Dear Doc.:

I was given a prescription for Noroxin to treat a UTI, but when I got back from Rite-Aid, the bottle they gave me contained Neurontin, which is used to treat epilepsy and pain. Somebody messed up, and from what I read, this could have been very dangerous. Why can’t someone keep this from happening by making sure that drug names are not confusingly similar?

Signed,

Confused Patient

Dear Confused:

Unlike regular trademarks for things like tractors, condoms and laundry detergent, names used on drugs are supposed to be unique, not confusing, and truthful. There is even an office at the US Food and Drug Administration (FDA) that is supposed to approve trademarks for drugs in an effort to prevent the over 1.3 million injuries each year that result from drug name confusion. Even though a drug company may be able to register a drug trademark with the Patent and Trademark Office (PTO), that does not mean that it will be approved by the FDA.

The FDA’s Division of Medication Error Prevention and Analysis (DMEPA) reviews all proposed names for confusing similarity to the names of other drugs or drug ingredients, including both trademarks and “established” or generic names. DMEPA typically rejects about one-third of all names reviewed. Some of the issues DMEPA hopes to avoid include names that suggest potentially exaggerated efficacy claims; names that could lead to erroneous prescriptions (e.g., wrong drug or dosage); and names that look or sound confusingly similar to other drug names.

According to the FDA, there are some ways to reduce the risk that a name will be found misleading during approval:

• Avoid names referring to an inactive ingredient in a way that suggests effectiveness;
• Avoid incorporating a generic name;
• Avoid names implying unique effectiveness (e.g., wonder or cure); and
• Avoid using terms that imply maximum strength, such as “Ultra,” “Max,” “Pro,” or “Super.”

Similar precautions can reduce the risk of using a name that the FDA will consider prone to cause medication errors such as names containing numbers.  For example, some pharmacists interpreted “Percocet 5″ to mean five tablets per dose.  Similarly, companies should avoid using prefixes, suffixes, and letter combinations that may have specialized meanings in the pharmaceutical field – such as “bid”, or “PRN”.

The FDA regularly tests drug names by using volunteers to assess whether names are confusingly similar. The FDA advises that applicants consider the sound of the name when spoken, as if recording a verbal prescription into a voicemail system, consider the appearance of names as printed, and consider the appearance of a name as written by a physician.

Even after a drug name has been approved, DMEPA monitors reports of problems with marketed drugs and can order changes in drug names it has approved. Sometimes the FDA simply orders changes in labeling to eliminate confusion, rather than a complete name change.

Despite all of these precautions, there are still many drug names that are regularly confused. For a list, take a look here.  The Doc, though, hopes that you seldom need more than a good night’s sleep to cure what ails you.

Monsanto, which owned a patent on the magic bean, filed suit against the farmer.  Monsanto believed that the farmer infringed Monsanto’s patent because the farmer made copies of the magic beans, violating the prohibition on making or using a patented product.  Monsanto’s beans were magic because they were genetically modified to survive treatment with glyphosate herbicides.  Use of the genetically modified bean allowed the farmer to kill the weeds in the farmer’s fields using herbicides without damaging his crop.

The farmer believed that once Monsanto sold the magic bean, then Monsanto had no further rights to the bean. The farmer’s friends agreed.  The farmer argued the doctrine of ‘patent exhaustion,’  which means that once a patent owner sells a patented product, the purchaser and any subsequent purchasers can use or sell the product and the patent owner has no further rights to control the patented product.  In this case, the genetically modified soybeans were twice-removed from Monsanto – Monsanto sold the patented soybeans to farmers, the farmers planted the beans, raised crops and sold their crops to a grain elevator, and the grain elevator sold soybeans from the crops to Vernon Bowman, the farmer of our fable.

The case of the magic bean went all the way to the Supreme Court.  On May 13, 2013 a unanimous Court ruled in favor of Monsanto.   The Court concluded that the doctrine of ‘patent exhaustion’ applies only to a particular patented article sold, in this case each genetically-modified soybean sold by Monsanto.  The doctrine allows the farmer to plant or eat soybeans purchased from Monsanto, to grow a crop and to sell the crop.  For soybeans that had the genetic trait and that Mr. Bowman purchased from the grain elevator, Mr. Bowman could re-sell those soybeans, feed the soybeans to animals or eat the soybeans.   However, ‘patent exhaustion’ did not allow Mr. Bowman to make copies of the patented soybeans.  Otherwise, a patent for a seed could never be of any value.  The patent owner could sell the first seed, which would then be copied by infringers, using the self-replicating nature of the seed.  The Court expressly limited the ruling to the facts of the case, recognizing that other situations may arise with other self-replicating inventions, such as computer programs, that might require a different result.

