“Artificial intelligence [will] be the ultimate version of Google. The ultimate search engine that [will] understand everything on the web. It [will] understand exactly what you want, and it [will] give you the right thing ” —Larry Page

On September 25th, LegalRnD will be hosting Brian Kuhn, Global Leader and Co-Creator of IBM Watson Legal, who will be speaking about Artificial Intelligence. If you are anything like me you might be wondering what artificial Intelligence (AI) is and why as a lawyer or potential lawyer, should I care? Some lawyers, like my coworker this summer, believe that AI will replace lawyers in the coming years and therefore, oppose the implementation of it within the legal industry. Others like Dan Linna Jr., Director of LegalRnD at Michigan State University College of Law, and Andrew Arruda, CEO of Ross Intelligence, have written articles, where both have agreed that use of AI will result in attorneys being more effective and efficient. 1,2.

Why should the legal industry concern themselves with AI?
In several recent studies, it has been reported that attorneys with 0 to 4 years of experience spend a third to three-fourths of their week conducting legal research. Startup companies such as Ross Intelligence have decided to use AI to address this waste. 4,5.

Ross Intelligence, an AI start-up company, helps lawyers find relevant cases using natural language search. The application allows you to ask your questions in plain English, as you would a colleague, and ROSS then reads through the entire body of law and returns a cited answer and topical readings from legislation, case law and secondary sources to get you up-to-speed. The application is not designed to replace lawyers, but rather help them with knowledge management: keeping up with all the latest legislation. 6.

There are other types of startups, like Law Pocket, that are using AI to help consumers structure their legal questions and then connects them to the best-equipped attorney to handle the issue. Law Pocket is developing an app that would help bridge the gap for access to justice by placing justice in the palm of consumers’ hands. 8.

In the United States, there is no right to counsel in civil disputes. Each year as many as 80% of low-income people who face civil legal problems that can threaten home, family stability and livelihood are unable to obtain assistance in resolving their problems. Meaning a majority of low to moderate-income Americans are left to face their legal problems alone. 7.

Mr. Kuhn mentioned during an interview with Legal Talk Network, that America is ranked last when it comes to access to justice. Fortunately, AI technologies that are being developed by companies like Ross Intelligence and Law Pocket have the potential to be used by attorneys to assist clients, in need of legal help, in a more effectively and efficiently.

Also in the interview with Legal Talk Network, Mr. Kuhn stated that lawyers should care about the usefulness of AI for three reasons: 1) there is a lot of data that exist from cases and negotiations that lawyers have conducted, 2) this data can be used for to the advantage of lawyers for improving service to the client, and 3) clients are beginning to require it from law firms. Interestingly, he stated that Watson legal can be used to analyze court cases to provide data for likely outcomes, which would be of interest for litigators and their clients. He also pointed to the fact that Watson legal could also reveal own biases in court decisions.

What was AI?

Artificial intelligence is a branch of computer science that deals with the simulation of human intelligence processes by machines. This process includes acquiring information and rules for using the information, using the rules to reach approximate or definite conclusions, and self-correction. For a more in-depth understanding of AI and how it is being utilized by Watson Legal, you should register below to attend Brian Kuhn’s discussion on Watson Legal on September 25th!

https://www.eventbrite.com/e/legalrnd-speaker-series-brian-kuhn-ibm-watson-tickets-37803615632?aff=ebdsorderfblightbox

1. http://www.legaltechlever.com/category/artificial-intelligence/
2. https://www.iltanet.org/viewdocument/beyond-the-hype-artificial-intelli?ssopc=1
3. http://searchcio.techtarget.com/definition/AI
4. http://www.aallnet.org/sections/all/storage/committees/practicetf/final-report-07102013.pdf
5. https://www.law.gonzaga.edu/files/Rebooting-Legal-Research-in-a-Digital-Age.pdf
6. https://medium.com/cognitivebusiness/how-watson-helps-lawyers-find-answers-in-legal-research-672ea028dfb8
7. https://blog.rossintelligence.com/how-to-leverage-legal-technology-and-bridge-the-justice-gap-3d63f096b32a
8. Law Pocket Startup: Jordan Gaither, CEO Founder & Mark Harris, CTO.

