Intellectual property, patents, and copyrights are interesting topics. If you were listening to music back in the 1970s, you might recall that George Harrison's song My Sweet Lord sounded a lot like the Chiffons' 1963 composition of He's So Fine. The Chiffons thought so too, and it became one of the more famous music infringement cases. George lost. Sticking with the music theme, in 1994 John Fogerty was sued for copyright infringement for copying his own work!
While using someone else's PowerPoint slide without permission or using a paragraph out of a book chapter in your brochure might not have quite the impact of a Top 40 stolen melody, understanding the rules that govern this sort of thing is nonetheless important. Sometimes it's an honest mistake. For example, just a few months back here on Page Ten, I used the term “Three-Peat.” I now know that this phrase was trademarked by Pat Riley (then coach of the Lakers) in 1989 (my people are talking to his people).
There also may be cases where you want to protect something that you have created—an idea, a device, or maybe just a clever name. Fortunately, there is an audiologist who has had extensive experience in this area, and she is here to tell us all about it.
Kathleen Campbell, PhD, is professor and director of audiology research at Southern Illinois University School of Medicine in Springfield, IL. She is a fellow of ASHA, served on the AAA board of directors, and is author of the books Essential Audiology for Physicians and Pharmacology and Ototoxicity for Audiologists.
After a job at a dude ranch in South Dakota, studying theater in Berlin, and teaching school in London, Dr. Campbell began her audiologic career in the East Kootenay region of British Columbia. Today she is internationally known for her research, publications, and inventions in the area of ototoxicity, and received a wide variety of grants from the NIH and other agencies.
Kathy has had first-hand experience in the area of intellectual property, as she holds 3 U.S. and 35 foreign patents with others in prosecution. These patents include D-methionine as a protective agent against noise-, chemotherapy-, radiation, and aminoglycoside-induced hearing loss as well as other side effects.
Whether you have a unique idea of your own, a clever logo or phrase you'd like to trademark, or simply want to use the work of someone else, I think you'll find the guidance provided here by Kathy most informative. That's all, folks!™
Page Ten Editor
™ Used with permission, Porky Pig
1 It seems that every day I'm hearing more about copyrights, patents, trademarks, disclosures, and all that kind of stuff. I need to know more about all this, but I'm not sure where to start.
Well, maybe I can get this little conversation started by talking about something called “intellectual property.” Intellectual property issues can affect all of us in a number of ways. For example, you may come up with a new idea for an earmold or an earmold cleaner or storage unit or even a new hearing aid circuit. Or you may create a new company logo or slogan that you don't want your competitor down the street to hijack once you have invested your advertising dollars and years of service to promote it. You may develop patient-education materials that you want to preserve as exclusive to your service or that you want to be able to sell. You also need to know when and how you can and cannot use the work of others.
2 That's exactly the kind of thing I need to know. For starters, let's say I have an idea for a new treatment or device to help the hearing impaired. It seems that the right thing to do would be to share my ideas freely, right?
Actually, just the opposite is true. Let's think big time and say that you have an idea for a drug or a medical device. In most cases, these will have to go through the Food and Drug Administration (FDA) for approval. That process can be very expensive, particularly for drugs. Right now it can cost approximately $1.2 billion to take a drug from bench to bedside.
No company is going to invest that kind of money if the drug isn't patent-protected, because another company could let the first company spend all the money on the FDA approval process and then undercut it on price with an immediate generic version of the drug after it has been approved. Therefore, if you just give your idea away without patent protection, no company will carry it forward and it will never get FDA approval. So, in the long run, it is the patients who get hurt. They don't benefit from a potentially useful drug or device because it was not patent-protected and thus not fully developed.
3 But I see things for sale on the web every day to prevent hearing loss or tinnitus, etc. Have they all gone through the FDA approval process? What if it says they are using an “FDA approved” drug?
Right now, no drug is FDA-approved to prevent or treat ototoxin- or noise-induced hearing loss. Always be careful if someone says a drug is “FDA approved.” Ask if it was FDA approved to prevent or treat hearing loss and/or tinnitus. It could be that the drug or device was approved for a very different purpose. If so, there is no assurance that the drug or device is safe or effective for a different purpose such as treating hearing loss or tinnitus. What's more, the dosing strategies can be really different when the same drug is used for different purposes, so approval for use in one area doesn't mean it's a good idea to use it for other areas.
