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PharmaPatents
Partner, Chem Bio Pharma practice, Foley & Lardner LLP
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Thanks for the shoutout on the PTA issue. I think HR 6621 would measure the 180 day period for bringing a district court action from the date of the PTO decision on the request for reconsideration, so no matter how long the PTO takes, the patentee would have 180 days from the decision to bring suit.
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Taking the lead from the USPTO, instead of hiring more attorneys and agents to write responses, I will hire web designers to create a dashboard so I can see how much work I have to get done and estimate how many EOTs it will take for me to clear my docket.
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The dashboard is interesting and may be useful for the USPTO to convince Congress that it needs more funding, but its not really helpful to applicants, becasue USPTO-wide statistics are not a good indicator of what is happening in a specific group/art unit/application. I also find the 95% quality statistics hard to swallow. Do you pass quality review if the claims are rejected for reason A and quality review determines that the claims should be rejected for some reason? The Applicant only can respond to the rejection that was made, so if reason A is bogus, that should fail quality review. Do you pass quality review if the claims are rejected for reasons A, B and C and quality review determines that reason B (but not A or C) was valid? That gives a "pass" on bogus rejections that Applicants have to respond to. As for the Examiner numbers, of course Examiners will leave for various reasons, but the same number or more should be hired, particularly in this economy when law firm hiring is down.
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And then it would be challenged on the basis of inequitable conduct because somehow in desigining your search parameters, selecting the "most relevant" prior art, or applying that art to your claims you did something that a competitor will make out to be a material misrepresentation or ommission and they will find some modicum of evidence of intent to decieve (or not, if the materiality was so great), so you patent will be unenforceable.
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And, seriously, if we want to promote U.S. innovation, why do we keep entering PPH agreements with other countries? Now if you have a Russian priority claim (or a PCT with no priorty claim) and get a Russian allowance, you can expedite examination of a corresponding U.S. application - cutting the line ahead of U.S.-originated applications. Not that I'm really opposed to the PPH (I do have foreign clients who may benefit), but it seems to be at odds with the goals of promoting U.S. job growth, etc.
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Ah, its times like these when I am so proud to be a native of the fine Commonwealth of Virginia! At least I don't live in the 10th Congressional District, which is the area that Rep. Wolf (R) represents. The USPTO isn't in the 10th District either, so I doubt that Kappos had anything to do with this. Wolf's website says that this legislation •Protects American intellectual property by restricting unnecessary foreign access to pending patent applications. The proposed law also includes an amendment to 102(e) that I can't quite follow: (4) CONDITIONS FOR PATENTABILITY- Section 102(e) of title 35, United States Code, is amended to read as follows: `(e) the invention was described in-- `(1) a patent granted on an application for patent by another in an international application filed under the treaty defined in section 351(a); and `(2) such application designated the United States and was published under article 21(2) of such treaty in the English language; or'. Is he doing away with the prior art effect of U.S. applications altogether? Aren't the timing terms missing from his proposed paragraph (1)? Another part of this legislation would let universities and affiliated patent holding companies jump to the front of the examination line: The Director shall give priority to the examination of an application made by an applicant that is-- `(1) an institution of higher education, as such term is defined under section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)); or `(2) a patent holding company affiliated with such an institution.'. According to Wolf's website, this: •Prioritizes patent applications from American universities to ensure that cutting-edge new technologies may be protected and rapidly-deployed for U.S. firms. Because univeristies are the hot-beds of job-creating innovation? I'm not saying their contributions aren't important, but why chose universities over small entites? Or, heck, why not just give priority to all U.S. applicants and let those foreign applications rot? I see this as an example of a legislator jumping into an area that he doesn't understand and making a proposal that may sound good to constituents who aren't patent savvy, but wouldn't work in reality. But, since Congress never will pass any meaningful patent reform, I don't think we really need to worry about this.
