Practice Areas

Click on a category name to view more information.

Business Entities/Non-Profit
Organizations

Interested in forming a business, but want a little guidance or deeper understanding? Ready to realize your dreams of a corner coffee shop, non-profit charity, or biotech startup? Hibbs Law, LLC can help you, whether it be with determining what type of entity best suits your needs, or with preparing your formation paperwork.

Already in business? Hibbs Law, LLC can help you stay proactive with documentation and operating agreements, explore options related to franchising or drafting and negotiating licensing agreements. We can provide regulatory consulting for your industry. Hibbs Law, LLC has working experience in several industry areas including: non-profit organizations, biotechnology and medical devices, and health care providers.

Copyright

A Copyright is any artistic expression on any tangible medium, and is federally regulated under 17 USCA, the Copyright Act of 1976. Several international agreements influence the mechanics of our copyright system, and many of their requirements are beneficial to artists. Section 101 of the Copyright Act defines these international agreements as including the WTO’s TRIPS treaty, as well as the UN’s WIPO agreements. Copyrights are the right to control one’s art by reproduction, derivative creation, distribution by sale or lease, performance, display, or playback. Creating a copyright is easy and inexpensive, but once it has been stolen enforcing it can take valuable time and investment. When your career and livelihood center around your art it is worth protecting. Hibbs Law, LLC works with writers, graphic designers, musicians, video game designers, and other artists to let them grow and create with confidence. As stated on our Client Services page, we want to make high-quality legal services as affordable as possible to the individual and small businesses. We do this by tailoring our services to meet your needs, not by maximizing billing hours. Whether it is helping you to formalize your registration, establishing a monitoring system, alerting users to possible enforcement, conducting dispute resolution and negotiations, seizing infringing goods, or litigation—you can gauge your actions with confidence, and make the choices that are right for you and your art.

Health Law Compliance

Health Law is a wide and varied area, encompassing the points where health and the law intersect. Health law includes the legal duties that doctors hold to patients, hospital entity formation and governance, medical research and development, regulatory bodies like the FDA and IDPH, and federal laws like HIPAA, EMTALA, ERISA, COBRA, and COPPA. Of high importance in our digital age, is security and privacy of personal information relative to the health care industry, as covered by the Health Insurance Portability and Accountability Act and Part 11 of Title 21. These regulatory frameworks touch almost every aspect of health law in the United States. Hibbs Law, LLC is particularly interested in providing advocacy and consulting for health clinics, small bio-tech companies, and patients’ rights organizations.

Testing & Research

For laboratories, research, development, quality control, and validations in the realm of Heath Law may require animal testing. To respect the gift of this participation, Hibbs Law, LLC can help you navigate USDA, FDA, NIH, and other organizational guidelines for laboratory animal care. So that you can provide the most humane treatment and highest quality of life.

Entities conducting research with human subjects, aside from some specific exclusions, must obtain their Federal wide Assurance (FWA) and form or engage an Institutional Review Board (IBR), sometimes called an Ethical Review Board. This is applicable to both NIH, and FDA, research studies. Protocols, consent forms, HIPAA privacy policies, and other materials must be reviewed and approved by IBR’s to protect the human participants. Multiple entities collaborating must align their standards and practices, often utilizing reliance agreements. The NIH and other agencies are streamlining duplicate administrative burdens by requiring a single IRB for multi-site studies, which an exciting utilization made possible through technology. Be proactive with your compliance; Hibbs Law, LLC can give you the answers you need and confidence in moving forward.

Biotechnology, Pharmaceutical,
and Medical Device Compliance

Within the Department of Health and Human Services, the Food and Drug Administration is the U.S. regulatory body relative to the development and use of therapeutic biological products, drugs, and medical devices. Manufactures and sellers of products used for the treatment, prevention, or cure of disease in humans must register with the FDA and pay an annual fee. Registered organizations are subject to FDA inspection, and Hibbs Law, LLC can assist you in appropriately responding to F483 results, untitled letters, and warning letters. Additionally, each therapeutic biological product, drug, or medical device must be approved for use in both human clinical trials and then to the public at large; or be considered otherwise comparably equivalent to such products that have already been shown to have the requisite safety and efficacy. Hibbs Law, LLC is ready to help you with your 510(k), Pre-market Approval, Biologic License Application, New Drug Application, Investigational New Drug Application, and Abbreviated New Drug Application submissions.

Before a chemical or compound becomes a medical treatment, early-stage research must identify the relevant biological targets and develop known pharmacological activity or other identifiable activity. This process to develop a potential therapeutic medicine or product is a daunting endeavor that requires commitment, investing of time and money, and unrelenting focus. It is possible that methods and techniques you need for your research are already subject to patents owned by entities that may seek to prevent our use. In some cases you research may qualify under the Hatch-Waxman §271e(1) as safe harbor. Hibbs Law, LLC can help evaluate your practices to lower risk. Knowledge of good practices and guidelines from the beginning will put a research team on the right track to pursue potential medicines and devices.

