Patents4Life

USPTO Request for Comments on Enhancement in the Quality of Patents

2010-02-08T09:36:00.003-06:00

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.
___________________________

Dear USPTO:

Following are my comments on Section V(5) -Proper Use of Interviews.

Examiners should be willing to, and encouraged, to grant interviews prior to a first action on the merits as well as after final rejection. Examiners should get credit for more than one interview per application.

Examiners should be responsive to requests that their Supervisor participate, and should be clear about whether or not such participation is required. Examiners should offer to reschedule interviews when a Supervisor unexpectedly cannot participate, with an appropriate amount of lead time.

Examiners or attorneys should be encouraged to propose amended, or even new, claims orally or in writing prior to the interview. If not presented at the interview itself, such claims would not become part of the record.

A more general suggestion: The USPTO should re-establish the position(s) of Prosecution Specialist(s) in the Pharma/Biotech art units (eg, 1600). These positons were once held by Richard Schwartz, Brian Stanton and Margaret Parr. The Specialists acted as ombudsmen for the applicants and attempted to mediate between Examiners and applicants, particularly in cases in which agreement could not be reached on focussed issues and/or the dispute appeared to turn on a particular point of law. The Specialists used to have real authority; they would review actions without identifying the particular application in question (eg,, so that the applicant would not suffer retaliation if the Specialist concluded that applicant's position was incorrect). If they felt that applicant's position was correct, they had the power to direct the Examiner to allow some or all of the claims, or at least could prevent the Examiner from filing an Answer if the claims went up on appeal. I worked effectively and regularly with Prosecution Specialists, until Brian Stanton left the Office and the program was, for all practical purposes, ended.

(This is a completely different approach than "second pair of eyes" review of Examiners' allowances, which applicants took no part in, and which encouraged Examiner's not to allow applications (for fear they would be found to have erred, and be penalized)).

Respectfully submitted,
Warren D. Woessner

12-09-09 Fed Reg - Request for Comments.pdf

BIO Joins Stakeholders in Expressing Concerns with Efforts to Restrict Gene Patenting

2010-02-05T16:51:00.004-06:00

Today, the Secretary’s Advisory Committee on Genetics Health and Society (SACGHS), approved, with on dissent, a draft report which recommends legislative changes to the patent laws in regards to gene patents and recommends restrictions on licensing of federally funded research. The report will be forwarded with minor changes to the Secretary of Health and Human Services, Kathleen Sebelius. BIO spearheaded a sign-on letter urging the Secretary to reject the SACGHS’ recommendations and released the letter at an event at the National Press Club in Washington DC yesterday. Participating in the event yesterday were Jim Greenwood, President and CEO, BIO, former Senator Birch Bayh, Co-Author of the Bayh-Dole Act, Brian Stanton, Task Force Member, SACGHS, Jim Davis, General Counsel, Human Genome Sciences and Jon Soderstrom, Ph.D., Managing Director of Yale University’s Office of Cooperative Research. See below for links to the letter and a podcast of the event.

Press Release

Stakeholder letter to HHS Secretary

Podcast

BIO Joins Stakeholders in Expressing Concerns with Efforts to Restrict Gene Patenting Restrictions would threaten advances in public health and harm the national economy
For Immediate Release 2/5/2010

WASHINGTON, D.C. (Friday, February 05, 2010) - The Biotechnology Industry Organization (BIO) released today a letter to Health and Human Services Secretary Kathleen Sebelius regarding the potentially harmful recommendations of the Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) in its Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests.

BIO was joined on the letter by the Association of University Technology Managers (AUTM), Genetic Alliance, the Wisconsin Alumni Research Foundation (WARF), and more than 20 other stakeholders in urging Secretary Sebelius to reject the Committee’s recommendations and to ensure that the fundamentals of the innovation system put in place nearly 30 years ago through the Bayh-Dole Act are preserved.

In the letter, the stakeholders stated, “We welcome efforts to improve patient access to genetic tests, and stand ready to work with you and other interested parties to do so. But we believe that the recommendations, if implemented, would unravel two sets of laws that are the foundation of life science innovation in this country – the patent system and the Bayh-Dole Act. This would do more harm to patients than good, by impairing the research, development and commercialization of the medicines and diagnostic tests of tomorrow.”

“By undermining the value of gene-based patents, these recommendations would chill future investment and innovation, and would undermine the investment-backed expectations of current patent owners and licensees,” stated BIO President and CEO Jim Greenwood. “The United States must preserve incentives for investment and innovation, particularly given the current state of the economy. It is not the time to undertake or recommend policy changes that would undermine the foundations of American life sciences innovation.”

The letter is available at http://bio.org/ip/genepat/documents/SACGHSsign-onletter2-4-2010final_000.pdf.

SACGHS Final Report on Gene Patents - Taking a Machete to the IP Thicket

2010-02-05T11:22:00.003-06:00

On September 17, 2009, the Secretary of HHS's Advisory Committee on Genetics, Health and Society (SACGHS) issued a Final Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests. The 66 page report amounts to a wide-ranging attack on biotechnology patenting and licensing, even as it proclaims that it does not opine on "protein-based genetic tests or patent claims on isolated proteins." The report also tries to draw a line between its disapproval of patents on isolated genes or on simple tests based on gene-disease associations (read Myriad), and the development of test kits and multiplex tests, which it concedes may require patent protection for commercial development.