The facts were favorable to Monsanto – Mr. Bowman acted to isolate and duplicate the patented Roundup Ready® soybeans and to take advantage of the herbicide-resistant genetic trait.  He treated his fields with glyphosate herbicide, ensuring that only soybean plants with the Monsanto-owned trait survived.  He also was familiar with the Roundup Ready® beans and used Monsanto-supplied beans for some of his needs.

The Monsanto patents address DNA having specific characteristics and seed and plants containing that DNA.  The Monsanto genetic modification now has been part of the environment for years and eventually will find its way as a contaminant into many, if not all, soybean crops.  The Court was silent on an issue raised in friend-of-the-court briefs; namely, what happens when an organic farmer who does not use herbicides saves seed contaminated with the Monsanto genetic modification.  Isn’t the organic farmer infringing Monsanto’s patent?  In a related question, how can any farmer ever grow any soybeans without being forced to buy Monsanto’s seed due to unintentional genetic contamination?  Those questions currently are in the courts in Organic Seed Growers & Trade Association v Monsanto.

In 2012, the Naked Cowboy (yes, you read it correctly) of New York City fame, sued CBS for trademark infringement when, in 2010, the network broadcast an episode of “The Bold and Beautiful” in which a character briefly appears dressed only in briefs, cowboy boots and hat, singing and playing the guitar just like the real “Naked Cowboy.” We’re sure you know this already, the Naked Cowboy is a New York street musician who has built a “financial empire” by performing in Times Square wearing only “briefs, cowboy boots, a cowboy hat, and a guitar.”  He owns a registered trademark for the words the “NAKED COWBOY” and his outfit, which is not registered, is distinguished by the “words ‘Naked Cowboy’ .. displayed across the back of his briefs, on his hat, and on his guitar…The word “Tips” or the symbol ‘$’ is painted on his boots.”  None of these distinguishing marks appeared on the CBS character; nor was the term “Naked Cowboy” used by the network although the terms were used in tags and Google Adwords associated with CBS’s YouTube clips of the episode.

In his complaint, the Naked Cowboy alleged trademark infringement and various other federal and state law claims.  CBS moved to dismiss the law suit on various grounds, including the defense of “fair use.”  The federal district court of the Southern District of New York granted the motion.  The court made three important points.  First, the CBS character did not use and, therefore, did not infringe the NAKED COWBOY trademark; second, without any of the distinguishing elements of the costume, the likelihood of confusion between the Naked Cowboy and the CBS character was small; and thirdly, CBS’ reference to the Naked Cowboy on YouTube was “fair use.”

The court was referring to what is known as “descriptive fair use,” which is when an unauthorized user of a trademark uses it in a descriptive sense. CBS’s use of “Naked Cowboy” merely described the contents of its video clips and not as a trademark to identify the source of the video clips.  Such usage created no confusion. “The fact that the Episode’s source is CBS and not [the Naked Cowboy was] clearly evidenced by the prominent display of the series’ title” and the CBS logo on YouTube.

There is another kind of trademark fair use, which the Naked Cowboy court did not address and that is the so-called “nominative fair use” concept.  This is an unauthorized but non-confusing use of a trademark to identify the trademark owner’s goods or services .  For example, Ford motors can have a commercial in which it compares a Ford Taurus with a Toyota Camry.  Clearly, it is using Toyota’s “Camry” trademark but it is not creating confusion over who owns the mark.  Similarly, a retailer can use another company’s trademark on its web site without a license if it is selling branded items from the trademark owner.  Pundits have written that nominative fair use is not really a fair use concept but simply another way of approaching the concept of whether trademark usage creates confusion in the marketplace.  In either case, the concept of trademark fair use can keep you out of court and provide a viable defense should you find yourself in front of a judge.

Pardon the quote of the Bard, but there is one area of patent law that, indeed, ponders “that is the question.” Bear with us for a moment while we try to set the stage. To qualify for a patent, the patent law statute passed by Congress states that an invention must meet three criteria: it must be new, useful, and non-obvious. For our present purposes, we will set aside the useful and non-obvious qualifications. To be new, in essence an invention must not have been thought of (or at least, disclosed) by anyone else. Simple enough.

