News and Other Events
May 30, 2025 – University IP and Startups
Universities are incubators of innovation, producing valuable technologies that can transform industries and society. But turning a lab discovery into a commercial product takes more than a good idea — it requires navigating the university intellectual property (IP) landscape.
Why Are Universities Involved in IP?
In 1980 the Bayh-Dole Act allowed universities to retain ownership of federally funded inventions and profit from licensing them with certain obligations:
Protecting and commercializing federally funded inventions.
Sharing licensing revenue with inventors.
Encouraging manufacturing in the US and licensing to small businesses.
Maintaining government rights to use the invention.
Thanks to Bayh-Dole, universities established Technology Management Offices (TMOs) to oversee patenting and licensing, turning academic discoveries into startup opportunities.
How Does the University IP Process Work?
When an academic creates what they believe is a novel invention, they submit an Invention Disclosure to the TMO before any public disclosure. The TMO evaluates novelty, patentability, and commercial potential. If promising, a provisional patent application is filed.
After filing, the TMO decides whether to invest further in full patent prosecution based on market interest and development progress. If the university opts out, inventors may receive a rights assignment to manage patents themselves.
TMOs seek licensees willing to invest in development costs. Startups are attractive licensees because they frequently involve faculty inventors motivated to commercialize and tend to actively develop technologies rather than “sit on” them like some large companies.
However, TMOs must balance risks — startups must demonstrate credibility, often via milestones or financing. To bridge gaps, TMOs grant Option Agreements: short-term exclusive rights to evaluate and advance a technology while securing the startup’s first-mover position.
May 20, 2025 – Regulatory Considerations Part 3: Wrapping Up with Practical Tips
Building on previous posts about regulations for drugs, devices, supplements, animal health, and GMO crops, here are some practical insights to navigate these complex paths:
Regulatory Risk Shapes Your Business Model
Regulatory hurdles impact time to market, cost, and your choice of business strategy. For example, lengthy FDA drug approvals mean biotech startups often need substantial upfront capital and investor patience. In contrast, medical devices cleared via 510(k) may reach the market faster but still require careful risk management.
Early Engagement with Regulatory Bodies
Startups benefit from early dialogue with regulators (FDA, USDA, EPA). Agencies offer guidance meetings, pre-submission consultations, and sometimes expedited programs for breakthrough or high-need products. Building relationships and clarifying expectations early can save months or years.
Documentation and Quality Systems Matter
Regulators expect detailed data on safety, efficacy, manufacturing processes, and labeling. Investing in robust quality management systems early on helps ensure compliance and smoother approvals.
Regulatory Strategy Is Dynamic
Regulations evolve. For example, standards for biosimilars are still developing, and GMO oversight involves intersecting agencies. Stay updated through professional networks, publications, and expert advisors to adapt your strategy.
Balance Innovation with Compliance
While innovation drives your product’s value, compliance protects your market access. A clear, realistic regulatory plan aligns innovation with what is practically achievable.
May 9, 2025 – Regulatory Considerations Part 2: Supplements, Animal Health, and GMO Crops
Following our earlier post on regulatory paths for drugs and medical devices, let’s explore additional areas: dietary supplements, animal therapeutics and devices, feed additives, veterinary biologics, and genetically modified (GMO) crops.
Dietary Supplements
Dietary supplements face a separate regulatory framework under the Dietary Supplement Health and Education Act (DSHEA). Manufacturers must ensure their products aren’t adulterated or misbranded before marketing. Supplements containing “new ingredients” — those not marketed before October 15, 1994 — require FDA notification with evidence supporting safety. Since no authoritative pre-1994 ingredient list exists, companies are responsible for proving their ingredient’s status or pursuing regulatory clearance as a new dietary ingredient.
Animal Therapeutics
Animal drugs are regulated by the FDA’s Center for Veterinary Medicine (CVM) via three application types:
NADA (New Animal Drug Application): Like human NDAs, requires safety and efficacy data.
ANADA (Abbreviated New Animal Drug Application): For generics after patent expiration, shortening approval time.
CNADA (Conditional NADA): Allows conditional approval for drugs targeting minor uses or species after proving safety, while effectiveness data is collected over up to five years.
Veterinary Devices
Veterinary device manufacturers are not required to register establishments or list devices with the FDA. However, they must ensure their products are safe, effective, and properly labeled. The FDA can take enforcement actions if devices are misbranded or adulterated and recommends reviewing product labeling and promotional materials to meet regulatory standards.
