by Dennis crouch
Sandoz Inc. v. Immunex Corp. & Amgen (Supreme Court 2021)
This new petition asks the Supreme Court to chime-in on the judicially created doctrine of obviousness-type double-patenting. The basic rule is that it is improper for a patent owner to extend the term of a first patent by simply obtaining a second patent that is an obvious extension. You might ask – why do we need a separate double patenting doctrine here? Doesn’t Section 103 obviousness do the trick already?
Evergreening via continuation used to be much more of a potential problem in days of yore when the 17-year patent term only began running at the the patent issue date. This would allow a patentee to receive a first patent in a family, and then receive a second patent extending out the patent term. And, that result was seen as an abuse of the system. The obviousness doctrine did not work for this situation because the first patent filing was not prior art to the second filing. Rather, obviousness-type-double-patenting and resulting requirement of terminal disclaimers were the solution.
Although the change in patent term has reduced the potential dramatic impact of term extension via double patenting, the prior art exclusions under 102(b)(2) and generous patent term adjustments for PTO delays maintain a steady demand for the principle.
In Sandoz, the patentee (Immunex) is attempting to extend its patent term with an arguably obvious innovation, but in a bit of a different way. The second patent is not a continuation or even a creation of the patentee. In addition, the second patent was not even one purchased or owned by the patentee. Rather, Immunex exclusively licensed the second patent from Roche. In its decision, the Federal Circuit held that obviousness type double patenting did not apply against Immunex because the company did not own both patents and did not even hold all-substantial-rights since Roche retained a “secondary right to sue” infringers. To be clear on this, the license appears to have been specifically designed to thwart an obviousness-type-double-patenting challenge.
In the end, however, the Federal Circuit court found that all-substantial-rights had not been granted since Roche retained a “secondary right to sue” infringers “if Immunex fails to rectify any infringement within 180 days after written request by Roche.” The distinction here of course is not actually meaningful in any way with regard to Immunex’s attempt to extend its exclusive rights over its product. [My prior post]
Sandoz now asks the following question to the Supreme Court:
May the patent owner avoid the rule against double patenting by buying all of the substantial rights to a second, later-expiring patent for essentially the same invention, so long as the seller retains nominal ownership and a theoretical secondary right to sue for infringement?
The petition primarily cites old precedent:
- James v. Campbell, 104 U.S. 356 (1881) (it is “hardly necessary to remark that the patentee could not include in a subsequent patent any invention embraced or described in a prior one granted to himself.”).
- In re Mann, 47 F.2d 370 (C.C.P.A. 1931) (applying double patenting to applications of different inventors)
- McCreary v. Pa. Canal Co., 141 U.S. 459 (1891) (second patent barred even if claims are changed).
- Miller v. Eagle Manufacturing Co., 151 U.S. 186 (1894) (“no patent can issue for an invention actually covered by a former patent, especially to the same patentee, although the terms of the claims may differ.”).
- Odiorne v. Amesbury Nail Factory, 18 F. Cas. 578 (C.C.D. Mass. 1819) (Story) (earlier patent creates “an estoppel to any future patent for the same invention”).
- Singer Mfg. Co. v. June Mfg. Co., 163 U.S. 169 (1896) (“It is self-evident that on the expiration of a patent the monopoly created by it ceases to exist, and the right to make the thing formerly covered by the patent becomes public property. It is upon this condition that the patent is granted.”).
- Suffolk Co. v. Hayden, 70 U.S. (3 Wall.) 315 (1866) (second patent to same inventor is void).
“May the patent owner avoid the rule against double patenting by buying all of the substantial rights to a second, later-expiring patent for essentially the same invention, so long as the seller retains nominal ownership and a theoretical secondary right to sue for infringement?”
Meaning that Sandoz wouldn’t have a problem were it patent-owner Roche who sued them instead?
Something doesn’t smell right here . . .
Further to Sandoz question: ” later-expiring patent for essentially the same invention”
If the patents aren’t commonly owned, and its the same invention then classic 102 would apply. If the patents aren’t commonly owned, and its essentially the same invention, then classic 103 would apply.
