Pfizer v. Teva (Fed. Cir. 2008)
A family of three Pfizer patents covers aspects of the bestselling drug Celebrex. Seeing some possible holes* in the patents, Teva field an Abbreviated New Drug Application (ANDA) with the FDA with a Paragraph IV certification challenging the patents as invalid and unenforceable.
Continuation-in-Part After Restriction: 35 USC 121 blocks the use of a parent application “as a reference … against a divisional application” if the divisional was the result of a restriction requirement.
One of the Pfizer patents (the ‘068) is a continuation-in-part (CIP) filed after a restriction requirement. On appeal, the CAFC confirmed that Section 121 does not apply to CIPs: “a divisional application contains an identical disclosure to its parent application, but a CIP introduces new matter. . . . [T]he protection afforded by section 121 . . . is limited to divisional applications.”
Thus, the parent application of a CIP will potentially be used for an obviousness-type double patenting rejection. Here, the CAFC held that the CIP claims were indeed obvious when compared to the parent application.
Pfizer’s Strategy: From Dan Feigelson’s comment below:
Pfizer could have cured the problem with the ‘068 patent – even during the trial or the appeal – by filing a terminal disclaimer in that patent. I’m guessing they chose not to b/c they had nothing to lose and everything to gain by having the court adjudicate the question of 35 USC 121 to CIPs.
Best Mode: A patent is invalid when the applicant fails to satisfy the best mode requirement of Section 112. The requirement can be broken down into two elements:
- Whether the applicant subjectively “possessed” a best mode for practicing the invention at the time the application was filed; and, if so,
- Whether the disclosure would objectively enable a PHOSITA to practise the best mode.
Like other invalidity issues, best mode is determined on a claim-by-claim basis. There was no real question here that the COX-specific claims did satisfy the best mode requirement. The appellate panel refused to speculate further on the moot issue of how the best mode requirement is met for claims covering a larger class of compounds.
Note:
- * The post was updated to ensure that Patently-O remains non-controversial (See comments below).
Nice article, added to favourites 😉
What the …? David’s post has got to be the most m0ronic comment I have ever seen on this site. At first I thought it was just a lame joke. Clearly David has no idea what racism means. David, hopefully for the last time, “a chink in one’s armour” is NOT pejorative. Talk to your wife. If she has a modicum of sense, she would tell you how m0ronic it is to complain about “chink” in the sense of “fissure”.
I am disappointed and a little sad at how readily Dennis caved in.
P.S. I am of Asian descent.
Nice one Malcolm.
They’ll be wanting Dennis to remove all references to “manual manipulation”, etc., next, in case the less educated think they apply only to males…
Cheers, Luke
It’s nice that people here aren’t niggardly when it comes to sharing their opinions regarding common idioms.
Captain Obviousness, I think you meant, “Not everyone is blessed with **hindsight** like 6k.”
JAOI, I don’t think the Patent Troll Tracker is going to be considered a lobbyist under the Lobbying Disclosure Act. The LDA defines a lobbyist as:
“any individual who is employed or retained by a client for financial or other compensation for services that include more than one lobbying contact, other than an individual whose lobbying activities constitute less than 20 percent of the time engaged in the services provided by such individual to that client over a six month period.”
I don’t think PTT spent 20% of his time writing the blog. If he did, it didn’t show in his work product.
In addition, a lobbying contact is defined as:
“any oral or written communication (including an electronic communication) to a covered executive branch official or a covered legislative branch official that is made on behalf of a client with regard to…” (many things)
I am confident that PTT did not make any communication TO such officials. Here, I believe the term “to” means a direct contact. Otherwise, for example, a journalist (who presumably spends more than 20% of his time at his job) might end up being considered a lobbyist when s/he writes an article. Unless you have found a distinction between PTT and other writers that is not based on the fact that PTT hid his identity? You don’t become a lobbyist just because a covered official asks you a question or reads what you write.