Animal Feed Additives
Approval of new animal feed additives requires submitting a Food Additive Petition (FAP) to the FDA with data on identity, composition, safety, use levels, labeling, and environmental impact. Ingredients classified as GRAS (Generally Recognized As Safe) can be self-affirmed with FDA notification unless the agency objects. After FDA approval or non-objection, products must be listed in the AAFCO Official Publication, a yearly listing essential for market acceptance in the U.S. Pet food and meat producers typically rely on this listing.
Veterinary Biologics
To manufacture and sell veterinary biologics, companies must hold both establishment and product licenses from the USDA. Products undergo a rigorous approval process assessing:
Efficacy: Ability to prevent, treat, or diagnose animal disease.
Safety: Mild or rare side effects, with ongoing post-market surveillance.
Potency: Sufficient active ingredient remains effective up to expiration.
Purity: Free from contaminants affecting effectiveness or safety.
GMO Crops
FDA: Developers submit a Safety Assessment addressing potential toxicity, allergenicity, and nutrient equivalence to traditional crops. Evaluations are complete only when FDA scientists are satisfied with safety and compliance.
EPA: Oversees pesticidal substances produced by GMO plants under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The EPA sets tolerances for pesticide residues to ensure the safety of food crops. Additional state and local pesticide regulations may also apply.
May 5, 2025 – Regulatory Considerations: The Landscape
When starting a life science company, navigating the regulatory landscape is an early and important step. Regulatory authorities play a heavy role in approving and monitoring products — impacting how quickly you can reach the market and even shaping your business model. Because regulatory requirements demand significant time and investment, they are often seen as a key risk by investors. Being clear about them from day one not only builds confidence but can guide your fundraising efforts effectively.
Understanding the Regulatory Path
Each product type has its own pathways and rules. For biotech startups, knowing which agencies govern your specific category — drugs, biologics, devices, diagnostics, dietary supplements, animal therapeutics, or GMO crops — helps you plan realistic timelines and budgets.
Drugs, Biologics, and Vaccines
Generic drugs: Approved via an Abbreviated New Drug Application (ANDA). Generics rely on patents of innovator drugs having expired, and they mainly prove their product is like the original with proper manufacturing controls. ANDAs shorten time to market and cut costs dramatically.
Biosimilars: The FDA is developing standards for biologic “generics,” but achieving interchangeability (exact matching) for biologics is more complex than for small-molecule drugs. As of now, clear paths are evolving.
Medical Devices and Diagnostics
The FDA divides devices into three classes based on risk:
Class I: Low-risk (e.g., sunglasses); often exempt from full FDA review.
Class II: Moderate-risk (e.g., blood glucose meters); usually require pre-market review via a 510(k) clearance or sometimes PMA.
Class III: High-risk (e.g., heart valves); always require Pre-Market Approval (PMA), which demands evidence of safety and effectiveness.
A less stringent 510(k) clearance may apply if your device is substantially equivalent to a previously approved “predicate” device. The Investigational Device Exemption (IDE) allows clinical trials before final FDA approval.
Diagnostic Tests and CLIA
Some diagnostics reach the market as Laboratory Developed Tests (LDTs), created within CLIA-certified labs. CLIA certification is a non-trivial process that lets labs develop and use their own diagnostic tests. Startups sometimes partner with or build CLIA labs to use this approach.
Stay tuned for the next post where I’ll cover regulatory aspects for dietary supplements, animal therapeutics and devices, feed additives, veterinary biologics, and GMO crops.
April 25, 2025 – Why Research the Market?
“If you build it, they will come.” It’s a nice thought, but in business, things rarely work that way. Many good ideas fail because entrepreneurs didn’t take customers into account. Before you invest time and money, ask yourself: If I build it, will they come?
Market research helps you find the answer by figuring out whether people will pay for your product or service and whether the market is big enough to support your business.
What Is Market Analysis?
Broadly, market analysis evaluates your product’s or service’s chance of success. It focuses on:
Market Size: This means how many units of a product are sold and at what price over a period. For example, in March 2025, about 1,525,200 new cars were sold in the US at an average transaction price of about $47,462 each, resulting in a total market value of roughly $72.4 billion for that month. Not all cars are alike. A luxury electric vehicle, for example, does not compete directly with an economy sedan. Tesla, however, once a niche player targeting a small segment of high-tech, eco-conscious buyers, now operates in a rapidly expanding and increasingly competitive market.