There is also a gray area under the DSHEA (Dietary Supplement Health Education Act) of 1994. The DSHEA covers nutraceuticals and herbs. In case you're wondering, “nutraceutical” is a linguistic blending of the words “nutrition” and “pharmaceutical” that is used to describe products that use extracts of food to provide—or at least allegedly provide—medicinal benefit. Because many drugs can be derived from foodstuffs or herbs, the distinction between a nutraceutical and a drug can be blurry. Under the DSHEA, safety is the responsibility of the manufacturer, so consumers do not have the same guarantees of safety testing or even package content that they have with a drug or device approved by the FDA.
The DSHEA also specifies allowable claims on labels and in sales literature. Under the DSHEA, without FDA approval, labels and sales literature are not supposed to claim that a compound prevents or treats any medical condition (including hearing loss or tinnitus). But sometimes the wording on the package dances all around it.
Also, I've seen things like “this is not intended to treat or prevent any medical condition” on the main page of a web site and then found that further on under “Uses” or “Ordering” the site contains specific dosing instructions for preventing or treating a medical condition.
Of course, another important issue is that recommending drugs and nutritional supplements is outside the scope of practice in our audiology and hearing aid dispensing licensure laws. So, if a supplement you recommend interacts with another drug the patient is taking or has any adverse effects, you may not be protected by your audiology or hearing aid license to practice.
4 But if a drug is FDA approved for one purpose, doesn't that mean it's safe to use for another purpose?
Not necessarily. The FDA approval process does look to ensure that a drug is safe and effective, but that evaluation is based on a risk/benefit analysis. For example, cisplatin is very ototoxic and causes hearing loss in a lot of patients. However, it is also very effective at killing cancer cells. So, the FDA has approved cisplatin to treat certain types of cancers since the benefits outweigh the risks for many patients. But FDA approval doesn't mean the drug doesn't have significant side effects.
Also, many herbs and nutraceuticals interact with other medications or medical conditions. That needs to be taken into account before recommending anything. Even grapefruit juice can alter the dosing of several prescription medications. Again, that is outside of our training and expertise as hearing care professionals.
5 Let's move on to devices. I do a lot of open-canal fittings, and I think I have a pretty good idea for a new earmold design. How do I know if it is patentable?
I hate to tell you, but the idea to use a horn tube has already been taken! But seriously, my understanding is that for an invention to be patentable, it has to be useful, not obvious, and novel. It doesn't necessarily have to be more useful than anything else available, but it does have to serve some useful purpose. And, since it needs to be novel, if it's something if you saw somewhere else, you can't patent it.
You will also need to carefully search the literature and other patents to make sure your idea isn't already out there. Patent searches can be complicated, so you probably want to hire a patent attorney to do it. It also has to be non-obvious to someone “skilled in the art.” So if your idea would be obvious to your colleagues, you probably can't patent it.
6 Should I get feedback from colleagues before moving forward?
No. A good patent attorney recently told me that the minute you publicly disclose your idea you lose most foreign patent rights and set the clock ticking for U.S. patent filing. For U.S. patentability you have only 1 year to file from the date of your public disclosure, so you want to protect your idea before you publicly disclose it. Also keep good signed and dated (preferably co-signed) records of your idea and be careful whom you tell about it before you protect it. That casual conversation in the hall may not be public disclosure, but you never know when someone might take your idea and run with it. So protect it first. But particularly, protect your idea before public disclosure.
7 Doesn't all this inhibit my ability to present and publish my work? I want to share it.
It doesn't need to inhibit you at all. You just need to file your patent application or provisional patent application first, and then you can present and publish all you want. You don't have to wait until the patent is issued.
8 What exactly constitutes public disclosure?
It could be an abstract, a poster for a meeting, or a talk that you give at a state or national convention. Certainly a book chapter or published article constitutes public disclosure. It can even be as simple as mentioning something as a possibility. For example, on a professional Internet listserve you might say, “I've found I get better retention with my open fittings if I use…” That could be public disclosure.
9 But if it was my publication or lecture, it wouldn't count against me filing a patent, would it?
Yes it could and it probably would. Even your own work, including articles, chapters, previous patents, and public lectures, may render it impossible for you to get a patent later.