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Malcom, here is claim 1: A modified release tablet having two portions, wherein a first portion comprises a first quantity of guaifenesin in an immediate release form which becomes fully bioavailable in the subject's stomach and a second portion comprises a second quantity of guaifenesin and a release-delaying matrix comprising a hydrophilic polymer and a water-insoluble polymer wherein the weight ratio of said hydrophilic polymer to said water-insoluble polymer is in the range of from about 1:1 to about 6.8:1, wherein said tablet demonstrates a Cmax in a human subject equivalent to the Cmax obtained when the first of three doses of a standard immediate release formulation having one third the amount of guaifenesin is dosed every four hours over a 12 hour period, and wherein said tablet also provides therapeutically effective bioavailability for at least twelve hours after a single dose in a human subject according to serum analysis. I don't know whether the functional language was required to distinguish the prior art. If the accused product met the physical claim limitations, maybe the functional language was all that was left to argue about. Or, if the accused prodcut did not meet the physical claim limiations, maybe you would argue that it was "equivalent" if it still met the functional limitations. Paul, that is the issue that caught my eye.
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Malcolm, as I recall, the patent claims are largely written in functional terms. It is (or was) a common practice for dosage forms. I think I agree with James that there is no inherent inconsistency between the preponderance of the evidence standard and the 90% confidence interval. You could have to establish that it's more likely than not that the accused product yields a result within the range at a 90% confidence interval.
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I wrote about another issue in this case: http://www.pharmapatentsblog.com/the-significance-of-numerical-claim-limitations/
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And, if there are public policy reasons to have more exceptions/limits on patent rights, that's for Congress to figure out.
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Malcolm, the exception you're talking about (35 USC 271(e)(1)) lets competitors develop new therapies, but not market them - it only applies to would-be infringing acts "solely for purposes reasonably related to" obtaining FDA approval. The intention was to let generics get through the FDA approval process before the patent expired, so that once the patent expires the generics can hit the shelves. So, in the ACLU case, competitor labs can't use the patented genes in their own tests without Myriad's permission or until the Myriad patent expires, but they probalby could go through the steps required to get FDA approval for their tests, so that once the patent expires they are ready to enter the market.
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Is the court saying that a "misrepresentation" cannot be attorney argument because it crosses the line from argument to un-truth? I haven't read the case or the underlying patent, but it seems that there could be a difference between what a reference "proposes" (sets forth expressly) vs. what that reference might mean to a skilled person reading the reference in light of the whole state of the art. Again, this decision is going to make patent attorneys want to say as little as possible. Why discuss the prior art at all? Just send it in an IDS and let the Examiner figure it out. Right, Malcolm? (I'm having a Newcaslte Brown Ale, how about you?)
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Thanks, 6, I can finally take a vacation now. Smashmouth, 101 is not jurisdictional, otherwise the court wouldn't have tha authority to invalidate a claim under 101. The Supreme Court did say that it was a "threshold" issue, but in King Pharmaceuticals this week, the Fed. Cir. decided not to reach a 101 issue when it could invalidate a claim under 102, so go figure. Ned, I can't speak for Malcolm, but an isolated DNA claim doesn't impact any uses of naturally ocurring DNA because the scope of the claims just doesn't reach naturally occurring DNA. If I patent an isolated human gene, I can't sue you for infringement (because your body is making or using naturally occuring DNA), no matter what the ACLU says. On the other hand, my patent could prevent others from making, using or selling isolated DNA for any reason. I think the public is generally OK with the use of patents to prevent commercial competition, but gets uneasy about preventing "research," etc. Of course, that's a question of enforcement - just because a patent owner could enforce a patent against a researcher doesn't mean that they will. People do license patents. This "gut reaction" also ignores the fact that even researchers must get funding from somewhere, and universities get their own patents and/or enter into joint patenting agreements (or licenses) with commerical entities. Now I'm agreeing with Malcolm's last post above. The whole patent system is based on the notion that granting patents encourages "progress." I haven't seen any justification for second-guessing the wisdom of our Founding Fathers and pulling the plug on patents in an entire field that promises the next breakthroughs in medical diagnostics and therapeutics. Don't "we" worry that socialized medicine will limit the cutting-edge healthcare that we are used to? But at the same time "we" want to "socialize" the fruits of genetic research so that it is "free" for everyone? We can't have it both ways.