While beginning with the self-evident conclusions that professors like to conduct cutting edge research and publish the results (e.g., of gene-disease associations), the Committee goes on to conclude that clinical testing services rapidly arise, if there is physician interest (e.g., if someone will reimburse): "The case studies [of gene-disease associated testing] show that those researchers who did not pursue patenting were willing and able to invest in developing genetic tests soon after their discovery, despite the threat that 'free riders' could then offer competing test services." I bet they are, but they are not offering the test for free - they are charging for it, and trying to use their brand names to gather market share. The Committee found that cost and regulatory hurdles were much higher for companies attempting to develop test kits "than for testing services" and that patent protection "may be needed for companies to be willing to risk resources in satisfying the regulatory requirement." The Committee also only found that exclusive providers did not price-gouge, provide poor quality control, or otherwise limit patient access (but they might). However, this barely slowed the momentum of the report toward pushing gene and "simple association" patents off a legal cliff.

The next section is an investigation of how gene patents might inhibit "multiplex tests" (e.g., lymphoma-on-a-chip) or whole genome sequencing that could have been written by Affymetrix (a company who is specifically mentioned at least twice). It is beyond the scope of this post to begin to point out the legal errors or omissions in this section which focuses on how allegations of infringement of patents on single genes might block development in this area (something that does not appear to have occurred - I just read a paper on characterizing the genetic basis of malignant breast cancer that used a commercial chip that included over 50,000 gene probes).

Nonetheless, one of the Report's conclusions is that "claims upon the act of simply associating a genotype with a phenotype should not be patentable because they are claiming laws of nature that cannot be invented around." The Commission concedes that "[i]t would be up to the courts [to] decide what 'simply' means." That is, enough complexity in a test might render it patentable.

The Report then has a long section on the case law and PTO policy that has ended up with the PTO granting patents on purified and isolated naturally-occurring materials, particularly genes. The Report glosses over the value that patents have provided to society in making hard-to-obtain vitamins and hormones available to patients. The Report goes on to recognize (and approve) that In re Kubin has made it more difficult to patent genes (but manages to skip how In re Fisher effectively delivered millions of pages of Seq IDs and claims to ESTs and SNPs to the recycling bin). The Report ends with the hope that KSR and Kubin revived the "obvious to try" (to clone) standard so that existing patents on genes will be challenged.

While I was sure that the Commission was headed toward a recommendation that patents on isolated genes should be outlawed, after noting that such claims are allowable in one form or another worldwide, the Commission recommended enactment of statutory exemptions from liability for those infringing gene claims by developing and selling tests developed for patient care purposes (but wait, earlier the Commission recommended barring patenting such tests altogether), and enacting an exemption for liability for those using patented genes 'in the pursuit of research" (I thought we already had this exemption under common law - the Commission also misses the legal point that a patented test can be evaluated to see if it works without infringement). The Report closes with a bit of a whimper, by re-endorsing the NIH Best Practices for the Licensing of Genomic Inventions and the "Nine Points to Consider in Licensing University Technology" endorsed by AUTM. Finally, the Report recommends that the PTO establish a scientific advisory committee on genetic testing. "The Committee believes experts in the field could help USPTO in its development of guidelines on determinations of nonobviousness and subject matter eligibility in this field once pending court decisions such a Bilski v. Kappos are decided."

Oddly, my phone remains silent.

Hearings On SACGHS Report

Court Decision in China Recognizes Novelty in Dosage Limitations in Swiss-Form Claims

2010-02-03T15:31:00.002-06:00

Peksung Intellectual Property Ltd sent an interesting article (link below) reporting that the Higher People's Court of Beijing held that both dosage form and dosage amount should be treated as limitations in Swiss-form claims. These "administration-related features" are often ignored by examiners in non-US jurisdictions as non-limiting. In issuing this judgment, the Higher Court apparently ignored the SIPO Guidelines for Examination. Although the ruling is non-precedential, it should provide the basis to appeal the rejection of second-generation Swiss-form claims, including claims under reexamination.

Patentability of medical use inventions.pdf

ESTHER KEPPLINGER JOINS PATENT PUBLIC ADVISORY COMMITTEE

2010-02-01T10:14:00.003-06:00

I would like to congratulate Esther Kepplinger on her appointment by Commerce Secretary Locke to the Patent Public Advisory Committee, along with Steven W. Miller of P&G and Dr. Benjamin Borson. Although I have not always been sure just what this committee has been asked to do in the past - it is supposed to advise the Director on PTO operations - Esther is well-qualified to increase its efficacy. Prior to joining her current firm, she was Deputy Commissioner for Patent Operations in the USPTO, where she worked with Steve Kunin on patent examination policy. In the past, she was also a patent examiner and supervisor in biotechnology, and holds a B.S. in biology.

I have known Esther for many years. If you would like to say "hello", she will be speaking on a panel that I organized on patentable subject matter, "You Can't Patent That! Can You?" at the Annual Meeting of AUTM in New Orleans on March 19th. Y'all come!

