Archive for the 'Intellectual Property' CategoryPage 2 of 13

3D Printing Pharmaceuticals: The Changing Legal Landscape

3D printing, perhaps more than any other invention since the internet,has the potential to completely change the face of business.  It could change how things are made and how they are bought.  3D printing has already shaken the medical profession to its core by opening up the potential for 3D printing prosthetics and even human tissue.  A few months back, the Food and Drug Administration (FDA) approved the first 3D printed drug—Spritam.

The drug is created by layering incredibly thin sheets of powdered medication using an aqueous fluid—resulting in a pill that dissolves extremely easily.  Beyond how easily it dissolves, however, the drug is currently no more efficient than a drug produced by normal mean.  The creator of the process, AppreciaPharmaceudicals, speculates that someday the process could allow for drugs customized to the person who takes them.

As 3D printing becomes more available to the public—3D printers are already available for less than $400—the implications of printing drugs become even greater.  Instead of giving prescriptions, doctors might simply 3D print your medication at their hospitals 3D printer.  They may even give you algorithms to allow you to print your pharmaceuticals in the comfort of your own home.

The Usual Suspects: Common Legal Issues with 3D Printing

This raises some clear legal issues, such as regulating the 3D printing of drugs and protecting the intellectual property of pharmaceutical companies.

Beyond restricting the sale of materials necessary to print drugs, it becomes awfully hard to regulate the quality of a drug when the patient is printing it at home with purchased materials—or even if it’s being printed at hospitals across the country.  The FDA will need to regulate not only when somebody print a drug, but also how they and be printed, on what kind of 3D printers, and more.  If private citizens are allowed to 3D print pharmaceuticals, there will obviously also need to be regulations that prevent 3D printers from printing drugs just any old time.  The potential headaches for the FDA are countless.

3D printing also has manufacturers fearing for their intellectual property rights.  Many have likened the availability of 3D printers to the digitization of music and fear the potential of a Napster for physical products.  One leaked design could undercut an entire physical product line by allowing anybody with the internet and a 3D printer to download the design and print the product for the cost of the materials.  This sort of infringement of intellectual property, much like music pirating today, would be extremely hard to trace and cut easily reach a scale that could put a manufacturer out of business. 3D Printing

There is not really a system in place to handle infringing designs posted online.  The safe harbor policies outlined in the Digital Millennium Copyright Act (DMCA) provides a well-known and important (albeit often criticized for its misuse) tool for quickly and cheaply having material which infringes copyright taken off of a website.  The DMCA has already been used to try and take down a 3D printing design at least once already—a design allowing the user to print a physical version of an optical illusion known as the Penrose Triangle.  It has also been discussed in a take down request from HBO over a 3D printing design of a phone charger based on the “Iron Throne” from their television show “Game of Thrones.”

Unfortunately, copyright is not really a good fit for 3D printing designs.  Copyright provides no or very little protection to useful articles.  The CAD files for a 3D printing design would likely fall under this umbrella in most cases.  This means that the designs may be limited to weak copyright protection or patent protection—losing the protection of the DMCA take down.  There is no similar system in place to deal with take downs of designs that might infringe a patent.  This would leave a pharmaceutical company with little recourse if an infringing design of a drug they spent years developing hit the web then spread like wildfire.

Intellectual property and regulation are legal issues which flow fairly logically from the sort of technological leap 3D printing represents.  However, an issue that a layperson might not expect is the potential issues that 3D printing could create for product liability.

Whose Product is It Anyway?

Products liability is an area of law dealing with a party trying to recover for damages caused by a defective product.  Such a claim can generally be brought by a purchaser of the product, somebody who uses the product, or a bystander injured by the product.

A product is considered defective in three situations: where the product is unsafe by design, where the manufacture of the product is defective, or where the product does not have sufficient warnings about its use.

These types of suits can be brought against the defective product’s designer, distributor, or manufacturer.  However, once 3D printing becomes readily available, who exactly is going to be the manufacturer?

Considering the risk inherent in creating pharmaceuticals, very small mistakes in design could have drastic consequences, this is an issue that is going to leave those injured by 3D printed pharmaceuticals scratching their head.  It may well be that whoever 3D prints medication is the manufacturer.  If this is the case we may never see hospitals 3D printing their own medication, despite potential saved costs and convenience, out of fear of the liability they may open themselves up to.

Law Catching Up to Science

3D printing will change the world—full stop.  As 3D printing becomes cheaper and more accessible, 3D printers have the potential to become as much a fixture in the home as a refrigerator.  As this happens, the technology around how 3D printers work will also likely see drastic strides.

