NASDAQ:LQDA - Get Rating) was the recipient of unusually large options trading activity on Thursday. Stock traders bought 6,623 put options on the stock. This is an increase of approximately 135% compared to the average volume of 2,824 put options.

Several research firms have recently commented on LQDA. Wedbush downgraded shares of Liquidia from a "neutral" rating to an "underperform" rating and lowered their target price for the stock from $4.00 to $3.00 in a report on Thursday. Needham & Company LLC began coverage on shares of Liquidia in a report on Thursday. They issued a "buy" rating and a $12.00 target price on the stock. 

Immuneering Applies for Phase 1/2a Trial of IMM-1-104 to Treat Advanced Solid Tumors

 Immuneering Corporation (Nasdaq: IMRX), a biopharmaceutical company using translational bioinformatics to advance a pipeline of product candidates designed to benefit large populations of patients with cancer and other diseases, today announced it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The IND application supports a Phase 1/2a clinical trial of IMM-1-104, an oral once daily small molecule in development for the treatment of advanced RAS mutant solid tumors. In contrast to the narrow approach of targeting specific mutations such as KRAS-G12C, IMM-1-104 is a third generation MEK inhibitor designed for broad pan-RAS activity as well as activity in other MAPK-activated tumors. Based on preclinical data to date, IMM-1-104 has demonstrated robust single-agent anti-tumor activity across a broad range of in vitro and in vivo tumor models driven by MAPK pathway activation events. This includes animal models of KRAS mutant pancreatic cancer, NRAS mutant melanoma, KRAS mutant colorectal cancer, and KRAS mutant lung cancer, regardless of the specific mutation upstream of MEK that drives activation of the MAPK pathway, and all while maintaining a well-tolerated safety profile in such models.

https://finance.yahoo.com/news/immuneering-announces-submission-ind-application-120900155.html

Biden’s Student Loan Forgiveness Plan: Here’s Who Benefits Most—And Least

 Favors high-income Americans: Despite the $125,000 income cap, research shows the White House plan still slightly favors higher-income Americans: Analysis of a $10,000 blanket relief program published Tuesday by the Penn Wharton Budget Model found 69.79% of overall debt forgiveness would go to the top 60% of Americans by income, while individuals who make between $82,400 and $141,096—placing them between the 60th and 80th percentile—would receive the greatest share of overall forgiveness, at 28.1%, though the additional relief for Pell grant recipients should bring further benefit to lower-income borrowers.

Generally, higher-earning Americans hold more student loan debt, with the top 10% of individuals holding 17.4% of all debt compared to 13.8% for the bottom 20% of earners, according to the most recent installment of the Federal Reserve’s Survey of Consumer Finances in 2019.

Only a little help for some: However, the relief does not move the needle much for the most indebted Americans: Some 38% of the $1.62 trillion in total outstanding federal student loan debt is held by borrowers with balances of more than $100,000, even though they account for just 7.5% of all borrowers.

https://www.forbes.com/sites/dereksaul/2022/08/24/bidens-student-loan-forgiveness-plan-heres-who-benefits-most-and-least/