Woessner, Warren D

On Monday, November 1st, the Supreme Court granted certiorari in Stanford v. Roche, 583 F.3d 832 (Fed. Cir. 2009), in which the Fed. Cir. decided that a professor could void his University-employer’s rights under the Bayh-Dole act to elect title to an invention he made with government grant support, by assigning his rights in the invention to a third-party, prior to the University’s electing title. The Solicitor General, at the Invitation of the Court, has filed an persuasive and informative amicus brief, which contains a very clear summary of the history and features of the Bayh-Dole Act, that should be perused by any patent attorney who has a substantial university-institutional practice. A copy of that amicus brief can be found at the end of this post.

Prior to enactment of the Act in 1980 – note that Chakrabarty was decided in 1980 and the Cohen-Boyer patent issued in 1980 – few university inventions made with Government grant support ever made it from “bench to bedside,” due to a patchwork of regulations on ownership and patent rights that differed from agency to agency. The Act founded the “industry” of modern university “tech transfer.” After passage of the Bayh-Dole Act, a university could elect to take title to an invention made with, say, NIH grant support, usually by filing a patent application on it, reporting it and making its election to the appropriate agency. The inventor(s) had no personal rights to inventions made with such grant support, but they were not left out in the cold. The Act required sharing of any royalties earned by licensing the patent with the inventor(s), and the university was required to use some of the funds to support research; often a portion of the royalties were returned to the inventor’s department. If a professor wished to patent, he/she was required to work with the university tech transfer office, who would in turn work with outside counsel to file patent applications and hopefully, license them to industry or to a v.c.-funded start –up. Over the last 30 years, this system has yielded hundreds of millions of dollars to universities and other non-profit organizations, and led to the commercialization of inventions as diverse as anti-HIV drugs (Ziagen), therapeutic enzymes (Myozyme), medical software, organic herbicides and a shrub willow bioenergy source. See http://www.betterworldproject.net/. A few universities even show up in annual lists of top patent-obtaining organizations.

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Warren Woessner will be a speaker on September 28^th at Q1 Productions’ “Pharmaceutical Patent Protection and Enforcement Conference” in Baltimore, MD.  Warren will speak on “Myriad: The District Court’s Opinion & Road Ahead”, a topic that has been the subject of a number of posts on patents4life.  More information on the two-day conference can be obtained by calling Q1 at 312-822-8100.

Last Sunday’s New York Times magazine had a provocative article about Plumpy’nut, a nutritive peanut paste that is foil-packaged so it does not need refrigeration. When eaten by malnourished children it can “cure” them in a relatively brief period of time. It is being touted as nearly a miracle food for countries in Africa or Central America, since peanuts are a cheap commodity in many of these countries and the product also does not require reconstitution with water.

However, Nutriset, a French company, is described as having patented this product essentially world-wide, and is characterized as aggressively defending its patents. (A copy of the U.S. patent is available at the end of this post.) Apparently, it has licensed the product in two African countries, but wants to make it in France. The advantages to, not just the health, but the economies of third-world countries, if they could manufacture and package the product locally, are clear. In fact, one organization has built a “factory” in Haiti and is making the product there. (Probably no Fed. Cir. equivalent to worry about.)

While recipes are notoriously difficult to patent in the U.S., it can be done, and the article reports that there is a U.S. patent on Plumpy’nut, which doesn’t expire until 2017. It is apparently the subject of an inter partes reexamination request, and so may not be around long. But if it is cancelled, the plot only thickens. The author speculates that big food companies, like General Mills or Cargill, may want to get into the business of manufacturing this or similar supplements and selling them to relief organizations, who would do the distribution. This may benefit a lot of children but it won’t do much for economic development in these countries and ultimately, may just provide lots of older and larger stomachs that need to be filled with something more substantial than fortified peanut butter.

patent 6346284

(This posting from my blog www.patents4life.com:

In December of 2009, I argued that President Obama’s Executive Order 13505, that lifted President Bush’s 2001 Order banning the use of federal funds for embryonic stem cell (ESC) research, should be a Top Biotech Story of 2009. The Bush Order had banned all federal funding for ESC research except for research on a small number of lines that existed prior to his order. Obama’s substitute order permitted agencies like NIH to fund research on cell lines produced after the Bush ban, so long as the funding was not used to produce the lines by the destruction of embryos. NIH went on to develop guidelines for approving fundable new cell lines.

In the December 2009 post, I noted that Congress had annually enacted the so-called Dickey-Wicker amendment that banned federally-funded research that harms or destroys human embryos. The Administration tried to argue that Order 13505 did not permit funding of obtention of ESCs from embryos, but the Judge found this a distinction without a difference.

Questions remain. While Judge Lamberth (D.C.D.C.) stated that the decision was intended to restore the status quo, the status quo, e.g., the Bush Order, is long gone. Research projects using newly approved lines have been started. Even if they can be continued with private funding, it is far from clear that these “illegal” cell lines can be used at all.  But what if the lines were produced abroad and sent to a U.S. lab? Would even the limited research permitted under the Bush order be fundable now? What is supposed to happen to ongoing projects that cannot find non-federal funds to keep the laboratory lights on? With patent protection for ESCs uncertain at best, the future of this research in the U.S. is cloudy at best.

Read New York Times Article on Judge Lamberth’s Decision.

In case you wondered if this was a settled question in the ever-shifting world of section 102, yesterday, In re Giacomini, (Rader, C.J.), (copy at end of post) the panel held that the effective U.S. filing date of a U.S. patent asserted to be prior art against a “later-filed patent” was the filing date of the corresponding U.S. provisional application claiming the same invention.

The court did not find merit in Applicants’ argument that the outcome should be controlled by In re Hillmer, 359 F.2d 859 (CCPA 1966) in which the court held that the date of  a foreign-filed priority application was not the effective filing date of a U.S. patent asserted to be prior art under 102(e). If nothing else, the decision underscores the necessity of fully disclosing the invention generically and specifically  in a provisional filing, even if enablement and WDR may be necessarily “iffy” for early-stage technologies.

