Patent Baristas

Under Secretary Jon Dudas identified three new United States Patent and Trademark Office (USPTO) initiatives that will speed patent prosecution, and which will save applicants about $30 million annually at a “town-hall meeting” held last Friday in Chicago. Of course, it was a town hall meeting that charged admission but I digress. According to a press release by the USPTO, the initiatives include changing the rules for appeal conferences, eliminating the backlog of ex parte re-examinations and creating a more transparent office.

Dudas said that USPTO customers will save at least $30 million annually due to a new program this year that allows applicants to request an appeal conference and learn the results before having to file an appeal brief. Currently, when applicants appeal rejections to the Board of Patent Appeals and Interferences (BPAI), they must file a notice of appeal and an appeal brief. The next step is an appeal conference. Statistics demonstrate that appeal conferences result in approximately 60% of cases being returned to the patent corps. I would like to see customers could save even more money by having more and better trained Examiners in order to avoid the necessity of many of the appeals in the first place.

In regard to ex parte re-examinations, the USPTO will change the way it handles requests to ensure that re-examination remains a viable, cost-effective alternative to litigation. According to Under Secretary Dudas, the new system will allow the agency to the complete processing of 420 cases that have been pending for more than two years. Also, three-examiner panels will be assigned to each re-examination, compared to the past practice of assigning a single examiner to each case – all to ensure that current and future ex parte re-examinations take no longer than two years to process.

Dudas also discussed his concept of a more transparent office, pledging to provide USPTO customers not only with more information, but information and numbers that have greater meaning. He spoke at a “town meeting” sponsored by the American Intellectual Property Law Association (AIPLA), the Federal Trade Commission, and the National Academy of Sciences.

Just when you thought it was safe to say “FDA”, and things seemed to be calming down ever so slightly with the uproar over COX-2 inhibitors and scrutiny over the FDA approval processes, the issue of suspect drugs plaguing the pharmaceutical industry has now spread to the biotech sector, with one of its best performing companies and a partner pulling their highly touted multiple sclerosis drug from the market.

Biogen, Inc., the makers of Tysabri, a new drug used to treat multiple sclerosis, announced Monday they are voluntarily suspending sales of the drug after one patient died and another developed a serious disease of the central nervous system.

Biogen Idec hammered out the details of the marketing suspension over the weekend in talks with FDA officials. The decision by Biogen Idec and the FDA to immediately suspend distribution and administration of Tysabri is a cautious approach that may have been influenced by the recent disclosure of newly discovered risks associated with the COX-2 inhibitors. Recall that in September, Merck pulled Vioxx off the market citing a new study linking the medication to increased risk of heart attack and stroke.
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Walker Morris in London sent a note regarding the October, 2004, opinion in the patents case Kirin-Amgen v. Hoechst Marion Roussel. The case was the first opportunity for the House to consider the critical question of the extent of protection conferred by a patent under the provisions of the European Patent Convention (EPC), which were incorporated into UK law by the Patents Act 1977.

The dispute between Amgen and Transkaryotic Therapies, Inc. (TKT) relates to the production of erythropoietin (“EPO”). EPO is produced in the kidneys in minute quantities. It was discovered that EPO had the useful property that it stimulated production of red blood cells and as a result it was very valuable for the therapeutic treatment of anemia.

Amgen invented a process of producing EPO by recombinant DNA technology. For this invention Amgen was granted a European Patent (EP0148605B2). Essentially, Amgen had discovered a way of inserting the genetic code for the expression of EPO (or a part of the EPO protein) into a host cell. Amgen’s patent was directed to this invention. TKT developed a different method of producing EPO. TKT discovered a way to “switch on” a cell’s natural ability to express EPO. This method was unknown at the priority date of the patent. Amgen sued for infringement of Amgen’s patent.
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The Baristas will be attending the Ohio Valley Affiliates for Life Sciences Group (OVALS) regional conference  "The Promise of Innovation: OVALS Making It Happen" on March 7-8, 2005, at the Dayton Marriott Hotel in Dayton, Ohio. 

Register and see Agenda.

The OVALS Partnership developed in 2002 as a forum to discuss and stimulate economic development opportunities for Life Sciences within the "Ohio Valley" region.

I was recently reminded about how easy it is to lose patent rights due to a miscalculated publication. Since I regularly represent universities and other research institutions in patent matters, I’m very familiar with publication pressure felt by faculty and students and the inherent rush to be the first to present findings to peers. I made many of these types of presentations myself as a graduate student.

Last month, I had a researcher who did all the things necessary to protect his invention, or so he thought. While the inventor knew enough to submit the invention for filing prior to publication in a journal, it came to light that the invention was disclosed by the inventor and his student a month earlier in a poster presentation at a conference. As you may know, a case this past fall illustrated the dangers of prior publications in the In re Klopfenstein decision.

Get the complete opinion here: Download file

In In re Klopfenstein, the inventors applied for a patent on October 30, 2000. Their patent application, Patent Application Serial No. 09/699,950 (the ‘950 application), disclosed methods of preparing foods comprising extruded soy cotyledon fiber. The ‘950 application claimed that feeding mammals foods containing extruded SCF may help lower their serum cholesterol levels while raising HDL cholesterol levels.