Law has historically lagged behind technology; decades after its invention we still haven’t found perfect solutions for matching law to a world where the internet exists.  3D printing will test our courts once again.  The potential for advancement in medical science through inventions such as Spritam is tremendous, but so too are the legal challenges that such advancements bring with them.

This Evidence Will Self-Destruct in 10 Seconds

Self-destructing messages were once the realm of James Bond, Mission Impossible and Inspector Gadget.  However, ephemeral messaging is now extremely common.  Phone apps such as Snapchat, Cyber Dust, Tiger Talk, and Confide all allow users to send messages which disappear shortly after they are read or watched.

This has allowed users an unprecedented level of privacy in the messages they send.  Services such as Cyber Dust and Confide encrypt your messages, prevent them from having a screen shot taken of them, and (of course) destroy messages you send shortly after they are read—keeping no digital record.  Snapchat, while not as secure, still features messages which “vanish” after they are viewed.

The flip side to this privacy is an easy way to send messages that could never be used as evidence in a lawsuit. Cyber Dust was created after Mark Cuban’s experience in his insider trading lawsuit with the Securities and Exchange Commission (SEC).  Mr. Cuban felt that the SEC mischaracterized every message he sent, so he made Cyber Dust to “save a lot of time and money because nothing sent or received on Cyber Dust is discoverable.” Cyber Dust is specifically pitched as the Snapchat for “a business with a lot of lawsuits.” Snapchat itself has been accused of being used a tool to conceal insider trading.

The evidence from ephemeral messages can often be crucial to cases. Just a few weeks back, an Uber driver sued a woman over brain damage he suffered when she hit his car from behind…while she was recording herself going 107 MPH with a Snapchat speed filter.  The video that the woman took, actually recording herself hitting the Uber driver while simultaneously recording her reckless speed, would be incredible evidence in that case.  However, due to the nature Snapchat, that evidence is likely gone.

Spoliation: Getting Rid of the Evidence

There is no universal duty to maintain anything that could ever be used as evidence. Making people keep every last document in case they get sued just doesn’t make sense.  In fact, most companies have policies regulating what records they maintain and when records should be destroyed.  However, there are situations where destroying or withholding evidence can get you in trouble—this is called spoliation of evidence. Have a Nice Day!

A person who negligently or intentionally withholds or destroys relevant information that will be required in a lawsuit is liable for spoliation of evidence.  To determine whether somebody has committed spoliation, courts look to three things: 1) whether a duty to preserve evidence attached before the evidence was destroyed; 2) whether the person accused of spoliation was at least negligent in destroying the evidence; and 3) the other party was prejudiced by the destruction of the evidence.

Whether the duty to preserve evidence takes effect varies substantially between state and federal law and from state to state. The duty can take effect when you first should know you’re likely to be sued for something or when you actually receive notice of a lawsuit against you.  Once you’re under a duty to preserve evidence, you can’t destroy or hide evidence relevant to the lawsuit you know of or are expecting.

When a court finds that somebody has committed spoliation, the court can bring a number of sanctions against them.  The exact breadth of sanctions varies depending on what court you’re in, but a common sanction is applying a “negative evidentiary inference.”  This means that a jury can assume that the evidence the person destroyed would have been bad for that person.

There are exceptions for destruction of evidence as part of a routine, good faith operation of an electronic information system. However, destruction of records after you know about a lawsuit or likely lawsuit —routine or no—is often as bad faith and sanctioned.  Ephemeral data—such as information stored in RAM—has also been treated differently from normally stored electronic data.  The evidence was treated differently because it would require a Herculean effort to preserve.  However, no court has ever dealt with the obligation to preserve where the data you send self-destructs by design.

Courts have dealt with people deleting social media content in the past. They specifically ruled that deleting either Facebook posts or a Facebook account can be spoliation.  Current law leaves it unclear whether use of ephemeral messaging, like Snapchat, will leave the user in danger of spoliation sanctions.  By using Snapchat, you are creating an electronic message with the knowledge it will be destroyed.  If this is done with relevant evidence after a duty to preserve takes effect, this is arguably spoliation.

Are Snapchats Spoliation?

As it is, spoliation law isn’t really prepared to deal with ephemeral messaging on such an enormous scale. The law is just unclear enough to put people and businesses using the services in a sticky situation.  If there’s a chance that sending that Snapchat will leave you in trouble in front of a judge, using the services can become a risk not worth taking.

The idea behind sanctioning people who commit spoliation is that their destruction of evidence implies a guilty conscience. Do users have such a guilty conscience when they send relevant evidence via a means they know will self-destruct?  Cyber Dust’s pitch, promising its users messaging that can’t be used as evidence against them, certainly makes this argument at least believable.

