Licensing, Legal & Compliance
Guidance
Guidance
Protecting and safeguarding intellectual property is at the heart of the healthcare business’s strategic plan.
When we represent a start-up or inventor (for example, of a medical device), our client may wish to assign or license the technology to a third party. Or our client may want to provide access to services through a subscription arrangement.
Protecting the Intellectual Property of a Healthcare Business or Practice
We advise clients about protecting their intellectual property through:
Confidentiality clauses in agreements
Copyright Law
Patent law
Trademark Law
Trade Secret Law
We also draft various agreements, such as:
- Licensing Agreements
- Publishing arrangements and book deals, co-author agreements
- Royalty-Sharing Agreements
- Other Agreements Involving Sharing of Technology
The terms of the agreement often get worked out by the parties in a letter of intent prior to the formal, longer document.
IP protection is something that healthcare practices and companies should think about early on in the game, before disputes arise. For example, the question of who owns the patient and customer lists is one that healthcare employers should address in the employment agreement.
When to Get Intellectual Property Advice
Our advice includes intellectual property protection both at the inception of the business, and when marketing or distributing strategic IP assets through licensing and other transactions.
In addition to providing legal guidance regarding IP protection, our healthcare intellectual property attorneys guide clients regarding issues including:
- Federal Copyright Registration Service
- Federal Trademark Registration
- State Trademark Registration
- Copyright and Trademark Disputes and Infringement Actions, including: Sending Cease-and-Desist Letters
- Responding to Cease-and-Desist Letters
Our intellectual property attorneys help clients identify when they have trade secret information and develop procedures and contracts enabling them to keep it secret. The Uniform Trade Secrets Act (“UTSA defines “trade secret” as:
Information, including a formula, pattern, compilation, program device, method, technique, or process, that: (i) derives independent economic value, actual or potential, from no being generally known to, and not being readily ascertainable by proper means by, other persons who can obtain economic value from its disclosure or use, and (ii) is the subject of efforts that are reasonable under the circumstances to maintain its secrecy.
The law of trade secrets is complex. Employers should seek legal counsel on ways to protect trade secrets from subsequent disclosure following employment. In contrast, employees should seek legal counsel to understand the breadth of the employer’s trade secret language and find ways to minimize miscommunication and mitigate potential later legal exposure.
Leveraging IP in Healthcare Practices and Businesses
Healthcare practices and businesses can leverage their intellectual property to maximize value. The healthcare company’s IP portfolio often gives it its key competitive advantage.
Sometimes it is patent protection that safeguards innovation, while at other times it is the copyright, trademark, or simply a trade secret. Healthcare companies should not only protect their IP initially but also use legal counsel to assert and defend IP rights where necessary.
We recommend that our healthcare clients secure trademark protection on their logos, marks, and significant advertising assets. IP is a critical component of due diligence in the M&A transaction as well, and thus crucial to an exit. Healthcare startups should pay particular attention to who owns the foundational IP; if the IP is in the hands of the owner, arrangements could be made to transfer the IP to the healthcare company formally.
Copyright protection can be powerful, although copyright law only protects the expression of ideas and does not protect the idea itself. Still, penalties for a copyright violation can be significant.
Where MSOs are involved, the MSO should seek ways to retain access to customer data even when the relationship with the MD or professional medical corporation ends. This can be complicated, given the interface of medical board regulations and state and federal law governing the privacy and security of protected health information (PHI).
Hidden IP Issues in Healthcare Contracts
Many healthcare companies and practitioners are unaware of the extent to which the agreements they sign—with or without the benefit of review by legal counsel—contain IP issues.
For example, the “work for hire” provision mentioned earlier gives ownership of the IP to the employer. Often, employees may think that the intellectual property they have developed ‘in their spare time’ belongs to them; however, strong work-for-hire provisions, together with provisions in Confidentiality & Proprietary Invention Agreements, can move ownership away from the employee and into the hands of the employer.
Intellectual property issues are often tucked inside the agreement and are not always easily understandable. For example, consider the following language from an Independent Sales Representative (ISR) Agreement:
Trademarks. The ISR shall have the right hereunder to represent that it is “an Authorized ISR” or “an Authorized Independent Sales Representative” of the Company or its Products, and to use the Trademarks in all advertisements and other activities conducted by the ISR to promote the sale of the Products. Any other use by the ISR of the Trademarks must be in a form and format approved by the Company in advance of such usage. ISR shall not, pursuant to this Agreement or otherwise, have or acquire any right, title or interest in or to the Trademarks. The ISR shall represent, market, and bill for sales of, the Products only under the Trademarks, and not any other trademark or logo.
