Offit Kurman Blogs
Intellectual Property
Patents and the FDA: Four Critical Considerations Medical Device Companies Must Know to Successfully Introduce New Products into the Market
The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen intellectual property (IP) portfolios, reduce risk, and attract investors. This article explores key issues and strategies to ensure your patent and FDA efforts work together effectively. An integrated patent and FDA strategy adds significant value to the business. Many companies focus solely on regulatory approval, overlooking how FDA submissions might affect their patent portfolio or vice versa. A coordinated approach between patent strategy and FDA strategy offers significant benefits to the business: stronger patent protection combined with FDA exclusivity creates complementary barriers to entry for competitors. This enhances your ability to protect innovations and ensures your patent strategy is embedded within the regulatory framework for the product that will be sold. Value for investors or later strategic acquirers is a direct result of an integrated patent and FDA strategy. Four areas where medical device regulation and patent law overlap that must be implemented carefully include: patent coverage in view of FDA submissions, Freedom-To-Operate (FTO) risk, product Labeling and Patent Marking, and patent term extension (PTE). Patent Coverage and FDA Submissions Regulatory submissions often include technical details that can affect patent protection. To avoid premature disclosures and ensure alignment, file patents before submitting your regulatory documents to the FDA. While you may have filed for protection early during the product development process, reassessing the product just before submission is an important step to ensure your patents cover what you are seeking to market in the United States. Patent counsel should certainly have the opportunity to consider the filing documents, in ALL of their detail, to consider new patent filings to augment your patent strategy. This strategy also serves other important purposes, like preventing premature public disclosures (e.g., in 510(k) summaries) that could compromise patent rights. Well-crafted summaries and filing documents could limit the usefulness of the confidential FDA data obtainable via Freedom of Information Act (FOIA) requests. Importantly, this key action ensures consistency between FDA filings and patent claims, avoiding statements that could lead to unenforceability due to inequitable conduct. In other words, saying one thing to the FDA that is inconsistent or contrary to the position you are taking regarding prior art can lead (it has) to a finding by the Court that patents are unenforceable. In addition, products evolve, certainly during development, but even after market introduction. A robust use of continuation patent applications can help maintain adequate protection as the product evolves. There are numerous benefits to considering FDA filings in light of the patent strategy and not doing this simple task is a wasteful use of resources. Talk to your patent counsel! Third-Party Patent Risk and Freedom to Operate (FTO) Patent litigation is prevalent in the medical device industry, and failure to consider your products’ freedom to operate can destroy business value. Before submitting a device for FDA approval, conduct FTO studies to identify potential infringement risks. These should include an analysis of IP related to predicate devices, especially for 510(k) submissions. In addition, understanding patents that cover competitive products is another key step in this process. Avoid using language in FDA submissions that could serve as a roadmap for infringement, such as instructions for use or device descriptions. Carefully drafting these documents is a viable way to limit risk and minimize the disclosure of otherwise proprietary information that is not Germane to the purpose of the FDA submission but might otherwise be important in the third-party patent context. Update FTO studies at key milestones, such as before submitting an investigation device exemption, 510(k), or PMA submissions. This is the best way to minimize patent risk once the product is approved, and the ever-important sales begin. Conducting this analysis based on what your business is authorized to sell in the U.S. is a critical consideration because patent risk only flows from making, selling, using, and importing into the U.S. a product that infringes a valid claim of a U.S. patent. Understanding the patent landscape related to the products that have high revenue generation potential is a required but pragmatic business practice to implement. Product Labeling, Patent Marking and Maximizing Damages Patent marking plays a crucial role in infringement cases. Generally, a patent owner is entitled to damages only after the infringer has been notified—either through a cease-and-desist letter, a lawsuit, or compliance with the patent marking statute. Because the FDA regulates product labeling, companies can implement their patent marking during regulatory submission, and in particular, where product labels are concerned. The U.S. allows for virtual patent marking, where a URL (e.g., mycompany.com/patents) is included on the product label. Once the product receives market clearance with this label, damages can accrue from that point forward. Failing to implement this strategy could delay damage accrual until after a lawsuit or cease-and-desist letter is issued. This can be potentially years after market introduction. A simple URL on a label, submitted with your FDA documents, can make a significant financial difference in your patent infringement case, should you need to file one later. There is no simpler way to increase