Read more about Esther's appointment at Patent Docs

WILL THE NIGHTMARE FOR BIOTECH PREP/PROS NEVER END?

2010-02-01T10:08:00.002-06:00

I recently gave a talk on patenting biomarkers, and was asked to talk about "push-back" by the courts and the PTO against getting useful patent claims in this emerging area (the gateway to "personalized medicine.” I was struck with how the Federal Circuit has gnawed away at the bundle of "rights" (laws/practices/policies) that formed the foundation of our value-adding profession, over a relatively short time span. In better times, one of my partners once called patent attorneys the "priests of the information age.” Well, if we are, the Federal Circuit must be Henry VIII and we are papists headed for the stake.

In re Kubin - Fed. Cir. holds that a claim to DNA encoding NAIL protein was obvious since the protein was in the prior art (even though it had never been isolated or sequenced). Good-bye Dueul (and that decision only came down in 1995!).

Noelle v. Lederman - Fed. Cir. ends de facto "antibody exception" to WDR, finding that one Ab does not enable a claim to any Ab that binds to a characterized antigen (mouse antigen on activated T cells was disclosed).

In another Ab case, In re Alonso - Fed. Cir., the case explicitly states that making and screening info is not sufficient to meet WDR. You need enough working examples to support the claim scope.

In re Fisher - This is an older (2005) decision, but should not be forgotten. The court affirmed the rejection of claims to five purified corn ESTs. The court found a failure to meet the PTO's substantial and specific requirement for patentable utility, even though Fisher proposed seven potential uses for such ESTs (probes of protein expression, etc.). The court stated: "the claimed ESTs themselves are not an end of Fisher's research effort, but only tools to be used along the way in the search for a practical utility."

About the WDR, don't even get me started. I am not saying that Ariad v. Lilly was wrongly decided, but if you think you can predict how (or even if) the Fed. Cir. will resolve the tension between the WDR and enablement, you should be picking stocks, not trying to get patents granted.

From past posts on this blog, you know how Bilski has cast a shadow on diagnostic and method of treatment claims. After the clearly wrong decision in Classen (assay involving immunization fails Bilski test), the Fed. Cir. tried to lift the fog a bit, with its decision in Prometheus v. Mayo, in which they clearly stated that methods of medical treatment are patentable (transformative enough, it seems), but this case still may be on its way to the Supreme Court, where three Justices would have decided that diagnostic assays are simply natural phenomena coupled with unpatentable mental steps (LabCorp. v. Metabolite Labs. (2006)). Do all of those elderly gentlemen have normal PSAs?

Finally (and I only stop because I am tired of typing fairly late on Friday), this perfect storm of anti-patent precedent undoubtedly encouraged the Ass'n of Molecular Pathology et al. v. USPTO and Myriad Genetics lawsuit (SDNY May 12, 2009) in which the plaintiffs seek rulings that the PTO is exceeding its statutory authority in granting patents on genes, since they are products of nature, that patenting "the concept of looking at or comparing human genes and [increased cancer risk] violates legal principles barring patents on laws of nature,” and that the Constitutional mandate to promote progress in the useful arts is violated by patents on gene-based screening methods. The PTO has tried without success to get this suit dismissed. If this anti-patent trend continues, we will converge with the Indian patent system in another five years (or less). TGIF.

ALCHEMISTS' LINK TO CHEM/PHARMA GOLD

2010-01-15T10:42:00.005-06:00

This link below will lead you to a wealth of recent chem/pharma caselaw and policy materials organized by Kevin Buckley for his lectures on Biotechnology Law at Washington University in St. Louis School of Law. Like the fabled Alchemists' Stone, this outline will turn the leaden feeling of the last few years of anti-patent caselaw and proposed laws and policies into a golden glow of "knowledge is power." (At the least, it will be a big help when you are putting together blog posts or powerpoint presentations.) Enjoy! (A link to Kevin's website BioCommericialization.com is also included on the sidebar of this site.)

BACK TO THE O.K. CORRAL - SHOULD PROFESSORS MANAGE IP LICENSING?

2010-01-13T11:03:00.005-06:00

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.

So the Kauffman team feels that there are lots of professors with under-appreciated technologies who would benefit by being able to leave the corral of their institution's TTO and ride off, if not into the sunset, into the arms of a third-party licensing entity who would make the translational connection needed to get the technology "from bench to bedside." Really?

To begin with, it is difficult to see how this would work in practice. The Kauffman memo suggests that the professor might have the option to prevent the TTO from even trying to license the technology while he or she shops it. Or will we now have dueling TTOs trying to license the same technology? (The memo suggests that a professor with an automotive invention who lives in, say, Kansas might want to use a TTO in Detroit.) And what will prevent third-parties from taking most of the licensing royalties? The memo mentions ownership, but it does not seem to consider who will pay for the patent costs, especially if a statutory bar date looms. A system in which the professor's TTO is paying the patent costs while the professor is out trying to license the IP portfolio via a different organization is difficult to imagine. And about conflicts of interest....

