Intellectual Property Topics for Mobile-Device Healthcare and Medical Information Technology

more+
less-

Developers seeking to innovate using wireless terminals, information networks and devices, as well as users seeking to exploit new innovations, generate proprietary rights that may need to be perfected, and which might be asserted against others. The same developers may have occasion to defend against rights asserted by others in connection with intellectual property (IP).

Mobile-device healthcare (mHealth) and information technology (medical IT) operations might have grounds to make or be subject to, among other examples, claims of misappropriation of confidential information and know-how; infringement of patents by production, use or sale of products or services; copyright infringement; trademark infringement; or cybersquatting on domain names. It can be useful, offensively and defensively, to keep up to date on the shifting sands.

In the Changing World of IP

Developments over the last few years have changed some longstanding aspects of the law and, in particular, the U.S. patent laws.

The Supreme Court decision in KSR v. Teleflex widened the ability of patent examiners to reject claimed inventions as obvious over prior art. A claimed invention now can be considered within the scope of obviousness due to an assumed level of common sense in a person of ordinary skill in the art. Obviousness is larger now than the subject matter for which documented prior art provides teaching, suggestion or motivation.

In Bilski v. Kappos, the Supreme Court limited the extent to which software-based inventions are deemed potentially patentable subject matter. The patent statute authorizes patents on methods of manufacture, articles of manufacture and certain asexually reproduced plants. Software inventions can be deemed unpatentable if they are claimed as methods that can be practiced "in one's head." A patentable claim must define an apparatus or a method that alters a concrete object in the real world.

A number of statutory changes to the patent laws were staged in from 2012 to March 2013 by the Leahy-Smith "America Invents Act" (AIA). The AIA revised the U.S. patent laws so the first inventor to file a patent application now prevails over the first inventor to conceive an invention and then reduce it to practice, i.e., the first person to invent, as under previous practice. The AIA also eliminates the one-year novelty grace period over prior art except in the case of a patent applicant's own publication of an invention in the year preceding filing a patent application. The United States is now effectively an absolute novelty country (consistent with most of the world), wherein one's patent application must be filed before the invention becomes non-confidentially known to others. The AIA institutes new procedures by which patents can be attacked by other parties on grounds of prior art. The AIA makes it impossible for non-practicing entities (also known as patent trolls) to assert a patent against a long string of allegedly infringing parties by making joinder rules more stringent.

There are good and adverse aspects to such changes. If it is more challenging to obtain patents on dubious or marginally unobvious inventions, then there is less risk that it will be necessary to defend a dubious but very expensive lawsuit. However, reasonable people can differ on the merit of inventions.

Meanwhile, the field of mHealth and medical information technology is blooming with new technology and opportunities. Wireless devices such as cellphones and touchpads are combining with government-supported efforts to improve the availability of information over medical information networks, while presenting challenges to privacy under HIPAA and as a general matter.

Patent Application Procedures

Under the AIA, the first inventor to file a patent application on a given invention is entitled to the patent, regardless of who was the first to invent, and there is no grace period to avoid prior art of others. It is important to file patent applications as soon as possible. A provisional patent application procedure allows an inventor to file a patent application that can be informal. It does not require claims. It carries only a modest official filing fee (between $65 and $260 depending on whether the applicant's size entitles them to discounted status). But a sufficient description of how to make and use the invention is required. Filing a provisional application establishes the applicant's priority date, as to inventions for which the provisional application contains a disclosure sufficient to enable a person of ordinary skill to practice the invention.

Provisional applications are not examined by the Patent Office. Provisional applications exist only as a priority date holder and only for one year. The benefit of the priority date can be claimed in a normal non-provisional application filed during that one year. The non-provisional application is examined, and may result in a patent. The Patent Office's information on provisional applications can be found at http://www.uspto.gov/patents/resources/types/provapp.jsp.

The scope of patent protection on a non-provisional application is defined by patent claims. The scope of allowable claims turns on the extent to which the claimed subject matter is novel and unobvious over prior art. The application contains a written description of the invention and drawings, as the enabling disclosure to support the subject matter claimed. After the claims of a patent application have been accepted by the U.S. Patent and Trademark Office, the patent application is printed up and becomes the granted patent.