Other Intellectual Property Rights. The ISR shall refrain from copying, reverse engineering, disassembling, decompiling, translating, or modifying the Products, or granting any other person or entity the right to do so. Further, the ISR shall refrain from infringing on any copyright, utility patent, or other intellectual property rights of the Company. The ISR shall not tamper with or otherwise adulterate the Products; nor shall the ISR repackage the Products and sell them under a different label. The remedy at law for breach of this provision being inadequate, the ISR understands, acknowledges and agrees that the Company shall be entitled, in addition to such other remedies it may have, to temporary and permanent injunctive relief for any breach or threatened breach of this provision without proof of any actual damages that have been or may be caused to the Company by such breach.
Notification of Infringement. The ISR shall promptly notify the Company of: (1) any claims, allegations, or notification that its marketing, licensing, support, or service of the Products may or will infringe the intellectual property rights of any other person or entity; and (2) any determination, discovery, or notification that any person or entity is or may be infringing the intellectual property rights of the Company.
Such language must be carefully drafted (or, if prepared by opposing counsel, reviewed) for hidden IP issues by an attorney skilled in trademark and other intellectual property law.
IP issues often arise with physicians who are medical academics, who are bound by trade secrets and other IP language, as well as conflicts of interest policies by their medical school or university. Our healthcare legal team can advise on negotiating the legal terrain that physician medical academics face, as well as on the commercialization of the intellectual property they own.
FAQ
Great! Let us know and we’ll do a conflicts check and then send you an engagement letter. Typically we want to know if we are going to represent you as an individual, or your entity (corporation or LLC); we’ll also want to know your website and some basic contact information.
Review our legal services to see some of the areas we like to work in; check our testimonials, client roster, and experience; read some of our blog posts; check out our Linked In community; or just call or email us to explore. Put simply, we represent health and wellness products, technologies, practices and ventures that accelerate health and healing.
We are very comfortable working with clients via phone and email. You can sign, scan and email the engagement letter, and submit the advance by check or online.
The answer depends on the complexity of the project. Each client’s situation is different. We want every client to receive the best possible advice, and so we want to be in a position to devote as much time as is required to do that. Look to our testimonials, client roster, and experience. We work with our clients effectively and efficiently and build long-term relationships based on mutual trust. We bill hourly and do not offer project or flat fees. Lawyering is an art, not a science – we’re intuitive as well as skilled lawyers.
Yes, like most law firms, we require an advance against fees and costs. Our typical advance ranges from $3,500 – $10,000. We offer our expertise and savvy and work hand-in-hand with you toward your goals. Occasionally, we will offer you a one-hour consult as a way to jump-start our work together, and give you an overview of critical issues, with guidance on the critical business cross-roads you’re facing. We do not take equity or deferred compensation.
Our Firm doesn’t quite “quotes” or answer “how much does it cost.” Through long experience, we’ve found that the answer is pretty much meaningless. Some lawyers and law firms give quotes, but if you read the accompanying disclaimer, you’ll see that the disclaimer basically says that you can’t depend on the quote for anything. In our long experience, “how much it costs” depends on a lot of variables, including:
- What the client is asking for
- What the client really needs
- What the client doesn’t know they don’t know
- What we discover as we dive into the legal research and analysis
- How complicated the problem really turns out to be
- How much client will want to do on their own
- Whether we can find some elegantly simple solutions to sub-parts of the puzzle
- What decisions we make together, and separately, as we explore the puzzle and put solutions and strategies together
In many cases, we might think a project is very complex but then as dig in, we can make executive decisions and recommendations that save the client dozens of hours of lawyer time and tens of thousands of dollars. This happens a lot with our clients. In other cases, the client might think the problem is simple but as we start to review it, the puzzle is much larger; sometimes the client throws in extra facts and complications at the last minute, and that will increase the expense and work; sometimes we’ll give the client “homework” so they can DIY a piece, taking it outside the need for lawyer time.
One thing we do is get our clients frequently on the phone. We find that the Legal Strategy Session often cuts through the fog. Where we need to do a chunk of written legal work, we’ll do so and let you know that’s what we think is needed. Where we can be more efficient with a call, we’ll tell you that as well.
Many clients come us after having wasted tens of thousands of dollars with other lawyers. Read our testimonials. We’re here to provide a lot more value than the retainer—our business model and Firm policy is to provide at least 3-5 times the value back to you. That’s our model and we’re sticking to it. We’re not trying to sell you on a “cheap retainer” or promise of discounts. We’re here to solve a big hairy problem and get you where you need to go, as efficiently and productively as we can.
Typically, assessing feasibility involves legal and strategic advice, which we provide in the 45-minute consult, in a way that is appropriate to the time we have together there.
The only way to know is to jump into the process. If you want to know more about us and how we work, browse our testimonials, look at our client rolodex, or review our experience on our website.
Work with us and find out how efficient and engaged we are with your business. We like to work with clients for life. It is a deep and trusting relationship.
Michael’s bio is online here. He has written books on healthcare law and policy, taught healthcarelaw as a faculty member at Harvard Medical School, garnered NIH and other medical research grants, and published over 100 articles in legal and medical journals. Michael speaks all over the world on healthcare topics.
