New technologies, old framework: maximising IP protection for 3D printing in the life sciences
3D printing technology has transformed the life sciences industry. It is already being used to make marketed medical devices and pharmaceutical products and, with some sources predicting overall 3D printing revenue as high as $21 billion worldwide by 2020, there can be no question that life sciences 3D printing will continue to grow in importance and scope.
However, the current intellectual property framework—which includes copyright, patents, trademarks, and trade secrets—is unable to fully address the unique challenges presented by 3D printing. Indeed, the Gartner group estimates that by 2018 alone, 3D printing will result in the loss of at least $100 billion globally per year in IP. Until IP law adapts, 3D printing innovators will need to take steps to minimise risk under the current framework.
A 3D printer deposits successive layers of a selected material to create a physical object. 3D printers can use different types of media, including plastic, polymer, resin, metal, ceramic, cement, wood, food, human cells, and nanoparticles. The specific parameters of the desired object—including its size, shape, thickness, and colour—are enumerated in digital blueprints known as computer-aided design (CAD) files. Not only can anyone with a CAD file print an identical object from any 3D printer, but duplicates can also be made by scanning the original object to create a new CAD file and then by using that file, in turn, to make copies.
The US Food and Drug Administration (FDA) has granted clearance to a variety of 3D-printed medical devices: hearing aids, dental crowns, bone tether plates, skull plates, hip cups, spinal cages, knee trays, facial implants, screws, surgical instruments, and orthodontics. 3D printing is also being used to produce medical models and medical device prototypes, as well as replacement parts. As for pharmaceutical products, the first completely 3D-printed drug—a high-dose, rapidly dissolving epilepsy drug printed layer-by-layer without using any traditional compression or moulding techniques—was approved by the FDA and entered the US market in 2016.
Bioprinting, the 3D printing of human tissues and organs by depositing cell layers onto a matrix, is another emerging and revolutionary industry. By creating customised organs with the recipients’ own cells, bioprinting could eliminate the need for donor organs and negate transplant rejection. To date, researchers have bioprinted ears, bones, and muscle structures and successfully implanted them into animal models.
3D printing implies novel IP issues
The current IP framework does not squarely address the unique issues posed by 3D printing. Before the advent of 3D printing, medical devices could be adequately protected both legally (through product and methods of manufacturing patents) and practically (due to the high initial cost barrier of setting up manufacture). 3D printing eliminates that practical barrier, permitting infringement by individuals and small manufacturers that is difficult to track or prosecute. The limited, additional layer of protection afforded by copyright, patent, trademark, and trade secret doctrines is addressed, in turn, below.
Copyright
Copyright protects works of original authorship from being copied, distributed, or incorporated into a derivative work, but its protection does not extend to the functional elements of the copyrighted work. 3D printing copyright disputes will probably focus on protection of CAD files under the Digital Millennium Copyright Act (DMCA). Because digital CAD files can easily be copied, stored, and shared (and indeed there are numerous websites with that sole purpose), 3D printing copyright suits under the DMCA will probably mirror the copyright battles of the music industry.
Although the DMCA permits suits against anyone who prints or distributes 3D objects made from copyrightable CAD files, suing patients or doctors will result in loss of customer and brand goodwill. Instead, 3D printing innovators should focus enforcement efforts on websites that host copyrightable CAD files.
Under the DMCA, copyright owners must issue a takedown notice to the hosting website. To avoid liability, the website must remove the offending CAD file and notify the posting entity of the copyright claim. If that entity reposts the file, the copyright owner has the basis for an infringement suit. Websites are not required to monitor for infringing material; instead, the copyright owner must expend the time and resources necessary to police hosting sites.
It is important to note that the current copyright framework requires that the infringer starts from the copyright owner’s CAD file. Copyright does not protect against users who scan the object to create a new CAD file directed to the object’s functional aspects, and then use that newly-generated CAD file to guide the 3D printer. Although a 3D-printed product of lower quality may result, this is an unprotected loophole.
Joint ownership and authorship present another challenge to copyright enforcement. Multiple people can collaborate in creating a CAD file. Unless IP assignments ensure complete transfer of authorship, 3D printing companies may be vulnerable to attacks regarding ownership when asserting copyright. Incorporating open-source code into a CAD file may present similar enforcement issues.