“Every business in the world needs to innovate in order to gain competitive advantage and survive in the marketplace—and lawyers are no longer an exception to this basic rule.” – Kathy Burns

Recently, Kevin O’Keefe, founder and CEO of Lexblog, published an article discussing Michigan State University College of Law’s growing recognition amongst the legal community for its Legal Research and Development Program “Legal RnD”. He highlights how using technology has played a role in the accomplishments of several recent graduates of the program, giving MSU Law national recognition usually reserved for those such as Harvard, Yale, or Michigan. As a result, Jay Evans and I wanted to write a blog post to explain what LegalRnD is and how it has benefited us so far.

What is it?

LegalRnD is a program that provides courses, lecture series, and networking opportunities to assist law students in their development as future lawyers. The program seeks to educate and train future lawyers on how to improve the delivery of legal services using technology. Technological innovation in the legal space is not meant to be “lawyer-replacing”; rather, innovation is meant to be a “lawyer-strengthening”. Learning the skills and technology available to enable processes improvement can help the legal profession automate monotonous tasks while reaching a broader client base, including those who may traditionally lack access to justice.

More recently, the center has published research on legal innovation. Dan Linna, Director of LegalRnD and Professor of Law in Residence at MSU, published Phase 1 of the Legal Services Innovation Index with the help of MSU law students. This detailed data collection was designed “to add to and improve legal-industry discussions about legal innovation and technology” and opens the doors to quantifiable analyses.

Jay Evans and I joined LegalRnD in September of 2016 as 1Ls. To illustrate the importance and benefits of LegalRnD we would like to share our experiences.

Why we joined LegalRnD?

Danielle – I first learned of LegalRnD while attending the 2016 Lean Law Process Improvement Workshop. Following the workshop, I decided to join LegalRnD because of the great value that it provided its members, including opportunities to learn about the law outside of the classroom and opportunities to network with forward thinking legal professionals. I am currently interning with an innovation based organization and creating a brand for myself through social media.

Jay – I decided to join LegalRnd because I knew that it would help me learn the best way to bridge my technical background with my interest in the legal field. After attending several meetings and programs, I quickly realized that I wanted to improve my chances of being a T-shaped lawyer and I knew that LegalRnD was my best opportunity to accomplish this goal. Because of Professor Linna’s encouragement to blog about emerging legal topics in my areas of interests of interest and his encouragement to use social media to promote my brand, I had the opportunity to work as an intern for my dream company this past summer.

How did it influence our summer?

Danielle – The internship that I obtained through attending a Spartan Hack-a-thon, as a LegalRnD representative, solidified the value of the program. This summer I witnessed how learning and using technology could positively affect in-house legal processes. Because my mentor, senior corporate counsel, had taken coding classes and dedicated time to learning technology she was able to more efficiently and effectively create contracts for the tech team; she could “talk tech”. Additionally, I was able to have in-depth discussions with the IT department about how blockchain could better improve the functions title industry because LegalRnD had introduced me to the technology.

Jay- As a member of LegalRnD, you are encouraged to brand yourself through social media and other networking events. During the spring semester, several of the LegalRnD students attended the ABA Legal Tech show to learn about rapidly evolving trends in the legal field. This summer, I had the opportunity to see how legal divisions within companies use many of the tools discussed at the tech show to streamline their legal processes. I had the opportunity to participate in on a number of meetings in which we discussed ways to use technology to streamline legal matters.

2L year

As second-year law students and members of the executive board of Legal Launch Pad—LegalRnD’s student group—we look forward to the upcoming events and opportunities to dive further into topics such as artificial intelligence and e-discovery. We invite you to come to our meetings to learn innovation in the legal field.