patent value than to implement patent marking on product labels during the FDA approval process. Patent Term Extension (PTE) for FDA-Regulated Products Patents last 20 years from the date a non-provisional U.S. application is filed. During that time, the patent owner has exclusive rights to the patented invention. Once expired, however, others may freely use the invention. However, certain devices, and Pre-Market Approval (PMA) products specifically, can qualify for up to an additional five years of patent term extension. To be eligible for PTE, the product must have undergone a regulatory review period before it can be commercially marketed. The patent must not have been previously extended, and the application for PTE must be filed within a specific timeframe (typically 60 days) after the product receives regulatory approval. This extended exclusivity can significantly impact revenue. Companies should therefore actively monitor regulatory timelines to ensure the timely filing of patent term extension requests. Carefully consider the most valuable patent for extension because there is only one extension per regulatory approval allowed under the law. And finally, avoid delays during prosecution, such as taking extensions of time to file a response, as each extension of time can reduce the potential extension period. In summary, four things that can maximize business value for your medical device are: Align patent filings with FDA submissions to ensure broad, enforceable claims. Conduct and update FTO studies throughout the product lifecycle. Share FDA submission materials with patent counsel to avoid inconsistencies. Incorporate virtual patent marking into FDA labeling at the earliest possible instance. File for patent term extension when available. A successful medical device launch requires a great deal from a business. A robust patent strategy, integrated with the FDA framework, can only support a successful launch; it will not hinder it. By proactively aligning regulatory and patent efforts, companies can secure stronger protection, reduce risk, and enhance business value.
July 16, 2025
Intellectual Property
When to Patent: Common Mistakes Business Leaders Make
Suppose a newly hired engineer on your team sketches a promising new concept for a health monitor in a notebook. Excited by the idea, you loop in marketing, and soon, your company is promoting the product’s features through emails, vlogs, and website posts. The sales team runs with it, offering the product to customers even though the device isn’t fully developed. Meanwhile, you start seeking investors, sharing pitch decks that highlight the product’s potential, projected revenues, and market opportunity. Then comes the first investor call. The question is immediate: “Is it protected?” You haven’t filed a patent, but you sidestep the question and end the conversation. Only then do you call your patent counsel. After hearing the story, their response is sobering: “Much of the damage is already done. We may not have a strong path to protection.” What went wrong? In short, you missed the critical window to file a patent application—after the concept was created but before any public disclosure or marketing. That single misstep may have cost you your ability to secure patent rights. But in reality, a sketch alone usually isn’t enough to file a strong application. So what should have happened instead? When is the Right Time to File for Patent Protection? Knowing when to file for patent protection is critical. Filing too late, as described above, and you risk losing key rights or losing the patent race to your competition. File too early, before there is a business case or before further concept development, and you may not have all the details needed to secure quality patent rights. Filing the right patent applications at the right time transforms your patent portfolio into a high-return investment that protects your competitive edge and supports your next phase of growth. The ideal time would be: Before You Go Public To preserve your rights—in the United States and especially in international markets—it is critical to file for patent protection before your invention is made public, especially in the way it is “made public,” as in the example described above. U.S. law bars the grant of patents for inventions that are patented, described in a printed publication, in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 35 USC § 102(a). Thus, the first stage of review should occur before emails, vlogs, posts on your website, and publications about the product are created. Indeed, these publicity-raising tactics are all things that potentially bar patent rights. Even offering your invention for sale, with a price term and quantity, to customers, as in the scenario above, is sufficient to invoke this provision of patent law, which prohibits securing patent protection in the future for the product sold. Finding a mechanism to alter or delay publication or offer for sale is a critical aspect of a patent strategy that can help preserve patent rights, which any business should implement. In short, any activity that includes publishing, pitching, selling, presenting at a conference, or even demonstrating your invention in public or a non-confidential setting can cause harm to your patent strategy. Despite the bars to patent described, U.S. law grants innovators some exceptions to this rule, such as the inventors’ own work, if made within one year of filing for protection. For example, should an inventor publish the invention in some form, you have one year to file patent protection to avoid losing those patent rights. However, this can be risky, as you often do not know what your competitors may be working on or even if they have completed a patent