JK, I think you meant to invoke Godwin’s Law, not jumping the shark.
Swastika is a symbol of peace and every religious invocation of peace to all humans ends invoking “svasti” even today in India which represents the world’s ancient cultures and 1/4th of the world’s population. Sanksrit word “Svasti” means well-being, fortune, luck, prosperity. Svastika is the symbol of well-being and prosperity.
New York, NY (February 26, 2008): The Hindu American Foundation (HAF) was represented in a delegation of Hindu spiritual and lay leaders that visited Israel last week to attend the Second International Hindu-Jewish Summit organized by the World Council of Religious Leaders (WCORL) in conjunction with the American Jewish Committee (AJC) and the Israeli Ministry of Foreign Affairs.
At the Summit, Rabbi Rosen formally read the Declaration upon which the leaders of the Rabbinate and the Hindu delegation had agreed. The nine-point Declaration broadly (a) reaffirms the common Hindu and Jewish belief in One Supreme Being both in its formless and manifest aspects; (b) expresses their common world view of the sanctity of human life; (c) recognizes that all religions are sacred for their people and therefore, no one should denigrate or interfere in the religious practice of others; (d) recognizes that the Svastika is an ancient Hindu symbol and was misappropriated by the Third Reich; and (e) calls for serious reconsideration of the Aryan Migration Theory–a largely discredited, racist theory that posits that an invasion by nomadic, non-Indian tribes conceived the Vedic civilization.
link to hinduamericanfoundation.org
“Second, why does the original meaning of a word automatically designate it to be the ONLY meaning?”
… and why would anyone (1) assume the anti-Chinese slur meaning and (2) be offended by it, when the original meaning (i.e., weakness in patents) is so obviously applicable and when the anti-Chinese slur would make no sense?
“Do the majority of people today still use the word “gay” to mean “happy?”
No. But I’m sure you could tell the difference between someone using the original meaning (“Don we now our gay apparel” from Deck the Halls) versus some who isn’t.
Consider the sentence: “Seeing their faggots were flaming, the boy scouts were gay.” The sentence has two meanings, but it’s pretty clear that the sentence was meant to invoke both. Dennis’s sentence, on the other hand, was clearly intended to invoke one meaning.
“On a broader example, do people who see the swastika symbol refer to it as a peaceful symbol?”
Anytime someone invokes Hitler or the Nazis, the argument has jumped the shark.
To be fair, I accused him of ign0rance, not stup1dity and I will be the first to admit I do not know David and maybe he is otherwise a remarkable individual.
However, not only did he make an ignorant statement, he persisted in maintaining his position after others pointed out the flaw in his reasoning.
I am considered to be fairly bright and knowledgeable among my peers, but some of my friends will be the first to tell you I have said some amazingly stup1d and/or ignorant things (much to their delight, sometimes). However, when it’s pointed out to me, I am suitably embarrassed and admit my mistake.
I do believe the person who questioned his logic abilities wasn’t over the line either.
Patently-O: Now with less racism!
. . . sheesh
Dennis, you’re a teacher. Please restore “chink” to its rightful place in your introduction. It simply serves better than “hole” (which is likely why you used “chink” in the first place). I am loath to give you advice as a teacher, but I respectfully suggest that your attempt to accommodate a reader’s linguistic ignorance is misplaced.
I’ve worked hard at learning English for more than 60 years, and still learn or re-learn a word or two every time I read the New York Times, or your blog for that matter. I admire both the Times and your writing because they don’t pander.
I admit I enjoyed reading the anti-PC comments above. However, I could have done without the comments on David’s intelligence.
As to the respondents who think themselves superior to “David”, I challenge you to read the last sentence of William Kristol’s op-ed piece in today’s New York Times (link to nytimes.com). It includes a perfectly appropriate phrase, in French, attributed to Georges Danton. I, a francophone Poli Sci minor, didn’t know who Danton was and needed a few minutes and a dictionary to fully understand the phrase. If you can do better, perhaps you are superior to David and me.
