Cost-Effective IP Strategies for Biotech Startups

By Pei Wu
October 21, 2018

Article Updated on November 2, 2018

Cost-Effective IP Strategies for Biotech StartupsA well-devised intellectual property (IP) portfolio can go a long way to ensure a startup biotech company’s success in the marketplace. In general, patents allow the owner to exclude others from making, using, offering to sell, selling or importing the claimed invention during the lifetime of the patent (35 U.S.C. §154). Typically, the IP investments of biotech startups are primarily comprised of utility patents designed to protect functional inventions and thereby serve as barriers to entry against competitors. When faced with budget constraints, however, biotech startups can tap into other forms of IP protection to ensure that the visual/ornamental aspects of their products, which can be just as valuable as the functionality of their products, are still protected.

Design Patents

A valuable, yet often overlooked form of IP protection, is a design patent. Unlike a utility patent, which protects the functional aspects of a product (35 U.S.C. §101), a design patent protects the ornamental appearance or visual characteristics as they are applied to a functional invention (35 U.S.C. §171). Where the aesthetic features of a product (e.g. in consumer products such as computer mice, speakers, phones, watches, etc.) are important to establishing and/or maintaining a brand and breed customer loyalty, design patents can be secured to protect the configuration, shape, or surface ornamentation of the product in a cost-effective manner. For example, novel and ornamental three-dimensional (3D) designs applied to electronic or robotic medical devices, as well as two-dimensional (2D) graphical user interfaces (GUI), can receive design patent protection. One could posit that it may even be possible to receive design patent protection for the 3D ornamental representation of antibodies, drugs, and chemicals, whether as part of a GUI or a standalone 3D structure.

A design patent is restricted to one claim, which can, at times, result in reduced up-front filing fees. Albeit, since design patents are limited to a single claim per application, a single product can warrant several separate applications, resulting in initial filing expenses similar to that of a utility patent application. Where a single portion of a product (for example, a sequence of animations, or a button/handle on an electronic device) is the aesthetically novel portion of the device, design patent protection can be secured relatively easily and quickly. The overall prosecution time of a design patent is generally shorter than that of a utility patent; where utility patents can take several years to be fully examined and granted, the general prosecution time of a design patent is approximately 18 months. Once granted, a design patent offers a lifespan of 15 years. Importantly, a design patent is not subject to publication. As such, the public does not see the contents of a design patent until it is granted.

Used strategically, design patents can successfully leverage a strong IP portfolio for biotech startups.

Trademarks

A trademark protects a symbol, name, word, logo, or design (15 U.S.C. §1127) used to indicate the source of goods or services. A registered trademark provides legal exclusivity for a mark that sets a startup apart from its competitors.

Trademarks are important for brand building and extremely valuable for distinguishing one’s product from the competition. With registered trademark protection, although more than one company can sell the same product, only one company can legally market that product under the trademarked name. An interesting example is the present day top-selling biologic drug, HUMIRA. Developed in the late ’90s by BASF Pharma and Cambridge Antibody Technology, this monoclonal antibody was simply called D2E7. Abbott Laboratories subsequently acquired the drug and gave it the name Humira, an acronym for human monoclonal antibody in rheumatoid arthritis. Humira has since been approved in nearly 100 countries worldwide for treating multiple autoimmune diseases, generating billions in annual revenue. Although Humira’s U.S. patents expired in 2016, and its EU patents will follow suit in 2018, following the 2012 split into two companies, the spinoff AbbVie is currently deriving branding revenues and is exclusively able to market the drug under the HUMIRA brand despite the product’s looming expiration date.

Unlike utility and design patents, which have limited terms, a trademark can offer long-term enduring protection. The initial term of a trademark is 10 years and is renewable in 10-year increments so long as it is still in use. Both design patents and trademarks can be used to protect a design simultaneously. Additionally, in some scenarios, a trademarked design may be easier to enforce against infringers compared to a patented design, as the standard for trademark infringement is “likelihood of confusion” caused in the mind of the consumer, which sets a lower hurdle than the design patent standard of a showing that an ordinary observer would find that the two designs in dispute are “substantially the same.”