Recently, in a notably unremarked decision, the Board reversed the Examiner, effectively canceling all of the claims to pluripotent human embryonic stem cells (ES) in Thomson (U.S. Pat. No. 7029913): The Foundation for Taxpayer & Consumer Rights v. Patent of Wisconsin Alumni Research Foundation (WARF), App. No. 2010-001854 (April 28 2010). The Examiner had reversed his original rejections on the basis that there would not have been a reasonable expectation of success that the mouse techniques disclosed in the prior art for producing mourse stem cells would work to yield stable cultures of humna stem cells. The Board reversed the Examiner.

The re-entry of an anticipation rejection based on Williams et al. (US 5166065) deserves a law review article, but it is the obviousness rejection that got my goat (or my murine species, to be more exact). While the Fed. Cir. has recently been reasonably temperate in its application of the somewhat fuzzy KSR standards to chemical composition claims, The Board latched onto one of the most poorly-reasoned early post-KSR decisions, Bayer v. Barr, 575 F.3d 1341 (Fed. Cir. 2009).

In the WARF reexamination, it was established that the art was using two basic techniques to try to isolate animal and human ES. One involving physically disassembling blasocysts (or very early-stage embryos) to get at the inner stem cells, and one involved using antibodies to remove the outer cell layers. Neither technique had been successfully used to produce human ES. In fact they had only worked in rodents (mice, rats, guinea pigs) and perhaps, in pigs. At least ten references were of record to this effect, and were quoted from by the Board. WARF had argued and the Examiner had found that there was no reasonable expectation of success that these techniques would lead to human ES. So what made the claimed cultured human ES obvious?

The Board relied on Bayer to find that “while a requirement that there be a ‘reasonable expectation of success’ …may be one useful standard in assessing the obviousness of an invention, it is not the only standard to be applied when [resolving the obviousness question]…..The Supreme Court has held that an invention may be proved obvious by showing that a combination of elements was ‘obvious to try.’…. A solution which had been known to work when applied to one system might, in some circumstances, be obvious to try in another. If the solution succeeded, the invention likely would have been obvious too persons of ordinary skill in the art…..[WARF] has not established that the protocol followed by Dr. Thomson necessitated him to ‘try all possibilities in a field unreduced by direction,’ but rather the evidence….points to significant guideposts that would have led the skilled worker in the right direction to successful isolation of human ES.”

But wait a minute. Those “significant guideposts” had only directed the art to mouse, rat and guinea pig stem cells (and maybe, pig), not even to dog, or horse, or cow. This reasoning is like saying, “Well there were signs to the base camp at 15000′ so the person of ordinary skill in mountaineering would have been successful in reaching the summit of Everest.” This is using the fact of the pioneer’s success against him/her, essentially as part of the prior art. In effect, the Board is saying, “Even if there was no reasonable expectation of success based on the prior art, the facts that there were techniques that were obvious to try AND that human ES were isolated using these techniques makes the invention unpatentably obvious.” As the Board concluded:

“Because it would have been obvious to have tried the known mouse protocols on human embryos [ed.: of course], and because such protocols would have resulted in human ES, we conclude that the claimed human ES would have been obvious to persons of ordinary skill in the art.”

This is an obviousness standard lifted from its context in KSR, a simple mechanical case, and dropped into a much more uncertain art area. I think what the Supreme Court could have said more clearly was that if the routes to try are available to the art and, if they are tried, the outcome of performing them is manifest (e.g., would be clear to the art worker), then the invention is obvious. The “guideposts alone” standard of KSR and Bayer has no real legal foundation in KSR, was applied improperly in Bayer, and endorses hindsight reconstruction. The Fed. Cir. should clearly disavow this “verdict now, trial later” standard as soon as possible.

If you enjoyed this posting, please visit my blog at www.patents4life.com for more.

Warren

Monday’s decision by the Federal Circuit to vacate the split panel decision in Therasense, Inc. v. Becton Dickinson & Co., 593 F.3d 1289 (Fed. Cir. 2010) (link at end of post) and rehear the case en banc makes it impossible for me to avoid discussing inequitable conduct in this blog. The Federal Circuit intends to decide some “big picture” issues, and has requested briefing on, inter alia, “Should the materiality-intent-balancing framework for inequitable conduct by modified or replaced?” and “If so, how?” and “Should the balancing materiality and intent standard be abandoned?” These are big questions indeed, and they point up the difficulty of enforcing a duty of candor and good faith standard that depends on deciding if the accused parties acted with specific intent to defraud the system.

Establishing specific intent to withhold 102(b) prior art in order to get claims allowed has pushed patent litigation into something resembling a TV crime drama. I have read the Therasense panel opinion twice now and I keep expecting to hit a paragraph in which the majority recounts that the patent attorney broke down on the stand, crying, and confessed his sins. The opinion is painful to read on a number of levels, but particularly the sections where the panel infers specific intent from the trial court’s findings that the testimony by the patent attorney and the Director of R&D for Abbott were not credible and evidenced an intent to deceive (not just a bad call on relevance).

See my blog at www.patents4life.com for the rest of this post.

Warren

The Vatican and the University of Maryland School of Medicine recently announced that the Vatican will contribute about $3M to fund research on stem cells derived from adult intestinal tissue. The funds will be used to support research at the Vatican’s Rome hospital. Of course, the research will not involve embryonic stem cells, and the Pope has had positive things to say in the past about stem cell research limited to “adult stem cells”. Read NPR story.

A map of the patent landscape in this area would have more hills than Rome, (Osiris’ extensive portfolio is based on adult stem cells), so this news may provide a further, somewhat blessed, incentive for you to attend the Stem Cell Patents Webinar on April 28th, that is the subject of the post below.

Three million dollars is not a lot of money as support for this cutting edge research, but it is more than the State of Minnesota has found to support stem cell research, but multipotent adult stems were discovered at the University of Minnesota!

For more postings, visit my web site:  www.patents4life.com

Warren

Patent Claims Coverage Webinar: Stem Cell Industry – Osiris Therapeutics – Amgen’s EPO – Wed., April 28, 12:00PM – 12:50PM CDT

Sunlight Research™ invites you to attend a Stem Cell Industry Patent Claims Coverage webinar presented by Robin A. Chadwick, Ph.D., Shareholder and Registered Patent Attorney, Schwegman, Lundberg & Woessner, P.A.

This webinar, scheduled for Wednesday, April 28 at 12:00PM CDT, will highlight patent claims coverage in the Stem Cell Industry and areas of opportunity. Special attention will be paid to the portfolios of Osiris Therapeutics and Amgen’s EPO portfolio.