If the patents are determined to be commonly owned, and it is the same invention, then statutory double patenting applies and the later-filed patent is invalid (or shouldn’t be granted in the first place.) If the patents are determined to be commonly owned, and its essentially the same invention, then nonstatutory DP applies. A terminal disclaimer filed in the later-filed patent (making its term co-terminus with the earlier filed patent) would overcome the nonstatutory DP rejection.
To use Dennis language, no “extension of the patent term” i.e., no extension of the exclusivity by reason of having two patents covering the invention, would occur.
What am I missing?
I think the patent most likely invalid (probably based on 102g) is the expired one. I think that is what is missing.
Actually, this is the opposite. Immunex could have made the invention first in the US, because Roche seems to have made the invention in Switzerland. So I am not sure why Sandoz foccuses its argument on double patenting instead of anticipation/invalidity.
“extend its patent term with an arguably obvious innovation”
Dennis – you know clear well that this statement is inaccurate. What you mean is obtain another patent on the drug. All of us know that one cannot extend patent term with another invention. One can only “extend a patent term” via PTA or PTE. Don’t perpetuate the use of inaccurate language. It is unbecoming.
Finally, what you appear to have a beef with is whether the later-filed patent by Roche should be allowed in view of the earlier filed patents. As Paul and Dvan have already pointed out, it is curious how the later-filed Roche patent was able to contain claims that potentially cover the product. We should be discussing the merits of how this was allowed to happen.
xtain, since the subject here is “OBVIOUSNESS-type double patenting” why is “extend its patent term with an arguably obvious innovation” [as claimed] an inaccurate characterization of what is argued?
Paul – The articles say “The basic rule is that it is improper for a patent owner to extend the term of a first patent by simply obtaining a second patent that is an obvious extension.”
This sentence is absolute nonsense. As a practitioner, I know of no way to extend the term of a first-filed patent by filing a later, second-filed patent.
It confounds patent term with time of exclusivity. A classic ploy of those who think that a pharmaceutical product can only have a single patent that claims the product.
The only way to “extend a patent’s term” is through PTE or PTA.
What Dennis appears to be complaining about is Amgen’s effort to seek and get another patent that also covers the pharmaceutical product. The grip is that Immunex took steps to extend their time period of exclusivity on their pharmaceutical product by having multiple patents cover the product.
I agree, we should discuss double patenting. It appears that Amgen argued that Immunex’s in-licensed and later-filed patent was invalid for obvious-type non-statutory double patenting and that the “ownership” requirement of a DP rejection was satisfied with the license. (I am unsure why Amgen didn’t argue a straight 103 rejection. The article doesn’t say) The Fed Cir appeared not to address the “obvious” part of the DP rejection, but rather decided that the “ownership” requirement of a DP rejection wasn’t met.
Re: “I know of no way to extend the term of a first-filed patent by filing a later, second-filed patent.”
If by “extending the term” one means the practical result of still having a patent on the only commercially desirable product version of the invention, that can occurs whenever someone gets a patent with generic claims on the basic invention concept with a not commercially desirable enablement, and later gets a patent with unobvious and supported [new species] claims covering a commercially desirable version of the generic concept. [Not the case here.]
For pre-AIA patents, the term of the first filed patent was rather frequently effectively extended by delaying filing divisional applications until the first application was about to finally issue.
Sorry, I meant to say it was the prior change in the patent term statute [not the AIA] that made delayed divisional filings effective for what some Congressional Committee members and others have attacked as “drug patent evergreening.” [Which “political hot potato” I assume xtian has an interest in strongly objecting to, and which this blog silently but directly relates to?]
I have no dog in that “drug patent evergreening” fight other than as a taxpayer and also paying for Medicare D insurance. But I note that also being attacked as “drug patent evergreening” are follow-on patent applications for different dosages of the same drug, pill or capsule versus liquid dosages, taking or not taking the drug with other drugs or food, etc. I think you might agree that what should be addressed in those cases is proper PTO 103 handling of those cases? Also, they can be challenged in IPRs, unlike some double patenting only situations.