Also a great reads:

Michigan State College Of Law Ranks Number One

The Legal Services Innovation Index (021)

ABA Innovation Center Urges Lawyers to Try New Things, Identifies Innovative Law Schools

http://appraisinglegalrevelations.lawschoolblogplatform.com/

http://legaltechlever.com

“Our probably fastest-growing sector right now is the legal sector” J. Paul Haynes, eSentire’s CEO


Ransomware is a type of malware that restricts users’ ability to access their computers or data and demands money to release it. Specifically, in a large law firm setting, ransomware can prevent litigators from accessing motions on a deadline, trial lawyers from obtaining key documents needed for preparing arguments, transactional lawyers from communicating with clients during the closing of multibillion-dollar deals.


Ransomware targets vulnerabilities that exist in computer networks and software like Microsoft Windows or other Windows administrative tools. Once a computer is infected, the ransomware spreads rapidly across the organization’s network. The ransomware encrypts confidential documents and then demands a ransom, typically in Bitcoin, in exchange for a digital key to unlock the files. 1

eSentire is a Canada-based cyber security company that has seen a spike in investments and its clientele over the past three years. eSentire states that one of the sectors that it saw a surge in clientele is in the legal industry. eSentire’s increase in law firm clients is because of cyber attacks that have plagued the law firms in recent months. Recently, law firms have experienced some targeted ransomware attacks that have been designed to capture clients’ data or disrupt services at the firm. Because of increasing attacks, clients have pressured law firms to improve their cyber security.


Clients have grown increasingly nervous after DLA Piper, one of the world’s largest international law firms, was a victim of a ransomware attack. The ransomware resulted in the international law firm having to shut down operations and work from their cell phones temporarily. The ransomware was designed to lock firms out of its computers and requests a payment of $300 in Bitcoin to obtain a “decryption code” that unlocks the firm’s files. DLA Piper has not stated whether it paid the ransom but does say it was able to isolate the ransomware by shutting down its systems and working with forensic specialists. The attack was a blow to DLA Piper because it holds its self out as a law firm with a specialty in privacy and security. The DLA Piper attack was the first time that a ransomware attack publicly crippled the daily operations of a large law firm.

Law firms are repositories of their client’s most sensitive information, which makes them likely targets for ransomware attacks. For example, one of the largest ransomware attacks resulted in the leak of information that is now known as the Panama Papers. During this leak, hackers targeted the large international law firm Mosack Fonseca and leaked 11.5 million emails, contracts, scanned documents and transcripts of celebrities and public officials.

Ways Law Firms Can Strengthen their Network Security

To ensure the safety of clients data, law firms should first hire a Chief Information Security Officer or outside cyber security firms, such as eSentire, so that the firm’s network traffic, systems, and IT infrastructure are being monitored, which will help uncover breaches and neutralize cyber attacks.

Law firms should continually update and patch all company software, like Microsoft Office, so that ransomware cannot target this vulnerability. Firms’ IT departments should work closely with the Chief Information Security Officer or outside counsel to ensure that network systems and software are up to date. The Chief Information Security Officer or outside counsel should consider working with hacker firms to test the companies’ cyber security protocols annually.

Firms should provide training to its employees so that they have the skillset to be best able to recognize potential cyber threats. Employees should be regularly updated and tested for their ability to identify suspicious materials. For examples, many corporations randomly send out suspicious emails to various employees to test their ability to recognize potential threats.

Firms should require employees to use password generators or password strength gauges when developing passwords, to help prevent hackers from taking advantage of weak passwords. Many organizations such as the National Institutes of Health require badges and passwords to be used in combination to access computer systems. This method would prevent outside hackers from using employees’ passwords to access company data remotely.

Firms should apply the 3-2-1 back up storage method to help protect against ransomware attacks. The IT department should set systems so that data is backed up and stored in two separate mediums within the firm and one air-gapped copy (offline) should be stored offsite. Ransomware attacks can result in files being damaged or held hostage, so having backed up versions of your data will help your firm continue business as usual as the repairs to the system are being done.

