Patent Eligibility in the
Life Sciences
For more information, please contact Jennifer Giordano-Coltart at jgiordano-coltart@kilpatricktownsend.com
Healthcare IT/Telemedicine
• Healthcare IT patents cover methods and systems for selecting patient treatment
– the heart of these methods is biostatistics. Telemedicine patents cover
methods and systems for remote diagnosis and treatment of patients using
telecommunication systems.
• Claims to these technologies have generally been analyzed as software claims
under Bilski3. As such, most claims challenged in these areas have been found
patent ineligible.
• Prosecution strategies for success: Patentability will rest on improvements in the
function of computer technology (Ensh4) or a technological improvement (i.e. a
technology based solution to a technical problem) (Trading Technologies5).
It’s been six years since the Supreme Court’s decision in Mayo v. Prometheus1 and ve years since the Court’s
decision in Association for Molecular Pathology v. Myriad Genetics2. How the standards for patent eligibility
have been applied in the life sciences tends to vary based on the technology.
Personalized Medicine: Diagnostic/Prognostic Methods
• This eld includes tools for genetic screening and methods of detecting,
measuring, and correlating patient outcomes to biometrics.
• The analysis in Mayo is directly applied to these types of claims. The biological
phenomenon at the heart of these claims is usually clearly apparent; thus, the
patent eligibility analysis shifts to whether there is something more than the
phenomenon in the claim that is innovative.
• Such claims are at issue in almost half of patent litigations in which patent
eligibility has been assessed. The vast majority have been found patent ineligible,
with the claims being considered as merely directed to implementation of a law
or a product of nature using conventional lab techniques. Claims that were found
to be patent eligible generally survived because the court considered them to be
an improvement over existing technologies (Exergen Corp.6). However, as most
of the challenged claims were broad in scope, it will be interesting to see if more
narrowly focused claims (i.e. claims issuing post Mayo) will fare better.
• Prosecution strategies for success: When drafting claims, include new reagents
and/or non-routine/unconventional steps or combinations of steps. Consider
other ways to claim technology (e.g., components used, end products). Argue
that the method provides signicant improvement over existing technology.
Methods of Treatment
• This category involves methods of administering some form of treatment to a patient.
In some instances, the claimed methods include diagnostic or prognostic elements
to them.
• These claims are important for the pharmaceutical industry, providing protection
around the identication of new dosing regimens and new conditions that a drug
can be used to treat. These methods typically are follow-on innovations for existing
drugs (i.e., the drug itself is not new).
• Dicta from the Supreme Court in Myriad and the Federal Circuit in CellzDirect7
suggested that methods of treatment were patentable. Some district courts have
found such claims patent ineligible, the Federal Circuit armed its position in Vanda
Pharma8 in April 2018. Because the decision in Vanda Pharma was split, the
Federal Circuit may choose to rehear the case en banc, and an eventual petition for
certiorari to the Supreme Court is possible.
Laboratory/Manufacturing Techniques
• Methods of performing laboratory techniques or for manufacturing products have had
the strongest position relative to other methods with regards to patent eligibility.
• Considered to be useful innovations, courts have focused on the “desired outcome”
and the “end result” achieved by these methods in nding patent eligibility
(CellzDirect9).
• Prosecution strategies for success: When drafting claims, include the desired
outcome/end result in the preamble and include, if possible, non-routine/
unconventional steps or combinations of steps. Argue that the method is a
signicant improvements over the state of the art. Demonstrate real-world tangible
applications for the method.
Compositions
• Technologies that fall within this category vary dramatically, including a diverse array
of chemical and biological molecules that are claimed as compositions (e.g., small
molecule drugs, proteins, peptides, nucleic acids, cells, formulations, and mixtures).
• The analysis for these types of claims generally rests on whether the claimed
products are “markedly dierent” from the closest counterpart in nature.
• Product claims that have been found patent ineligible include cloned animals and
DNA primers (isolated genomic DNA).10 However, cDNA, combinations of DNA
sequences that do not occur naturally together (e.g., combination of heterologous
sequences), and sequences with non-natural substitutions are considered patent
eligible.