Chief Scientists, R&D Managers, Scientific Advisors, Business and Corporate Development, Licensing Executives, Senior Management, Venture Capitalists and Industry Analysts can all benefit from the information that will be presented.

The information is available as three separate patent reports: Stem Cell Industry, Osiris Therapeutics and Amgen’s EPO.

Sponsored by Sunlight Research: The Number One Source for Patent Analysis. Click here to register.

Warren

The USPTO recently announced the creation of an ombudsman program to resolve applicant/examiner logjams in all of the Tech Centers. This is a move that the Office (and practitioners) have needed badly for a number of years, ever since the demise of the “Strong” Patent Prosecution Specialists in the pharma/biotech groups (1600/1800). Patent Prosecution Specialists like Richard Schwartz, Brian Stanton (now at NIH), and Margaret Parr were given real power to move stalled applications forward by mediating amendments acceptable to both sides or, in some cases, by simply telling the Examiner that he/she was wrong and to allow the claims in question. However, if this is simply a return to the “Weak” QA Specialist program that was no more than window dressing on the no-Patent Office, why bother? We need change we can believe in, not a PTO where Examiners are encouraged to just say “No”!

For more of my postings see:

www.patents4life.com

I watched “60 Minutes” last week, during which Kevin Noonan got about 30 seconds to justify “patenting genes” and the Myriad BRAC1-2 assays. He did as well as could be done, speaking about the good the patent system does in incentivizing investment in medical advances. However, “big bad” Myriad declined to be interviewed, so all the viewer saw was a few shots of their posh-looking headquarters. Arguments about economics are not going to make a big impression as compared to two cancer patients who claim they can’t afford the assay or have no place to go for a second opinion, and Chris Hanson, the ACLU attorney, who likens patenting genes to patenting gold nuggets panned from a stream – a product of nature, no more no less. No one should get a patent on something like that!

I read all of Judge Sweet’s opinion and could see that Myriad was trying hard to convince the court that “isolated and purified DNA” is obtained by chemical and physical processes that necessarily alter the chromosomal DNA after it is purified, and that it is not just “purified” from a cell, but they have to try harder. I have little doubt that the Federal Circuit will reverse this decision, but the ACLU and the plaintiffs are swinging for the fences. Go back and listen to the July podcast “debate” between Chris Hansen and me that is in the archives of this blog. His arguments are reflected in the decision almost verbatim.

For the rest of this post, visit my blog www.patents4life.com

Warren

In a lengthy opinion released yesterday in Assoc. for Molec. Pathology v. USPTO, __F.Supp.2d___(S.D. N.Y.) (PDF below), the court invalidated claims directed to isolated DNA sequences, as well as to cancer screening methods using them, and even to methods of screening potential anti-cancer compounds using them. Although the Judge stated that his opinion was limited to DNA sequences, it is difficult not to extrapolate his reasoning to many heretofore patentable chemical compounds that are obtained by purification from natural sources, including body tissues, fluids, cells and the like. For background on this lawsuit, including representative claims and patents, please refer to my post of May 18, 2009, archived under “Patentable Subject Matter.”

After construing the DNA claims to cover “real and tangible molecules of deoxynucleotides linked by a phosphodiester backbone” that are “substantially separated from cellular components which naturally accompany a gene [including the rest of the chromosomal DNA],” the Judge’s reasoning took an interesting turn. The opinion contains an extensive review of the older case law, such as Funk Bros. Seed Co. v. Kalo, and again and again, the Judge carved off what he viewed as findings of novelty for s. 102 examination and subject matter that might be “new” for s. 101 but was still an unpatentable “product of nature.”

For more on this post, visit my blog www.patents4life.com

Warren

In a majority opinion authored by Judge Lourie for the Federal Circuit sitting en banc (Appeal No. 2008-1248 (Fed. Cir. March 22, 2010)) (a PDF of which is attached to the end of this post), the court held that there is indeed a written description requirement (WDR) in section 112 that is separate from the enablement requirement and that the claims-in-suit in U.S. Pat. No. 6,410,516, broadly directed to reducing NF-kB activity in cells, are invalid for failure to meet the written description requirement. This decision, though lengthy, amounted to an affirmance of the earlier panel’s decision and, of course, of the “possession” test first articulated (by Judge Lourie) in UC v. Lilly in 1996. Judge Lourie spends about 20 pages writing and re-writing his opinion in UC v. Lilly (which he essentially concedes would be decided differently today). The problem the majority feels they are addressing has not, however, changed in the almost 20 years since UC v. Lilly was decided.

For the rest of this posting, please visit my blog www.patents4life.com.

Warren

The most interesting session I attended today at the AUTM Annual Meeting was one on patent reform. What was most interesting was not a recap of the aspects of S.515, which is the most up-to-date reform bill pending, but the summaries of the considerable differences between what the IT Industry and the biotech/pharma industry (and most universities) would like to see or not see in a final bill (if there ever is one).

David E Huizenga of Arnall Gordon Gregory LLP noted that all of the Supreme Court’s IP decisions over the last three years have weakened patents. The “biotech model” is roughly one product=one drug=one patent. Most pharmaceuticals are protected by a relatively small number of patents, and those patents are protecting the big returns needed to support development, often of a single compound, over several years. Therefore, certainty becomes important, and this leads to opposition to post-grant attacks on patents, or at least a desire to have a high evidentiary threshold for their initiation. At least the most recent versions of the Senate and House bills have relatively short time periods after issuance within which such “oppositions” can be initiated.

It is relatively easy for pharma to show big damages in terms of lost profits, so a move toward reasonable royalties as a preferred remedy is a no-go. On the other hand, biotech/pharma want a repeal of the inequitable conduct defense, which can gut a small patent portfolio on subjective evidence and would also support proceedings in the PTO designed to permit submitting art to moot a later charge of inequitable conduct. Biotech supports the repeal of the best mode defense. No surprise there.

Charley F. Brown of Ballard Spar presented the IT industry perspective and it couldn’t have been more different. The IT industry is focused on the threat of litigation by NPEs or “trolls.” He hastened to add that universities are not trolls since they contribute much more to society than bothersome patents. One electronic product may be covered by more than 1000 patents, giving NPEs lots of targets. Because the industry is standardized, there are also lots of defendants and they can be sued anywhere they have sales (like in the E.D. Tex.). The NPE can argue for a “reasonable royalty” on the entire device. This has led to at least five verdicts of over $500M each in the last seven years.