But the U.S. Supreme Court, as judge made law, has grafted onto patent law the concepts that one cannot obtain a patent on a law of nature, a natural phenomenon, or an abstract idea. For instance, Einstein’s famous equation E=MC2 is said to represent a law of nature and, therefore, be unpatentable. Devices utilizing the law, like the bomb, are patentable. The idea here is that laws of nature belong to everybody and cannot be the exclusive property of anyone, while new applications of the law are patentable. In concept, a pretty straight forward approach. However, recently in the biotechnology realm, the concept of a law of nature has become twisted, contorted, stretched, strained, and abused – but we’ll talk about that another time.

For today, we weill briefly delve into what is meant by “abstract” although we confess up front, that we cannot give you an unambiguous explanation. The meaning of “abstract” lies hidden under the murky waters of patent law involving much judicial semantic nonsense promulgated in major part by the U.S. Supreme Court. One interpretation is that a basic idea of an invention is abstract if it totally captures all possible uses of an idea. In this guise, patent examiners routinely reject applications that seem to have a mathematical expression at their core, especially computer and software implemented inventions. One court has recently expanded the  concept of what may be abstract to the analysis of a method for hedging risk in financial dealings between two parties. Lest you think that we are ducking a good explanation of abstract, another federal appellate court recently decided (CLS Bank Int’l v. Alice Corp.) such a hedging idea was abstract, but could not articulate a consistent interpretation of why. In fact, seven different opinions were filed including at least three different tests for evaluating patent eligibility. Like pornography, the courts seem to know “abstract” when they see it.

Which brings us full circle: To be (abstract) or not to be (abstract), that is the question.

I used to have “rabbit ears” on my TV. On stormy nights, I had to stand “just so” near the left ear to see channel 17, but other than that, it worked just fine. Then the electronics companies and the gub’ment told me that I needed “digital” TV or cable. Now, I like Leave It To Beaver as well as the next guy, but I was not gonna pay $75 a month for that stuff! So I went and got a digital adapter, plugged in my rabbit ears, and quicker than you can say, “Gee Wally!” I had… SNOW. And glitches. And buzzing sound. A whole lotta nuthin’ for my trouble. Don’t get me wrong…Not having TV has saved me lots of time, but I hear there’s a new company called Aereo that will put up an antenna in a good place, link it to a digital video recorder, and let me use the whole thing on the Internet for $8 a month. Is this too good to be true? Can they really do that? How does it work? Won’t the TV stations sue them into the ground? Isn’t that June Cleaver one hot lady?

Signed,

Eddie Haskell

Dear Eddie:

You sure ask a lot of questions for a fictional character! Oh well, here goes:

The FCC, when it set up the “digital transition” for television, calculated reception as follows: “Signal strength calculations are based on the traditional TV reception model assuming an outdoor antenna 30 feet above ground level. Indoor reception may vary significantly.” If you had that kind of antenna, you were in for some great viewing. If not, well, tough luck.

Aereo is a company that has developed a tiny (postage stamp-sized) digital television antenna. They put thousands of them on panels and mount them on buildings where the digital TV signal is strong and clear. Then they link each antenna to a multi-tuner and a DVR, and put that online on the Internet. As long as you live in an area where the broadcast signal could reach you if you had the right antenna, you can sign up for the service for $8 a month (or $80 a year). You then use your computer, tablet, or smartphone (even when you’re not at home!) You only get the stations that broadcast over the air for free (not cable channels) but in major cities, there are a lot of those. As the company president said recently, “The last time I checked, there’s no need to have Desperate Housewives or the Real Housewives of Orange County running on four channels at the same time.”

You are also correct that as soon as they heard about this, the TV stations and networks (Fox, PBS, Univision, ABC/Disney, CBS, NBC) sued Aereo in Federal Court. They claimed that the company was violating copyright by rebroadcasting their signals (see, this IS about copyright law after all!) The TV stations and networks wanted an injunction against Aereo to stop it from doing business. The District Court denied this request, finding that a prior decision in favor of the cable operator CableVision, which provided a DVR service to its customers that operated on big servers, rather than on set-top boxes was legal, also favored what Aereo was doing. The TV guys filed an appeal, of course, and on April 1 (no joke) the Court of Appeals for the Second Circuit upheld the trial court’s denial of an injunction in a 2 to 1 decision. The case will now be scheduled for trial some time in the future, but Aereo has announced that it will expand beyond the New York market to 22 more cities by July 2013. You can go to Aereo.com to see if the service will be coming to an Internet near you, so that you can finally put away those rabbit ears for good.

