Saturday, January 5, 2013

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

As a national strategy, China is trying to move from being a world manufacturing factory to being an innovation leader.  Since the introduction of the “Law of the People’s Republic of China on Progress of Science and Technology” in 2008, China has made staggering progress toward promoting the scientific and technological innovations, which is evidenced by dramatic increase of patent filings by Chinese nationals in China and abroad in the past several years.

In 2009, approximately 300,000 applications were filed in China with about equal number of utility patents and inventions patents.  In 2011, according to the World Intellectual Property Indicators 2012 published by WIPO, China’s State Intellectual Property Office (SIPO) received 526,412 applications overtaking the United States Patent and Trademark Office (USPTO) to become the largest patent office in the world.  In comparison, USPTO received 503,582 applications and JPO received 342,610 applications. 

There is no sign that the patent filing in China is slowing down.  Since 2008, China has introduced an array of incentives including cash bonuses, better housing for individual filers and tax breaks for companies that are prolific patent producers to encourage domestic and foreign patent filings.  According to the “National Patent Development Strategy (2011-2020)” published in November 2012 by SIPO, China’s goal for annual patent filings by 2015 is two million.

The patent filing in China by foreign applicants has also seen steady increase.  The reasons are twofold.  First, China is the most populous country in the world, which implies a big consumer market.  Second, a large and inexpensive talent pool in China coupled with the increased recognition to IP rights have accelerated R&D outsourcing to China by foreign companies. 

Obtaining patent protection in China is becoming an important corporate IP strategy.  Therefore, it is important for companies and inventors to familiarize themselves with the basics of Chinese patent law.  Understanding the patent eligible subject matter under Chinese patent law is a necessary first step.

There are three types of patents in China: invention, utility model, and design.  According to the Article 2 of the Patent Law of the People's Republic of China, invention-creations mean inventions, utility models and designs.  The invention patent is similar to the utility patent in US.  The design patent is similar to the design patent in US.  There is no US equivalent of utility model patent.

Similar to US, China grants patents to products (including both manufactures and compositions), devices, and methods or processes.  According to the Article 2 of the Chinese patent law, inventions mean new technical solutions proposed for a product, a process or the improvement of those; utility models mean new technical solutions proposed for the shape and structure of a product, or the combination thereof, which are fit for practical use; and designs mean, with respect to a product, new designs of the shape, pattern, or the combination thereof, or the combination of the color with shape and pattern, which are rich in an aesthetic appeal and are fit for industrial application.  Examples of patent eligible subject matter include mechanic devices, systems, surgical tools, implants, diagnostics tools, new chemical compounds, isolated genes (including human genes), pharmaceutical compositions, nontherapeutic cosmetic hair treatment methods such as giving permanent waves or dyeing, methods of sterilization that are not directly practiced on the animal or human body, methods of treatment and preservation of corpses, methods of measuring physiological parameters solely for the purpose of perfecting a medical instrument, etc.

Invention-creations that violate the law or social ethics, or harm public interests are not patent eligible according to Article 5 of the Chinese patent law.   For example, in biotech field, cloning of human beings, commercial use of human embryos and human embryo stem cells and their preparation are not patentable as they are considered to contravene social ethics.

China does not grant patents on inventions that are accomplished by relying on genetic resources that are obtained or used in violation of the provisions of laws and administrative regulations. (See, Article 5.)  This law protecting the generic resource in China was introduced by the Third Amendment of the Patent Law in 2008 in response to several high profile exploitations of Chinese genetic resource materials by both foreign academics and foreign companies in the early 2000s.  The term “genetic resources” refers to any materials of human, animal, plant, microbial or other origin contain functional units of heredity and having actual or potential value.  The term “inventions that are accomplished by relying on genetic resources” means inventions which are accomplished by exploiting the hereditary function of the genetic resources.  When an applicant claims an invention that is accomplished by relying on a genetic resource, the applicant must indicate the direct and original sources of the genetic resource in a special form for disclosure of genetic resource.  The form can be filed either with the filing of the application or during the prosecution.  The direct source must be provided.  However, if the original source is unknown to the applicant, the requirement for the original source may be exempted with an explanation from the applicant as to why she has no knowledge of the original source.