Don Champagne, Primary Examiner
USPTO Art Unit 3688
Hey Edith,
These here patent attorneys I have noticed are as thin skinned and predujanced as I am. Get me another beer, will ya- meathead… out of the chair.
“If you just learn a single trick, Scout, you’ll get along a lot better with all kinds of folks. You never really understand a person until you consider things from his point of view, until *YOU* climb inside of his skin and walk around in it”
David, you missed the most important aspect of that quote. Most people who are thin-skinned want others to do that trick *for* them.
The true trick, however, is for *YOU* to climb into someone else’s skin, without being thin-skinned yourself. And that means giving your neighbor the benefit of the doubt when he says something that might or might not be objectionable, putting yourself in his shoes (and not being thin-skinned).
Perhaps you’ll see this more clearly someday….
David: I hope that you use better logic than that when you prosecute patents.
David,
Wow! Are you really that ignorant?! Are you seriously saying you never heard the term “chink in the armor” before?
Context matters when a word has dual meanings. There is a huge difference between the example I just used and the antisemitic “jewing someone down.” The latter is entirely based upon an ethnic slur and the former is not.
ok, my final comments on this because I don’t want to waste anymore of Dennis’ bandwith on this. First, I never demanded that he take down his quote – just thought I would point it out that some people find it offensive. I didn’t know earlier and a lot of people don’t know. Whether you like it or not, that’s how they feel. Second, why does the original meaning of a word automatically designate it to be the ONLY meaning? Do the majority of people today still use the word “gay” to mean “happy?” On a broader example, do people who see the swastika symbol refer to it as a peaceful symbol? Like it or not, meanings change. You can bang your head on the wall but it doesn’t change that fact.
Finally, a quote from a well known character named Atticus Finch: “If you just learn a single trick, Scout, you’ll get along a lot better with all kinds of folks. You never really understand a person until you consider things from his point of view, until you climb inside of his skin and walk around in it”
*Cite to Lee, Harper, “To Kill A Mockingbird,” 1960; lest I get sued for copyright infringement.
Peace! Shalom! Heiwa! He Ping! Paix! Paz! Phyongh’wa! Ashtee! Frieden! Salaam!
Dennis, I am dismayed by your editing of the post to appease a baseless critic. PLEASE do not cave to the pressures of those who are uneducated and unjustifiably thin-skinned, or we will be left without a language. An objection to the phrase “chinks in the patent” is as ridiculous as objecting to the use of the word “slope” because it was a pejorative slang term applied by U.S. soldiers to Asians during the Vietnam War. Mathematicians across America are not being racist when they use a word that had a clear meaning prior to its use in a pejorative context. It’s our language–we need to defend it.
Gentlemen,
In your opinion,
Was what Cisco’s Tricky Rick did unlawful considering THE LOBBYING DISCLOSURE ACT OF 1995?
Why so?, or, why not so?
This is Jaoi(TM) and I’d like to know, because, as Patently-O readers know all too well, I, a self-employed inventor, am passionately biased in favor of America maintaining its world leadership and the strong American pre-Festo patent system that contributed to that prestigious and advantageous position We the American People enjoy. And I’d like our children and grandchildren to enjoy that as well.
Dennis, sorry, your post isn’t non-controversial yet.
I performed a text-analysis of your post against the words listed in the Racial Slur Database:
link to rsdb.org
Unfortunately, you used a word (the sixth word after ANDA… I can’t bring myself to repeat it, and probably couldn’t get it through the spam filter if I tried) that can be taken as a slur not only against Hispanics, but against Hispanic children!
Additionally, there are approximately twenty other instances where racial slurs are hidden within words (for example, “non” is hidden in “non-controversial” which you added by the update, and “bro” is hidden in “broken”).