Interestingly, trademarks tend to be industry specific. For example, the same or similar wording used within a logo for an automobile manufacturing company, which would protect from infringement by another business in the automobile industry, might not prevent another company in a completely different industry from using the trademark if there is no likelihood of consumer confusion.

While there is no strict deadline following the public release of a product to file a trademark, it is imperative to secure an early filing date when possible; the filing date helps the U.S. Patent and Trademark Office determine who has priority when another entity tries to trademark something identical or similar to a mark. As such, waiting too long to file may render the business unable to use the mark. In that case, customers may become confused about what products a company makes, ultimately losing their loyalty and suffering financial loss.

A majority of startups use “intent-to-use” (ITU) filings more than “use-based” filings. The average fee for a trademark ITU filing is between $225 and $600. It usually takes between six and 16 months to process the application. The applicant can use the mark on their products during this time. However, if the mark fails to meet the novelty standard to qualify for trademark protection, and the products later infringe another’s rights, it will need to be removed from those products. During the time that the application is pending, the TM symbol can be legally used with the mark. After the trademark application is approved by the USPTO, the registered trademark symbol ® may be used.

Copyrights

Another IP protection option is copyrights, which protect “original works of authorship fixed in any tangible medium of expression.” (17 U.S.C. §102). Examples of copyrights include literary works, paintings, music pieces, movies or websites. Biotech startups can use this option to protect writings, images, and videos such as a marketing brochure or instructions in a user guide. A company may indicate a work is subject to copyright by applying a copyright notice, which consists of the copyright symbol, ©, the date of first publication and the name of the copyright owner. A copyright restricts others from the unauthorized copying, selling, or using of the content therein.

Copyright protection is secured when the creator first fixes the work in a tangible form. Notably, however, legal registration of a copyright offers the holder the option to take legal action against another entity for infringement, and also to recover attorney fees and statutory damages when the registration is timely (i.e., prior to the accused infringement). The fee to legally register a copyright is generally $35-$55.

Tight budget constraints should not prevent any company from obtaining intellectual property protections beyond core inventions. Judicious selection of the most appropriate IP vehicles, including design patent, trademark, and copyright options, can complement a startup’s core utility patents and help businesses maximize their goals within a limited budget. It is recommended that biotech startups seek an intellectual property professional as they begin building their business to discuss which types of intellectual property protection will work best with the company’s goals.

Article Updated on November 2, 2018

The Author

Pei Wu

Pei Wu is an attorney with Banner & Witcoff, Ltd. Dr. Wu focuses her practice on patent prosecution and patent portfolio development in the fields of biotechnology, molecular diagnostics, medical devices and pharmaceuticals. She has extensive experience in preparation and prosecution of U.S. and foreign patent applications relating to genes, proteins, enzymes, recombinant antibodies, microorganisms, medical diagnostics, blood products, cell matrices, tissue engineering, dietary and food supplements, cancer treatments, gene therapy, drug discovery and formulation, epigenetics, biopolymer, vaccine, and genomics.

For more information or to contact Dr. Wu, please visit her Firm Profile Page.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

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There are currently 1 Comment comments. Join the discussion.

  1. Daniel Cole October 22, 2018 3:53 pm

    Design patents for biological inventions beyond the most basic would I think be difficult. A specially produced chemical or fuel for example how would you separate the ornamental aspects from the functional? The logo used I agree can be protected but that wouldn’t give any real protection on the actual chemical or fuel invention (chemical structure).

    The rest is correct trademark and copyright are often overlooked. You should also mention provisional patents though – these can be a good way to provide protection while you do market research and gather investment. Just be sure to convert to a nonprovisional within a year!

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