The Kauffman fellows seem to have no sense of the chaotic history of tech transfer prior to Bayh-Dole (BD) (or in its early years). When I was doing patent prosecution at a big IP firm, one client I was given was a professor from a prestigious university that did not have a tech transfer policy. Since he was free to do what he wanted with his new method of cancer treatment pre-BD, he had paid the firm to file applications on it, and eventually licensed them to big pharma for a lot of money (in those days). The university got nothing at all. The first talk I ever gave was about the BD Act and the audience was professors, not administrators.

Also, there were a number of "for-profit non-profit" entities gathering up loose technologies from universities without technology policies (let alone TTOs). Research Corp. Technologies (RCT) was one of the most successful. RCT would not take on a technology unless it could get an assignment (not a license) from the inventor(s) and institution(s) in question (if the university even asserted any ownership rights). RCT would then front all the patent costs and attempt to license the technology. If it was successful, the inventor(s), and sometimes the institution (if it cared), would get some of the royalties. Before the rise of TTOs that developed their own licensing expertise, RCT and other organizations like it scored some major tech transfer homeruns, but they could only handle so many proposals at once. BD has been referred to as an "unfunded mandate," but it did motivate universities and other institutions getting NIH and other Federal funding to step up to the plate and swing, at least at the fat pitches.

There are still a few lone wolves out there trying to make it as "hired guns" (pardon the metaphors). Believe it or not, I am still approached by small companies that want to file on inventions brought to them by university professors who are either unaware that their universities have TTOs (or at least tech transfer policies) or think they can ignore them. They can't. The present system is not "optimal," but at least it is organized. A few years ago, a prominent researcher told me that his colleagues used to look down on him because he was patenting his discoveries and licensing them (often to start-ups). He was using a TTO, incidentally. He said that today it is the professors who are not patenting and licensing who are considered to be out of step. I don't believe that there are hoards of break-through technologies languishing in dusty lab notebooks in academe and, if there are, I don't believe that loosing professors trained in life sciences to bring them to market is going to change anything for the better.

TechTranPanel_Report.pdf

Privilege Primer

2010-01-08T09:57:00.003-06:00

Guest Posting from Ron Shutz

Case: Keefe v. Bernard, 2009 W.L. 346738 (Oct. 30, 2009).
Topic: Corporate Attorney/Client & Work Product Privilege

Facts

The attorney representing both the doctor and his corporate employer in a medical malpractice action interviewed an orthopedic surgeon also employed by the corporation. The plaintiff sought discovery of a report the defendants’ attorney prepared summarizing the interview. The trial court ordered it produced despite the defendants’ claim of attorney-client privilege. In an interlocutory appeal, the Iowa Supreme Court addressed the first impression corporate attorney-client issues the case presented. The Court held that communications between an attorney representing a corporation and a corporate employee are only protected by the attorney-client privilege if the discussions cover the employee’s actions as they relate to the potential liability of the corporation. Here, the report revealed that the surgeon was interviewed solely as a witness to the events at issue. The Court held such discussions are not attorney-client privileged. However, the Court found that the report was attorney work-product privileged because it showed the attorney’s mental processes. Though protected material, the defendant was required to turn the report over to the plaintiffs as a sanction for defendant’s failure to notify plaintiffs of the interview as required by Iowa law. In order to protect disclosure of the attorney’s opinion work (which the Court noted “is for all practical purposes, immune from discovery”) the Court ordered the report redacted to disclose only the facts, information and statements attributable to the surgeon.

BuLITS Points

• As a general rule, when an employee discusses with company counsel his or her own actions relating to the potential liability of that company, those communications are protected by the company's attorney-client privilege.

• Depending on the law of the jurisdiction, if an employee is interviewed by corporate counsel and provides information as a witness to the actions of others, those communications may not be protected by the attorney-client privilege, but could still be protected as attorney work product.

To avoid possible sanctions, counsel should ensure there are no statutory limitations or ethical prohibitions before interviewing or deposing a witness.

And Remember

There are two layers to the attorney work product privilege. An opponent might be able to get at relevant non-privileged information embedded in your work with a demonstration of substantial need or undue hardship. But (unless something far worse has occurred) your mental impressions, conclusions, opinions, or legal theories should never face such a disclosure.

www.rkmc-bulits.com
www.rkmc.com

You Say Tomato . . . I Say Tah-mah-to . . . Hewlett-Packard Company v. Acceleron LLC

2009-12-28T11:15:00.002-06:00

Authored by Ronald J Schutz of Robins Kaplan Miller & Ciresi LLP

The Federal Circuit says: “declaratory judgment jurisdiction,” even if the patent holder’s notice letter waltzes around phrases like “infringement” or “assertion.” In Hewlett-Packard Company v. Acceleron LLC, the patent holder sent a letter that avoided using those phrases while still implying the possibility of litigation. The Federal Circuit said a patent holder cannot escape creating declaratory judgment jurisdiction simply by dodging certain words or phrases. Here, patent holder’s actions were “definite and concrete” enough to create a “substantial controversy.” Accordingly, the Federal Circuit reversed the district court’s determination that it lacked subject matter jurisdiction and remanded the claims for declarations of non-infringement and invalidity for further consideration — making it too late, presumably, for the patent holder to say “Let’s call the whole thing off.”