Finally, Firms should purchase cyber security insurance to help handle with the mitigation of potential losses from the cyber-attack. Cyber security insurance will require the adoption of pre-emptive measures, along with an implementation of best practices. Cyber incidents are often excluded from general commercial liability and property insurance policies, leaving firms to pay out of pocket for data “destruction, extortion demands, crisis management, legal claims for defamation, fraud and privacy violations.”2

1. Aristedes Mahairas, a special agent in the cyber division of the New York City’s FBI field office, reported that ransomware attacks have increased, resulting in law firms having to pay ransoms for its clients’ confidential information.

2. Cybersecurity Insurance, Homeland security, (August 26, 2017) https://www.dhs.gov/cybersecurity-insurance.

Abstract

Pharmaceutical companies have become the pioneers of health care innovation, providing new therapies to diseases that remained untreated. As a consequence of this innovation, pharmaceutical companies have used the patenting process to hold a monopoly on their ideas and product so that they might recoup their investment in research and development. Because of these patents, drugs have increased in price and many citizens of developing nations are unable to afford therapies that they need. Members of these developing nations have challenged the World Trade Organization to allow for developing nations to ignore patent rights during a time of public health crisis. This article addresses the balancing of public health and patent rights.

Emergence of Pharmaceuticals in America

Health is an important social and economic asset to our global society. Illnesses not only affect the person who is diagnosed but also their families and society. The healthier a society, the more productive it is. Before America became an industrialized society, individuals were forced to rely on medical treatments from the local medicine man. Often these treatments were not successful at curing the illnesses of the patients and patients were often left with death wishes. During the late 19th century, an emergence of pharmaceutical chemistry and pharmacology led to the establishment of pharmaceutical companies in the United States. These pharmaceutical companies began identifying and developing synthetic drugs aimed at various pathological conditions. The pharmaceutical companies began to observe the positive effects of the synthetic drugs on these pathological conditions, ultimately leading to the rise of the field.

Pharmaceutical Companies’ Role in Innovation

The pharmaceutical industry is known for playing a critical role in the innovation that has occurred in the health care field. , The emergence of pharmaceutical companies in America led to a number of breakthroughs in the development of synthetic vitamins, antibiotics, hormones, antihistamines, and new vaccines. Pharmaceutical companies were now developing cures for illnesses such as tuberculosis, diphtheria, and pneumonia. Due to the advances in therapeutics, mortality rates in the United States were cut in half and maternal deaths were nearly eliminated. Profits from the development of therapeutics such as penicillin by American pharmaceutical companies created the capital for these companies to invest in their infrastructure, ultimately leading to the style of firms we have today.

From the creation of American pharmaceutical companies until 1937, the pharmaceutical industry operated without regulation. , In 1937, a chemist decided to use “antifreeze” in his cough syrup to make it sweet tasting. The cough syrup was not extensively tested and resulted in over 100 deaths, leading to the development of the Food and Drug Administration (FDA). , . From 1937 until the present, pharmaceutical companies are not required to share data from studies conducted in-house, but the FDA does require companies to conduct phase 1 to 3 studies on humans to prove safeness and effectiveness.

Due to the new regulations placed on the pharmaceutical industry, new products that are developed take a very long time to reach the market for patients in need. Today, the average therapeutic takes 10–15 years to be developed and validated for its safety and effectiveness before being granted market approval by the FDA. It is reported that only 5 in 5,000 drugs that enter preclinical trial testing successfully make to human testing and of those, only 1 in 5,000 make it to market. The average cost for development of each therapeutic is estimated to cost a pharmaceutical company around eight-hundred million dollars.

Patent Rights are Critical for Pharmaceutical Companies Success

Because drug development is such an expensive undertaking for pharmaceutical companies, they usually rely on strong patent protection to recoup their investment in pharmaceutical research and development. Patents provide inventors the legal right to exclude others from replicating and using their invention. This protection was included in the United States constitution to help promote the progress of science by providing the inventor a limited time to recoup their significant investment in research and development. Inventors of patents are given a twenty-year exclusivity to protect their investment. Due to recent changes in patent law, the United States is moving to the European Union standard, meaning patent ownership is now based on the first person to file the invention. In order for the pharmaceutical company to protect their investment, it is required to file the patent early on during the development of the patent. Because patents take on average 10–15 years to bring to market, a significant portion of the patent term for the invention is lost before the pharmaceutical company is able to earn a single dollar from its invention. Once the therapeutic is on the market, the pharmaceutical company has on average 11.5 years to recoup its investment.