Thank you for Patently-O. (I checked, there are no slurs hidden in the your trademarked coinage “Patently-O”.)
Gentlemen,
I appreciate your concern apropos the use of pejorative names and terms referring to certain groups of people – that is certainly not called for among sophisticated patent attorneys, attorneys who should know better, and who should respect laws relating to important national issues, such as the Lobbying Disclosure Act of 1995
link to lobbyingdisclosure.house.gov
What I find remarkable is why patent attorneys would lightly toss about the pejorative “patent troll” when referring to a particular class of clientele comprising non-practicing entities et al.
I understand why Cisco’s employee, IP Director Rick Frenkel, a/k/a “Tricky Rick” (rhymes with Tricky Dick) described Patent Troll’s as, for example, “people who prefer to remain hidden under the bridge or rock” while Tricky Rick was fraudulently lobbying on Cisco’s behalf for patent reform – Cisco got their patents now Cisco wants to close the barn door behind them.
In my opinion, what Tricky Rick did was fraudulent and or unlawful given THE LOBBYING DISCLOSURE ACT OF 1995 which reads in part as follows ([[insert]] and emphasis added):
“SEC. 2. FINDINGS. 2 USC 1601 The Congress finds that—
(1) responsible representative Government requires public awareness of the efforts of paid lobbyists [[the term “lobbyists” includes employees of an entity]] to influence the public decision making process in both the LEGISLATIVE AND EXECUTIVE BRANCHES OF THE FEDERAL GOVERNMENT;
…
(3) THE EFFECTIVE PUBLIC DISCLOSURE OF THE IDENTITY and extent of the efforts of paid lobbyists to influence Federal officials in the conduct of Government actions will increase public confidence in the integrity of Government.”
The excerpts below came from Cisco’s Director’s Troll Tracker website before it was taken down. Cisco IP Director Tricky Rick stated “all I am doing is reporting what I find publicly on the internet” …
I don’t think so – I think Cisco IP Director is purposely disparaging a particular class of patentee in order to influence government officials while trying to come off as “filling a void, talking about something nobody really publicly talked about”, i.e., a public service. Proponents of Cisco Tricky Rick’s Troll Tracker blog one after the other described it as a “public service.”
More excerpts from Cisco Director Tricky Rick’s Troll Tracker blog on Oct. 20, 2007:
“Blog Milestone … the blog is nearly 6 months old. I have received 30,000 visits … My readers include those from the Senate and House of Representatives, the Patent and Trademark Office … people have told me I am filling a void, talking about something nobody really publicly talked about before in a blog. … There are just too many people making too much money out there off of lawsuits by non-practicing entities … all I am doing is reporting what I find publicly … I am shedding light on people who prefer to remain hidden under the bridge or rock … So, I have decided I am no longer allowing comments and emails.”
——————-
This is Jaoi(TM) and I approved this message, and, God willing, I will have more.
6k says “duh”, but this slipped past (1) the Examiner, (2) the attorneys prosecuting for Pfizer, (3) the attorneys for Teva (who didn’t raise the issue until after the DC trial I believe), and (4) the attorneys litigating for Pfizer. That’s a lot of smart people who didn’t notice it or at least realize the implications. Not everyone is blessed with omniscience like 6k.
David,
Until you wrote
“I see – so context is important. So by your “context” definition, it is ok to negotiate a business transaciton by “‘Jewing’ someone down.” So this is also not offensive to anyone?”
I thought you were joking. I still suspect you are, but the above statement does not have the irony I inferred from your original post. You do see the difference between what you wrote and “a chink in the armor” don’t you?
Are we going to ban “Spic n’ Span” next?
“Posted by: David | Mar 10, 2008 at 12:07 PM” said:
“I see – so context is important. So by your “context” definition, it is ok to negotiate a business transaction by “‘Jewing’ someone down.” So this is also not offensive to anyone?”
