Researcher Frequently Asked Questions and Answers
Updated June 2024 by Bradley
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Patent eligibility is governed by 35 U.S.C. § 101 (the U.S. Patent Act), which states:
“Whoever invents or discovers any new and useful process, machine, manufacture or composition of matter, or improvement thereof, may obtain a patent, subject to the conditions and requirements of this title.”
It should be noted that patentability under § 101 is an extremely fluid area of the law that is subject to rapid change with the resolution of each pending case. Additionally, legislative efforts are underway to codify four statutory exclusions to patent-eligible subject matter. If successful, such legislation would prevent mathematical formulas (aside from “useful invention[s] or discover[ies]”), non-technological processes, mental processes, solely natural activity (devoid of human intervention), unmodified human genes, and unmodified natural material from receiving patent protection.
Generally, patent eligibility is analyzed under a two-step framework:
1. Does the invention claim: (a) a law of nature, (b) an abstract idea, or (c) a natural phenomenon?
- Examples: mathematical algorithms, the disinfecting nature of sunlight, and physical phenomena (water boiling at 100C)
If the answer is no, the invention is patentable subject matter. If the answer is yes, the analysis proceeds to Step 2.
2. If so, are there additional claim elements (amounting to an “inventive principle”) that sufficiently transform the claim?
- Must amount to “significantly more” than the ineligible concept itself
- A narrow “practical application” of an ineligible concept might suffice
If the answer is yes in Step 2, the invention is patentable subject matter. If the answer is no, the invention is not patentable subject matter.
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The Section 101 patentability analysis involving biology/genetics/genomics is normally focused on whether the invention is directed to a law of nature or natural phenomenon. The complete use of a natural law, or a discovered natural correlation, is not eligible for patent protection. Inventions for processes involving laws of nature must contain additional features limiting an inventor’s monopoly over such law. These additional features cannot be purely “conventional” steps (e.g., routine, well-known steps to those of “skill in the art”) that fail to add something of significance to the use of the natural law itself. Instead, the claim’s additional features generally must limit the application of some natural law within a specific process or method. A method claim needs to identify a way of achieving the intended result, not just claim the result itself.
- Examples of patent INELIGIBLE inventions:
- Electromagnetism
- Inhibitory or non-inhibitory properties of naturally occurring bacteria
- Naturally occurring DNA segments
- Cloned animals without “markedly different” characteristics from naturally occurring animals
- Synthetically produced forms of naturally occurring natural products that do not exhibit markedly different characteristics from the natural product
- Examples of patent ELIGIBLE inventions:
- Man-made, genetically engineered bacterium to break down oil spills
- Man-made, distinct, non-naturally occurring DNA segments (e.g., the larger DNA may be part of a “natural law”, but the smaller, specific DNA segment only exists in its form through manipulation or creation)
- Man-modified plant gene sequence
- Process for extracting non-naturally occurring DNA fragments
- “[A] specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome”
- Examples of patent INELIGIBLE inventions:
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The computational/data analysis inventions go through the same general Section 101 analysis discussed in Section I above. During the first step of the Section 101 analysis, again, the focus is on whether the invention is directed to an “abstract idea”, and if the invention is directed to an “abstract idea”, in the second step (if applicable), whether there is some “inventive concept” or principle to transform it into a patentable invention.
Generally, patent claims regarding computation/data analysis are only eligible where the claim involves an “improvement” in the efficiency of a computer function, or constitutes a specific technological solution to a technological problem.
When the purported “invention” involves simply “processing” data on a computer in a manner that is faster or more efficient that previously methods that did not use computers, and is effectively using a computer to implement “longstanding human activity” with use of generic computer technology, it is likely not patent eligible. Use of conventional computer components, like a “receiver”, “transmitter”, “processor”, and “memory”, in their conventional manner to process, analyze, and store data is also not likely to be patent eligible. Moreover, just converting data from one format to another format is often found patent ineligible (unless that conversion allows for better functioning of the computer, or better data compression, etc.). Further, claimed inventions cannot cover purely “functional” computation processes, such as the mass collection of performance data.