Patents were included in the Constitution to encourage pharmaceutical companies, and inventors to continue the development of new therapeutics for diseases that affect the human race globally, by providing it with protection for its investments. For pharmaceutical companies to receive such protection, they must disclose to the world patented research and science underlying the invention. Thus, important scientific information behind a new cancer drug becomes available immediately to researchers worldwide. Pharmaceutical companies are often criticized for the cost of their therapeutics and their use of patents to exclude generics from entering the market in developing companies.

WTO TRIPS Agreement and access to medicines

The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement was an agreement that was created by the World Trade Organization (WTO). The WTO is a global international organization that helps create rules of trade between nations. As of July 29th, 2016, there are 164 nations that are members of the WTO. The TRIPS Agreement was drafted and implemented to provide minimum standards of protection for intellectual property amongst these member nations. The TRIPS Agreement is said to have a western influence because it provides patent protection for 20 years in the member nations, and protects both process and product patents. All of the member nations were given until 2006 to implement the TRIPS Agreement.

Developing nations are fearful of the effects of the TRIPS Agreement because it is believed that it will have a damaging effect on the access to medicine for its citizens. The Developing nations feared that by protecting patents in their nation that it would increase the number of monopolies pharmaceutical companies would have on the drug market in their nations. Developing nations fear that these monopolies will lead to increased drug prices, therefore, limited the availability to those who can afford them rather than are in need. The fears of the developing nations are ones that are legit when comparing the prices of drugs on patent to their generic counterparts. Developing nations argue that by preventing or limited patent protection, allows for competition in the market and results in lower drug prices. The lower the drug prices the more accessible the drug.

Access to Medicine in Developing Countries

The AIDS crisis in the developing world lead many developing nations to questions the potential effects of the TRIPS Agreement, and whether member nations would stand by the flexibilities built into the Agreement for nations in crisis. During times of crisis, the TRIPS Agreement would allow developing nations who lack the capital to bypass patent protection that was awarded to patent holders to address public health issues in their nation. Many developed countries wanted the TRIPS Agreement to prevent developing nations from importing generic versions of patented drugs from other nations or mass producing it within the country.

In these non-member nations, generic therapies are created from reverse engineering the patented therapies on the market. The developing nations, who are members of WTO, argue that its citizens who are unable to afford the patented drug prices will have to wait years until the patent on the drugs expires. Access under the TRIPS agreement has become such an issue that over 60 nations requested a TRIPS Council Session to discuss access to medication in their nation. These nations proposed to have a separate declaration in Doha on the TRIPS Agreement and access to medicine. These nations were seeking to a declaration that would find that public health and lives were more important than intellectual property. The nations are asking to be able to set aside patent rights to provide the proper medical treatment for their citizens. The issue developing nation face is while you want to be able to set aside patent protection to help the citizens, you also want research and development for new therapies.

Pharmaceutical companies in USA, Japan, Switzerland, Australia and Canada opposed the declaration, because of the importance of intellectual property protection for research and development. It was argued that protection granted to drug and device companies allows for the further production of products aimed at addressing other public health issues. By allowing pharmaceutical companies to have restricted access to their inventions, it agrees to continue to innovate in areas such as public health. In order for innovation in the public health field, which is driven by pharmaceutical and device companies, to continue their ideas and work products have to be protected so that funding for innovation can continue. Patents protection is critical for innovation, it is reported that 70%-80% of a pharmaceutical company’s revenue comes from its patents.