In Hewlett-Packard, a patent holding company owned the patent at issue. Within three months of acquiring the patent, the patent holder sent Hewlett-Packard a letter identifying certain HP products potentially impacted by its patent rights. The patent holder imposed a two-week deadline for execution of a letter agreeing, among other things, that Hewlett-Packard would not initiate litigation during negotiations. In response, Hewlett-Packard requested that the parties enter into a mutual no-litigation “standstill” agreement for 120 days. The patent holder refused and Hewlett-Packard filed its declaratory judgment action. Weighing the totality of the circumstances, the district court found that “the litigation was too speculative a prospect of support declaratory judgment jurisdiction.”

The Federal Circuit disagreed and specifically relied on MedImmune to reach its decision. While recognizing that the decision lowers the bar for what constitutes a justiciable controversy, the Federal Circuit said MedImmune nonetheless requires that a patent law declaratory judgment plaintiff demonstrate a dispute that is both “definite and concrete” and “real and substantial.” Not every fact pattern will rise to the necessary level of “a substantial controversy” and an objective review of the relevant facts is required. Necessary factors to be reviewed include consideration of whether the patent holder is a holding company or a competitor of the putative infringer, the patent holder’s history of enforcing the patent, the specific language used in any communications including their tone and implication and the status of relevant product lines and product plans. The Federal Circuit focused on the fact that the patent holder here was a patent holding company who, in response to the putative infringer’s answering letter, failed to agree to a confidentiality agreement or a mutual standstill of litigation that would have allowed the parties to engage in negotiations without litigation.

Either (or eye-ther), after Hewlett-Packard, regardless of what patent holders say, they most likely won’t be able to dance their way out of declaratory judgment jurisdiction if the reviewing court discerns an implied threat of litigation. Neither (nye-ther) should patent holders set overly burdensome conditions or precursors to further negotiations lest those demands become the evidence of a real dispute or controversy. Patent holders will also have to evaluate the use of “file, but not serve” rules in order to protect their chosen forum, but still engage in negotiation prior to full scale litigation.

Clearly, patent law declaratory judgment jurisprudence continues to evolve after MedImmune (leaving litigants on both side ample opportunities to argue that their unique facts should control). Still, no matter how you say it, after Hewlett-Packard, effectively initiating patent licensing negotiations while avoiding creating declaratory judgment jurisdiction remains patent law’s current hot potahto.

Recent EPC rule changes restrict filing of Divisional Applications

2009-12-15T12:32:00.004-06:00

Attached is an article by Malcolm Lawrence of HLBBshaw, Epping, UK

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

PTO Launches Pilot Program to Speed Patenting Green Technologies

2009-12-14T09:14:00.003-06:00

On December 8th, the Patent Office implemented a pilot program in which an applicant may have an unexamined application filed before December 8, 2009 made special upon a showing that the putative patent would "materially enhance the quality of the environment by contributing to the restoration or maintenance of the basic life sustaining natural elements." 74 Fed. Reg. 64666 (Dec. 8, 2009) (a copy is attached at the end of this posting). The petition to make special must state the basis for the special status, but there are a lot of them. The notice lists them by classification, and they fall broadly into alternative energy production, energy conservation, environmentally friendly farming (including all of "plants and plant breeding " - 800 (!)) and environmental purification, protection or remediation. The subclasses cover everything from swimming pool heating to wind-powered ships. Of course, biotech faves like "biofuel," "toxic material clean-up," and "recycling" are included, as well as "using microbes and enzymes [to destroy toxic materials], and "genetically engineered organism" [to produce fuel, I assume]. Somewhat more exotic ones include "emission trading" (a business method?), "drag reduction," and nuclear power. One area I have worked in but couldn't quite find was "herbicide alternative" or some such, although "fertilizer alternative" is present. Maybe this would fall within "yield enhancement" but so would quite controversial inventions like Bt corn or glyphosate-resistant soybeans.

Of course there are lots of strings attached. The program has a limit of 3000 petitions, which must be filed before December 8, 2010. The claims must be directed to a single invention and there can only be three independent and twenty total claims (shades of the recently departed rule package?). Both this Green Pilot program and the Abandon to Advance Pilot Program at least exhibit a startling level of creativity for an Office not known for that trait, but I worry that the resources may not be there to expeditiously process all these petitions. If you try it (and I intend to), please let me know if you like it!

74 FR 64666.pdf

Give A Little, Get A Little: New PTO Program Aims to Speed Examination

2009-12-10T08:29:00.000-06:00

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.

I can see this being of some use to small pharma/biotech companies that have filed on technologies that they could not partner, or have otherwise decided to cease developing, and wish to speed up prosecution of newer, or more promising technologies. The program may also be of value to universities who have multiple portfolios, including older ones that may have "safety continuations" pending, but otherwise have little life left in them. Of course, even under the old rules, petitions to make special were rarely used, since it took as long, or almost as long, to have them reviewed and granted as it did to get the first office action. If this program catches on, it will provide some measure of how many paperweight file wrappers are really in the Office. The notice indicates that the procedure may be extended to all applicants if it is deemed a success. If it flops, it may be withdrawn, but at least this would show that most applicants have not given up on the value of their IP. After all, it is the season of hope, and it is about time for a little hope after the Pandora's Box of miseries the PTO has released into the prep/pros world for the last decade or so.