David, I think that the example that you gave above fails to make your intended point, for three reasons:
First, the word “chink” has an original meaning that had nothing whatsoever to do with its later use as a perjorative — specifically, it had nothing to do with people of Chinese descent. Unless you can give me an example of the use of the word “jew” to mean anything other than a reference to Jewish people, your analogy is inappropos.
Second, your hypothetical is, in fact, and excellent example of why context DOES matter. Even if “jewing” had another, original meaning that has nothing to do with a group of people (as is the case with the word “chink”), the fact that it is being used in the context of a negotiation strongly implies that the word “jewing” is being used in a perjorative way, i.e., to imply that the person that you are negotiating with is acting in a way that has stereotypically been associated with Jewish people.
Third, if context is important (and it is), your should have concluded that the use of the phrase “jewing someone down” would NOT be OK, rather than coming to the opposite conclusion.
Lest you (or anyone else) conclude that I am prejudiced against people of Chinese descent, let me hasten to say that while I agree that perjorative terms are dangerous because caricature enables vilification, I also believe that demanding that everyone cease using a word that has a perfectly benign original meaning, just because you find it offensive, does not further the cause of preventing discrimination, but in fact damages that cause — by offending those who previously had no opinion about you either way and by giving more ammunition to those who were already against you.
chink
“slit,” 1535, from M.E. chine (with parasitic -k) from O.E. cinu “fissure,” related to cinan “to crack, split, gape,” from PIE base *gei-, *gi- “to germinate, bloom,” connection being in the notion of bursting open. The unrelated derogatory slang word for “a Chinaman” first recorded 1901.
I agree with Luke, but I would like to add that it appears that if the infinger asserts that the parent patent and the CIP patent are obvious variants, ie. obvious-type double patenting,then the infringer may also be commiting estoppel by admitting that the infringing product also falls with in the scope of the parent patent under the doctrine of equivalence. If the infringing product reads on the CIP and the CIP is admittedly an obvous variant of the parent, then the infringing product is an obvious variant of the parent, and thus also infringes the parent. Naturally, this assumes that the subject matter claimed in the patents at issue reflect the subject matter of their respective specifications.
Dennis, I’m disappointed that you capitulated to the PC people with their niggardly world view. Just because a word has both offensive and non-offensive meanings doesn’t mean you should give in to those who can’t tell the difference.
“On appeal, the CAFC confirmed that Section 121 does not apply to CIPs: “a divisional application contains an identical disclosure to its parent application, but a CIP introduces new matter. . . . [T]he protection afforded by section 121 . . . is limited to divisional applications.” ”
This interpretation of 121 by the CAFC cannot be correct. I agree 121 does not apply to CIPs. But the statute certainly allows one to add new matter to a divisional. In fact, it says if you choose not to add new matter you don’t have to file the declaration. To wit:
“If a divisional application is directed solely to subject matter described and claimed in the original application
as filed, the Director may dispense with signing and execution by the inventor.” 35 USC 121.
That is a huge IF. There is no other way to interpret this sentence than that the applicant has the option of filing a divisional with new matter and also a declaration, or a divisional w/out new matter and no declaration. Either way its still a divisional and 121 applies. The intent of Congress could not be any clearer.
Adding new matter to divisionals was one of the statutory provisions Dudas was trying to deep-six with the new rules. Looks like the CAFC has done it for him.
It appears to me that Pfizer’s problem was they didn’t call their CIP a divisional. But this should be curable with a reissue.
It is only 9 Am on the left coast and I have not yet read Pfizer or researched this point recently, it’s simply a straight-forward reading of the law. Consequently, I reserve my right to eat crow upon reading your learned responses/opinions. (Particularly 6K’s, who obviously sees himself as the preeminent authority on all things patent but who is unable to see any “newsworthy” issues in this case.)
