In the previous blog, our blogger discussed how 3D Printing is set to revolutionize healthcare. However, there are several concerns of ethical patenting plaguing this sector. This blog delves into this issue to understand how the US Government is trying to protect authentic inventions.
The market for 3D printing is expected to grow to over $8.4 billion by 2025. Today 3D printers, which are available at a mere $250, are increasingly becoming staple business and household items. Added to this are open source designs for a wide range of products that will soon be freely available on the Internet. While 3D printing harbours great potential to alleviate human effort in laborious industrial manufacturing procedures, and prolong life of patients through artificial implants and prosthetics, it may pose an equal level of threat to mankind if misused to fabricate firearms and destructive weapons.
Legal and security threats
Congressional Democrats have proposed a ban on plastic guns, especially those created using 3D printers, while the US State Department has issued two new statements that give it more control over the publishing of 3D printable gun files and other weapons-related ‘technical data’ online.
Under the Undetectable Firearms Modernization Act (UFMA), gun manufacturers can still design and create guns made with plastic. However a major component of every gun will be required to contain enough traces of metal to be identified by x-rays or metal detectors. Importantly, removing the metal component would either be illegal, or render the gun inoperable.
The State Department also announced in a filing to the federal register that it will require prior approval for the online publication of any and all ‘technical data’ that provides information and/or instructions for creating weapons at home using 3D printing.
Challenging patent eligibility
The criteria of patent eligibility have changed dramatically in recent years owing to two landmark recent U.S. Supreme Court opinions. In the Alice Corp. v. CLS Bank International, the court denied patent eligibility for certain computer-implemented processes, and in Assoc. for Molecular Pathology v. Myriad Genetics, Inc., it rendered isolated DNA sequences un-patentable. Both cases are expected to have implications on 3D printing.
Wondering how? If a scientist uses a 3D printer to replicate human tissue, should he or she be permitted to patent the manufactured tissue, that’s the question.
In the Assoc. for Molecular Pathology v. Myriad Genetics, Inc., the court found that synthesized complementary DNA is patentable; however isolated strands of naturally occurring DNA sequences are not. If the 3D printed tissue is identical to “naturally occurring” tissue, the tissue itself may not be patent-eligible under Myriad, although the printer used to create the tissue could be patented. On the other hand, if the 3D printed tissue represents an improvement over “naturally occurring” tissue, then the tissue itself may be patent-eligible. Current patent law, therefore, may create a hurdle for scientists attempting to create human tissue through 3D printing. The more real the 3D printed tissue, the less protectable it may be.
Materials used for making 3D printed objects may or may not be patentable depending on the U.S.C. 101. If the material is novel and synthetically fabricated, it can be patented. However, naturally occurring materials like tissues and genes used as bio-ink in 3D printing are not patentable. This directs patent applicants to draft more product-by-process claims (i.e., patented inventions described by the process to make the product rather than their direct characteristics of the product).
In addition, certain improvements to 3D design software and computer readable data for manufacturing the 3D object may no longer be patent-eligible in light of the Supreme Court’s recent decision in the Alice Corp. v. CLS Bank International. For instance, faster algorithms or more powerful design tools alone may not be sufficient to grant protection. This is because streamlined calculations may not be a “technological improvement” to the field, as they may require only a “generic computer to perform generic computer functions.”
Licensing – a better alternative to litigation?!
Following years of research, winning the argument of patent eligibility and finally earning a grant signals the beginning of the next war – patent monetization and infringement litigations!!!
Let’s take the case of John selling a scanner to Jack. Now Jack uses it to scan a patented product and posts the design online. Jill then uses that design to print an object using a 3D printer that she purchased from Jim. The patent holder now has quite a few entities to sue in this case:
- Sue Jill for directly infringing the patent – though this may be unwise given that they are likely to also be the patent holder’s (potential) customers and there may be a lot of them;
- Sue Jack for inducing Jill to infringe the patent.
- Sue Jim for making the 3D printer that allowed Jill and Jack to infringe the patent and contribute to the product-by-process claims.
To ensure wholesome damages and mitigate the litigation expenses, patent holders will need to sue printer manufacturers and design developers. This will require patent holders to draft patent claims cleverly such that they encompass all possible infringer/user scenarios.
Licensing seems to be a better option for patent holders than litigation as it will allow multiple parties to flourish in the symbiotic ecosystem.
Patents for the deserving
While the world is going gaga over the possible applications of 3D printing, the USPTO and the government are preparing to scrutinize every 3D printing invention and application through a magnifying glass. They aim to channelize this cutting-edge invention for the benefit of mankind rather than endanger it – allow inventors to make improvements and be rewarded by assigning patents if and only they actually deserve it.
(Featured image source: https://commons.wikimedia.org/wiki/File:3D_print_in_process_(9437659715).jpg)