Patent Application Reducation Stimulus Plan.pdf

David Kappos and The Impact of KSR – A Unique Opportunity For Our Profession

2009-12-07T10:30:00.003-06:00

By Paul Cole
Visiting Professor, Intellectual Property Law, Bournemouth University, UK

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.

For the avoidance of doubt, what we are looking at here is the Manual of Patent Examining Procedure at 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness. There are various headings giving examples and the opportunity here is to submit counter-examples. Here are the various headings:

A. Combining prior art elements according to known methods to yield predictable results. Anderson's Black Rock is one example and US v Adams is a counter-example but mentioned only for teaching away which is not really in point here. Do we have any more recent examples which could usefully go into the MPEP? The Adams case itself provides a good example of persuasive new function, and the nineteenth century examples of Winans and the Washburn & Moen Manufacturing (Glidden barbed wire) case are also instructive. But good recent examples should also be included e.g. compositions exhibiting surprising synergistic properties.

B. Simple substitution. Are there any decisions which could usefully be contrasted with In re Fout, In re O'Farrell, Ruiz v AB Chance and Ex parte Smith?

C. Use of known techniques to improve similar devices. Are there any decisions which it would be good to include in MPEP and which can be contrasted with In re Nilssen and Ruiz v Chance?

D. Applying known techniques to a known device. What decisions might be included to contrast with Dann v Johnson and In re Nilssen?

E. Obvious to try. What decisions should be included to contrast with Pfizer v Apotex, Alza v Mylan Laboratories and Ex parte Kubin? See also the MPEP at 2143.02.

F. Variations prompted by design incentives or other market forces. The examples here are Dann v Johnson, Leapfrog v Fisher Price, KSR itself and Ex parte Catan. Can we provide instructive and hopefully easily comprehended counter-examples?

G. The TSM test. Here Graham and DyStar are mentioned. Do we have any post-KSR examples where it was appropriate to continue to apply the TSM test and a positive finding of patentability was made?

Readers of this blog will obviously be looking for cases which emphasize the empirical nature of research in the chemical, biochemical and pharmaceutical arts. One suitable candidate might be the recent CAFC decision in Sanofi Synthelabo v Apotex which concerned the drug Plavix used for the treatment of heart attacks and strokes. It turned out that the enantiomers had the property of “absolute specificity’ with one isomer providing all of the anti-platelet activity, but no significant neurotoxicity whereas the other had no anti-platelet activity and all the neurotoxicity. Evidence was adduced that there was no scientific principle which allowed prediction of which isomer would be more active, and that weak stereospecificity was more common than strong stereospecificity; also that activity and toxicity were correlated so that the more active isomer would be expected to be the more toxic. Furthermore, in compounds where biological effectiveness is delivered through metabolism in the body, the acid environment of the stomach or other metabolic processes may restore the racemic state. On this basis the CAFC held that the biological activity of the claimed isomer could not reasonably have been predicted

Hopefully readers will respond with references to instructive Board of Appeals, District Court and CAFC cases where patents were held to have inventive character.

Cole Paper

A Look Back at the Roots of the Thorny WDR Problem

2009-12-07T10:22:00.002-06:00

As the date for oral argument looms in Ariad v. Lilly, as does an en banc decision as to the existence and/or the role of the written description requirement (WDR) in Section 112, I thought it would be worthwhile to re-visit an article I published in the April 2003 issue of JPTOS. (A copy can be found at the end of this posting.) Please read the concluding part of this article in view of my posts on this site of August 24, 2009 and May 5, 2009. The article is entitled "Do-Over! -- The Federal Circuit Takes a Second Look at Enzo v. Gen-Probe."

Put simply, the debate within the Federal Circuit is between the Judges who want to return the WDR to its role in settling priority disputes, and the Judges who want the WDR to ensure that the specification demonstrates that the inventors had "adequate possession" of the invention – to do something more than simply teach the interested public how to make and use the invention. Even a disclosure of actual reduction to practice (e.g., of actual possession), is not, per se, sufficient for this group. ("While 'possession' is a relevant factor in determining whether an invention is described, it is only a criterion for satisfying the statutory written description requirement. Showing possession is not necessarily equivalent to providing a written description.") The specification must also permit the art to "visualize or recognize the identity of the subject matter of the claim." Enzo I, 285 F.3d at 1018.

Thus, in late 2002, the legal battle lines are sharply drawn. One camp of Judges, led by Judge Rader, believes that the WDR is no more than a semantic test for the "right to use" the claim language in question. If the claim language is supported by the specification, the WDR is satisfied. Enablement is a separate issue that is to be resolved by application of the very fact-specific Wands factors. In re Wands, 858 F.2d 731 (Fed. Cir. 1988). These eight factors, used for determining whether or not the enablement requirement is met, include the nature of the invention, the breadth of the claims, the level of ordinary skill in the art, the level of predictability in the art and the existence of working examples. See also M.P.E.P. 2164.01(a) (8th ed. 2001). The camp led by Judge Lourie expects a lot more from the WDR; along with the enablement requirement, it now imparts or denies the "right to claim" the invention at issue. That is nearly as equitable a mission as that assigned to the doctrine of equivalents.