Claimed “improvements” in the efficiency of computer function usually involve the use of specific or unique techniques that depart from previous solutions to solve computation problems.
Examples of patent INELIGIBLE inventions:
o Use of a computer algorithm alone
o Use of an algorithm to update alarm value in manufacturing process
o A process for drug dosage by measuring a patient’s blood drug metabolite levels
o An improved method of calculation tied to a specific end use
o A computerized method and system of distributing a digital image processing function based on GPS location
o Methods and system of automatically updating customer records (replacing manual entry)
Examples of patent ELIGIBLE inventions:
- Use of an algorithm as one step in an industrial process of molding rubber
- An encoded RFID transponder with a memory structure accommodating a specific hardware-based number scheme
- An efficient, improved method of encoding data that relies in part on irregular repetition
- A particular method of breaking the fixed relationship between the timing of a downlink USF and subsequent uplink transmission
- A specific set of steps in a process for authenticating the identity of device users
- A multi-level encryption method and system that allows encrypted files to be nested within other encrypted files
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It is important to understand that there are certain “disclosures” to a third party (referred to herein as “third party ‘disclosures’”) of an invention that, if made before patent applications are filed, can completely bar later patent protection for that invention. These third party “disclosures” of an invention might be a proposed publication submitted to an academic journal, a request for research grant, a synopsis for a speech to be given at a symposium, or just a meeting with a collaborator. So, from a “best practices” perspective, it is always best to submit any invention disclosure statements to the appropriate personnel within HudsonAlpha well before any potential outside “disclosure” to third parties. This allow HudsonAlpha time to evaluate, and if appropriate, file patent applications before any outside “disclosure”.
A. Timing For Patent Protection in Foreign Countries – File Before Any Third Party “Disclosure”
Historically, HudsonAlpha has sought foreign patents for some of its inventions. One driver for ensuring invention disclosure statements are submitted before any third party “disclosure” is due to strict requirements for foreign patent protection. Notably, and unlike the United States, most foreign countries are considered “absolute novelty” countries. That means that any third party “disclosure” of an invention before a patent application is filed prohibits the applicant from seeking protection in that country. In other words, if HudsonAlpha personnel make a third party “disclosure” of an invention before an application is filed, foreign patent protection may be unavailable.
While each country is a little different, and one type of invalidating thirty party “disclosure” in one country may not be automatically invalidating in another, the safest course is to consider all foreign countries as requiring patent applications be filed before any “disclosure”. It is also worth noting that applicants are not necessarily required to have a patent application filed in every foreign country in which it seeks protection before the third party “disclosure”, but rather a patent application from which it can claim priority.
B. Timing For Patent Protection in the United States – 12 Month Grace Period Available, But Recommend Filing Prior to Any Third Party “Disclosure”
Although many foreign countries are absolute novelty countries, for inventions made after March 16, 2013, applicants in the United States can still file patent applications within (1) year of three categories of third party “disclosures”. These three categories include: (1) those made by an inventor themselves; (2) those made by a third party (who obtained the disclosed information from an inventor, directly or indirectly); and (3) those made by any third party, IF the inventor disclosed first. In other words, in many cases, US-based patent applications can still be filed within twelve (12) months after a “disclosure” of the invention by the applicant. It is still a best practice to file a patent application prior to such disclosure, but there is a “grace period” that allows many filings within twelve (12) months of certain disclosures.
One (1) year after a public “disclosure” of the invention, it is generally too late to seek patent protection.[2] For example, an applicant might have a US patent application pending for an invention, and three months after filing, a third party “disclosure” of the invention. That applicant can still file for foreign patent protection (either through direct national filings into the desired countries, or by filing a Patent Cooperation Treaty (“PCT”) application) within twelve (12) months of the US filing, and have an “effective filing date” in foreign countries before the third party “disclosure” date.
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A “disclosure” for the purpose of this answer can occur anywhere in the world but generally requires that it contain enough information to enable a person ordinarily skilled in the art to recreate or fully use the invention.