Similar to US, China does not allow patents on scientific discoveries, law of nature, physical phenomena, abstract idea, mental process, and mathematical algorithms and formula. (See, Article 25.)  Therefore, the discoveries, such as electricity, electromagnetic signal, light, relativity theory, string theory, or the first law of thermodynamics, are patent ineligible in both countries.

Rules and methods for intellectual activities and methods for the diagnosis or treatment of diseases are not patent eligible in China.  This differs significantly from the US law.  Specifically, business method, which is a hotly debated topic in US, is not patentable in China.  Regarding methods of treatment and diagnosis, these subject matters are not patent eligible: dosing regiments, immunization schedules, methods for determining risk of illness, methods for preventing diseases, assays or tests directly leading to diagnosis such as endoscopic and ultrasonic methods, gene screening diagnosis, acupuncture, radiotherapy such as prophylactic treatment, immunization schedule, methods of treating wounds, methods of contraception, artificial insemination, and embryo transfer.  However, these exclusions do not apply to methods not directly applied on the body. For example, methods of treatment and diagnosis applied to tissue and other biological materials isolated and separated from the body are patentable subject matter. Methods of analysis, treatment, and data collection as applied to the body for purposes that are not disease related are also allowed, as are products and compounds used for treatment and diagnosis of diseases.  Another exception is the first and second medical use inventions written in Swiss-type claim format such as "Use of substance X in the manufacture of a pharmaceutical drug for the treatment of disease or condition Y", which is patent eligiblee in China.

Animal and plant varieties are not patent eligible in China. This exclusion is mainly directed toward organisms, so the non-biological processes used for producing animal and plant varieties remain patent eligible.  The term “animals and plant” includes not only common definition of animals and plants but also transgenic or bioengineered animals and plants and living materials capable of developing into animals and plants.  The exception is microorganism including bacteria, fungus, and virus.  Microorganism isolated as a pure culture is patent eligible in China. 

China also does not allow patent on methods of nuclear transformation and substances obtained by means of nuclear transformation. “Methods of nuclear transformation” refers to the process of one or more nuclear things forming one or more new nuclear things through segmentation or polymerization, such as methods of magnetic mirror traps and close traps for realizing the nuclear fusion reaction and methods for realizing nuclear fission by various reactors.  However, the particle acceleration methods are included in this definition, which is therefore patent eligible.  “The substances obtained by nuclear transformation” primarily refer to various radioisotopes manufactured and produced by accelerator, reactor or other nuclear reaction apparatus.  Such isotopes are patent ineligible.  

There are significant overlaps on patent eligible subject matters between US and Chinese patent law.  However, as summarized above, there are subject matters that are patent eligible in US but not in China.  However, clever claim drafting can emolliate some of these restrictions.    

Thanks for reading.

Connie


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



Wednesday, October 3, 2012

Patenting Strategies for Small Businesses and Individual Inventors—Patentability Search Techniques on the internet

In my last post, I talked about how to do the patentability search in the USPTO database.  For a relatively simple patentability search, besides the USPTO database, you should always do a general internet search.  Try your search on multiple search engines and always try different combination of the keywords.  You can use common words search.   That often generates a lot of search results that take a long time to click through.  However, if you are too strict with your keywords, search results might be too limiting and narrow.  Two good ways to increase the search efficiency is to use Wildcards in keyword and use Boolean logic in your search.