The exception is for routine, good faith, deletion of electronic records. Where an electronic messaging service automatically deletes all messages, that deletion is certainly routine.  However, after you know of a lawsuit, is sending a message with relevant evidence via a means you know will self-destruct good faith?  The exception explicitly doesn’t apply where routine operation is used to hide evidence.

What’s more, courts have sometimes required people to prevent the deletion of otherwise routinely deleted data in order to avoid spoliation sanctions. How could a user of Snapchat or Cyber Dust preserve something that is designed to disappear?

There is a clear tension between the dangers of compromising the privacy offered by ephemeral messaging and the dangers of allowing some users of ephemeral messaging to shelter from justice by actively destroying evidence. Putting every user of ephemeral messaging services at uncertain risk of serious evidentiary sanctions is obviously not an ideal solution.  However, neither is allowing messaging services to shelter users from legal repercussions for illegal actions.

It is likely that a determination of whether sending any given ephemeral message could constitute spoliation would be highly fact specific. However, as it stands, the framework around the treatment of ephemeral messaging is so unclear as to leave parties incapable of entering a courtroom fully prepared.  It is high time that law catches up with technology. Snapchat and ephemeral messaging have been around for over half a decade.

In order to truly know whether use of ephemeral messaging services are spoliation, two things need to be firmly established. First, the exact classification of ephemeral messages.  Whether they will be treated like other types of ephemeral data or like other types of social media.  Second, whether their deletion is routine and in good faith.  Seeing as it is nigh impossible to preserve ephemeral messages, will sending them be subject to an exception to spoliation?  Until this murky area of law is cleared up, users of ephemeral messaging services will be forever left in the lurch.

140-Character Copyright: Are Tweets Subject to Copyright Protection?

Approximately 6,000 tweets are tweeted to Twitter every second.  If you thought that sentence was confusing, that’s nothing compared to hashing out whether these tweets are protected by copyright law.  Twitter’s terms and conditions certainly imply that they believe tweets merit copyright, promising to respond to notices of copyright infringement.

However, the answer to the question of tweets receiving copyright protection under U.S. law is a resounding “it depends.”  Whether your tweet will be protected depends on the content of your tweet and how your alleged infringer used your tweet.

Copyright in the U.S.

In order to receive copyright protection in the U.S., a work must be original and fixed in a tangible medium. Fixation is achieved by storing the work in any medium that can be perceived, reproduced, or otherwise communicated.  To be original, a work requires only minimal creativity.  Once a sufficiently original work is fixed, copyright attaches to that work immediately upon its fixation.  While registering a copyright provides numerous advantages in a lawsuit, it is not necessary to receive copyright protection. twitter lawyer attorney

The act of posting a tweet online certainly is sufficient to establish fixation. Originality is a very low standard, usually only requiring more than mere mechanical reproduction of a previous work.  While recitations of facts are not protectable on their own, a telephone book listing phone numbers could receive copyright protection based on an original form of sorting these numbers.

However, U.S. Courts have historically looked with disfavor on short phrases when it comes to originality.  This is the largest issue in determining whether any given tweet will receive copyright protection.

The Originality Test for Short Phrases Such as Tweets

The courts’ disfavor towards short phrases usually comes up when they are separated from a larger work. So what about the originality analysis when the short phrase is the work—such as with a tweet?

Some types of short phrases are explicitly not protected, such as titles of works or catchphrases. However, the actual length of a phrase is not determinative when it comes to originality; rather the court will look at the uniqueness of the phrase.

In Heim v. Universal Pictures, the court determined that a particularly unique short phrase could receive protection.  As example, the court gave the titular first line of Edna St. Vincent Millay’s sonnet, “Euclid alone has looked on beauty bare.”  They also noted that a line from Jabberwocky, “twas brillig and the slithy toves,” was sufficiently original as a phrase due to the inventiveness of the language.  This established that short phrases could be protected, but these short phrases require more creativity to be protected.

Short phrases, such as tweets, can be protected under U.S. copyright law. However, the higher standard for originality means that not every tweet will be protected. Tweets that merely relate facts certainly cannot receive copyright protection.  However, tweets whose brevity lends to their wit may well be protected.

Recently, Twitter took down a number of posts which copied a joke from freelance writer Olga Lexell without crediting her. Ms. Lexell’s posts are likely the exact sort that would satisfy the heightened originality test.

It is worth noting that the heightened originality test only applies to written tweets. Original photographs embedded in tweets will almost always be subject to copyright protection, be they cat pictures or selfies.