There is a delay after filing an application before the Patent Office considers the patentability of the claims, which is typically around two years. During that time, the subject matter is "patent pending." For a time after filing (and also during the one-year term of a provisional application, if any), the contents of the patent application cannot be determined by the public. For that reason, the phrase "patent pending" carries somewhat of a warning against copying when applied to a new product or service. Since 2002, applications have been published at 18 months after the earliest filing date and all proceedings are made available to the public online, unless the applicant agrees to refrain from filing foreign applications and submits a nonpublication request when the application is filed.

When the application is considered by the Patent Office, a succession of official actions from the patent examiner ensues, with opportunities for the patent applicant to amend the patent application and renew arguments that the invention is patentable. The applicant's amendments are not permitted to add "new matter" to the disclosure. The applicant usually narrows the claims defining the invention, thus distinguishing the definition of the invention from the prior art cited by the examiner. The back-and-forth process of official rejections and applicant amendments produces a record of negotiating and, ultimately, may force a skeptical and unwilling patent examiner to agree that the invention is being claimed narrowly enough that the subject matter claimed would not have been obvious to a person of ordinary skill. That record is quite useful to competitors who want to understand exactly how they may avoid the scope of the patent claims that are eventually granted.

Published patent applications are searchable at http://appft1.uspto.gov/netahtml/PTO/search-adv.html and granted patents are searchable at http://patft.uspto.gov/netahtml/PTO/search-adv.htm. The Patent Office proceedings of application, rejection and argument are public records in the public Patent Application Information Retrieval (PAIR) system ( http://portal.uspto.gov/external/portal/pair/) under the patent number of a granted patent or the serial number of a pending application.

The owner of a granted patent can prevail in a civil action against an infringer if the patent owner proves that the infringer has made, used or sold subject matter meeting all the limitations of at least the broadest of the claims in a granted patent. Usually the claims must be met literally, as opposed to according to principles of equivalence (although there are arguments available as to equivalence in limited circumstances).

The term of a utility patent is 20 years from the application filing date, provided that official fees are paid at four-year intervals to maintain the patent. The maintenance fee rates increase at each interval and become substantial toward the end. For that reason, many patents are allowed to lapse early. The paid or unpaid maintenance fee status of a patent can be checked through the Patent Office public PAIR system, http://portal.uspto.gov/external/portal/pair/.

Patent protection can be broad or narrow depending on the prior art. For mHealth and medical information technology inventions, one should take care to disclose and claim inventions as apparatus, as opposed to methods that might be practiced mentally. Usually that can be done, but some methods such as certain diagnostic ones involve computing a solution from input data in a way that need not involve or rely on computing apparatus, and that may announce a conclusion but do not make a concrete change to any items in the real world. These inventions carry some challenges for the applicant and its patent attorneys.

Copyright

Copyright protection is available for software, but the protection does not extend to ideas for methods or apparatus. Copyright protection is likely to be much narrower than other forms of IP protection such as patent protection, or the exclusivity afforded by keeping information confidential as a trade secret. But copyright is much easier to perfect.

Copyright protection arises as soon as a work is fixed in a tangible medium. Registration of the claim of copyright is not mandatory, unless one wishes to bring a civil action for infringement. One can and should use the copyright notice on works, regardless of whether the claim of copyright has been registered.

If registration is sought, the copyright examiner is unlikely to object to the application on grounds of substance. The term of protection is the author's lifetime plus 70 years. If the work is anonymous, pseudonymous or a "work for hire," the term is 90 years after first publication or 120 years after creation.

The scope of copyright protection is narrow, compared to patents, because copyright does not encompass ideas or processes that may be disclosed in a work. Copyright protects only the form of expression and not the ideas that are disclosed. See 17 U.S.C. § 102(b), http://www.copyright.gov/title17/92chap1.html#102.

This is a fundamental difference between these forms of intellectual property. If one can exploit the ideas in a copyrighted work without copying the original expression of those ideas, the copyright is not infringed. Copyright is not available for most forms of useful articles even if artistically ornamented (See design patents). Copyright does not extend to names, titles and short phrases (See trademark registrations).