Wildcards in Keyword Searching
One technique often used by patent searcher to avoid the search being too narrow is to use a wild card symbol “$”at the end of a word root. 
The wildcard symbol may take place of any number of additional letters that may come after that root.  For example, in “cardi$,” the dollar sign replaces any other possible characters that would follow the five letters, “cardi.”  Therefore, “cardi$” would scoop up the words such as cardiac, cardiology, cardiologist, etc.
You can also use wild card symbol “?”  to replace any single character in a word.  For example, “h??t” would return with words “heat,” “hoot,” “hilt,” “hart,” “haft,” etc.
Boolean Logic in Keyword Patent Searching
Boolean logic is a built-in function for many search engines.   If you want both keywords to appear in search results, use AND as an operator.  The more keywords you use with the AND operator, the smaller the number of matches you will obtain, and the more meaningful each match will be.
If you want search results to contain one of the keywords, use OR as an operator.  Therefore, OR operator is used to widen the scope of the search results.
If you want to exclude keywords from your search results, use exclusive OR (XOR).  XOR means that overlapping area is not included in the search results.  Only one of the keywords combined with the XOR operator will appear in each of the document in your search results.
ANDNOT is a combination of the AND and NOT operators.  The NOT operator, by itself, returns all the documents that do not contain the keyword behind NOT.  You may use the ANDNOT operator to exclude specific keywords from the search results.  In the following diagram, parentheses are used to indicate that the words within the parentheses are evaluated first.  From the results generated by searching the terms inside the parentheses, any document containing the keyword C is then excluded.
Thanks for reading.
Connie

Patenting Strategies for Small Businesses and Individual Inventors—Patentability Search Techniques on USPTO website

Before you spend money and time to apply for a patent, you should always do a patentability search to make sure that your technology has not been patented or published by others before.  For a patentability search, U.S. Patent and Trademark Office (USPTO) website is a good place to start.

Here is the patent search website from USPTO: http://patft.uspto.gov/  You will notice that you will have to search Patent database and Patent Application database separately.  For each database, there are three search choices: Quick Search, Advanced Search, and Number search.  The following are the links you can follow for each type of search:


Patent
Patent Application
Quick Search

Advanced Search


Number Search




Number search is similar to a document fetch function.  If you know a patent number or patent application number, it’s a good place to go.  In Quick Search, you can use a simple combination of keywords and field codes to do a quick search.  The function is useful if you are doing a relatively narrow or targeted search.  For me, the most useful tool is the Advanced Search function, which provides you more flexibility to define what you are looking for.  You can use the following Field Codes to narrow your search. 

Field Code
Field Name

Field code
Field Name
PN
Patent number

IN
Inventor name
ISD
Issue date

IC
Inventor city
TTL
title

IS
Inventor state
ABST
abstract

ICN
Inventor Country
ACLM
Claims

LREP
Attorney or Agent
SPEC
Description/specification

AN
Assignee name
CCL
Current US Classification

AC
Assignee city
ICL
International Classification

AS
Assignee state
APN
Application serial Number

ACN
Assignee country
APD
Application date

EXP
Primary examiner
PARN
Parent case information

EXA
Assistant Examiner
RLAP
Related US App. Data

REF
Referenced by
REIS
Reissue Data

FREF
Foreign references
PRIR
Foreign priority

OREF
Other references
PCT
PCT information

GOVT
Government interest
APT
Application type





Here are some additional tips:
1.       by placing a field code outside a set of parentheses in complex Boolean queries, you can apply that field code to every keyword in the contained expression.  For example, ABST/(((Fire AND protection) AND (Building OR structure) ANDNOT sprinkler)
2.       Search for a phrase.  For example, ABST/”absorption spectroscopy”
3.       Limiting the range of years searched.  You can apply the ISD field code to a range of dates by using the -> operator. For example, ISD/1/1/2003 -> 12/31/2005 AND ABST/“absorption spectroscopy”
4.       Inventor name search: IN, followed by the name of the inventor, last name first, with the placement of a dash (-) between the last and first name and between the first name and the middle initial.  For example, search Dr. Robert L. Forward, IN/Forward-Robert-L
Your search should return a list of patents or patent applications each hyperlinked to a HTML text document.  Unfortunately, the HTML text document does not include figures, drawings, and chemical structures.  If you want to see the image of the patent document, you will need to click on the “image” button at the top of the page, which will take you to the scanned images.
Thanks for reading.
Connie