So the IT industry supports vigorous post-grant opposition proceedings and wants to be able to present evidence of public use and sale of the product in question. IT would support limits on forum-shopping and preliminary injunctions. Damages reform is also a big plus for any reform bill.

So this is a real yin/yang situation. University advocates like COGR generally support the current Senate bill, but I wonder if they are giving in too easily on first-to-file. Remember, the EP does not have ss.102(e)/103 “prior art” rejections. More on that later.

Warren

For more of my postings, visit www.patents4life.com

During oral argument before the Fed. Cir. in Ariad v. Lilly, as reported by Patently-O, the government attorney was pressed for specific evidence that a separate WDR “is necessary for USPTO to perform its examination function”, e.g., that it serves a practical function. Chief Judge Michel was quoted thusly:

“I can’t remember ever seeing a patent office rejection that was based only on the failure of written description. I’m not saying there aren’t any, but the flow of cases that come through this court at three or four hundred a year, it is exceedingly rare that the patent office hangs its case on written description. I can’t remember a single case.”

The government’s attorney, Mr. Freeman, couldn’t either. To the contrary, those of us in the prep/pros trenches should be able to recall a few that made it to the Fed. Cir. from the Board, “based only on the failure of written description.” It took me five minutes in my not-very-well-organized WDR file to locate In re Wallach, 378 F.3d 1330 (Fed. Cir. 2004)(“Without amino acid sequence, or with only partial sequence, a nucleic acid molecule’s structures cannot be determined and the WDR is consequently not met.”); In re Alonso, 88 USPQ 1849 (Fed. Cir 2008)(Claim to use of any Mab to human neurofibrosarcoma to NFS based on one example fails WDR.) and Capon v. Eschhar and Dudas, 418 F.3d 1349 (Fed. Cir 2005)(Claims based on combining known gene fragments do not per se fail WDR. Remanded for evaluation of support for generic claims). In re Alton, 76 F.3d 1168 (Fed. Cir 1996) is bit more aged, but it is oft-cited for the proposition that it is error to disregard factual evidence relating to the adequacy of the WD in a specification. These are not obscure decisions – their impact is/was not “minuscule” and, to top off the irony tank, Judge Michel was on the panel that decided Alonso and Alton.

Can any one else add to this list (remember, failure to meet WDR must be the ONLY issue on appeal from the Board)?

If you recall any, post your answer on my blog www.patents4life.com

Warren

In Perricone v. Medicis, 432 F.3d 1368 (Fed. Cir. 2005), the court reversed the Board, and found that a claim to treating sunburn with certain vitamin esters was patentable in view of art disclosing the same compounds to benefit normal skin. The Board had found the claim invalid as inherently anticipated by the prior art use, but the court found no disclosure in the prior art of applying the compounds to sunburned skin.

In Ex parte Matsubara, Appeal 2009-006581 (Feb. 10, 2010), the Board affirmed the Examiner’s rejection of a claim to a method for improving bone metabolism by (a) selecting a human or animal having a tendency toward a decrease in bone density (e.g., afflicted with osteoporosis), and (b) therapeutically administering to said human or animal certain types of fermented soy milk or “FSM.”  The Examiner rejected the claim as inherently anticipated by a publication that disclosed studying the lipid metabolism in aged, ovariectomized rats after giving them FSM, in view of a publication that established that such rats were an art-recognized model of osteoporosis. Applicants argued that the prior art showed no effect of FSM on osteoporosis and no “selection step” of choosing the rats to evaluate, since the prior art was not concerned with studying osteoporosis.

Please visit my blog at www.patents4life.com for the rest of this posting.

Warren Woessner

This post from Paul Cole, UK patent attorney:

The Lilly patent for olanzapine has been litigated in many jurisdictions including the US, Canada, the Czech Republic, Finland, Romania, Slovakia, Slovenia, Spain, China and Hungary. In US Court of Appeals for the Federal Circuit in Eli Lilly v Zenith Goldline (26 December 2006) Judge Rader held that allegations of lack of novelty and of obviousness did not succeed, whereas in the Canadian decision in Eli Lilly Canada v Novopharm (5 October 2009) O’Reilly J. held that the patent did not meet the requirements for a selection patent and was invalid. Key issues before the UK Court of Appeal were how novelty and obviousness of a secondary patent in the pharmaceutical field should be evaluated, the extent to which decisions of courts within the UK prior to the introduction of a “new law of patents” in 1977 remained relevant, and in particular whether the reasoning in the Canadian decision should be followed. The members of the court included Lord Neuberger in his capacity as Master of the Rolls and Sir Robin Jacob, both very experienced in handling pharmaceutical patent disputes.

Their decision confirms the extent to which, at least in this field, the law in the UK has departed from relatively restrictive pre-1977 standards and has become aligned with more open decisions of the EPO Appeal Boards. It also shows that in future there will be scope for differences between decisions of the UK courts following the “new” post-1977 law and those in e.g. Canada, India, Australia and New Zealand where the link to the older common law remains unbroken.

The Court of Appeal refused to hold that disclosure of a class was disclosure of all members of that class, relying on a quotation from G. K  Chesterton’s Father Brown story “The Sign of the Broken Sword: “Where does a wise man hide a leaf? In a forest?” Accordingly the invention as claimed was novel. And even though prior art disclosures included ethyl olanzepine which differed from the claimed compound in only a single carbon atom, the court refused to hold that an objection of lack of inventive step had been established.

The decision includes scathing comments on a prior art reference with a Markush claim allegedly covering some 10-to-the-19th compounds. The court observed that all the skilled reader would get from that reference was a vague promise of neuroleptic, sedative or relaxant effect for all the 10-to-the-19th compounds with an equally vague promise of high therapeutic index coupled with no evidence to support these promises. Given that the whole field was unpredictable, the woolly teaching of the reference (described by Lord Neuberger as “mere speculation”), if not totally useless, was no guide to any particular compound. It could not be said that any compound out of a vast class was obvious if there was no real idea how any individual member of that class might behave.