“follow-on patent applications for different dosages of the same drug, pill or capsule versus liquid dosages, taking or not taking the drug with other drugs or food, etc. I think you might agree that what should be addressed in those cases is proper PTO 103 handling of those cases”
If those inventions are not novel or obvious, 102 and 103 will dispose of them. Correct. However, to disparage these “follow-on patents” as not somehow nefarious or gaming the system is disingenuous.
How does one get “generic claims on a basic concept” in the first place?
Trying to fit the language as the courts have taken to using the language (while recognizing that different legal aspects may be at point, such simply has not stopped the courts from doing what my question implicates).
What is a basic invention? Is that like a patent on the phone, and then follow-on patents are patents on a phone with a foldable touch screen, or a phone with three cameras, etc….
Are you advocating that for pharmaceutical drugs, only the active pharmaceutical ingredient is allowed to be patented? Even if there is a novel way of later administering that same pharmaceutical ingredient it isn’t allowed to be patented because the drug already had a “basic patent” on it? I am trying to understand this viewpoint. Are you saying that public policy should be a factor in determining whether a follow-on patent should be granted even if it survives 102 and 103?
Xtian, re your last paragraph, those questions should obviously be addressed the various academic writings, statements in C-Span Congressional committee hearings on drug prices, etc. about alleged drug “patent evergreening.” Not mere news-readers here. Not adequately appreciating that this is now a hot political topic, with some dangers for ill-advised patent law changes, is not going to make it go away. Well written, factually supported, substantive legal articles are needed for effective rebuttals. Including explaining why the subject case here is not an “evergreening” suspect.
What seems strange to me, simply based on the article and reading the decision, is how the later issued patents were even allowed. It seems to me that if the original patents covered the active antibody that they would be prior art against the later patents. By asserting the later issued patents in litigation with respect to the antibody, the patentee is admitting those later patents cover the same exact antibody as found in the original patents. Why are those original patents not anticipatory prior art against the later one? Has anyone read and compared the claims in the patents in the case to see why that hasn’t happened?
Seems like first to file should make this all but moot. Not sure how you can ever take advantage of this in first to file system.
That was my thought as well. I am not sure that the situation here is all that problematic, but even if it is, it is a problem that will cease to matter shortly enough. This sort of situation will never be a problem under the AIA.
Greg and Votexx, could you please explain why the prosecution tactic asserted by Petitioner in the quote in 1 below would not work the same under the AIA? I did not see any indication in the Petition itself how the earlier patent was somehow avoided as prior art under pre-AIA law? What am I missing here?
P.S. Is the Petitions pre vs post AIPLA argument confusing patent term calculation with prior art date calculation? Was the extensively amended licensed “second” application here filed first or second?
BTW, the reason I am interested in this cert petition is that it is not like the more typical losers. An alleged term extension of a pharmaceutical patent [think public drug costs] by alleged application prosecution legerdemain, and which is allegedly contrary to rather than overturning prior Sup. Ct. decisions, could be quite appealing for a cert grant.
From the cert petition: “Having acquired control over Roche’s patent applications, Immunex set about repurposing them to cover etanercept. A decade into the prosecution, Immunex’s lawyers deleted Roche’s earlier claims covering the p55 receptor and added new claims covering Immunex’s p75-IgG1 fusion protein—i.e., etanercept…. Immunex made corresponding changes to the specification [to allegedly add p75 receptor disclosure not originally in the spec.] .. By taking over and reworking Roche’s applications, Immunex effectively extended its etanercept patent protection by a decade. ”
If this is really true, how did they avoid a new matter rejection of that application and 112 defenses in litigation if not even IC?
In another paragraph of the petition: “the applications discussed only the p55receptor and several other Roche receptors. .. They did not describe Immunex’s
p75 receptor—much less the full etanercept protein.” ?
“If this is really true, how did they avoid a new matter rejection of that application and 112 defenses in litigation if not even IC?”
Am wondering the same thing Paul.
Anyone know?
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