Posts Tagged: "written description"

The memorandum points to Amgen for stating that the “newly characterized antigen” test could not stand because it contradicted the quid pro quo of the patent system whereby in order to obtain a patent one must describe an invention (the antibody, not the antigen recognized by the antibody). The memorandum states that in view of Amgen, “adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional.”

In invalidating the Idenix patent, the Delaware district court effectively overturns what had been the largest award for royalty damages in a U.S. patent infringement case ever handed out. After a two-week trial in December 2016, the jury had awarded Index $2.64 billion in damages, which was based on finding Gilead infringed the Idenix patent – U.S. Patent No. 7,608,597 — by selling the hepatitis C virus (HCV) treatments Harvoni and Sovaldi.

In what appears to be a clear departure from the past, in Amgen, the Federal Circuit has rejected the test, basing its rejection on the ground that it effectively eliminates the written description requirement.  Amgen at 15, 16.  According to the Court, where a functional genus claim to antibodies to a newly characterized antigen is concerned, the underlying science is not so advanced as to establish that “make and use” is equivalent to the required description of the claimed antibodies.  Id. at 16.  Drawing such equivalence, the Court said would amount to declaring a contested scientific proposition to be so settled as to be entitled to judicial notice, which the Court was not prepared to do.  Id.

The purpose of the written description requirement is broader than to merely explain how to make and use the invention, which is the subject of the enablement requirement. Rather, to satisfy the written description requirement the applicant must also convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention… While the written description is just that – written – having multiple drawings that show the invention and various aspects of the invention from a variety of viewpoints can be extremely helpful. This is because every figure should be described with at lease one paragraph of text, frequently more.

Join Gene Quinn on Thursday, November 9 at 2:00 PM ET for a free webinar conversation on the trends and reality of 112 disclosure requirements. Gene will be joined by Todd Van Thomme, a shareholder with Nyemaster Goode PC, and Cynthia Gilbert, co-founder of Blueshift IP. Van Thomme specializes in mechanical and food science related innovations, while Gilbert specializes in computer implemented inventions. We will, therefore, focus our 112 discussions on these specific areas.

You absolutely want to file a patent application with a description that is a mile wide — that part is good — but you also need to also drill down far more than one inch deep in order to teach the various nuances of at least the key aspects of the invention. And there are always nuances that can go a mile deep for any and every invention, no matter how simple it may seem to you as the inventor… How do you know how far you need to go? You really should strive to remove doubt and questions from the reader’s mind. While a certain amount of experimentation is allowable, and patents do not need to contain blueprint level detail, ask yourself whether a knowledgeable reader would know from what you’ve written enough to understand your invention without asking additional questions. If answers to additional questions would be necessary to fully comprehend the invention then answer those questions.

The Federal Circuit vacated three interference decisions, in which the Board found that Stanford’s claims were unpatentable for lack of written description, and remanded for further proceedings… The Court thus vacated the interference decisions and remanded for the Board to (1) “reconsider whether Quake’s relevant patents and applications satisfy the written description requirement” and (2) examine whether the artisan “would have known, as of the priority date, that the … specification references to Illumina products meant random MPS sequencing as recited in the claims” and whether he or she “would have understood that the … specification disclosed random MPS sequencing, as opposed to whether the specification did not preclude targeted MPS sequencing.”

The crux of this so-called adequate description requirement is that once the first four patentability requirements are satisfied the applicant still must describe the invention with enough particularity such that those skilled in the art will be able to make, use and understand the invention that was made by the inventor. For the most part this requirement can be explained as consisting of three major parts. First is the enablement requirement, next is the best mode requirement and finally is the written description requirement.

As a general rule the ordinary plain meaning of the term as would be understood by someone of skill in the relevant technology area or science will be used. That may or may not be bad, and it may or may not be what you intended… When I teach this topic the example I tend to use relates to “standard room temperature.” If you have invented a process that needs to be carried out at 68 degrees F you might say that the process can or should be carried out at standard room temperature, for example. In the U.S. standard room temperature is generally referred to as 20 degrees C, which is 68 degrees F. But in some parts of the world what qualifies as standard room temperature is a bit warmer, sometimes up to 25 degrees C. So this illustration is particularly useful for several reasons. When you say standard room temperature did you even know that it has an accepted meaning in the scientific community? Were you aware that the meaning could vary depending upon whether the person reading the disclosure is in the United States or some other part of the world? This is where defining what you mean could be particularly important.

Various Synopsys parties and EVE-USA, Inc. (collectively “Synopsys”) sued Mentor Graphics, seeking a declaration that Mentor’s ’376, ’531, and ’176 patents were invalid and not infringed. Mentor counterclaimed for willful infringement of those three patents, and also asserted infringement of two more (the ’526 and ’109 patents). The court consolidated the case with another involving a fourth patent owned by Mentor (the ’882 patent)… A jury does not have to further apportion lost profits to patented features of a larger product after applying the Panduit factors, which implicitly incorporate apportionment into the lost profit award. Claim preclusion applies when a claim was asserted, or could have been asserted, in a prior action. It does not bar allegations that did not exist at the time of the earlier action.

One big mistake inventors make is they will go on page after page in their draft patent application about how they came up with the idea for the invention, what the market for the invention is and how they plan on tapping into that market. None of that is appropriate for a patent application. Various pieces, perhaps even all of it, would be appropriate for a business plan. So the first thing inventors need to understand and really internally appreciate is that a patent is NOT a business plan. If you are going to attempt to raise money to pursue your business objectives you will undoubtedly need a business plan and attaching a well drafted and previously filed patent application as an appendix can be useful at times, but a business plan and a patent application play very different roles.

Being your own lexicographer means is that you who can define your invention using whatever terms you choose, and after attributing pretty much whatever meaning you want to give to the terms you use. Indeed you get to define the terms you use so long as any special meaning you assign to any particular term is clearly set forth in the specification. It is true that the ordinary plain meaning of the terms as would be understood by one of skill in the relevant technology field will be applied if you do not provide your own definitions, but leaving nothing to chance is generally a good idea. It is an absolute prerequisite if you are using a term that has multiple possible meanings, or if you are referring only to a certain subset of what the term generally means or could mean.

The best mode requirement still exists, although the America Invents Act (AIA) has largely removed any consequences for failing to disclose the inventor’s best mode, which means the current state of the law is at best a bit murky. But why would you ever want to file a patent application that does not disclose something that you prefer or regard as better? The goal of filing a patent application has to be to completely disclose your invention with as much detail and description as possible, paying particular attention to alternatives and variations. So while you may be able to get away with not disclosing any preferences doing so would likely be a tragic mistake.

One of the biggest mistakes I see inventors make is they spend too much time talking about what the invention does and very little time explaining what the invention is and how it operates to deliver the functionality being described. Many inventors also make the mistake of only very generally describing their invention. If that is you then you are already light on specifics, which is extremely dangerous in and of itself. But the other problem I want to discuss is the flip side of the coin. It is important to be specific, but not just specific.

In short, a concise description of an invention is an inadequate description of an invention, period. The goal has to be to provide a full, clear, exact description of the invention in a way that particularly points out and distinctly identifies what the inventor believes he or she has invented and wants protection to cover. Even knowing what the legal standard is for the description that must be present in a patent application does not ensure that those without training will be able to satisfy the requirement. The blame for this goes to the way most people describe things as they engage in ordinary, everyday communications.