Clinical testing and public use/sale of FDA regulated products also generate issues of Quality Systems Regulations (QSR) and current Good Manufacturing Practices (cGMP). Even labeling and marketing is regulated. Hibbs Law, LLC can assist you in reducing non-compliance risk. Therapeutic biological products also face additional requirements of safety, purity, and potency under the Public Health Services Act, when applicable to the prevention, treatment, or cure of a disease or condition of human beings. Therapeutic biological products includes: viruses, therapeutic serums, toxins and antitoxins, vaccines, blood and blood component derivatives, proteins, immunomodulators, and monoclonal antibodies.

Hibbs Law, LLC is looking to form long-term relationships with research teams, diagnostic groups, start-up biotechnology entities, generic developers/manufactures and other health care innovators in pursuing their dream to improve quality of life for human kind.

Patents

The Constitution protects "useful arts" by inventresses and inventors, commonly known as "patents", the registration and maintenance of which is administered by the USPTO. The registration process is lengthy and costly, but necessary to secure a limited monopoly for an invention. Different types of inventive design and inventions require different types of applications and claims, and the circumstances of you unique situation will effect your options.

Knowing when to file a patent application and when to continue research and development is key to any inventive process. And now that the US has adopted the international "first-to-file" system, such timing is all the more crucial. Hibbs Law, LLC can assist you in understanding the state of the art around your invention and what space may be unique to you. We can evaluate your idea, compare it to existing technology, and outline the possible risks and strategies. So that you can make an informed decision. We can prepare the necessary documents for your application, prosecute your patent application through the examination process, and navigate and respond to USPTO office actions or PTAB appeals. Once your patent rights are secured we can help you develop enforcement practices, asset your rights against infringing actors, and negotiate licensing and other agreements to make the most of you limited but precious monopoly. Patent terms may be extendable through delays by the USPTO or mechanisms like the Hatch-Waxman Act.

Before a chemical or compound becomes a medical treatment, early-stage research must identify the relevant biological targets and develop known pharmacological or other identifiable activity. This process to develop a potential therapeutic medicine or product is a daunting endeavor which requires investment of time and money. Without sharp attention to possible dry candidates and novel research tools, opportunities may be lost or remain unrealized. Hibbs Law, LLC can assist you in determining whether materials, methods, or tools you develop in your research can be the basis for a claim to patent protection.

As the research process progresses, small or large organic molecules may be identified for further exploration. Identifying stable compound & determining potency, and developing assays for activity are primary goals in developing therapeutically meaningful results. Contact Hibbs Law, LLC about the possibilities open to you in protecting your innovations.

Trademarks

"Legal drama can be overwhelming and confusing. Luckily, we found Hibbs Law, LLC. They helped us navigate the trademark laws, they offered expert advice, communicated well, and we are very happy our lawsuit settled."

Michael Snell, BEST GAY Inc.

A Trademark, like a mystical talisman of old, is imbued with the power to protect its possessor from unscrupulous tactics of competitors. While this power is wielded by the provider of the service or product, the degree of power is determined by the consuming population. In other words, does your Trademark or Servicemark draw a line in the mind of the consumer between your product and you as the origin of that product?

Early in building a business, trademark registration is often set to the side. Later, as the business becomes established and stable, attention often shifts to a more long-term perspective. Federal registration is a worthwhile investment. There is some cost in initially obtaining registration, but after that, trademarks maintained with periodic fees do not expire as long as they are used. Owning a registered trademark provides a National remedy against competitors who may try to capitalize on your hard-earned goodwill. Specifically, they prevent others from using your trademark in a way that would likely confuse the customer as to the origin of the goods. Most commonly, this is when a competitor produces goods that are intended to make customers think that they are buying your 'genuine article'.

At Hibbs Law, LLC, we can walk you through the process of determining what logos, words, and characteristics you should trademark; of obtaining trademark rights through state and federal registration; and of evaluating your sentry procedures, maintaining your mark, and enforcing those rights.

Unfair Competition

Unfair Competition under Section 43(a), also known as 15 USCA 1125, is a powerful tool for small business owners and individuals. It functions as a sword for the innocent man, a white knight of justice if you will, against wrongdoers. In the most casual terms, Sec. 43(a) possesses the following powers:

  1. It stops someone from using a false designation of origin, misleading descriptions or representations of fact, or another's mark in a way that
    1. causes confusion, mistake, affiliation, or association with you and your goods, services, or commercial activity, OR
    2. uses commercial advertising to misrepresent the nature, characteristics, qualities, or geographic origin of you and your goods, services, or commercial activity

This statute protects people as individuals, as their good or services, and as their commercial ventures. At Hibbs Law, LLC we will evaluate your unique circumstances and provide you with all the options. As with our trademark services, we can provide actions ranging from cease and desist letters to litigation.