Breadth of Protection for Tweets

While the originality test for short phrases helps determine what tweets will receive protection, it does not end the discussion of the exact breadth of that protection. Copyright protects the expression of an idea, but not the idea itself.  This means that a work is protected from those who copy the expression of the underlying idea of the work; either through exact copying or the creation of a similar work where the author has access to the original.

However, copyright’s goal is not to checkmate the public out of the ability to discuss an idea. Thus, when a work’s expression cannot be extracted from the idea it represents, or that expression is necessary to a genre or concept (a concept known as scenes á faire), it will only receive protection against verbatim copying or no protection at all.

With a work as short as a tweet, the expression and the underlying idea can become very hard to separate. Thus, while verbatim copying of an original tweet will almost certainly be protected, there are many cases where that will be the full extent of their protection. There will also be many tweets so intertwined with their underlying idea as to receive no protection whatsoever.

Defenses for Twitter-Fringers

Potential tweet infringers will have several defenses available to them.  Where a party can establish that they independently created a substantially similar work to the one they are accused of infringing they receive equal copyright protection to the accusing author.  With works as short as a tweet, this defense will be much easier to prove.

Retweeting for non-commercial purposes will almost certainly not constitute infringement as it will be considered fair use, an absolute defense to infringement.  Even commercial retweeting is unlikely to be infringing as the author of a tweet almost certainly gives an implied license to others.

So What Does All This Mean?

Not every tweet is going to be protected. The heightened originality standard for short phrases in the U.S will keep many tweets from qualifying for copyright protection.  Even where a tweet is protected, that protection is often going to be fairly limited.  However, for people like Olga Lexell who make a living off of short jokes, this protection is extremely important.  They say brevity is the soul of wit, but there will have to be a lot of wit in your brevity in order to receive copyright protection on 140 characters.

Managing Your Digital Life After Your Death

A majority of American adults don’t have a simple will. Perhaps you think it’s not necessary, too complicated, too time consuming, or too expensive. Or, you mistakenly believe that your spouse and/or children will automatically receive any assets you have.

Whatever the reason, now is the time to take action to ensure your family is financially taken care of in the event you pass away. The benefits of estate planning are plenty. You can identify your wishes and leave your assets as you wish. You can take advantage of tax savings or save money on court fees following your death.

Once you are ready to write a will, make sure your will covers digital assets. Digital assets include your online accounts, mobile apps for banking, email, social media, video and photo sharing, gaming, personal websites, blogs and more. With the advent of digital era, so many of us conduct our financial transactions and personal business on the web. Digital estate planning helps us manage our digital assets after we die.

Necessary Protocols to Access Deceased’s Digital Assets 

Providing executors access to financial accounts and other digital assets with a power of attorney is standard estate planning. Estate planning attorneys incorporate this standard to their practice. Various online tools for estate planning address how digital assets shall be accessed and to whom they shall be passed. Still, the concept of digital estate planning is relatively new and unknown. When a will is silent on digital assets, the surviving family is left with a burdensome and frustrating procedure when they wish to access the decedent’s digital life.  Wills and Trust

After her husband passed away, Peggy Bush, a 72-year-old resident of Victoria, B.C., wanted to play card games on their iPad, but could not because she did not have a password for their Apple ID account. Peggy knew the iPad’s login password, but did not know the Apple ID password had been set up by her husband. To access all of their downloaded apps, she had to insert Apple ID password.

According to the Washington Post, her husband had a will by which he left her most of his real property as well as personal property. However, his will did not mention digital assets such as online passwords. When she contacted Apple, she could not gain access to apps on the couple’s iPad. After contacting Apple multiple times, providing them with a notarized death certificate, a copy of the will, and the iPad’s serial number, Peggy thought she was finally able to access to their account. Instead, Apple told Peggy to get a court order if she wanted the access.

The Current Law

Although the strict protocol for allowing access to the decedent’s families aggravates the emotional distress of the loved ones who are dealing with their loss, such formalities may be inevitable to safeguard the privacy of the decedent’s while preventing the estate from potential harm. Unauthorized access to online accounts may be subject to attacks such as hacking, fraud, and data breach.

Then how can an executor access certain online records to close a bank account or email account without violating federal law, the privacy of the deceased, and the privacy of everyone who communicated with that person? The answer is not simple.

First, federal law, the Electronic Communications Privacy Act (ECPA), protects the privacy of our online communication content. Without express consent from the sender or recipient, or a court order or warrant, contents of online communications cannot be released after death or incapacitation. However, ECPA, which was enacted nearly 30 years ago, has limitations to address the protection of privacy issues arising from emerging technology let alone the issue of various digital assets of the decedent.