filing within that one-year timeframe. Additionally, should an inventor share the invention with a third party, such as a potential investor or supplier, there is a risk that the third party could file for its own protection for the concept before you do. They could even combine that shared content with their work, making it difficult for you to secure patents. While there are some provisions under U.S. law to sort this out, for example through derivation proceedings, these complex procedures can be avoided by filing for patent protection before sharing the invention with any third party, as in our example above. When It’s More Than an Idea A completed product that is ready for marketing and manufacturing is sufficient and ready for patenting. Mere concepts and ideas are often not enough to secure quality patent rights. Patent law requires an enabled, written description of the invention, along with patent claims that specifically set out the scope of the invention. This often demands a reasonable level of detail of the invention, its working principle, and a description of various alternatives that might be used in the future by the market you are planning to serve through your business. There is no requirement to submit a working model or software code for software-related inventions, for example. However, there is a need to include reasonable details related to the invention and alternatives, so that meaningful patent protection can be secured. The objective is to do more than merely describe the conceptual goals of the product; details matter here as you and your patent counsel will want to rely on passages of the patent text to craft the desired patent claims during the prosecution of the patent application in the future. This ensures that you can cover the technology you are developing and also address competitive threats through amendments to the claims as needed. Without details in the patent application that anticipates what might happen in the future regarding the underlying products, your options for securing meaningful patent protection are limited, if not barred altogether. Conclusion So when do you file for protection? In our example above, a significant amount of engineering and development remains in order to get the product ready for the market and manufacturing at scale. In this case, it would make sense to consider filing for patent protection once the idea has been developed enough that you can describe how it works and how it will be used in the market. That clarity also increases the strategic value of your patent, as described above. In addition, while there is ongoing product development is common, consider filing for patent protection at key development milestones, such as completion of market studies, when a significant technical hurdle is overcome, and before substantial capital outlays are required, such as the development of production models or the purchase of capital equipment. Do not consider a single patent filing sufficient enough to protect the product adequately. Additional filings should be made as the product changes over time. This ensures that your patents align with the business's commercial plans. If there’s an urgent business need, it’s important to file a patent application quickly, even if the product is still in development. For instance, investors and partners want to see that you’re protecting the innovation that underpins your business. Filing a patent application before sharing the idea is critical and an appropriate step, as it creates a tangible asset that can help secure funding or favorable deals. This changes the conversation with investors completely, in our example, and focuses the discussion on the more important aspects of an investment, such as valuation and revenue. Sometimes, this requires filing before the concept is fully vetted and complete. That is okay, as you can file as a provisional application and then file follow-on patent applications that cover the key innovations you develop as the product matures into a business-ready revenue stream. If you have partners or employees that make premature publication of the invention, as discussed above, be sure to file a provisional application ahead of time, even if there is only enough information to cover the broad concept. Again, follow-on patent filings can be used to strengthen earlier filed but “sparse” provisional patent applications. Filing a patent at the right time is a strategic move that protects the investments you’ve already made in R&D, product development, and innovation. Getting the timing right is an vital aspect of implementing a robust patent strategy that secures patent rights for the business. Best practice is to file for patent protection, via a provisional application or regular patent application, before any public facing activities begin. Furthermore, executing a robust non-disclosure agreement (NDA) with anyone whom you plan to share information regarding the invention will give you added protection, while also minimizing the effect of such disclosure on foreign patent rights. For instance, you might consider an NDA with a potential investor before sharing information with them, or other situations with a potential supplier or contract manufacturer. Losing patent rights can be significant and can undermine your commercial objectives. More specifically, delaying patent protection can cost you: Priority rights, if a competitor files first. Ability to license or sell the technology. Legal protections in global markets. The opportunity to support valuation and fundraising efforts. In short, failing to file timely or filing late can remove a competitive advantage you once had, minimizes potential revenue streams, and lessens likelihood of meaningful investment.