Pharmaceutical companies argue that the price of therapeutics is the only issue that developing nations must address. For example, if Pfizer decided tomorrow that it would offer a number of its therapeutics for free to several developing nations, it would still not help the issue because it would not reach the individuals in need. Many of the developing nations have poor health infrastructure, which contributes significantly to the access of medicine for its citizens. Another issue developing nations face is the lack of proper sanitation. Not having the proper sanitized facilities for drug and medical device production can lead to cross contamination or microbial multiplication in the product. This would result in a more complex medical issue for the citizens of that nation. Finally, manufacturers in developing nations often face a shortage of funding for the production of generic drugs. Shortage of funding can often lead to citizens not having access to much-needed therapy or can lead to short cuts by the manufacturer to save money, both ultimately harming the public health of the developing nation. Parallel imports are subject to the same issues of lack of safety and effectiveness, lack of proper sanitation, and lack of proper funding which is often not monitored by the country seeking the import. This ultimately means that a country could be important sub par or contaminated product for their citizens.

The Doha Declaration on the TRIPS Agreement

At the WTO Ministerial Conference of 2001, members of developing nations brought their concerns of access to medication before the WTO. The WTO explained that the goal of the TRIPS Agreement was not to prevent member nations from promoting public health within their borders. The WTO explained that the TRIPS Agreement had built in flexibility that would address this concern, within the agreement was the option for compulsory licensing and parallel importing. The developing nations brought the concern before the committee, not because of the lack of clarity in the agreement, but rather the obstacles that they were facing at the national level when they were attempting to implement the flexibilities built into the agreement. The declaration to the TRIPS Agreement clarifies various forms of flexibility available to the developing nations to address the access to medicine by further addressing for compulsory licensing and parallel importing. Compulsory licensing refers to the ability of a government to allow someone else to produce a patented product or process without the consent of the patent owner. A parallel import is when an importer finds a cheaper price for the product in another nation and imports it to avoid paying higher local prices. The first question that arises is how would it be determined whether a nation meets the requirement to be able to utilize compulsory licensing and parallel importing? The next question for developing nations becomes whether or not it has the infrastructure to utilize the compulsory option?

Compulsory licensing and parallel importing create a number of issues for not only the pharmaceutical industry but also for the developing nations themselves. Pharmaceutical companies argue that if left unmonitored compulsory licensing can be a slippery slope and could easily result in abuse of the intellectual property rights of patent holders, which WTO was designed to protect. Compulsory licensing is designed to address a public health issue such as AIDS/HIV, but instead it also creates one. Therapeutics that have been developed by patent holders have undergone years of inspection and validation to prove that they are safe and effective. Allowing manufacturers to reverse engineer a patent compound could prove to not be as safe and effective as the patented product. In order for manufacturers to offer generic therapeutics at such a reasonable rate, it requires the bypassing of certain corners in the development and validation phase. However, changing even a methyl group can affect the properties of a therapeutic. An example of this is Budeprion, which is a generic version of Wellbutrin that was pulled from the market by the FDA for not being functional. Developing nations have to be careful to not allow local manufacturers to produce therapies like Budeprion, which may leave the citizens of developing nations taking ineffective medication. Citizens deserve to have access to therapeutics that have been extensively studied and validated.

Conclusion

The Doha Declaration creates a complex problem for members of the WTO who signed the TRIPS Agreement because it forces them to decide on the appropriate way to promote public health and innovation. Pharmaceutical companies argue that in order for them to continue to innovate, it must make a profit off the patents and products that it has on the market. Developing nations, on the other hand, argue that their citizens do not have access to proper medication because of the cost. In many of the developing nations, citizens are forced to live on less than several dollars a day because of the nation’s economic system. There would be no way for a citizen of this country to be able to afford a 50,000 cancer therapeutic. Leaders of these developing nations argue that under the TRIPS Agreement, they have a right to ignore patent owners’ rights in the name of public health. Pharmaceutical companies argue that this will ultimately hurt the citizens that the leaders are protecting because it would prevent innovation in other needed areas and opens the door to less safe and effective therapeutics.

To bridge this gap, WTO leaders should bring both patent owners and developing nation leaders to the table to see if there possibility for reducing the cost of the therapeutics. One mechanism maybe tax breaks for the pharmaceutical companies in their home nations or maybe the WTO can work in conjunction with the world health organization to develop grants for cost effective therapeutics for diseases plaguing the third world nations.