Patents
Patents protect new, useful, and non-obvious functional inventions, so they safeguard aspects of innovation not covered by copyright law. A patent owner can sue an infringer (1) directly for making, using, selling, offering for sale, and/or importing a protected invention; or (2) indirectly for knowingly inducing or contributing to another’s direct infringement. In the context of 3D printing, a patent owner can sue an infringer for manufacturing or using a 3D-printed copy of a protected device or for deliberately attempting to encourage others to use or manufacture that device.
“Copyright does not protect against users who scan the object to create a new CAD file directed to the object’s functional aspects.”
Despite this broad scope of protection, however, there are notable challenges to patent enforcement. First, targeting individual patients and doctors for patent infringement is difficult, expensive, and poses public relations issues. It is also typically difficult to prove the ‘knowledge’ element required for claims of indirect infringement. Furthermore, a ‘repair’ loophole exists for 3D printing a replacement part, if that component is not separately patented. Last, bioprinting-related claims are vulnerable to patent ineligibility attacks: because a bioprinted organ mimics its naturally-occurring counterpart, it potentially runs foul of 35 USC §101.
Trademarks
Trademark law uses words, symbols, colours, or other uniquely brand-identifying features to protect the goodwill of a brand from misappropriation. A company can combat counterfeiting by marking its products, including the key components, with its trademark. This protection is limited, however, because copiers can avoid trademark liability by removing the originator’s mark from the counterfeit object and its CAD file.
Trade secrets
Trade secrets law protects information that offers a competitive advantage and is not known to others, with the newly-enacted federal Defend Trade Secrets Act further supplementing state law. Public disclosure of an innovation negates eligibility for trade secrets protection, so to take advantage of these laws, a 3D printing manufacturer must keep key technical information, such as CAD files, secret. Although this might protect that specific CAD file, it will not prevent copiers from producing their own CAD file based on scans of the original object. As such, trade secrets provide only limited protection in the 3D printing context.
Strategies for 3D printing innovators
Although there are challenges to maintaining IP protection in the 3D printing context, innovators can take steps to minimise risk and maximise enforceability.
First, companies must maintain careful ownership and control over their IP rights. IP assignment clauses should be required for all potential authors or inventors and confidentiality/non-disclosure agreements should be entered into with employees, independent contractors, and external parties. To minimise disclosure, companies should have policies restricting access to, downloading of, and distribution of CAD files either within or outside the company.
Reliance on open-source code should be carefully monitored to avoid potential ownership challenges during enforcement. Additionally, by imbedding minute tracers within CAD files and marking them as copyright and patent-protected, a company will be better prepared to identify infringers and attest that notice was given.
Companies should also proactively establish multi-layered IP portfolios. Patent portfolios should include claims directed to the object itself, its unique component parts, methods of manufacture with 3D printing, 3D-printed versions of the object (including product-by-process claims), and instructions to 3D manufacture that contain computer-readable medium information. With such a wide variety of claims, companies will be better equipped to assert both direct and indirect infringement. Furthermore, claims to bioprinted inventions should be distinguishable from naturally-occurring organisms in order to avoid §101 patent eligibility issues. Companies must also monitor websites that permit the sharing of CAD files and aggressively pursue take-downs of infringing files via the DMCA.
Since users of 3D-printed products in the life sciences industry are often individual patients or healthcare providers, against whom infringement actions are difficult or inadvisable, companies should consider providing free or low-cost alternatives to infringement. For example, a company might choose to license CAD files, allowing customers to print high-quality replacement parts instead of being forced to create inferior parts through scanning and generating a new CAD file. Doing so will generate customer goodwill and encourage product loyalty, as well as provide a secondary revenue stream for the company.
IP law has yet to catch up with the technological capabilities of 3D printing, but by taking pre-emptive action, companies can maximise their IP protection under the current legal framework.
Arlene Chow is a partner at Hogan Lovells. She can be contacted at: arlene.chow@hoganlovells.com
Nitya Anand is an associate at Hogan Lovells. She can be contacted at: nitya.anand@hoganlovells.com