The WDR is evolving one fact situation at a time, and without en banc review, entire classes of patents will move in and out of its invalidity shadow. Two hypothetical fact patterns may serve to illustrate the uncertainties in the current WDR. In the first, an inventor isolates a new protein, factor X, from liver cells. The inventor knows nothing about the structure, or even the class of protein, such as an enzyme or a hormone, only that it is not an antibody. However, the protein binds to a receptor site on prostate cancer cells and blocks their division completely. If the inventor files at this point, the court is presented with actual possession and purely functional claiming. If the inventor deposits some of factor X, a step usually not taken with a pure chemical compound, the claim to "factor X" and its functional language could presumably be within the Enzo safe harbor. The American Type Culture Collection does not list "proteins" as materials it will accept for deposit. If the inventor fails to deposit prior to issuance, the specification would not meet the WDR, the claims would be invalid, and a continuation-in-part fully characterizing factor X would not be entitled to the filing date of the parent, since the description of factor X in the parent would not meet the requirements of Section 112. 35 U.S.C. Section 120.

In the second hypothetical case, an inventor uses computational chemistry to identify consensus sequences that are responsible for the enzymatic activity of a protein encoded by a series of related plant genes. The software developed by the inventor then "mixes and matches" the consensus sequences on the inert peptidyl framework to optimize the bioactivity of the enzyme, arriving at a genus of hypothetical high-activity enzymes, all defined by complete sequences. If the inventor files at this point, with adequate directions as to how to assemble the synthetic enzymes, he has produced a presumably enabling specification with complete structural data, but with no actual reduction to practice whatsoever. Is this an example of a specification that should fail the heightened WDR, or one that should meet the precise definition test of the new WDR? Do we need more than the Wands factors to evaluate the ability of the specification to place the invention in the hands of the public? Should this inventor, who never walked into a laboratory receive a patent, while the inventor of factor X be left with nothing but the satisfaction of curing cancer?

If factor X is an antibody, and the target is known, perhaps binding affinity language would meet the WDR. But what if it is a hormone, or a small molecule, or an "anti-inflammatory steroid," an example of inadequate description given by the Enzo II panel? And is it really the best use of the court's time to resolve endless fact situations on the basis of five words in the statute that provide no guidance whatsoever as to what they require, beyond some degree of correspondence between the specification and the claims? With the clearly articulated division of opinions within the court, the fate of any patent appealed from a WDR decision below will depend entirely on the panel that appellant draws. Whether or not the interested public all agree with the Wands requirements, they have proved to be a workable test for meeting the make-and-use requirement of Section 112. It is time for the court to deliver Lilly and Enzo (I) to the doctrinal scrap heap where holdings like Durden and Druey ended up, and let the evolution of biotechnology patent law continue in a productive direction. However, we all know that "bad facts make bad law," and I don't see how Ariad will be able to move WDR jurisprudence in a direction that will favor patenting early-stage biotechnology.

JPTOS.pdf

POST FROM AUSTRALIA - NON-ENGLISH LANGUAGE PUBLICATIONS MAY NOT BE CITABLE ART.

2009-11-18T09:49:00.001-06:00

By Bill Bennett, Pizzeys, Canberra, AU

A unique aspect of Australian Patent Law is the requirement that a reference must be "reasonably ascertained, understood and regarded as relevant" by the hypothetical skilled person before it can be applied in an inventive step rejection.

In practice, this means that references which are difficult to find, or difficult to understand, or which are not, prima facie, relevant to the problem being solved by the skilled person, may be excluded from the prior art base for inventive step considerations.

For some time we have speculated that it may be possible to have a non-English reference excluded from the prior art base for inventive step considerations on the basis that the hypothetical skilled person could not be reasonably expected to understand the reference and hence would not regard it as being relevant to the problem being solved.

The APO has now handed down a decision in which a German reference has been excluded from inventive step considerations. It is worth noting that the German reference did not have an English-language abstract. If there had been an English language abstract, the outcome may have been different as the abstract may have led the hypothetical skilled person to have obtained an English translation of the German reference.

Similarly, it may be possible that Figures or drawings in the reference may have been enough to cause the hypothetical skilled person to have investigated the reference more closely. However, no evidence was led by the opponent on this point.

The full decision can be found here (see paragraph 86 in particular):
http://www.austlii.edu.au/au/cases/cth/APO/2009/21.html

"LOOKS BAD FOR BUSINESS METHODS" -- A note by Erwin J. Basinski

2009-11-17T08:30:00.001-06:00

The Bilski case before the US Supreme Court came up for oral argument on November 9. After a couple of reads, My initial impressions are:

1. Most of the questions from the Justices (primarily Scalia, Breyer, Roberts, Sotomeyor, Stevens, Kennedy, Ginsburg) seemed focused on a concern that a) if they upheld the machine or transformation test they would interfere gravely with existing software, biotech and other patents as well as kill all business method patents; and b) if they negated the machine or transformation test but only killed business method patents, how would that square with BM processes that DO have a valid machine element or DO have an acceptable transformation involved.