ABSTRACT:
Prescribing off-label medications is commonplace in the field of medicine. Despite the indisputable value of off-label uses and the corresponding need for doctors and other prescribers to be informed about them, the FDA has categorically banned manufacturers of drugs and devices from promoting their use for unapproved purposes to the medical profession. Here, we summarize and discuss the risks and benefits of off-label promotion and how this relates to pharmaceutical companies in the RARE disease space and personalized medicine.

Introduction:
Therapeutics are often found to have additional benefits for uses that exceed those listed on its FDA approved label. This off-label use often includes treatments for disorders that the therapeutic was not initially investigated for by the FDA, dosages or delivery mechanisms that have not been approved, or use of the therapeutic in a patient population that was the focus of the clinical study. Conducting a clinical trial for each indication of the therapeutic could cost a company millions of dollars and lasts for an average of 8 to 12 years, making it infeasible or illogical for a company to conduct clinical trials for every possible indication of the therapeutic. (1)

The FDA began cracking down on pharmaceutical companies’ promotion of off-label use in 1968, after members of Congress became concerned with the Methotrexate scandal. The FDA was made aware of a medical journal article that encouraged physicians to suggest to their patients the off-label use of Methotrexate, which members of Congress believed was linked to the recent deaths from the therapeutic. Congress began pressuring the FDA to develop a clear policy on off-label use by physicians, but the medical community fought the FDA’s efforts.(1) Under the pressure of Congress and the medical community, the FDA decided to focus on the “dissemination of information about off-label use by the product manufacturers, and not the use itself. “

The FDA argues that legalization of off-label promotion will lead to an increase in false and misleading labeling, resulting in less effective and safe medication. Pharmaceutical companies have argued that these therapies have already undergone a phase 1 clinical trial, proving their safety, and that it has a right to disseminate information if it has data that truthfully shows its effectiveness. This assumes that therapies that have undergone its rigorous process are safer and more effective than off-label therapies, which is not an absolute truth. Merck’s blockbuster anti-inflammatory drug Vioxx went through the FDA’s rigorous testing and was approved, but ultimately lead to the death of thousands.(1)

The FDA’s stance on off-label use assumes that physicians are unable to determine what is scientifically and medically substantial. Much of the standard care in oncology have come from doctors prescribing off-label therapies for their patients. In fact, the off-label use of drugs has significantly contributed to the therapeutic armamentarium of many different diseases in medicine.(1) A great example of benefits that have come from off-label use would be aspirin, which is now being used to help reduce the risk of heart attacks. (1)

The effect of the FDA’s stance:
Should we expect a pharmaceutical company to remain silent when it knows that the off-label use of one of its drugs could save the life of a patient with a rare disease?

The FDA’s guidance for the industry restricts communication between industry professionals and physicians, if the indication is not specified within the label. The FDA’s stance could be problematic for a few sectors in the pharmaceutical market such as rare disease. Lives of patients suffering from rare diseases rely on the information that their physicians have access to, and physicians have been shown to have a limited knowledge of many orphan diseases and new treatment options. In the case of rare disease, where the number of patients suffering from the disease rarely exceeds 200,000, the most knowledgeable individuals often work for the pharmaceutical company developing the therapy.(1)

When roughly 90% of the thirty million patients suffering from a rare disease are prescribed at least one drug for off-label use, should we stop the free flow of information and advancement between physician and pharmaceutical company? (1) This would mean that by following the FDA’s guidance, both the physician and pharmaceutical company would be doing a disservice to the very patient population that the guidance was aimed to protect. The current stance of the FDA would leave health professionals and patients in the dark about potential advances. “With diseases of such rarity, proper diagnosis is often a major challenge. Getting appropriate treatment is even harder.” (2) Pharmaceutical companies should be able to provide information about advances in the rare disease, giving doctors more treatment choices for the patient. Unfortunately, physicians face a time constraint and are unable to see patients, attend rare disease conferences, and or read every journal for newly released advances.

