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Top Adding - After KSR - Stronger Patents or Just Harder to Get?
A recent United States Supreme Court ruling is causing quite a stir in intellectual property circles. The case is KSR Int'l Co. v. Teleflex Inc., et al., 127 S. Ct. 1727 (2007).
Background
To obtain a patent, the invention must be useful, novel and non-obvious. See Patents. The first of these, utility, is prese
Background
To obtain a patent, the invention must be useful, novel and non-obvious. See Patents. The first of these, utility, is prese
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
nt for nearly every invention. The second, novelty, generally requires that the invention claimed is not disclosed in full in a single reference (patents, published applications or any published document anywhere in the World), and the third, non-obviousness, generally requires that the invention as claimed is not fully disclosed in a com
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ination of references. Previously, to reject a patent for obviousness though a combination of references required some suggestion or motivation in the references themselves (excluding the subject patent application) that would lead one skilled in the pertinent art to make the combination of their teachings.
In Graham v. John Deere Co.
In Graham v. John Deere Co.
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
of Kansas City, 383 U.S. 1 (1966), the U.S. Supreme Court laid out the requirement that the skill level is "the level of ordinary skill in the pertinent art". That is typically the level of skill that an engineer in the field would possess and is not related to the skill of the inventor.
The previous standard for combination of refer
The previous standard for combination of refer
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nces was the teaching, suggestion, motivation (TSM) standard as articulated in Al-Site Corp. v. VSI Int'l, Inc., 174 F.3d 1308 (Fed. Cir. 1999). That is, there must be some suggestion or motivation within the references cited to combine their teachings. This test arose in part to overcome the inherent bias that an examiner would h
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ave after reading a new invention disclosure and applying hindsight to reject the claims as obvious in light of the references. The language of the holding by the Federal Circuit in Al-Site allowed the nature of the problem to have an effect, holding that "[a] suggestion or motivation to combine generally arises in the references t
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
emselves, but may also be inferred from the nature of the problem or occasionally from the knowledge of those of ordinary skill in the art.") Id. at 1324 [Emphasis added]. Thus, a problem in need of a solution can be considered to provide motivation. This appears to be the real focus of KSR.
Previously, just because som
Previously, just because som
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
thing is "'[o]bvious to try' has long been held not to constitute obviousness". In re Duell, 51 F.3d 1552, 1559 (Fed. Cir. 1995) citing In re O'Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988). Such obviousness to try would likely arise from knowledge of a problem in need of a solution.
In KSR, the language of the U.S. S
In KSR, the language of the U.S. S
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
preme Court holding that if "a design step [is] well within the grasp of a person of ordinary skill in the relevant art and that the benefit of doing so would be obvious", then the invention does not meet the test of obviousness. KSR, Syllabis. This is slightly different from In re Duell. But perhaps this is really not exp
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
ansive, but rather more of a clarification?
Is KSR really important?
The effect of KSR may be mitigated by the fact that many examiners already merely state that the invention is obvious and claim that there is a teaching, suggestion or motivation (TSM), but do not actually identify such teaching, suggestion or mo
Is KSR really important?
The effect of KSR may be mitigated by the fact that many examiners already merely state that the invention is obvious and claim that there is a teaching, suggestion or motivation (TSM), but do not actually identify such teaching, suggestion or mo
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ivation as is required. Technically, this does not meet the requirement that the examiner establish a prima facie case which then shifts the burden of rebuttal to the patent applicant. Of course, because the examiner has not identified any TSM, it then falls to the patent applicant to point out this defect in the examin
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
r's reasoning. Yet, even so, examiners will often merely respond that "the arguments have been considered, but are unpersuasive", again without pointing to any identification of TSM in the references. This forces the patent applicant to appeal, for which many applicants are unprepared to pay the cost. So, in effect, the TSM standard has
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
long been ignored anyway as applied to many patent applicants, since from a practical standpoint many individual inventors and small companies do not want to spend the money and effort to show that the standard was not met. Thus, use of the TSM standard has never been a rigid rule, and the effect of KSR is moot for most patent appl
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
icants. (It should be noted that the U.S. Patent Office has stated that they won't necessarily adopt KSR and cease pointing to teaching, suggestion or motivation.)
Other factors of importance from KSR
What is particularly of concern to the author is the language of the U.S. Supreme Court in KSR in stating
Other factors of importance from KSR
What is particularly of concern to the author is the language of the U.S. Supreme Court in KSR in stating
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one." KSR [Emphasis added] This implies that the U.S. Supreme Court may be considering at a future date expanding the scope of non-obviousness to include not o
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
ly analogous references, but any reference, irrespective of the field of art.
What is perhaps even more interesting is that this case on its face appears to be such a clear case of obviousness – the same field of art appears to have been involved, it was merely whether references combining solutions to different problems in the s
What is perhaps even more interesting is that this case on its face appears to be such a clear case of obviousness – the same field of art appears to have been involved, it was merely whether references combining solutions to different problems in the s
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
me field could be combined – that one wonders why the U.S. Supreme Court went to such great lengths to reverse when it could have done so merely on the basis of In re Duell.
Will KSR make patents stronger?
Clearly, if a patent applicant can overcome obviousness rejections where the scope of obviousness has been br
Will KSR make patents stronger?
Clearly, if a patent applicant can overcome obviousness rejections where the scope of obviousness has been br
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
oadened as in KSR, then the patent that issues will be stronger as it will be less subject to obviousness claims in a reexamination or infringement action.
Will KSR make patents more difficult to get?
For individual inventors and small companies, no. Their position is likely not changed. For larger entities that
Will KSR make patents more difficult to get?
For individual inventors and small companies, no. Their position is likely not changed. For larger entities that
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
would normally have fought through the appellate process to show that an examiner was not showing a teaching/suggestion/motivation, probably.
For more information on the patent process, please visit Patent Information.
C2007, Williamson Intellectual Property Law, LLC; all rights rese
For more information on the patent process, please visit Patent Information.
C2007, Williamson Intellectual Property Law, LLC; all rights rese
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ved, world-wide.
This article, and/or the reading thereof, shall not be construed as offering, containing or receiving of legal advice, may not be relied upon, and shall not create any attorney-client relationship or privilege. If you are considering protecting your intellectual property, you should consult with an attorney of your choice
This article, and/or the reading thereof, shall not be construed as offering, containing or receiving of legal advice, may not be relied upon, and shall not create any attorney-client relationship or privilege. If you are considering protecting your intellectual property, you should consult with an attorney of your choice
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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