The battle of the bulge: Intellectual property and an emerging area of men's health

If you were to ask a sample of people what “battle of the bulge” signifies, two common answers are likely a person’s ongoing weight battle and the last major German offensive on the Western Front during WWII, which led to a significant depletion of German resources. As it turns out, there is yet another meaning – an intellectual property (IP) battle between two cosmetic penile implant companies, whose cosmetic devices “enhance and enlarge the length, girth, and size of your penis.” (See Nance v. International Medical Devices, Inc., et al., Case No. 2:21-cv-02281 (EDCA Dec. 10, 2021)(noting the filed and quickly dismissed class action involving the Penuma device, which articulated the purpose of the of the medical device).

Let’s hit pause for a moment and consider what “cosmetic” means in the context of breast and penile situations. Not everyone who undergoes a cosmetic breast augmentation is purely for aesthetics. For example, the Women’s Health and Cancer Rights Act of 1998 (WHCRA) requires that most group health insurance plans that cover breast cancer mastectomies, also cover post-mastectomy breast reconstruction. A woman losing her breasts can have adverse psychological and intimacy impacts and breast reconstruction/augmentation plays a role in alleviating those items. Similarly, think of a man who has a trauma that may be the result of an accident, military service-related injury or a congenital condition related to his penis. A “cosmetic” penile implant that restores structure and function is equally material for men’s psychological health.

The recent outcome in International Medical Devices, Inc., et al. v. Robert Cornell, et al., Case No. 25-1580, Dkt. 53 (Fed. Cir. Apr. 17, 2026), which pitted the Penuma device against the Augmenta device and overturned the lower court’s denial of Defendants’ judgement as a matter of law (“JMOL”) - essentially when a lawyer asks the court to rule because no reasonable jury could reach another conclusion, illustrates a key distinction in intellectual property disputes involving medical devices – trade secrets over existing patents. Here are some key points:

• “The trial court, without objection defined the four asserted trade secrets in accordance with plaintiff’s request as: (1) ‘[t]he incorporation of internal pockets or voids of space within the silicone body of a cosmetic penile silicone implant to add softness and elasticity’ (the ‘internal-pockets trade secret’); (2) ‘[t]he incorporation of mesh tabs embedded in or around the distal tip of a cosmetic penile implant to facilitate tissue ingrowth’ (the ‘absorbable-sutures trade secret’); and (4) ‘[a] particular list of instruments and materials used to perform the surgical method associated with the place of a cosmetic penile implant referred to as the Penuma Instrument and Supply List’ (the ‘instrument list trade secret.’).” (emphasis added). The jury found that each trade secret was both “protectable and misappropriated.”
• “As a California Court of Appeal held in In re Providian Credit Card Cases, 116 Cal. Rptr. 2d 833 (Cal. Ct. App. 2002), “[p]ublic disclosure, that is the absence of secrecy, is fatal to the existence of a trade secret.” The burden of proof is on the plaintiff to show that the trade secret is not generally known. According to the Court of Appeals, “[p]laintiffs’ position in this respect [that the trade secrets were not generally known] is unsupported and incorrect.”
• “The Supreme Court has held that patent law and trade-secret law can co-exist without conflict. See Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 491-93 (1974). But ‘[t]he Court has also articulated another policy of the patent law: that which is in the public domain cannot be removed therefrom by action of the States. ‘[F]ederal law requires that all ideas in general circulation be dedicated to the common good unless they are protected by a valid patent.’ Id. at 481 (quoting Lear, Inc. v. Adkins, 395 U.S. 653, 668 (1969)).”
• Federal Court and California State Court cases are similar in that once information is placed into the public domain, whether in a patent, a medical device application or other avenue of disclosure, secrecy ceases and the trade secret evaporates. “A trade secret is a secret. A patent is not. That which is disclosed in a patent cannot be a trade secret.” Atl. Rsch. Mktg. Sys., Inc. v. Troy, 659 F. 3d 1345, 1357 (Fed. Cir. 2011); see also Glob. Protein Prods., Inc. v. Le, 255 Cal. Rptr. 3d 310, 321 (Cal. Ct. App. 2019).
• A distinction was made by the plaintiffs between a “therapeutic penile implant (designed to address erectile dysfunction) [and] … cosmetic penile implants (designed to increase penile size).” Yet, the court highlighted that as the record reflects, the design of the internal pockets had no bearing on the designation of therapeutic or cosmetic.

The outcome was that Defendants prevailed on all but one claim and a separate jury instruction related to a “good” (i.e., penile implant produced by the manufacturer) versus “service” (i.e., the surgical procedure performed by a physician).

One item of note that is material to the medical device industry but was not the focus of the Opinion is the U.S. Food and Drug Administration’s (“FDA”) requirements for the 501(k) premarket notification process. A September 30, 2022 letter from the FDA to Augmenta, LLC regarding the Augmenta Penile Implant (K200073) (“2022 Letter”) illustrates what the court correlated to a patent. That which is publicly disclosed cannot be a trade secret. The 2022 Letter substantiates the public availability of the Penuma device’s information on page 1 and Augmenta’s 510(k) Summary, page 2. Specifically,

“We have reviewed your Section 510(k) premarket notification of intent to. Market the device referenced above and have determined that the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, …. You may, therefore, market the device, subject to the general controls provision of the [Federal Food, Drug & Cosmetic Act].”

In sum, doing a FDA database search is another way for a company to substantiate that a product and specifications were disclosed publicly and, therefore, not trade secrets. And, as this “battle of the bulge” demonstrates, there are bright line requirements that distinguish trade secrets from patent infringement. As a matter of public policy, just as there are a variety of breast implants that are similar in form and function, in order to deter monopolies and give patients’ choices, it is prudent that more than one cosmetic penile implant option is available.

Rachel V. Rose, J.D., MBA, advises clients on compliance, transactions, government administrative actions and litigation involving health care, cybersecurity, corporate and securities law, as well as False Claims Act and Dodd-Frank whistleblower cases. She also teaches bioethics at Baylor College of Medicine in Houston. Rose can be reached through her website, www.rvrose.com.