1. Tim Mackey & Bryan A. Liang, Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access and Limiting Inappropriate Pharmaceutical Marketing, 45 U. Mich. J. L. Reform 1 (2011).

2. Coleen Klasmeier and Martin Redish – “Off-Label Prescription Advertising, the FDA and the First Amendment: A Study in the Values of Commercial Speech Protection,” American Journal of Law & Medicine, Volume 37, Numbers 2&3 (2011).

What is blockchain?

A blockchain is a virtual decentralized ledger that allows for the adding and tracking of entries. A decentralized ledger is not regulated by a single entity; rather, the decentralized ledger is regulated by a community of individuals, who prevent entries from being modified or removed from the blockchain database. The blockchain database allows for communication, storage, and processing of the entries added by the community. The blockchain database is publicly accessible to those who are interested in reviewing a copy of the entry.

Individuals who contribute to the blockchain’s computing power are given a unique identifier that allows for tracking of entries added to the blockchain database. Members to the blockchain community can use unique identifiers to contract with each other. For example, members of certain blockchains may contract over real estate. The process of contracting between members of the blockchain community is named “Smart Contracts.” Smart contracts are programmed protocols “that facilitate, verify, or enforce the negotiation or performance of a contract, or that make a contractual clause unnecessary.”

Smart contracts help you exchange money, property, shares, or anything of value in a transparent, conflict-free way, while avoiding the services of a middleman. The best way to describe smart contracts is to compare the technology to a vending machine. Ordinarily, you would go to a lawyer or a notary, pay them, and wait while you get the document. With smart contracts, you simply drop a bitcoin into the vending machine (i.e. ledger), and your escrow, driver’s license, or whatever drops into your account. More so, smart contracts not only define the rules and penalties around an agreement in the same way that a traditional contract does, but also automatically enforce those obligations.

Blockchain provides an opportunity to streamline a timely and costly patent process

It typically takes a very long time for a patent to be reviewed and approved.  Traditionally, inventors and patenting agents conduct preliminary research and determine whether an invention should be patented. For an invention to be patentable, the invention must be (1) novel, (2) non-obvious, and (3) useful. To determine whether an invention is novel, an inventor or patenting agent conducts patent research, which could take 1-3 weeks. If there are not conflicting patents, it will take an average of 2-4 weeks to draft the application for the client to review.  Finally, the patent would be reviewed and approved; however, this process could take 32 months to 3 years.

One of the first large costs that an inventor or small business owner obtains is the cost of a patent search.  This occurs when the inventor or small business owner hires an intellectual property attorney to conduct patent searches for prior art. Hiring an intellectual property attorney will cost the inventor or small business owner well over $1,000. The second large fee for drafting a patent comes from the hiring of an IP attorney to handle this complex process. This process will cost the inventor or small business owner anywhere from $2,000 to $20,000 depending on complexity of the invention. Finally, the cost of submitting the patent to the USPTO can range from a few hundred to a few thousand depending on the invention. These costs can be cumbersome to a small business owner and inventor trying to patent their invention.

 

Using blockchain to automate the patent application can decrease the overall time and cost

The patent application process is one of the best possible uses for a blockchain platform because it would enable inventers and small business owners to save on cost, facilitate faster transactions with the USPTO, and give greater transparency to processes. Searching for patents can be a difficult task because each country or region records its own patents in a closed off registry. A patent blockchain would provide a database for patents globally, opening searches of patents in America and abroad. A patent blockchain would also allow access to prior art globally, resulting in a decrease in patent searching cost and the time a patent examiner spends on that patent. Finally, blockchain would allow for an integrated, cloud based collaborative platform that would automate and streamline the patent application process.

Blockchain would have the capacity of cutting prosecution and processing time of the patent application by weeks, while still retaining the quality. Blockchain has the unique opportunity to ease patenting cost for inventors and small business owners so that more capitol can be spent on developing the invention or marketing. Blockchain also has the capacity of cutting the number of litigation cases by prevent duplication of similar patents. Therefore, blockchain provides endless opportunities to field of intellectual property, including but not limited to my next topic smart contracts and licensing.