Sunday, December 30, 2012

What’s patent eligible and what’s not: patent eligible subject matter comparison – US


When an inventor comes up with an invention/idea, the first task is to decide if the invention/idea is a patent eligible subject matter.  Passing the “patent eligible subject matter” bar is the first requirement in the path to a patent.  If you are an entrepreneur inventor, before you invest money and time to further develop and commercially explore the invention, you should figure out whether the invention is patent eligible or not.   Obtaining a patent is not necessarily a requirement for you being able to commercially exploit your “invention.”  However, with or without a patent, your plan for commercialization could be very different. 

What is patent eligible in one country is not necessarily patent eligible in another country.  In this series of blog posts, I will provide a comparison on patent eligible subject matters in various countries.  I will try to cover all the major markets hoping the information will be useful for you in the commercialization of your invention or idea.

US patent law, 35 USC § 101, describes inventions that are patent eligible.  Here is the text of the statute:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

Therefore, in US, a utility patent will only be granted to these four types of inventions: a process, a machine, a manufacture, or a composition of matter.  Thinking from an inventor or entrepreneur point of view, these four categories can be roughly grouped into two types: processes and products.

A process under §101 is a manner or means of achieving a certain result or arriving at a certain goal.  It could be a process, a method, an act, or an operation, which includes one or a series of acts or steps to achieve an end result.  Examples of processes include a business method, a process of performing an act, a method of manufacturing an article, a method of synthesizing a chemical compound, a method for treating a disease, a method for diagnosing a disease, a surgery method, or process of purifying a protein.

The products categories are more tangible and therefore easier to define.  

A machine essentially includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result. See Corning v. Burden 56 U.S. 252 (1854).  A machine under §101 could be a device, an apparatus, a system, or a combination of devices.  It may consist of fixed or moving parts that work together to form some function.  Examples of machines include a needle, a battery, an endoscope, an apparatus for performing an act, a pencil sharper, a wash machine, a car, or an airplane.

A manufacture is “the production of articles for use from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by hand-labor or by machinery.” Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980) (citing American Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1, 11 (1931)). It is distinguished from a thing that is a product of nature. Examples of manufactures include a chair, a tire, a chemical compound, an isolated natural compound, a synthetic gene, an isolated gene (?), a synthetic protein, an antibody, a bioengineered microorganism, the Oncomice, or a polymer.

A composition of matter “includes all composite articles, whether they be results of chemical union, or of mechanical mixture….” Shell Development Co. v. Watson, 149 F. Supp 279 (DC Dist) (citation omitted). Compositions of matter are not limited to any physical form or element: solids, powders, liquids, and gases all qualify.   They could be the results of chemical union or of mechanical mixture.  Examples of composition of matters include a polymer composite, a pharmaceutical formulation, a facial mask formula, or a drink mixture.

In US, the Leahy-Smith America Invents Act and case laws have excluded the following categories from patent eligible subject matters:  

·       laws of nature and scientific principles: examples include transitory forms of signal transmission (for example, a propagating electrical or electromagnetic signal per se), In re Nuijten, 500 F.3d 1346, 1357, 84 USPQ2d 1495, ___ (Fed. Cir. 2007); electricity, electromagnetic signal, light, relativity theory, string theory, or the first law of thermodynamics.

·       physical phenomena and natural phenomena: examples include a naturally occurring organism, Chakrabarty, 447 U.S. at 308; a new mineral discovered in the earth, or a new plant found in the wild, sky, cloud, or rainbow.

·       abstract ideas, disembodied concepts: examples include a computer program per se, Gottschalk v. Benson.

·       mental processes, systems that depend on human intelligence alone: examples include a legal contractual agreement between two parties, see In re Ferguson, 558 F.3d 1359, 1364, 90 USPQ2d 1035, ___ (Fed. Cir. 2009) (cert. denied).

·       disembodied mathematical algorithms and formulas: examples include a game defined as a set of rules, addition algorithm, or a linear equation.

·       any kind of human organism (bioengineered, new human species, or chimeras).  See, The Leahy-Smith America Invents Act (AIA), Public Law 112-29, sec. 33, 125 Stat. 284 (September 16, 2011).

·       a mere arrangement of printed matter, In re Miller, 418 F.2d 1392, 1396, 164 USPQ 46, ___ (CCPA 1969).

·       Tax planning strategies. See, The Leahy-Smith America Invents Act (AIA).

Thanks for reading.

Connie


Monday, December 24, 2012

The development and commercialization plan requirement in a license agreement

Many technology-centric start-ups are based on the technologies generated from universities or from government funded projects (in places such as national labs, projects in non-profit institutes, or even small companies).   As an entrepreneur, if you want to start a technology based company, one place to look for the opportunities is the technology portfolios managed by the technology transfer offices in universities and government agencies.  For example, the Department of Energy (DOE) is running a program, “America’s Next Top Energy Innovator,” which allows startup companies to license groundbreaking technologies developed by DOE’s 17 national laboratories for $1,000 and build successful businesses.  See, http://energy.gov/articles/secretary-chu-announces-second-round-america-s-next-top-energy-innovator-one-year 

Negotiating a licensing agreement from a university or a national lab can be tricky.  The top commercialization priority for universities and the government is to make its research and knowledge available for the benefit of the general public.  This is contrary to the commercialization priorities of other IP holders, which often prioritize financial benefit and competitive advantage over the benefit to the general public.  Therefore, in a license agreement, a university or the government often requires a “development and commercialization plan.”  The key motivation behind such requirement is to ensure that the technology will not be shelved by the licensee of the technology. 

The development and commercialization plan varies greatly from deal to deal.  Sometimes, a general plan to develop and commercialize the technology is enough.  The plan may be part of the business plan on developing the technology based product or service.  Sometimes, the plan may call for a detailed schedule with built-in performance milestone.  For example, a development and commercialization schedule for a pharmaceutical compound may include the following milestones.  The milestones are often pegged with a timeline.  The achievement of each milestone may trigger a payment to the university or government licensor. 

·        Identification of lead compound(s)

·        Completion of preclinical investigation of the lead compound

·        Filing of Investigational New Drug (IND) Application with the FDA

·        Completion of Phase I clinical trials

·        Completion of Phase II clinical trials

·        Completion of Phase III clinical trials

·        Filing of New Drug Application (NDA)

·        FDA’s approval of the New Drug Application (NDA)

A development and commercialization plan should incorporate relatively “firm” milestones.  Ambiguous milestones can cause future disagreement over whether a milestone performance is satisfactory and therefore triggers a payment to the licensor.  Usually, commencement of a next phase milestone should be deemed as the “satisfactory completion” of a previous milestone and such definition should be included in the license agreement.   

Failure to “hit” the milestones (nonperformance) usually triggers some kind of “penalty.”  The severity of the penalty can vary from loss of an option, loss of exclusivity, to termination of the license.   Because of the unpredictability of the technology development, sever penalty such as termination of the license is usually tied with the right to cure including a grace period to cure the non-performance.

In general, if you are interested in obtaining a technology from a university or the government, be aware of the development and commercialization requirement.  Before the negotiation, think through how you would use the technology, how you would incorporate the technology into a product or service, and what it would take to bring the lab-based technology into the commercial product/service your envisioned.  You may want to start with a business plan.  Then, you may be able to distill your business plan into a development and commercialization plan for the license agreement.  In addition, be creative with the rewards or penalties triggered by performance milestones to minimize severity of a penalty. 

Thanks for reading.

Connie