Copyright is available for software, and therefore, it is essential to mHealth and medical information technology. Yet if the copyright encompasses the form of expression, such as the coding and the graphics, rather than the ideas and processes that are embodied or carried out, it may be advisable to keep confidential so much of the software as discloses unprotected ideas. Often, developers use copyright notices but do not register or disclose their source code or their operational documentation, flowcharts, maintenance information and the like.

Ownership

An invention is owned in the first instance by the inventor. It is most often the case that the inventor has a contractual obligation to assign to an employer or business and usually complies.

The Leahy-Smith AIA has relaxed the requirements for an employer or company who can show a sufficient proprietary interest, permitting the employer to undertake filing and prosecuting a patent application if the inventor does not cooperate. Unless the inventor (or perhaps the heirs of a deceased inventor) eventually assigns ownership, the employer may need to bring a civil action against the inventor to force a transfer of ownership, or may need to join the owner as a party if a civil action is brought for infringement.

In regards to copyright, ownership of a physical item embodying a work of authorship is distinct from owning the copyright. If one owns a painting, one can display the painting but cannot legally market prints, postcards or derivative works copied from the work, unless the copyright has expired. If one owns a book, the book can be loaned or sold but not copied and reprinted. Copyright literally is the right to copy.

Except in the case of independent authors and inventors who own their own work, ownership of intellectual property is usually a question of contractual obligations. There are any number of fact scenarios. Disputes may arise in contexts of employment, when businesses merge together or split apart, when ideas or suggestions are passed between parties without good documentation of an agreement or when there is some aspect of derivation of information.

Particular pitfalls exist with respect to resolving copyright ownership because the copyright statute has a concept of works for hire. Outside of employment situations, one might believe that the author of a work (the person who did the creative work) is the owner of the work and its copyright. However, under the copyright law concept of works-for-hire, if a work is made by an employee in the course of employment, the employer is considered the author for hire. Absent some agreement to the contrary, the employee who did creative work in the course of employment is neither the author nor the copyright owner.

One might also believe that if a customer pays a vendor (whether the vendor is a person or a business) to do technical or creative work, that the customer may expect to be the owner of the resulting work. Misunderstandings occur when the customer is not the owner of the copyright, or the customer contracts with a party that does not in fact own the copyright, thinking that the copyright is being acquired. These situations occur where there is confusion about status as independent authors, independent contractors (who may or may not have contributing employees) and works for hire.

In short, multiple persons may contribute to a creative work. It can be hard to ascertain which of the contributors is an employee of a company (making the company the copyright owner for hire) and which is an individual (making the individual the owner). Ownership of a copyright can be conveyed (the statute requires that the conveyance be in writing and signed by the copyright owner). But the buyer needs to be sure that the seller (independent contractor or author for hire) is in fact the owner of the copyright.

Another issue is what is meant by "employment." In Community for Creative Non-Violence, et al. v. James Earl Reid, 490 U.S. 730, 109 S. Ct. 2166; 10 U.S.P.Q.2d 1989, the copyright statute was construed as to whether employment is met where the customer directs and controls the artist/author about what the customer wanted (and got) in a sculptural work, but did not "employ" the sculptor in the sense of paying wages, providing benefits, setting hours, dictating the workplace location, withholding taxes, managing hiring of assistants, etc. The Supreme Court held this to be an independent contractor situation. As a result, the Community for Creative Non-Violence may have owned the sculpture, but Reid as an independent contractor owned the copyright and all rights to control reproduction.

In the context of software development, mobile app development and the like, it is common to have multiple parties contribute to a work, some but not all of which may be employees of others. There are graphic artists and GUI designers, mobile device app developers, network communication specialists, database designers and managers, and so forth. Resolving ownership or licensed rights will require the customer to determine the identity and employment relationships of all the contributors in order to contract with the parties who own the rights that the customer seeks to acquire or license.

Topics:  America Invents Act, Copyright, First-to-File, Healthcare, mHealth, Mobile Devices, Patent Applications, Patent Reform, Patents, USPTO

Published In: General Business Updates, Health Updates, Intellectual Property Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Duane Morris LLP | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »