topic 4: enablement requirement applied to biotechnology, complete

Patent Law is Technology Specific: Enablement, Written Description,

and Biotechnology

Elisabeth A. PimentelUniversity of Connecticut

School of Law

Introduction: Biotechnology

• Biotechnology industry began in 1970’s with the advent of recombinant DNA techniques.

• The Global biotech industry continues to grow despite the economic down turn

• As of 3rd Quarter of 2009 – U.S. Biotech had Net Revenue of $57 billion– European Biotech had Net Revenue of € 12 billion

Industry Statistics from Ernst & Young Global Biotechnology Report 2010

Biotechnology Industry Economics

• Aggregate Profitability– U.S. Industry Milestone: industry maintained

aggregate profitability ($3.7 billion)– The European biotech industry has not yet

reached aggregate profitability (-€288 million)

• Number of Employees– U.S. biotech industry employs 110,000 workers– European biotech industry employs 49,000

workers


• Invades many aspects of modern life:– Therapies and vaccines– Medical Diagnostic Testing– Agriculture– Environmental– Industrial applications– Forensic Science


• High cost of innovation– Expensive to develop

– Long development times

– Stringent regulatory oversight

Enablement: Predictable Arts

• PHOSITA can bridge gap between claim and disclosure

• Typically have only had to show one embodiment to enable a broad claim

• Even if the claim read on other embodiments that were not adequately disclosed

• Changing?

Enablement: Unpredictable Arts

• Often the PHOSITA cannot bridge the gap between claim and disclosure

• Courts have required a much more detailed disclosure, including the disclosure of multiple embodiments.

The Problem Generally

• The U.S. Patent Statute does not distinguish between different fields of invention, but in the application of the Patent Statute the Federal Circuit holds different technologies to different standards.

The Problem for Biotechnology

• Specifically, the Federal Circuit has imposed stringent enablement and written description requirements on biotechnology patents that have not occurred in other technologies.

• The Federal Circuit has based its decisions on a central maxim that conception for biotechnology requires a definition of structure, formula, or definitive properties.

Constructive Reduction to Practice

• Theory: Invention refers to inventor’s conception of the new idea rather than the physical embodiment of that idea

• Courts have ruled that which has not been built, but has been fully conceived is eligible for patent protection

• Not for biotechnology and unpredictable arts

Biotechnology:Written Description

• Unusually strict for biotechnology cases• For cases involving DNA the Federal Circuit

has required that the written description disclose precise DNA sequences to demonstrate possession– The inventor does not conceive of a DNA

invention until she actually creates it


• In addition to structure, biotechnology inventions can be described by functional characteristics– Must have a previously known or disclosed

correlation between structure and function– E.g. Antibody claims: court suggested that could

describe an antibody by describing which antigen it binds to


• The Federal Circuit clarified what the written description does NOT require:– Examples are not necessary– Requirement may be met even where actual

reduction to practice is absent– No per se rule that an invention involving a

biological macromolecule must contain a recitation of known structure

Biotechnology:Enablement

• Unusually strict for biotechnology cases

• Again, dealing with DNA and disclosure of DNA sequences– Amgen, Inc. v. Chugai Pharmaceutical Co.• Claimed nucleic acid sequences that coded for

erythropoeitin and other proteins with the same biological function


• Amgen (continued)– Court said the few examples provided did not

enable the multitude of gene sequences claimed

– An example of claiming a genus while only enabling a few species.


• Examples and Embodiments– While not technically required by statute,

realistically biotechnology patents must disclose multiple examples and embodiments to fully enable a broad claim.

– Tension between how many examples or embodiments are necessary and how much experimentation a PHOSITA has to engage in

Biotechnology:The Results

• requiring heightened written description and enablement standards by mostly requiring the claims to be limited to the embodiments and examples disclosed creates an environment where it is easy for imitators to make a minor change and side step the patent, rendering the patent useless

• Creation of an anti-commons • Patent Thicket

But Isn’t Flexibility a Good Thing?

• Yes – patent laws were constructed at a time in which inventions were primarily mechanical

• Yes – practically, in U.S., Congress cannot implement a new statute every time a new technology arises

• Yes – when properly tailored to incentivize innovation in a particular industry.

How to Attain Flexibility

• The Person Having Ordinary Skill in the Art (PHOSITA) is a central source of flexibility – Within the doctrines of the patent statute– Between different areas of technological arts

• The PHOSITA is mentioned in two places in the Patent Statute, in the enablement requirement and the nonobvious requirement

PHOSITA

• While not specifically mentioned in any other place, the PHOSITA also plays a role in:– Utility: the definition of enablement affects the

utility requirement because the invention must operate as described if the PHOSITA is to be enabled

– Written Description and Best Mode: compliance with these requirements is measured from the perspective of a PHOSITA

PHOSITA

– Definiteness of patent claims: claims must be written so that a PHOSITA would understand to where the boundaries of the patent right extend

– Doctrine of equivalents: a fundamental test for equivalence is the whether a PHOSITA would reasonably interchange the elements at issue

PHOSITA

• Between different technologies the PHOSITA is different based on:– Comprehension of prior art

– Time frame

– Level of skill in the art in the time frame in which the PHOSITA is placed

What the Biotechnology Industry Needs from Patent Law

• Broader Patent Protections– High cost of innovation– Regulatory Oversight– Emerging industry– Rapidly changing technology– Investment structure of biotechnology

PHOSITA in Biotechnology

• The PHOSITA for biotechnology cases seems to need a very high degree of certainty and explicit instructions before being able to make and use an invention

• Federal Circuit focuses on the uncertainty inherent in the field of biotechnology

• The Federal Circuit has continued to view biotechnology as an undeveloped field even though the field has matured

How Can the PHOSITA Help?

• The PHOSITA doctrine can be helpful in navigating among differing technologies if two principles are rigorously adhered to:– The level of skill of the PHOSITA must be

determined anew in each case.– Be mindful of the time frame in which the

PHOSITA will be understood • Beware of hindsight bias

Broad Can Be Bad

• Concerns with broad patents– Concentration of patents– Decrease in innovation

• Broad protections do not easily allow for future partitioning within an industry– Current case law mostly deals with DNA– Future unknown

• Broader not Broad

European Patent Office

• EPC Article 83: Enablement– requires an inventor disclose the invention in a

manner sufficiently clear and complete for it to be carried out by one skilled in the art

• EPC Article 84 aka Written Description – The claims shall define the matter for which the

protection is sought. They shall be clear and concise and supported by the description.

European Approach to Biotechnology

• Directives– Cumbersome process akin to U.S. Congressional

process – Directive on Legal Protections of Biotechnologies• Significant step in improving patent climate for

biotechnology in Europe• Limitations on technologies associated with

transgenic experimentation and human cloning


• More flexible approach to description and enablement– Focused on knowledge, not structure

• Acknowledges the informational link between DNA and protein

• Claims cast in functional language are allowed


• Disclosure of a single embodiment is sufficient– The European PHOSITA generally can carry out

varying embodiments without undue burden

• Generally require fewer species to be described in order to enable a broad claim to genus

• Morality– Potential to affect the scope of allowable claims– Europe has less human life-science biotechnology

A Timely Digression

• On May 20, 2010 a U.S. biotech company announced a breakthrough in synthetic biology: the formation of a synthetic organism– DNA was synthesized, cell was wild type

mycoplasma mycoides with original DNA removed: so not entirely synthetic

– Looks and acts like a naturally occurring cell until examine DNA structure which has embedded in its code names of inventors, websites, and quotations

Synthetic Genome

• The big advance is that the genome was productive and self-replicating

• The project took 15 years and $40 million to complete– At least one Nobel Laureate

• A single base error in the synthetic code caused 3 month delay

Synthetic Genome

• Potential applications– Using cells to create fuel– Building vaccines to tackle new strains quickly– Agriculture: create plant cells that can grow with

little water and fertilization

“DNA is the Software of Life”

• The ability to create viable DNA sequences out of four chemicals has been equated to writing software code– Mycoplasma mycoides JCVI-syn 1.0

• Ironic comparison because written description and enablement requirements of software industry are often contrasted to those of biotechnology because of vast difference.

How Might Federal Circuit and EPO Respond?

• Patent on precursor methods to the synthetic organism is in the midst of prosecution at USPTO– Written description deficiencies– Enablement scope deficiencies: very broad claims

• Will this reinforce the Federal Circuit’s focus on structure?

• Will the EPO morality clause prevent this type of biotech from development in Europe?

Conclusion

• Modulating the Patent Statute to differentiate between industries is desirable– The American way of splitting up the fields– Tailored to the needs of specific industry– Best done by modulating the PHOSITA

• Federal Circuit needs to re-evaluate its stance toward biotechnology patents

• The EPO may need to address viability of morality clause