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FEEHER Y HANK: In the pharmaceutical industry theres a real incentive - PDF document

MODERATOR: The proposed legislative move from a first-to-invent system to first-to-file would bring U.S. patent law into line with Europe and Japan. Coupled with proposed patent office rule changes, how would this affect your practice? DELMASTER:


  1. MODERATOR: The proposed legislative move from a first-to-invent system to first-to-file would bring U.S. patent law into line with Europe and Japan. Coupled with proposed patent office rule changes, how would this affect your practice? DELMASTER: In the United States a lot of people think this is a catastrophe,that it’s just not fair.It certainly is going to be an issue in a patent attorney’s first contact with a new inventor or a sizeable company where inventions get generated on a fairly regular basis. There’s going to be a lot of consideration given to getting things done quickly and efficiently,getting patent applications on file in a hurry. FEEHERY HANK: Y ou’ve got real strategic changes caused by the proposed new rules in terms of how you’re filing your application, what’s in your claim, what your claims are going to look like, which claims are going to be representative.And now you’re saying,“And we need to be in the patent office as soon as possible because one day late means you could lose your rights.” RUDNICK: This dovetails with the proposed patent office rule change granting only one continuation application as a matter of right. In accordance with these two proposed changes, early in the process you would be identifying strategically what you want to claim and what the boundaries are, what you think your invention is and how many patent applications should be involved — and you would no longer have the option to sit and think about it before filing or to make significant decisions after filing. DELMASTER: The question about whether or not first-to-file is fair has already been settled in the rest of the world.They don’t care. MODERATOR: Isn’t the inventor supposed to get the patent? RUDNICK: Our constitutional charge is literally for Congress to make laws to promote the progress of science by grant- ing inventors the exclusive right, for a limited time, to their discoveries. Historically, Congress has defined “inventors” as those who are first to invent.We recognize that giving you that right will allow your competitors to look at what you did, based on a full disclosure in your patent, so they can design around you and come up with an even better idea. Nothing in the Constitution prevents Congress from changing the definition of inventor to “first to file.” DELMASTER: Is it possible that the real inventor of an invention can be disenfranchised under the first-to-file rule? Absolutely. Is it fair under the broadest concept of fairness? Probably not. But it’s the way the world operates, and it’s about to be the way the United States operates, too. RUDNICK: In Japan, in certain technology segments, the minute somebody comes up with an idea they scribble a 2-page description and file it as a patent application. But Japanese examiners only examine those patents for which applicants later file,after some thought,a request for examination.In the U.S.every filed patent application is intended to be examined. So if we’re going to have a flurry of very short applica- tions, with less than 10 representative claims under new patent office rules, this could result in a much heavier burden for the patent office. DELMASTER: Maybe, maybe not. If we talk about the practi- calities of the first-to-file system, we do have the provisional patent application, which doesn’t burden the patent office because it does- n’t get examined. But it does give you a bookmark date in the patent office as to when you invented what’s in the provisional application. Once first-to-file is the law, I will counsel clients that if the invention they bring to me is fully realized right now, then let’s write it, illus- trate it and file a provisional application as quickly as we possibly can. FEEHERY HANK: Y ou may see patent attorneys saying,“We have a full-blown applica- tion here.We have all of our claims.We know as much as we can up to this point, but we’re filing it as a provisional because it gets us another year to know the lay of the land.” DELMASTER: If it’s going to be done effectively, the closer a patent lawyer can work with a technology manager or the internal legal counsel managing intellectual property, the better it’s going to work. FEEHERY HANK: Right. It’s a day-to-day type of thing. DELMASTER: W e would all agree, I’m sure, that industry’s aim usually is to keep the patent attorney — if there’s no in-house patent counsel — out of it until it’s absolute- ly necessary for them to be in it.That’s not going to be a very good strategy in the future.

  2. FEEHERY HANK: A lot of what we see with our clients now is,“Well, we keep good records.” Good records are nice to have in pulling together a good patent application, but under a first-to-file system those records are not going to be what you fall back on.What you’re going to fall back on is what’s filed with the patent office.There will be some people who say that first-to-file is unfair:“I invented it first. I just didn’t get to the patent office that week.” Under this proposal, it's the first to file. And it would become one of the few bright-line rules that we’d see. RUDNICK: On the defense side, the use of what we commonly refer to as “submarine patents” may disappear.That is when someone files a broad patent application and continuation after continuation — for many years in some instances.Y ou wait for a technology segment to mature, then you refine your claims — in what I refer to as “predatory claim drafting.”All of a sudden you have a patent that lets you go after everybody in the industry. MODERATOR: As Robert mentioned, the patent office has proposed a limit to the number of claims to be examined. FEEHERY HANK: Y ou will be limited to no more than 10 claims as representative.Y ou would not initially be able to separately argue the patentability of any nonrepresentative claim in that application. If you designated more than 10 claims, you would be required to file an Examination Support Document.This would be very expensive because it goes through each prior art–reference point by point, claim by claim, element by element, saying what is new and what is different and why you should get a patent over it — essentially doing what the patent examiner is currently supposed to do. RUDNICK: In the past if you came up with one new product and, say, there were five or six features that you were think- ing of patenting in that new product, you might file one or two patent applications and group claims for the features together to save the time and expense of filing multiple patents.Later you could use continuation applications to separate out the grouped claims and features as necessary. I have significant concerns about filing this Examination Support Document that Maryellen referred to because you are taking a position with regard to prior art and pending claims. Each statement you make can be used against you later. DELMASTER: Y ou’re vulnerable against the future opponent in litigation; that is, to having that opponent pick apart what you have written in this Examination Support Document and then go so far as to allege that you misrepresented something to the patent office and got the patent by nefarious means.And we all know where that goes. MODERATOR: That goes to invalidate a patent.Any other issues raised by the proposed patent office rules? FEEHERY HANK: The patent office is saying that they do not want cumulative documents, which is a very big thing because if you believe that the document is cumulative and you do not disclose it to the patent office, it’s likely that the first thing that will come up in later litigation is,“Y ou did- n’t disclose this document to the patent office.” And you’re going to be arguing,“It was cumulative.”Anything that’s slightly different about the doc- ument could be used against you. RUDNICK: I have a feeling there will be a lot more patent applications being filed in particular technology areas.So although it may take a shorter time to actually examine up to 10 claims of a given patent application, examiners in these areas would face an increase in the total number of applications so that any intended reduction in the workload because of the 10-claim limit would be lost. FEEHER Y HANK: In the pharmaceutical industry there’s a real incentive to get a patent as soon as you can on something that would cover the product so that you can be listed in the FDA “Orange Book”— the idea being that at least then you know if someone is filing a generic-drug application and you have the ability to do what you can to stop it.Under the proposed rules it may be more difficult to say,“Y es, we’ll take these claims and we’ll file a continuation application to fight it out for broader claims. ” DELMASTER: This is not streamlining for industry or for small inventors but, rather, for the patent office. It puts the onus on everyone else to do the job better before it gets to the patent office. FEEHERY HANK: Y our initial strategy just has to be ironclad. DELMASTER: Many people in industry and some attorneys complain that there are

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