BabelBoy
I see – so context is important. So by your “context” definition, it is ok to negotiate a business transaciton by “‘Jewing’ someone down.” So this is also not offensive to anyone?
link to yourdictionary.com
Again Dennis, I apologize for veering off topic. I enjoy your blog.
Wow, that’s a lot of really immature talk on a topic that has nothing to do with the blog. Are you all teenagers, or do you just act like it?
I agree with your wife David. I am white and I am offended everytime a waiter at a resturant asks me if I want Crackers with my soup.
Chink means a crack, cleft or fissure. There are no Chinese people in Pfizer’s patent and there is no reference to China. In English language, words have several meanings that depend on the context.
So instead of chinks, Denis should have said”
“Seeing some possible [Asian descent] in the patents, Teva field an Abbreviated New Drug Application (ANDA) with the FDA …”
FU
David, when used to refer to someone of Chinese descent, “Chink” is a perjorative. But it also can mean a narrow opening or a crack – e.g. “a chink in his armor” – which is how Dennis used the term. It’s the context that matters.
I know it wasn’t your intent but “chink” is an offensive term. My wife, who is of Asian descent informed me since I previously used the same term but apparently is offensive to many Asian folk.
link to google.com
Examiner#6k,
Grow up. If you don’t have anything productive to say, don’t say it. We are all very tired of your immature attitude. You remind me of a know-it-all teenager. It’s very boring.
But Teva still loses on the other patent claims – so, why isn’t this ruling deemed nonprecedential? If one party doesn’t prevail in toto, then why should the CAFC fill up the F.3d with rulings affirmed-in-part-reversed-in-part-part-we-couldn’t-agree-on-vacated-in-part-and-remanded-for-proceedings-not-inconsistent-with-any-part-of-this-ruling?
Well said, Luke. Your post also got me wondering–does anyone know of a similar blog site for European patents? It would be really great to learn more about that case law, but especially given the difference in styles, to say nothing about the underlying laws, I have a difficult time understanding it, and a blog would be great.
Pfizer could have cured the problem with the ‘068 patent – even during the trial or the appeal – by filing a terminal disclaimer in that patent. I’m guessing they chose not to b/c they had nothing to lose and everything to gain by having the court adjudicate the question of 35 USC 121 to CIPs. If they filed a t.d., then the ‘068 would have expired in 2013, at the same time as the parent, rather than two years later. So if the court were to invalidate the ‘068 for obviousness-type double patenting, they’d have lost nothing, since they’d still have the two other patents to protect the product until 2013. On the other hand, if the other two patents were invalid for inequitable conduct or failure to comply with best mode, then the ‘068 would likely have gone down too. Under those circumstances, why not gamble and see if the court will apply the protection of 121 to a CIP filed to cover restricted-out subject matter?
Jim Demers hints at an interesting question: what if I file a divisional to cover restricted subject matter and then file a CIP on the divisional? From this decision, it sounds like I should be careful to claim in the CIP only the new material, and any originally disclosed material should be claimed in the divisional or continuations thereof rather than in the CIP.
6k, one reason services like Dennis’ are valuable is precisely because they mean you don’t have to “cipher” (sic) any of it out for yourself – you are told about it in easily-digestible way precisely so you don’t have to use even half your brain figuring it out.
Figuring out even the obvious takes time and therefore money. And in this game, what is obvious may not, of course, even be correct, so it’s nice for someone else to confirm things for you.
This of course also applies even if you already knew this piece of lore, rather than having to figure it for yourself. Reinforcement is a valuable learning tool, you know.
Cheers, Luke
Section 121 certainly shouldn’t protect the new matter in the C.I.P. from the prior art effect of the parent application. If I read this decision correctly, however, *all* claims in the application, not just those that rely on the new matter, lose the benefit of 121. This is a very literal application of section 121, and I think it directly conflicts with the legislative intent behind the statute.
Um, duh? How is this newsworthy? You’re trying to tell me this is new? Anyone with half a brain could cipher that out.
Comments are closed.