Yet further confirmation has been given to the realistic approach of UK courts to inventions in empirical research fields, and to the supportive judicial attitude towards the research-based pharmaceutical industry as also demonstrated by Sir Robin’s speech on 29 November 2008 to the EU Directorate-General of Competition at the time of their preliminary report on their Phrma-sector enquiry, see Patents and Pharmaceuticals

Warren Woessner, www.patents4life.com

In the December 9, 2009 issue of the Fed. Reg., the PTO requested public comments on a wide range of patent preparation and prosecution topics, from "Finding the Best Prior Art" to issuing and responding to first office actions and "proper use of interviews." (Request attached.) The PTO recently extended the response deadline from Feb. 8th until March 8th. Clearly, any currrent prep/pros attorney or agent could write a textbook on the five topics "in which the PTO is particularly interested" and you are encouraged to reply by email. So I spent some time on one of the topics (and tried to lobby for the return of Prosecution Specialists, at least to 1600). My comments are below. I hope you will take time to send in your thoughts. After all, they don't ask that often.

See my blog www.patents4life.com to read my comments on examiner interviews.

Warren Woessner

Last summer, Bob Litan and Lesa Mitchell of the Kauffman Foundation sent a short memo to Esther Lee at the Dept. of Commerce entitled "Accelerating the Commercialization of Government-Funded University-Based Research." Although the Foundation, based in Kansas City MO, has been interested in university tech transfer at least since 2003 when it issued a report "Accelerating Technology Transfer & Commercialization in the Life & Health Sciences" (PDF at end of posting), this memo attracted little attention until, in December, The Harvard Business Review named it as containing one of the "Ten Breakthrough Ideas for 2010." The alleged breakthrough is the proposal in the memo that, while universities will continue to own inventions made with Federal funding, professors should be free to not use their university's technology transfer office (TTO), but to have the option of licensing their inventions through whatever agency they prefer. The Kauffman premise, to put it bluntly, is that most TTOs are "suboptimal" and that professors would be better off, in many cases, shopping their technology to faster-moving licensing entities (of some sort). The stated goal is to speed up the commercialization of new technologies while allowing universities to collect the same royalties as under the current system.
Read the rest of my note on this topic at my blog:  www.patents4life.com

Warren

1. Background

On 25th March 2009, the Administrative Council of the European Patent Organisation issued decision CA/D 2/09 which introduces stricter requirements regarding the filing of divisional applications. These stricter requirements have apparently been introduced because the EPO considers that some Applicants have abused the divisional system.

To read the entire article see attached Recent EPC Rule Changes.pdf 

On November 27, 2009, the USPTO published the "Patent Application Reduction Stimulus Plan" (74 Fed. Reg. 62285) (a PDF is found at the end of this posting). Briefly, a procedure has been established whereby a small entity applicant can have a petition to make special granted in an unexamined application that is ready for examination by submitting a request that documents that the applicant has expressly abandoned one of their co-pending applications that was also ready for examination but had not been examined. There are lots of conditions attached. The applications must be co-owned or have an inventor in common. All the fees must be paid and the applications must have actual filing dates prior to October 1, 2009.
For more information on this program, visit my blog at www.patents4life.com

Posting by Paul Cole on Patents4Life.com:

On Tuesday 24 November, David Kappos made a posting on the Director’s Forum including the following statement:
"Some have suggested that the Office is determining obviousness in a way that stifles innovation by refusing patents for truly inventive subject matter. They’ve asked us to provide examples of non-obvious claims in view of KSR. Such examples would serve as a complement to the examples of obvious claims already in the guidelines."

Mr. Kappos gave a presentation at the AIPLA Annual Meeting in Washington in October, and in a question and answer session that followed there were three questions which concerned KSR, more than any other topic. The two questioners who preceded me expressed dissatisfaction with seemingly unjust and arbitrary rejections for lack of inventive step. I asked whether the US examination guidelines on inventive step could be brought into line with those of the EPO, where positive and negative examples are carefully balanced, and the suggestion created a burst of applause from the audience. More detained comments on the suggestion are found in a paper on KSR that was published in the John Marshall Review of Intellectual Property Law in 2008 (a copy is attached at the end of this posting). 

It now seems that there is at least a chance that the suggestion that I and others have made may be acted on, and that the possibility is under active consideration in the USPTO. For the most to be made of this opportunity, we as students and users of the patent system can help by suggesting additional positive decisions which it would be good for the USPTO to include in the revised inventive step Guidelines.
 

Visit www.patents4life.com for more on potential new USPTO examination guidelines.

See my blog at www.patents4life.com for a note from Erwin Basinski on the Supreme Court arguments on Bilski and the likely fate of business method patents.

Warren

Reading the transcript of the oral arguments presented yesterday (a copy is attached at the end of this posting) as Bilski was presented to the Supreme Court, I was struck by how quickly certain Justices homed in on one of the last frontiers of patentable subject matter, namely whether or not the simple transmittal of information from one person to another should be patentable subject matter.

Visit my blog at www.patents4life.com to read the rest of my post on this topic.

Warren

A Senate bill intended to codify the Seagate opinion includes a provision that willfulness cannot be found (the report incorrectly reads "cannot not") if there was an "informed good faith belief of patent invalidity. unenforceability or no infringement." If passed in this form, the provision likely would put back in place the need (but not obligation) to have a competent opinion before launching a product. While touted as a codification of Seagate, this Senate bill is thus a change from the understanding many litigators attribute to Seagate. As currently interpreted by many litigators, Seagate eliminates the obligation and need to have a competent opinion before launching a product. If this bill passes, companies still will not be obligated to have such competent opinions before launching but will have an express need to obtain such opinions. The need is founded upon the provision that willfulness cannot be found if there was a good faith belief of patent invalidity, unenforceability or non-infringement. A clear demonstration of such a good faith belief would be a competent written opinion by outside counsel.
For more information and more of the bill's language, see my blog www.patents4life.com

Warren

Visit my blog www.patents4life.com for an article written by Ron Schutz of Robins, Kaplan, Miller and Ciresi, posted with his permission.  Its a cautionary tale regarding the nuances of patent assignments involving university inventors.