Second, your state may or may not have the relevant privacy law governing digital assets. Some states have passed or are considering digital assets legislation. However, even if the statute addresses digital assets, tech companies such as Facebook, Google, Twitter, and Linkedin set forth terms of service that differ significantly from others.

Access as Default or Privacy as Default?

States are taking up legislation to determine the default for how digital assets are handled. The Uniform Fiduciary Access to Digital Assets Act (UFADAA) model law is one proposal.  UFADAA relies on the principles of fiduciary duty to ensure that no harm results from granting access to accounts. UFADAA allows personal representatives, executors and fiduciaries to obtain control of and access the online accounts of decedents unless the access is prohibited by the Stored Communications Act (SCA) . While nearly half of U.S. states have introduced legislation in 2015 to enact the UFADAA, most of those efforts have stalled due to opposition. Only two states – Louisiana and Delaware – enacted legislation in 2014, and New Mexico legislature, where the bill passed in the State Senate in February 2015, has substantial progress made toward enactment.

Opponents who criticize UFADAA as a disregard of the interests of the deceased, created an alternative act, “Privacy Expectations Afterlife and Choices Act (PEAC).” Mainly, the opposition comes from privacy groups, email service providers and social media companies. PEAC provides limited access to subscriber records and log files, but not to the contents of those records and files unless the deceased user had consented to release of such contents. In short, PEAC sets privacy as default.

No matter which legislation your state enacts, it is best you plan ahead and make sure you include digital assets in your estate planning. Without clear guidance, however, lawmakers should consider encouraging companies to create tools for users to express what they would like to do with their online accounts.

The Price For Privacy

Privacy has been a growing concern for everyone online. A recent Pew Research study found that 93% of the adults they surveyed said that being in control of who can get information about them is important.

However, most companies sell user data to third parties, who then use that data to create targeted ads. Although companies disclose that they engage in this practice in their privacy policies, most users are unaware of what specific groups have access to their information.

One remedy that companies may start using is the pay for privacy model. Since companies are paid by third parties for this data, the pay for privacy model would reimburse a company for the approximate difference if the company didn’t sell the consumer’s data. Consumers would instead pay a subscription fee for websites to ensure that companies won’t sell their information.

What Is Behavioral Targeting?

Many of the ads we see online today are placed through a technique called behavioral targeting. Advertisers work with companies to use technologies like clear gifs and cookies to track your web surfing behaviors online.  Chained Laptop

The data that is collected for behavioral targeting is not necessarily personally identifiable data such as your name or social security number. Instead, behavioral targeting focuses on data like the news articles you click on or the specific product you stare at while shopping on Amazon. The advertisers can then take this information and direct specific ads to you as an individual.

Would Paying for Privacy Work?

In early 2015, AT&T attempted to roll out a pay for privacy program with its high speed gigabit internet service. Users could either receive individually targeted ads or pay an extra $29 per month for a service with ads that don’t use behavioral targeting.

AT&T went under heavy criticism for this option, but it is not illegal. They make no promises that the number of ads would be reduced regardless of what choice consumers make. Moreover, to avoid liability of any state or federal privacy laws, AT&T’s website makes clear exactly what users are paying for if they choose to sign up for the premium option. AT&T continues to offer this option to their GigaPower subscribers.

Some consumers found a workaround through the use of other technologies like Virtual Private Networks. Others argue that as long as companies are transparent regarding their use of data, consumers are willing to make such exchanges for their data privacy.

In 2014, performance artist Risa Puno showed that people were willing to provide her with personal information like their social security number in exchange for a homemade cinnamon cookie.

Although many people have concerns over who has access to their private information, they may be more than willing to trade it for goods or services if presented the opportunity.

Should Companies Use the Pay for Privacy Model?

Pay for privacy models are new for social media websites, but exchanging your personal data for a benefit has been around for a long time. For example, grocery membership cards provide consumers a discount in exchange for personal information. In addition to the information you entered to sign up for the membership, grocery stores can also track and sell your purchase data to provide you with targeted ads at the checkout line.

When companies are earning additional revenue through the sale of consumer data (as well as the resulting targeted ads), pay for privacy may be the only solution companies are willing to try. With low subscription fees or an exchange of goods or services, consumers can agree to pay for their privacy now.

However, the slippery slope of pay for privacy is that privacy may become a luxury that can only be afforded by people who are able to pay. Consumers who are not able to afford an additional $29 per month charge to ensure their informational privacy may be stuck with directed advertisements and other intrusions into their privacy.



<