“Public” disclosures or publications are generally those which are publicly accessible by at least one person ordinarily skilled in the relevant art. Whether or not the disclosure was actually accessed is irrelevant, as courts only consider whether it could have been accessed. One recognized “public” disclosure is a single cataloged thesis within a university’s library.
Other factors courts may use to determine whether a disclosure is sufficiently “public” include: (1) the duration of the disclosure; (2) the expertise of the disclosure’s intended audience; (3) the expectation (or lack thereof) that the disclosure’s relevant information would be copied; and (4) the simplicity or ease of copying such information. In the internet context, courts may also consider whether the disclosure was “indexed.”
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Whether any consent is required in order to commercialize or practice certain intellectual property rights depends on the nature of the intellectual property and its intended use. Two separate, but typical, situations are discussed below.
A. Where IP is developed inhouse at HudsonAlpha and Sought to be Commercialized:
One situation where certain consents might be sought is the intended commercialization of certain inventions or other intellectual property developed inhouse at HudsonAlpha. The various intellectual property rights that might be impacted, and for which some “consent” might be required include: (1) copyrights; (2) patents; (3) trademarks; and (4) trade secrets.
For many of these types of intellectual property, if it was developed inhouse, and not knowingly using or based on existing third party technology, there is no real need to seek consent from third parties. For example, copyright protects certain works of authorship, which in HudsonAlpha’s situation, might include certain software or perhaps images. If HudsonAlpha’s development of its own software did not use any third party software in the development, it should not have to worry about some third party asserting rights over HudsonAlpha’s software. The same analysis is largely true for trade secrets. If the developer was not using proprietary information from a third party, there is no real need to seek consent or approval from third parties. If the converse is true, that third party software or proprietary trade secrets are used or incorporated into HudsonAlpha’s development, then consent to use that proprietary work of authorship (for copyright) or that trade secret information would be required.
The same issue is largely true also for trademarks – if we are using or referring to a known third party trademark, HudsonAlpha may need to seek the trademark owner’s consent (or license) to use that mark. If HudsonAlpha seeks to adopt and beginning using its own new trademark (for example, some new name for a software offering), that mark should be vetted and cleared for use before beginning such use.
The primary issue of “consent” for commercialization of certain intellectual property often comes up when a new patentable system or method is developed and HudsonAlpha seeks to commercialize that invention. In many cases like this, before a full-scale commercialization occurs, the IP owner will seek to understand if there is third party intellectual property, primarily patents, that may impact such use by having a “freedom to operate” search and analysis performed. This entails surveying the existing state of the art and relevant industry to determine whether the use of any then-existing IP may be required to practice the newly developed IP. If so, consent or a license can be obtained from such third party. In most instances, a third party search firm is engaged to conduct the search using details about the specific nature of the intellectual property to be commercialized.
These same “freedom to operate” searches are sometimes conducted when a party just seeks to license its intellectual property for use by third parties, rather than commercializing the intellectual property itself. This may be helpful to assess risk if HudsonAlpha were to asked to indemnify any licensee of the intellectual property against third party intellectual property claims. If no such indemnity is offered in the license, most licensees of intellectual property do not separately conduct the “freedom to operate” analysis.
B. When collaborating with third parties on new IP:
If a third party brings their existing IP into a collaboration to develop new IP, the existing (or proposed) joint development or collaboration agreement normally outlines each party’s “background IP.” Such agreements will explain exactly what “license” to use such background IP is granted to the other party. These “licenses” may limit the other party’s use of the background IP only to “research purposes.” When limited in this way, a separate license to commercialize the background IP may be required when planning to license or commercialize any newly created IP.
The joint development or collaboration agreement also normally details how the ownership or commercialization of any newly developed IP will be handled. These agreements could contain various ways of sharing or dividing the ownership or commercialization of newly developed IP. Some agreements allow for each party to commercialize, use, or license the newly developed IP. Others may divide a given market into segments, allowing each party to commercialize within given segments or require royalties from given segments to be paid to each party.