Customer Research: Once you know your relevant market, dig deeper to find out who your customers are, what they want, why they buy, and how they decide. Learning what motivates customers and what features they value helps you tailor your product and messaging. Trends here can tell you if demand will grow or fade.
Competitor Research: Know who else sells similar products or services. What are their strengths? Where do they fall short? This helps you refine your unique offering or decide if the market is too crowded.
Barriers to Entry: Some challenges make it tough to enter a market—like regulations (more on this later), customer habits, or big sales forces. Identifying these up front lets you prepare strategies to overcome them. Plus, these barriers can protect you from future competitors once you’re in.
Key Questions to Answer in Your Market Analysis
What product or service am I offering? How does it meet a specific customer need?
Who exactly are my target customers? What do they want or need?
What value does my product or service provide?
How big is the total market? More importantly, how big is the relevant accessible market now and later?
Who are the competitors? How do their offerings compare? How many customers do they serve?
What barriers exist to entering the market? How will I overcome them? How might these barriers protect me later?
Answering these helps you focus on real opportunities, reshape your product to fit the market, and avoid wasting effort on ideas that won’t take off.
In Short
Market research isn’t just data — it’s knowing your customers, your competition, and the real market you want to enter. It gives your business a much better chance to succeed.
So, before you build anything, start by asking: Will they come? Then do the work to find out.
April 17, 2025 – Business Formation: Choosing the Right Entity for Your Startup
Forming a company officially under State and Federal IRS rules is the first step to becoming a recognized legal entity. This entity shields the founders’ personal assets from liabilities, such as debts or lawsuits, that may arise from business activities. In this roadmap, we focus on two popular business types for startups: the Limited Liability Company (LLC) and the Corporation. Note, the term “C-Corp” refers to a tax status, not an entity type, though corporations are taxed as C-corps by default unless they opt for S-corp status.
LLCs and Corporations: What’s the Difference?
LLCs offer flexible tax options. A single-member LLC is generally ignored for tax purposes (a “disregarded entity”) unless it opts for corporate tax treatment (C-corp or S-corp). Multi-member LLCs typically face partnership taxation but can elect corporate taxation if they prefer. Corporations taxed as C-corps face what’s called “double taxation,” where both the company profits and the individual dividends are taxed.
Which Entity to Choose?
Startups often debate whether to form an LLC or a Corporation. Corporations are typically favored by professional investors, such as venture capitalists. However, LLCs may offer tax advantages to startups planning to generate early profits with minimal investment. Transitioning from an LLC to a corporation is feasible and, when handled by legal professionals, can be done within about a week.
Why Form a Corporation?
Corporations exist as independent legal entities owned by shareholders. This setup protects owners from personal financial risk if the business fails or faces lawsuits. This “limited liability” is the main protection corporations provide — your personal assets remain separate from business debts and obligations.
Why Opt for an LLC?
LLCs also offer limited liability akin to corporations but have the appealing feature of “pass-through” taxation. This means the company’s income is taxed only once at the owner level, avoiding the corporate tax layer. LLCs can also pass losses through to investors, which can be attractive to angel investors.
Tax Elections: C-Corp vs. S-Corp
Both LLCs and corporations can choose tax treatment as C-corporations or S-corporations. C-corps pay corporate taxes and are subject to double taxation — company profits taxed at the corporate level and again at the shareholder level when distributed as dividends.
S-corps pass income directly to shareholders, avoiding double taxation, but have limitations: Only one class of stock and up to 200 shareholders. Despite these perks, many investors prefer C-corps because the tax filing and compliance duties rest with the corporation itself, not the individual shareholders. Also, C-corps can issue multiple classes of stock — an important feature for financing flexibility.
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March 21, 2025 – Midtown IP featured on the Mountain Echo Podcast
Please check out my new podcast interview with Will Newberry at the Mountain Echo. In it, I share my journey from a space-loving youth in Huntsville to becoming a chemistry PhD and a leading IP attorney in Chattanooga. Tune in to hear how I'm using my expertise at Midtown Intellectual Property, PC, to support the industry and commerce of Chattanooga and its surrounds.
➡️ Listen now: www.themountainecho.org, Apple Podcasts