10 Here's another thought. Maybe it would be better just to approach a manufacturer about my idea and let them handle it?
Before you do that, you should see a patent attorney or someone who works with technology transfer. They will generally help you file a confidential disclosure agreement (CDA) before you release any information to a company. That way you and your idea are protected. You may also wish to file your patent before you meet with them if you haven't already done so.
11 What if I am testing out a company's new hearing aids and have an idea to improve them? Since they already have a patent, there's nothing I can do, right?
Again, you should check with a patent attorney. If your idea is truly novel, useful, and non-obvious, you may be able to file for a patent or try to become a co-inventor on the company's patent if it is a significant improvement.
12 If I actually get a patent, how long is it good for?
A patent lasts for 20 years from the date of application. However if you have to go through the FDA approval process, you may be able to get an extension for some of the time spent in FDA clinical trials.
13 What if I just came up with a catchy name or slogan for my company and I don't want someone else using it. Can I patent that?
You probably can't patent it, but you could try to trademark it. For example, you may decide to call your chain of clinics Ears2U. You use the name in your clinic title, brochures, and advertising and invest thousands in doing so. You probably don't want the clinic down the road to then call itself Ears2U and cash in on your word-of-mouth referrals and advertising. So you apply for a trademark and protect it. If you have a distinct and original logo, etc. that identifies your clinic, you may be able to protect that too.
14 Does that expire in 20 years too?
No. A trademark can be continually renewed without expiring as long as you keep using it in your business.
15 If I have a web site or publish a brochure for my business, can I use someone else's figures or graphs? For example, could I take a picture of noise-exposed hair cells and post it on my web site to show people what damage looks like and provide an interesting looking page?
Generally, you can only use other people's work if you have their permission and give them credit for their work. Anything that is published is especially likely to be covered by copyright. And remember, this applies to most photographs too. You may need to get permission from the photographer even to publish a photo of yourself!
A common concern relates to the use of copyrighted material for teaching purposes. Any time you use someone else's work you should be sensitive to copyright issues. Even if something isn't copyrighted, you should always get permission and credit the source.
Let's say you would really like to use someone else's slides in your lecture or in a course you are teaching. You need to contact the author of the slides first. You may find out that they are copyrighted or taken from copyrighted publications. In that case you may need to get permission from the publisher of the material. In other cases they may not be copyrighted, but, in my opinion, to use someone else's slides without permission or credit is unethical, even in cases where it may not be illegal.
We are all part of the hearing service community and we need to treat each other well, including crediting sources whenever appropriate. Another item of etiquette is that you should never take photos during someone's presentation without permission. Speakers may be presenting work that they haven't published yet and don't want you to photograph. The same goes for poster sessions. Always get permission before photographing.
16 How about book chapters or journal articles? Sometimes these Page Ten articles are so darn good that I like to copy them and use them as handouts for referral sources or some of my patients. Is that okay? Can I post articles and book chapters to a web site?
Copyright issues, like patent issues, can be complicated. There are some limited fair use exceptions for copying with permission, but I believe these examples fall outside the scope of the exceptions. Before taking too many chances, consult an intellectual property attorney to flesh out those specifics.
17 I've developed a lot of handouts for my patients and want them to be exclusively used in my clinic. How do I copyright those?
Just go to www.copyright.gov and you'll find information about how to copyright your creation.
18 How long does a copyright last?
A copyright lasts for the author's life plus 70 years. So, unless you are talking about the history of how we manage hearing loss, just about any publication you want to use will be under copyright. Of course, that also means anything you write and get copyright protection for will have equally long coverage.
19 Finally, I just have to ask, what is a “trade secret”?
Hmm. Do you have one? A trade secret is a property right for information that companies keep secret for competitive advantage. Keep in mind that chemical and engineering analyses by competitors can be pretty sophisticated, so be sure and talk to your patent attorney about the advantages and disadvantages of trade secrets versus patents.
20 Where can I get more information about all this?
The U.S. Patent and Trademark Office web site (www.uspto.gov) has a lot of consumer-friendly information. However, if you're serious about pursuing a patent or trademark, it is in your best interest to hire a patent attorney. Legally, you can file a patent yourself, but in reality the area is complex and you will need an attorney's expertise. If you work for a university or company, seek out the services of its technology transfer office.