June 27, 2025
Intellectual Property
Building a Patent Strategy that Actually Works for Your Business
If your business relies on bringing innovations to market that generate returns on investment, then a well-designed patent strategy is critical for realizing those returns. Patents help introduce new products to the market, secure investment, and establish your business’s competitive edge, all supporting and controlling the top and bottom lines. A thoughtful patent strategy simply helps turn innovation into long-term business value. However, achieving this long-term business value requires you to consider patents as part of the big picture of your business; business goals, market dynamics, and product roadmap are all important. Patents are not simply a check-the-box activity or even pure costs; they are investments in the future of your business. But how do you turn patents--powerful legal rights-- into business value? Start With the ‘Why’ Before jumping into the legal process, consider what patents could do for your business. Do you need to: Protect the core technology that drives your revenue? Create barriers to entry for competitors? Support a licensing model or open new revenue streams? Make your business more attractive to investors, acquirers or strategic partners? If the answer is yes to any of the above, a proactive patent strategy deserves a place in your broader business plan. Timing is Critical Patent law rewards those who act early in the innovation process. In fact, certain activities can result in the loss of patent rights. It is important to file for patent protection for an innovation before disclosing your invention publicly, whether through a sale, publication, presentation, or even a demonstration. But timing is a balancing act. Concepts that are too general or have not undergone some level of technical and market vetting may not be ready for patenting, but filing too late, after public disclosure can be catastrophic. Aim to file for patent protection when you can describe a clear use case and the market can identify key technical features important for that use case and market, ideally before you raise funds or launch publicly. Today, product development often requires engaging third parties early in the process. Two tactical steps can be used to bolster your strategy and provide some flexibility in timing: Use non-disclosure agreements with third parties you need to share your concept with to get help File provisional applications if you want to secure a filing date while continuing to refine the invention. Think Beyond One Patent Your strategy shouldn’t stop with one patent application or even one type of patent. Patents grant you the right to exclude others from making, using, or selling the invention as claimed. But patents often are not broad blocking patents. Patents are often focused on incremental innovations, and patent law generally limits one patent per invention. Often, several inventions are built into a product, and robust protection would therefore require multiple patents. You may need to: Protect multiple components or processes within a single product. File in international markets where you plan to sell or manufacture the product. Keep an eye on adjacent technologies and file follow-on continuation patents as your product and market evolve. At least considering these options allows you to manage your patent strategy to your product roadmap, keep an eye on competitive threats, and help manage your patent more proactively. Patents are Investments, Not Costs Filing a patent isn’t just a line item on your legal budget — it’s an investment in your business’s future. Like any other asset, patents have the potential to generate returns, whether through increased valuation, market exclusivity, licensing opportunities, or strategic advantage. What makes patents more of an investment than just a budget line item? First, delaying or forgoing patents gives your competitors a free pass to use innovations you developed for their own gain. Without patents, competitors will capitalize on what your business introduced to the market, leaving little recourse for you after the fact. Those competitors can then file patents that could hamper your ability to sell your products. This has a direct impact on the topline and undermines R&D investment. Proactive patent protection avoids this altogether and serves as a competitive deterrent. Second, patents can help add revenue through licensing. However, licensing revenue is nearly impossible without legal rights protecting the products. Patents are an effective tool to support licensing or acquisition opportunities. Third, patents attract and retain capital. Investors always ask if the technology has protection. The larger the investments you seek, the more scrutiny will be placed on your patent strategy and how it relates to the technology supporting your innovations. Investors often look for competitive advantages, and patents provide that. Patents are assets and can help support business valuations that facilitate investment. Related to direct investments, patents can also act as collateral to secured transactions, facilitating investment or debt for financing other parts of the business. Without patents protecting your technology, you are forgoing an effective tool that drives investor confidence, which, in turn, drives investment in your business. A well-timed, well-aligned patent strategy doesn’t just protect what you’ve built, it helps justify and maximize the investments you’re already making in innovation. Treat patents as part of your business assets and budget for them accordingly. Encourage Internal Innovation An intentional patent strategy doesn’t just protect innovation, it helps fuel it. When your innovators know there’s a process in place to capture and evaluate their ideas, they’re more likely to share them. Encouraging your team to share and disclose ideas that may be patentable unlocks potentially patentable concepts that can support your business goals. A great way to maximize patent value is to create an invention disclosure system that harvests innovations within your organization while rewarding disclosure among your team. This can form the basis for an engaged team oriented towards protection innovation. An excellent supplement, patent seminars can help educate your staff about the patent process and what it takes to be an inventor under U.S. law. The Bottom Line A strong patent strategy isn’t about legal red tape; it's about creating leverage, supporting your growth, and building real, lasting value. Treating patents as an investment—not a cost—unlocks their full potential as a driver of innovation, funding and long-term success.
May 23, 2025