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IANAE - On your first hypothetical, you have to review the requirements for induced/contributory infringement. You can be liable for infringement if you encourage others to use a product in an infringing manner, even if the product per se is not patented. My experience with European patents is that you can obtain patents on new uses of known drugs just as easily (or not) as you can in the U.S. You have to phrase the claims differently, but even that is getting easier with recent EP decisions. In Europe, we now can claim : "Old compound X for use in new method Y." Isn't the "First Amendment" issue a red herring? The First Amendment doesn't prevent you from enforcing your copyright to keep me from performing a song, why should it be different in the context of patents? I walk through some of the "printed matter" cases in my article on this case. http://www.pharmapatentsblog.com/pick-your-poison-patentineligibility-or-inherency/index.html
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Why am I surprised that I agree with Malcom Mooney's first post? Ned, if I discover that a certain compound in bark that has been ingested for medicinal (or recreational!) reasons has the desired effect, I can patent the isolated compond (if its otherwise novel) and a method of using the isolated compound for the same medicinal reasons. I have promoted the progress of the useful arts by identifying the active compound, and for disclosing that discovery to the world I get my 20 yrs patent term. Didn't the "mineral" case confound 101 and 102?
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6, thanks for your explanations. Can you give us an idea of the size of your "New" docket? If you only do act on one case from that docket every bi-week, how long would it take for you to "have" to work on an RCE filed now?
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The backlog at the Board is 2 yrs and growing. If we think we can make any progress with the Examiner we will file an RCE. We often get finals that make new rejections (because our claim amendments overcame the first ones) or new rationales for maintaining rejections that we think we can work through so an RCE makes sense and is effective. I wrote about our post-RCE inventory on PharmaPatentsBlog.com.
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Yes, people with claims similar to Prometheus thought they were safe after Bilksi, until the remand came out. See my article at: http://www.pharmapatentsblog.com/catching-a-breath-after-bilksi/ Does the MOT require the M or T to be novel per se? If not, how can it matter that the "transformation" is performed by known methods? If so, how can all those business method patents that recite the use of a "computer" to comply with MOT actually be patentable? Isn't patentability evaluated as a whole, rather than on a line-by-line basis? The panel opinion addressed the "data gathering" issue and determined that the steps at issue, while useful for obtaining data, also were essential to the methods, and so could support patent-eligibility. We'll see what happens on remand. I agree that the Prometheus/Classen/Myriad case present an interesting trio that could have a major impact.
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The duty of disclosure applies to information that a "reasonable examiner" would find to be relevant. Usually patent attorneys/agents have a better understanding of this standard than inventors. Inventors often don't understand why a secondary reference was cited when the point of the reference has nothing to do with the invention, and inventors tend to focus on what a reference shows (e.g. with experimental data) rather than what is said in the introduction or conclusion. If inventors don't understand why the Exmainer cited a reference, are they the best people to decide which references should be submitted in an IDS? Maybe for the first cut of references, but probably not for close calls.
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Another interesting study would be to see what fraction of cited references are already in the hands of the PTO (such as in another application file)! You might be interested in my article on the McKesson problem: http://www.pharmapatentsblog.com/articles/duty-of-disclosure/
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The Strategic Plan includes the following hiring goals: 250 IP-experienced examiners in FY 2010 1000 examiners in FY 2011 1000 examiners in FY 2012. Doesn't say the net gain they are counting on to meet their pie-in-the-sky goals (50% reduction in backlog).
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Sometimes we have to file RCEs to submit an IDS driven by McKesson. Even if we think our response will result in an allowance, we have to file an RCE to submit references/Office Actions from co-pending applications.
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Am I reading this right? http://www.uspto.gov/patents/stats/examstaffing.jsp For FY 09, there was a total increase in examiners from 6063 to 6143 (net gain = 80), with 588 new hires, which means that 508 examiners left.
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Once the application that claims priority to the provisional application is published, the provisional is open to the public. You can usually access it on PAIR, through the "Continuity Data" tab of the published application.
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One rationale of Milburn that is left out of today's decision was that but for the (necessary) delays of the patent examination process, the application at issue would have been publisehd as of its filing date: Clifford had done all that he could do to make his description public. He had taken steps that would make it public as soon as the Patent Office did its work, although, of course, amendments might be required of him before the end could be reached. We see no reason in the words or policy of the law for allowing Whitford to profit by the delay and make himself out to be the first inventor when he was not so in fact . . .. With provisonals, you can create secret prior art by taking delibrate steps to keep your application secret, e.g., by filing a provisional application instead of a non-provisional application. I'm not saying this is right or wrong, just a bit of a twist from aspects of Milburn. Also, someone said that this has alwasy been the rule, but I have a vague recollection that back in the early days of provisional applications it was different - U.S. applications might not have been cited as of their provisional dates, based on the theory that they never were intended to be published. Does anyone else remember this from the late 90s?
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