However, in October 1998, the inventors presented a printed slide presentation at a meeting of the American Association of Cereal Chemists (“AACC”). The fourteen-slide presentation was printed and pasted onto poster boards. The printed slide presentation was displayed continuously for two and a half days at the AACC meeting. In November of 1998, the same slide presentation was put on display for less than a day at an Agriculture Experiment Station (“AES”) at Kansas State University. The poster presentation presented to the AACC and at the AES in 1998 disclosed every limitation of the invention disclosed in the ‘950 patent application.

The court noted that neither presentation contained a disclaimer or notice to the intended audience prohibiting note-taking or copying of the presentation. No copies of the presentation were disseminated either at the AACC meeting or at the AES, and the presentation was never catalogued or indexed in any library or database.

The examiner found all of the claims anticipated by this reference or obvious in view of it and other references. The inventors argued that this reference was not a “printed publication” because no copies were distributed and because there was no evidence that the reference was photographed. The examiner rejected these arguments and issued a final office action rejecting the claims of the ‘950 application. The inventor’s appealed the examiner’s decision but the Board of Appeals affirmed on the grounds that the full invention of the ‘950 application was made publicly accessible to those of ordinary skill in the art by the this reference and that this introduction into the public domain of disclosed material via printed display represented a “printed publication” under 35 U.S.C. § 102(b).

In its decision, the court stated that “distribution and indexing are not the only factors to be considered in a §102(b) ‘printed publication’ inquiry.” The court looked at the length of time the display was exhibited, the expertise of the target audience, the existence (or lack thereof) of reasonable expectations that the material displayed would not be copied, and the simplicity or ease with which the material displayed could have been copied.

Finally, the court held that:

Upon reviewing the above factors, it becomes clear that the Liu reference was sufficiently publicly accessible to count as a “printed publication” for the purposes of 35 U.S.C. § 102(b). The reference itself was shown for an extended period of time to members of the public having ordinary skill in the art of the invention behind the ‘950 patent application. Those members of the public were not precluded from taking notes or even photographs of the reference. And the reference itself was presented in such a way that copying of the information it contained would have been a relatively simple undertaking for those to whom it was exposed—particularly given the amount of time they had to copy the information and the lack of any restrictions on their copying of the information. For these reasons, we conclude that the Liu reference was made sufficiently publicly accessible to count as a “printed publication” under § 102(b).

After reviewing this case, I had to wonder whether or not it would have saved the application if the inventors had just included a statement on the poster presentation to the effect of “Proprietary Materials. Copying of any information contained herein is strictly prohibited.” I would argue yes given that the court made a point of stating that the inventors should have taken protective measures … “even a simple disclaimer informing members of the viewing public that no copying of the information will be allowed or countenanced.”

The court made a big deal about how long the poster was accessible stating that “The duration of the display is important in determining the opportunity of the public in capturing, processing and retaining the information conveyed by the reference. The more transient the display, the less likely it is to be considered a “printed publication.” … Conversely, the longer a reference is displayed, the more likely it is to be considered a “printed publication.”

This doesn’t leave researchers with very clear guidance. Since it seems that the inventors in In re Klopfenstein left their poster on display too long, it begs the question as to how many minutes or hours are still transient. Had the presentation been only the “less than a day” display at the AES conference, would that have been OK? Several hours? Fifty-seven minutes? Without any clear guidelines, researchers should be on notice that anything beyond a very “transient” slide presentation should be approached with caution.

I just wanted to pass along the information as an FYI. While faculty and students will always want to present their research in abstracts, posters and papers, I think it would be valuable to advise them to err on the side of caution. It could be living dangerously but one might want to try to (a) omit critical details from any such poster presentations to keep them from being enabling in a patent sense, (b) limit presentations to as little time as possible, and (c) add a disclaimer that the materials are proprietary and copying if strictly forbidden.

In the collaboration which was initiated only about two years ago in 2003, Pharmacopeia scientists identified lead compounds – from Pharmacopeia’s proprietary collection of 7.5 million drug-like small-molecules – acting at Celgene’s inflammation-related kinase target. The optimization of the potent and selective lead compounds to a pre-clinical development compound took little more than a year, so that the total time taken from target selection through to development was well under two years.

Pharmacopeia is entitled to on-going payments to the extent Celgene advances the program into and through clinical development, including annual payments and milestone payments at classical value inflection points. Pharmacopeia is further entitled to royalties on commercial sales of any products resulting from this collaboration.

It will be interesting to see whether or not their success will continue into 2005, but it appears as though they have the right formula for success, especially in view of the large library of compunds and lead drugs identified by Pharmacopeia. Certainly a testament to the capabilities of combinatorial chemistry, now at least twenty years old.
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Ten members of the Food and Drug Administration advisory panel who voted that a group of COX-2 inhibitors should continue to be sold had ties to the drug makers, a new analysis shows.

A study by the Center for Science in the Public Interest indicates that 10 of the 32 panel members had ties to either Pfizer Inc., or Merck & Co., ranging from consulting fees and speaking honoraria to receiving research support from the companies.
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The Electronic Frontier Foundation (EFF), along with consumer advocacy groups Public Knowledge, and the Consumer Project, filed an amicus brief in the Merck v. Integra case asking the Supreme Court to protect scientific researchers from patent infringement.

Merck v. Integra, as we posted earlier here, deals specifically with information researchers submitted to the Food and Drug Administration regarding a potential cure for cancer. The EFF believes it raises broader questions about whether patent owners can stop academic researchers and inventors from studying patented inventions in order to research or improve upon them.
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