• Nutraceutical compositions have recently been called into question at the district
court level.11 Composition claims to specic unit dosages of natural substance(s)
or combinations of natural substances were found patent ineligible as directed to a
natural product/phenomenon. Similarly, method of use claims were found patent
ineligible as merely directed to the eect of the natural substance in the body (natural
phenomenon). As all method of treatment claims rely to some extent on a law of
nature or natural phenomenon, extension of similar reasoning to claims to other
formulations would be problematic.
• Small molecule compositions and formulations are generally considered patent
eligible. Aggressive litigants have challenged claims to compositions having
particular pharmacokinetic eects, but these arguments were rejected.12
• Biologics, such as protein therapeutics, may be more vulnerable to challenge as their
development often aims for them to be very similar to their natural counterparts.
• Prosecution strategies for success: In applications, emphasize novel or nonobvious
characteristics dierent from the closest counterpart found in nature, such as
biological or pharmacological functions or activities, chemical and physical
properties, and structure and form (e.g., chemical, genetic, physical). Consider other
ways to claim technology (e.g., kits, product in combination with other components
during use).
Medical Devices
• Claims to medical devices – instruments, apparatus, implements, machines, or
implants used alone, or in combination, for a medical purpose – have the strongest
patent eligibility position of all the life science technologies.
• However, aggressive competitors have challenged such claims on patent eligibility
grounds, illustrating the expansive use of Section 101 in challenging patent claims.
General Tips:
• The lines between Section 101 and Sections 102 and 103 are blurred, with a number
of courts borrowing nonobviousness principles when assessing patent eligibility.
• Draft applications to provide support for the inventive concept; identify problems
in the art and improvements provided by invention.
• The Federal Circuit’s recent decisions in Berkheimer13 and Aatrix Software14 establish
that the patent eligibility analysis can include questions of fact.
• Lay groundwork in the application for what is considered well-known, routine,
and conventional in the art at the time of the invention, and distinguish invention
from this prior art.
• Identify distinguishing characteristics for compositions relative to counterparts
in nature.
1 Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012).
2 Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013).
3 Bilski v. Kappos, 561 U.S. 593 (2010).
4 Ensh LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016).
5 Trading Technologies Int’l, Inc. v. CQG, Inc., 675 Fed. App’x 1001 (Fed. Cir. 2017)(non-precedential).
6 Exergen Corp. v. Kaz USA, Inc., Nos. 2016-2315, 2016-2341 (Fed. Cir. March 8, 2018); see also Ameritox, Ltd. v. Millennium Health,
LLC, 88 F. Supp. 3d 885, 892 (W.D. Wis. 2015).
7 Rapid Litigation Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016).
8 Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd., Appeal No. 16-2707 (Fed. Cir. April 13, 2018)(precedential).
9 CellzDirect, Inc., 827 F.3d at 1048-49, 1052; see also Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., Civil Action
No. 11-11681-NMG, 2017 WL 2623167 (D. Mass. June 16, 2017) (settled shortly after Federal Circuit decision in CellzDirect).
10 In re Roslin Institute (Edinburgh), 750 F.3d 1333 (Fed. Cir. 2014); In re BRCA1- and BRCA2- Hereditary Cancer Test Patent Litigation,
774 F.3d 755 (Fed. Cir. 2014).
11 Natural Alternatives Int’l, Inc. v. Allmax Nutrition, Inc., 2017 U.S. Dist. LEXIS 99581 (S.D. Cal. June 26, 2017); Natural Alternatives Int’l,
Inc. v. Creative Compounds, LLC, 2017 U.S. Dist. LEXIS 143434 (S.D. Cal. Sept. 5, 2017).
12 Shire LLC v. Amneal Pharmaceutical, LLC, 2014 U.S. Dist. LEXIS 85369 (June 23, 2014); Endo Pharmaceuticals Inc. v. Amneal
Pharmaceuticals, LLC, 2015 U.S. Dist. LEXIS 114816 (S.D.N.Y. Aug. 14, 2015).
13 Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018).
14 Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121 (Fed. Cir. 2018).