So there you have it. It’s likely that Aereo’s service will not be shut down by the lawsuits, because it fits an important exception written into the Copyright Law by Congress. It’s likely that many will use the service, and that Aereo will someday do deals with the cable operators to expand the programming that they offer, thus increasing the price. It’s likely that you will still be able to watch Leave It To Beaver. And yes, Eddie, that June Cleaver is one smart, beautiful woman, who can cook a mean pot roast while dressed in pearls and high heels, while being a great mother and wife (and is WAY smarter than her husband.) Please though – no jokes about how Ward disciplines his younger son.

Yours truly,

The “Doc”

– Lawrence A. Husick, Esq.

Patrick Cariou, who made approximately $8,000 from his book of Rastafarian photographs, believed that Prince ripped him off and sued him in federal court for copyright infringement. Prince defended himself by asserting the legal doctrine of “fair use,” which, under the U.S. Copyright Act, permits use of copyrighted works for purposes of “criticism, comment, news reporting, teaching, scholarship, or research.”  The lower court rendered its judgement in favor of Cariou holding that to qualify for fair use, the secondary use must “comment on, relate to the historical context of, or critically refer back to the original works.”   Because Prince’s works did not comment upon the original works of Cariou, the court held that Prince’s works did not qualify as fair use.  Prince, who was not short of funds, appealed.

In a complete reversal, the U.S. Court of Appeals for the Second Circuit rejected the reasoning of the District Court judge, and concluded that there is no legal requirement that the secondary use must comment upon the original work to qualify as fair use even if the use “serves some purpose other than those” cited by the statute.  The Court wrote that the requirement of fair use only requires that the new work be “transformative” and that it “alter the original with ‘new expression, meaning, or message.’”  The Court of Appeals held that Cariou’s work is “serene” and “beautiful” while Prince’s work, whch is “crude,” “jarring,” “hectic,” and “provocative,” is fundamentally different.

Here’s an example from the court’s opinion, what do you think?

From Yes Rasta by Patrick Cariou (from the opinion)

Graduation by Richard Prince (from the opinion).

– Adam G. Garson, Esq.

Every inventor feels the tension between the need to maintain secrecy and the need to  disclose the invention.  If you are a regular reader of this newsletter, then you are aware that your sale or offer of sale, public use, or written or verbal disclosure in public can terminate your patent rights forever, with some actions such as public use or sale terminating your rights immediately.  But to develop your invention, you cannot avoid having to disclose.  You have to present written proposals. You have to demonstrate the invention.   You have to consult with others – designers, engineers, manufacturers, business consultants, lawyers, investors and lenders.  How do you talk to other people about your invention, including demonstrating your invention, without losing your patent rights?

You have two options: (a) bite the bullet and file a patent application, or (b) have the persons with whom you are consulting sign non-disclosure agreements.  A non-disclosure agreement is a written contract between you and the person to whom you disclose the invention.  In return for receiving information about your invention, the other person agrees to keep the information in confidence.  After signing, the other person is no longer a member of the public and owes you a duty of secrecy.  If you demonstrate the invention to that person, you are not using the invention ‘in public’ and do not immediately lose your patent rights.  If you disclose the invention to that person in writing, then your written description is not a ‘publication’ and so does not trigger the patent right termination deadlines.  If you describe the invention verbally to that person, then your verbal description does not make the invention ‘otherwise available to the public’ to trigger the running of the time to terminate your patent rights.

The other major advantage of a non-disclosure agreement is that it is immediately enforceable.  If the person who signed the non-disclosure agreement copies your product, you can file suit in court immediately. You do not have to wait the three years or so that it will take for your patent to issue.

There are weaknesses to non-disclosure agreements.  Beware selling or offering the invention for sale. Even if a person signs a non-disclosure agreement, offering to sell the invention to that person likely will terminate your U.S. patent rights instantly and forever.

There is also the problem of who signs the non-disclosure agreement.  If the other person is a corporation, the person signing the non-disclosure agreement on behalf of the corporation must have authority to sign, or at least ‘apparent authority.’  The company CEO has ‘apparent authority.’  The CEO’s secretary does not have ‘apparent authority.’  Without actual or apparent authority on the part of the person signing, the nondisclosure agreement will not protect you.  Demonstration of the invention likely will immediately terminate your patent rights.

There is also the problem of proving that your non-disclosure agreement applies to a particular disclosure.  If, for example, one of the corporation’s employees violates company policy and posts on his Facebook page: “I saw the coolest invention today” along with video of your invention, then it will very difficult to show that a similar invention in, say, a video from Kazakhstan was derived from your disclosure.  That Kazakh video likely will be prior art for your subsequent patent application and may prevent you from obtaining a patent.