I have heard rumors for some months that the dreaded "Second Pair of Eyes" review of Examiners' intent-to-allow patent applications had been eliminated. For those of you who are not on the front lines of patent prosecution, the "SPOE" review began in 2000 in response to the high rate of allowance of business method patents in Group 705. A "senior examiner and a review panel" (as one writer described it) was inserted between the Examiner and the Office of Patent Quality Assurance (which reviews about 4-5% of all proposed allowances) to block allowed applications in this Group from even reaching OPQA. This apparently worked quite well, and by 2001-02, the PTO had extended SPOE to other examining groups, including biotechnology. Like the sorcerer's apprentice who could not control the forces he unleashed, SPOE cut the overall allowance rate of patent applications from about 72% in 2000 to about 44% in 2008. One Examiner told me that if he received two "reversals" from an SPOE review, he could be fired. Examiners get points if an application is allowed or abandoned. With this sort of threat hanging over every allowance, which path would you choose, especially if you were an Examiner working in a controversial area like most of biotechnology? But did this program lead to a perception that the quality of issued patents was improving?
For more on this topic, please visit my blog at www.patents4life.com

Warren

Judge Randall Rader of the Federal Circuit was the luncheon speaker at the AIPLA Annual Meeting Friday in DC and, as usual, he spoke well. So many of his fellow- (and one female) judges where there that he quipped: "Now that we're here and we have a quorum, shall we vote on inequitable conduct?" (Nervous laughter from large audience.) He set up his comments by recalling a meeting he had with the judiciary in Brazil, where he encountered a "Patent Skeptisauros" judge who argued that the patent system itself was outdated, nonfunctional and was doing damage to Brazil and other less-developed countries.

Judge Rader said he replied that it was the accuser's understanding that was non-functional and destructive. He argued that we live in a world where technology is decentralized and that no single entity can "keep pace with the patent system." Rather, the patent system functions to bring innovators together to cooperate and to coordinate their work. A "patent thicket" should not be thought of as a legal minefield, but rather as an invitation to begin such cooperation and coordination. He recalled a conversation with a Japanese colleague who said, in effect, that the comparative global advantage of the U.S. going forward is innovation and invention and asked, "Why are you trying to limit it?"

For more on Judge Rader's comments, please visit my blog at www.patents4life.com

Warren

On October 5, 2009, Ariad filed a 60 page brief (not counting attached appendices) with the Federal Circuit in support of its appeal in Ariad v. Lilly. (Attached below.) As you will recall from my post of August 24th, the Fed. Cir. granted en banc rehearing of a panel decision invalidating the claims-in-suit for failure to meet the WDR. See also, my posts of April 13, 2009 and May 5, 2009, on the panel's decision in Ariad v Lilly and Judge Linn's concurrence, urging a return of the WDR to post-Lilly status:

"The question is, ‘Does the written description describe the invention recited in the claims - themselves part of the specification - in terms that are sufficient to enable one of skill in the art to make and use the invention and practice the best mode contemplated by the inventor?’ That is the mandate of the statute and is all our precedent required, prior to Lilly."

For further commentary on this rehearing, please visit my blog www.patents4life.com.

Warren

On Sept. 30th, Harold C. (Hal) Wegner gave a talk on current developments that emphasized the importance of inter partes reexamination, particularly as a weapon of patent destruction. His opinion, summarized by me, is that KSR is increasingly being applied to biotech claims by Examiners. Applicants then are forced to put in declarations arguing secondary factors and to argue criticality in order to get claims allowed. Requestors are aware that, during inter partes reexamination at the PTO level, 60% of patents have all their claims cancelled and 80% have independent claims cancelled. Attacker-requestors will put in declarations to show that "everything was expected." If the Examiner and the Board support the attacker, patentee is dead since, if the attacker put in substantial evidence, the Federal Circuit will give deference to the PTO finding. Also, if the attacker argues that a claim should be interpreted so as to read on the prior art, claim interpretation will be an open question before the Federal Circuit, who reviews claim construction de novo as a question of law.

Visit my blog www.patents4life.com for more interesting insight from Hal Wegner on inter-partes reexamination.

Warren

Rasmussen v. SmithKline Beecham Corp., 413 F.3d 1318 (Fed. Cir. 2005) (link below) was a truly scary decision that many of us practitioners hoped would be ignored by future Fed. Cir. panels as an aberration brought on by over-extensive prosecution, a litigation setting, and good lawyering. 

Apparently not so much. In Janssen Pharmaceutica v Teva, appeal no. 2008-1594, 2009-1070 (Fed. Cir. Sept. 25, 2009) a split panel affirmed the invalidation of U.S. Pat. No. 4663318, claiming the use of a known compound, galanthamine, to treat the symptoms of Alzheimer's disease, on the basis that the specification "does not satisfy the enablement requirement because [the specification] did not establish utility." Yes, the specification was short, there was no experimental test data (even in vitro) and the inventor offered little in the way of explanation for the mechanism of action (e.g., did not say "While not intending to be bound by any theory of action, it is believed that..."), but honorable jurists, HE GUESSED RIGHT! Subsequent animal model tests were positive and, as the majority noted without comment: "In February 2001 [the inventor] received approval from the [FDA] for using galantamine to treat mild to moderate Alzheimer's disease."

Visit my blog at www.patents4life.com to learn more about this decision and my thoughts on the topic.

In re Lister, the Federal Circuit repeatedly cited In re Klopfenstein, 380 F.3d 1345 (Fed. Cir. 2004) (link below), a decision that held that a poster presentation that was available for viewing at a meeting for 2-3 days was a "printed publication" under 102(b). This decision has lots of interesting dicta that indicates, for example, that a slideshow with an oral presentation would not necessarily be considered a "printed publication" if no printed copies were available since the slides were only transiently visible. A thesis defense per se would also not be considered a printed publication. Even the brief display of a poster may not qualify as a printed publication, and presentation of the poster at a meeting with a non-copying notice may have disqualified the poster as a printed publication.
To learn more about poster sessions as printed publications under 102(b), visit my blog at www.patents4life.com.

ln re Lister, appeal no. 2009-1060 (Fed. Cir, Sept. 22, 2009) involves a "method for playing an organized game of golf."  While that case involved an issue of what constitutes the publication of a potential prior art reference, the more interesting question may be whether or not such a method, as it was claimed, meets the "M or T" test.  Visit my blog at www.patents4life.com for more on this topic.

On September 15, 2009, Director David Kappos spoke at the National IPO Meeting in Chicago. (A link to the text is found below). I got calls almost immediately about various aspects of his comments. Like the blind folks trying to characterize an elephant, there are many "hints" in the remarks of changes to come. One caller said that the Director commented that an appeal process that is so complex that nearly half of the appeal briefs filed are rejected for formal defects is a failure by definition (my gloss). But note that he called for cutting the pendency of appeals to 3 months. The Director also seems to be willing to develop a "satellite examiner" program along the lines of the satellite attorney program that has worked well for our firm from the beginning (SLW now has six satellite shareholders). His comments about how he will not tolerate discrimination among technologies might relate to attacks on business method patents but could just as easily relate to the difficulties we practitioners encounter in getting biotech claims of reasonable scope. I will leave it to you to root other acorns of hope from the Director's remarks. Perhaps this is the beginning of another chapter of change we can believe in!

Visit my blog www.patents4life.com to get a copy of Director Kappos' speech.

On September 16, 2009, the Federal Circuit reversed the holding of the district court that a process for monitoring and adjusting a method of medical treatment was unpatentable as attempting to claim non-statutory subject matter (Prometheus Labs., Inc. v. Mayo Collaborative Services, Appeal No. 2008-1403 (Fed. Cir. Sept. 16, 2009)). The patent’s claims at issue recited (a) administering a drug such as AZA that provides 6-TG metabolites to a subject and (b) determining the levels of the metabolites. The measured metabolite levels are then compared to pre-determined metabolite levels and may "indicate a need" (e.g., provide a warning to the doctor) to increase or decrease the amount of drug that is administered so as to maximize efficacy of treatment.   Visit my blog at www.patents4life.com to read more about this important decision intepreting the Bilski "machine or transformation test."

In my June 22, 2009 post, I discussed the district court decision that found a claim to optically-pure oxaliplatin (U.S. Pat. No 5,338,874) not infringed by defendants who made it by processes other than the HPLC process disclosed in the specification. I noted that this was an extreme case of "patent profanity" being used against a patentee to effectively convert a compound claim into a product-by-process claim, despite qualifying language used in the specification that HPLC purification is an "illustrative method" and a "representative process" by which the claimed compound may be prepared. I suggested that such language should always be employed and that applicants should focus on the distinguishing properties of the claimed compound when arguing patentability, not on the need to use a specific process to prepare it.

These are just the arguments that Sanofi used on appeal (Please see disposition attached at the bottom of this post), and the Federal Circuit found them convincing.  Visit my blog www.patents4life.com to read more on this reversal.

As a supplement to the "instructions" discussed in my last post, the PTO has now provided a compact slideshow to Examiners to assist them in evaluating claims for statutorily patentable machines, processes or compostions of matter. Ironically,the flowcharts are a nearly perfect example of an attempt to embody abstract thoughts in words. As in the instruction materials, chem and biotech processes or methods are not mentioned or exemplified, except via "naked" identifiers like natural phenomena and laws of nature. It will be interesting to see the spillover into chem/biotech by Examiners who want to appear to be cutting-edge in cutting back patent protection for medical subject matter.

Visit my blog www.patents4life.com to get a copy of the slideshow and view my last post on this topic.

The present dispute concerned the patentability of the enantiomeric quinoline antibiotic levofloxacin covered by Daiichi’s expired EP (UK) 0206283 and by a supplementary protection certificate (SPC) based on it.

Please visit my blog www.patents4life.com for the full case brief provided by one of my favorite British patent attorneys, Paul Cole. 

From a prosecutor's standpoint, the '231 patent (link at bottom of this post) has "dream claims" to a new class of stem cells. Claim 1 reads:

An isolated adipose-derived stem cell that can differentiate into two or more of the group consisting of a bone cell, a cartilage cell, a nerve cell, or a muscle cell.

Adipose is "fat", and because there is so much of it around, and it is easy to obtain, it may nearly be an ideal source for "pluripotent stem cells."

Visit my blog www.patents4life.com to learn about an instructive inventorship contest over this patent and the accompanying claim construction arguments.

Warren

This 2008 pre-Bilski decision is of interest since the Board purportedly applied the Diamond v Diehr "standard” – "[t}ransformation and reduction of an article 'to a different state or thing' is the clue to the patentability of a process claim that does not include particular machines" (450 U.S. at 184) – that the Federal Circuit adopted as the rule by which to judge whether or not a process or method claim is patentable subject matter. The Board applied this much-criticized test to affirm the Examiner's ruling that a claim to a method to provide LASIK corrective surgery that was patient-customized was not patentable subject matter under section 101.

Visit my site www.patents4life.com to learn more about this curious decision.

On July 10, 2009, the Court of Appeals for the Federal Circuit in In re Pod-Ners, Appeal No. 2008-1492, affirmed the Board's rejection of all of the claims of U.S. Pat. No. 5,894,079. The Board had rejected as obvious claims to, inter alia, a pinto bean plant producing yellow beans of a certain color, as well as claims to the beans themselves, which had been deposited in the ATTC. The claims were rejected over a publication argued to disclose the same yellow bean, in view of another non-prior art publication relied upon as demonstrating that the claimed bean and the "well known" yellow bean are gentically identical.  The decision has an odd anti-biotech air about it that I don't think I am imagining.  Check my blog www.patents4life.com for more discussion of this case.

For some years, Tom Irving of Finnegan Farabow, et al. has been giving a very amusing, but increasingly serious, talk about the dangers of what he calls “Patent Profanity.” The version I heard in May was, “Patently Profane at You and Your Client’s Peril.” He warns that the specification and prosecution history will be used by the courts to construe the claims, and that appellate review of claim construction is de novo. By “patent profanity,” he means statements in the specification or arguments made in the prosecution history that will lead the court to ignore the once well-established maxim that “[a]s a general proposition, a limitation that does not exist in a claim should not be read into that claim.” McCarty v. Lehigh Valley R. Co., 150 U.S. 110 (1895) The district courts, following the lead of the Federal Circuit, have increasingly side-stepped this principle by casting the issue as one of claim interpretation, not of claim limitation.  See my blog www.patents4life.com for more on this topic.