Bottom line:  The safest approach is to file a patent application prior to disclosing the invention and certainly prior to demonstrating the invention or selling the product, coupled with non-disclosure agreements with the persons to whom you disclose.  You then have the best of both worlds – you avoid loss of patent rights because your patent application is already filed and you enjoy the ability to immediately enforce the non-disclosure agreement without waiting for that patent to issue.  We can help you with both your patent application and the non-disclosure agreements.

– Robert Yarbrough, Esq.

– Robert Yarbrough, Esq.

Dear Doc:

 I’ve been listening to NPR, and when they talk about Supreme Court cases, they talk about someone standing around, and how much that matters to all them old folks on the Court.  Then they complain that folks lack standing (I guess they never heard of those tall desks like old Tom Jefferson used.) Now, I can understand a bunch of senior citizens being concerned about people standing, but why does it matter to the rest of us, and why don’t they just get more chairs in the courtroom?

Signed,

Supremely Clueless

Dear SC:

NO! NO! NO! It’s not a lack of chairs, it’s a lack of standing. Let me explain…

Under the Constitution, Article III (stay with me here) our courts are only allowed to decide “cases and controversies”. That’s a way of saying that you’re not allowed to ask a court a hypothetical question, like, “If I were to shoot an arrow into the air and it came down I know not where, but, like, onto the top of my good-for-nothing son-in-law’s thick skull, would I be found guilty, or be given a medal for thinning out the gene pool?”

Courts can’t answer such questions.  The Founding Fathers wanted to be sure that judges would not have to work very hard, so they made sure that only REAL cases can come before the courts. Since judges can’t just come right out and tell folks to get out of their courtrooms, they invented this concept called “standing”.

For you to have standing, the outcome of the case must affect some right or interest of yours. You literally can’t just be a bystander. When the Supreme Court really, really does not want to answer a question, it can determine that one of the parties to the case actually never had a right to bring the case to the courts in the first place. So, let’s say that you see that Monster Corporation has just been granted a patent on a product that you want to make, right after you convince your brother-in-law to invest $1 million in your company. You can’t sue Monster to invalidate the patent because they have not threatened to sue you. Monster can’t sue you, because you have not “made, used, sold or imported” the patented product — you’ve only thought about it. See? Nobody has standing, and the courts will politely throw you out in the street if you try to bring a lawsuit.  Got it?

Good!  Now why are you just standing/sitting around reading this? Listen to your Mother…go outside and play in the fresh air!

The “Doc”

Ok, let’s hear your comments about why this image is funny….

– Lawrence A. Husick, Esq.

the owner of a particular copy … lawfully made under this title, or any person authorized by such owner, is entitled, without the authority of the copyright owner, to sell or otherwise dispose of the possession of that copy . . . .

The first sale doctrine permits owners of copyrighted works, even if they are not the creators, to resell copyrighted works without fear of lawsuit by the creators.  Copyright owners, such as Wiley, argue that the “lawfully made” language, quoted above, only applies to works that are manufactured in the United States.  Assuming that is correct, then the first sale doctrine would not apply to works manufactured outside of the country.  Therefore, Kirtsaeng’s importing and reselling of foreign purchased textbooks would not be exempted by the first sale doctrine.

At trial, the federal district court prohibited Kirtsaeng from raising the first sale doctrine as a defense to copyright infringement and as a result, the jury found in favor of Wiley and awarded it damages for intentional copyright infringement.  Since our newsletter was published, the Court of Appeals for the Second Circuit affirmed the lower court, concluding that §109(a)’s “lawfully made under this title” language indicated that the “first sale” doctrine does not apply to copies of American copyrighted works manufactured abroad.

Kirtsaeng did not take “no” for an answer and appealed the Circuit Court’s decision to the United States Supreme Court, which issued its opinion on March 19, 2013.  The Court reversed, holding that the  first sale doctrine applied to any work whether it is published in the United States or abroad. The  Court’s opinion was based largely on statutory interpretation.  Here are the highlights:

• Section 109(a) says nothing about geography, the lower courts’ reading “bristles with linguistic difficulties”;
• Historical and statutory context indicate that Congress did not have geography in mind when it drafted the current statute;
• The common law “first sale” doctrine did not embrace a geographical component and, therefore, one must assume that the statutory version retained the common law given no evidence to the contrary;
• imposing a geographical component to Section 109 would not further the constitution directive of “promot[ing] the Progress of Science and the Arts;”

Justice Breyer delivered the opinion of the Court.  If you would like to read the entire opinion, click here.

– Adam G. Garson, Esq.