The materials from the June 3, 2009 USPTO Customer Partnership Meeting are available online but I have downloaded them into a PDF format available my blog www.patents4life.com.

A recent article by Ken Garber in Nature/Biotechnology, 27, 494 (June 2009) summarizes the recent Federal Circuit decision invalidating the claims-in-suit in Ariad v. Lilly for failure to meet the WDR. (See my post of April 13, 2009 “Federal Circuit Throws Wrench Into ‘Mechanism of Action Claims’” for a summary of the decision.) Various patent law “experts,” including this author, are quoted. Mr. Garber did a good job of summarizing the court’s position, but I don’t recall saying that affirming the validity of Ariad’s claims would be like “accepting a claim on anti-gravity.”
See my blog www.patents4life.com for the rest of my comments on this topic.

Posts and pens have been busy reporting that the Federal Circuit, en banc, overruled Scripps v. Genentech, and ended the debate over whether a product-by-process claims should be construed to be limited by its process steps for the purposes of determining infringement. Judge Newman weighed in with an eloquent 39 page dissent, defending the need for a “rule of necessity” for difficult-to-define inventions and pointedly pointing out that there now are difference legal standards for validity and infringement.  See my blog www.patents4life.com for my full posting on this case.

Although this report (see my blog for link) is of the March meeting, I hope to have current reports of meetings soon after they occur - if they continue to occur. It also gives me a chance to visit memory lane. In the 90's, the Partnership was made up of a small group of senior PTO Examiners and Officials and a small group of practitioners (e.g, maybe ten of each). If you were a practitioner, you were supposed to attend as a representative of a user group, such as AIPLA or the ABA IP Law Committee. We actually sat across from each other and debated points of PTO policy, such as what does "sequence identity" mean, or how can restriction practice be improved. Practitioners also presented informal training programs to Examiners at lunch meetings. The discussions could get heated (including between practitioners) but these were effective forums to hash out differences face-to-face, without a particular client's interests at stake.
Later, the Partnership Meetings were thrown open to one and all and became like small one-day conferences, where senior Examiners mainly showed up to "school" the practitioners on their latest positions.

So I stopped attending, although these "semi-inside" reports are still of interest. I hope we get a report from the June 10th meeting, Ray!

Visit my blog for the meeting report from 3/3/09.  www.patents4life.com

On May 12, 2009, a coalition of interested parties, lead by the Association for Molecular Pathology, and including researchers and breast cancer patients, filed suit in the U.S. District Court for the Southern District of New York to invalidate certain of the claims of seven patents exclusively licensed to Myriad Genetics, Inc. (A copy of the complaint can be found on my blog.) The claims in question are directed to, inter alia, DNA that encodes the BRCA1 and BRCA2 polypeptides and a method for diagnosing a predisposition for breast cancer in a human by comparing his/her BRCA2 DNA sequence with the wild-type BRCA2 DNA sequence wherein an alteration (mutation) in the subject’s BRCA2 DNA sequence indicates a predisposition to said cancer. See U.S. Patent Nos. 5,747,282 and 6,033,857, respectively. (A copy of these patents can be found at the end of my blog.)  For more on this story, see my blog www.patents4life.com.

I thought I would take time out from my rants about the written description requirement, and patentable subject matter, to let you know about this important addition to IP education tools. In 2003, Professor Mueller, now at the University of Pittsburgh Law School, published the first edition of An Introduction to Patent Law, which was intended to fulfill a need she perceived for an introductory textbook for patent law students that was also rigorous in its analysis of the law, while being manageable in length.  See my blog www.patents4life.com for my review of Janice's newest edition of her valuable book.

In my post of April 13, 2009, I concluded with a brief summary of Judge Linn’s cogent concurrence, and noted that I would revisit it. Judge Linn does not believe that it was ever necessary for the court to graft “a separate written description requirement [WDR] onto section 112, paragraph 1.” Visit my blog www.patents4life.com for the rest of my analysis.

Where the panel In re Bilski “went bad” happens early in the exhaustive opinion. In re Bilski, 545 F.3d 943 (Fed. Cir. 2008). Like Justice Breyer in his Lab. Corp. of Amer. Holdings dissent, the Fed. Cir. panel was struggling to define a “natural phenomena” or a “fundamental principle” in order to decide if the claims before them were unpatentable subject matter (along with “laws of nature and abstract ideas”. See Diamond v. Diehr, 450 U.S. 175 (1981)).

Visit my blog www.patents4life.com to read more.

In my earlier post on Ariad v Lilly on my blog www.patents4life.com, there is a detailed discussion of the Federal Circuit’s recent decision that invalidated all of the claims-in-suit for failure to meet the written description requirement. The Federal Circuit rejected Lilly’s attempts to establish inequitable conduct, in part based on the failure of Dr. Baldwin to submit papers he published on the mechanism-of-action of NF-kB after the effective filing date of the ‘516 patent. The panel stated: “Lilly did not show that Dr. Baldwin appreciated the inherent anticipation theory to which the references allegedly pertained.” Visit my blog to learn more about the inherent anticipation theory and the meaning of the title of this post.

Technology Transfer Tactics, in conjunction with FreePatentsOnline, has created a site which they state can allow the visitor to view all of a given university's patents by just clicking on the name of the institution.  Visit my blog at www.patents4life.com for my review and more information about the site.

A three-judge panel of the Court of Appeals for the Federal Circuit recently decided Ariad Pharmaceuticals, Inc. et al. v. Eli Lilly & Company, appeal no. 2008-1248 (Fed. Cir. April 3, 20009), involving Blatimore et al. (U.S. Pat. No. 6,410,516). The “et al.” is M.I.T., The Whitehead Institute and Harvard University. Despite the impeccable scientific credentials of the inventors, that included two Nobel Prize winners, the panel reversed the district court’s denial of Lilly’s motion for JNOV of a jury verdict finding of validity and infringement of the claims in suit.

I will post more details and my analysis regarding this case Monday morning on my blog www.Patents4Life.com

On April 3, 2009, a three judge panel of the Court of Appeals for the Federal Circuit unanimously affirmed the decision that the Board of Patent Appeals had reached in Ex Parte Kubin . The Board’s decision is discussed in my case note posted on my new blog www.patents4life.com. My blog also discusses the precursor cases In re Deuel and the leading written description requirement decision, Lilly vs. UC.