2. Malcomb Stewart, Esq., Deputy Solicitor General, spoke for the US Patent Office and said that they fully believed that the hedging claim of Bilski was basically an abstract process with no physicality, and that they would be happy if the court so ruled. Chief Justice Roberts asked why the court shouldn't so rule and avoid the issue of whether the machine or transformation test is OK. Justice Sotomayor asked "How about if we say something as simple as patent law doesn't cover business matters instead of what the Federal Circuit has begun to say, which is technology is tied to a machine or a transformation of the substance, but I have no idea what the limits of that ruling would impose in the computer world, in the biomedical world, all of the amicii who are talking about how it will destroy industries? If we are unsure about that, wouldn't it be safer to say it doesn't involve business methods?" [I am not sure what this really means.] But Solicitor Stewart responded that this wouldn't work because of the State Street Bank case , pointing out that the innovation in State Street was a "machine" whereas the Bilski case relates to "processes". This led to a long and confused discussion between Stewart and several of the Justices about machines made to be unique by a specific computer program, etc., etc. Justice Ginsburg reminded Mr. Stewart that the PTO had proposed the machine or transformation test to the Federal Circuit and was now saying this test should not be supported by the Supreme Court because of the ambiguities about "what is a 'machine'? and what exactly is an acceptable transformation?" She quoted Justice Meyer in the Federal Circuit Bilski opinion as saying " . . . it has a simplicity to it. It says, if its technology, then its within the realm of patent, and if its not technology, it isnt, if it is based on science or technology, and that seems to be what is used in other places [i.e. she means countries]? Mr. Stewart said focusing on whether technology is involved would not make the patent eligibility argument any easier, and moreover such a test would not allow a court to avoid the difficulties that it has identified with the machine-or-transformation test.

3. Chief Justice Roberts, and Justices Kennedy, Stevens, Breyer and Ginsburg found difficulty in Mr. Stewart's argument that State Street was decided correctly and would be today because it was claimed as a machine and was deemed by the Federal Circuit (and agreed by the PTO) to be a computer changed into a new machine by the computer program involved. All of them felt that State Street's claim was merely a business process programmed to run on a general purpose computer in which the focus should rightly be on the "process," and seemed to imply that it should have been rejected as a business method process. Mr. Stewart argued it would pass the machine or transformation test. So Justice Breyer summed up by saying - well all of the hypothetical business methods we seem to have excluded from patentability sound like that could be patented if we simply programmed a computer to execute the process according to the PTO. [These Justices appear to be leaning towards denying the patentability of business methods whether or not a computer is used to execute the process.]

4. Mr. Stewart said that the PTO would be happy if the court would affirm the machine-or-transformation test without trying to define what a machine or transformation is [sounds like the Europeans and their happiness with no court trying to define what technology is].

A majority of the Justices seem to be against the patenting of business methods in general but some worry about the impact on the Internet and new and emerging technology, including medical diagnostic methods.

My guess is that the Supremes will rule somewhat as follows:

A Business Method defined as a process of abstract steps of doing something NOT tied to any technology is NOT patent eligible. Implementing the process on a general purpose computer, whether claimed as a machine or process, does not make the business method patent eligible.

The "machine-or-transformation" test for determining patent eligibility for a process is not affirmed, but some non-trivial physical steps or elements must be included in a claim for a process to be patent eligible.

The fact that Congress has recognized some business methods as patentable in section 273 regarding prior user defenses, seems to be a nettlesome issue for the court here but I suspect they may find some way around this.

The Bilski claim at issue will likely be deemed a business method having abstract steps not tied to any technology and is therefore deemed not to be eligible for a patent.

The Court might even overturn the State Street Bank case.

Erv Basinski

TRANSMISSION OF INFORMATION IN EUROPE - PATENTABLE SUBJECT MATTER?

2009-11-17T08:23:00.002-06:00

By Paul Cole, Lucas & Co., UK

The UK counterpart of In re Ngai is Bayer’s (Meyer’s) Application [1984] R.P.C. 11. In that case a claim to a package containing a known drug together with instructions for a new use were not allowed because the inventive step set out in the claims resided in the information given in the instructions, which was mere presentation of information and accordingly not an invention under Section 1(2)(d) of the UK Patents Act, 1977. That decision was followed closely in time by the EPO Enlarged Appeal Board decision in G 0005/83 EISAI/Second Medical Indication which approved Swiss form use claims, and which has since been followed by the UK courts, see John Wyeth and Schering’s Application [1985] R.P.C. 545. After that time it was no longer necessary to pursue claims to a substance plus instructions for use.

Sir Isaac Newton is reputed to have lost some £20,000 in the South Sea Bubble which was a financial crisis of 1720 and said: “I can calculate the movement of stars, but not the madness of men.” One of the infamous companies launched in that year was ‘for carrying out an undertaking of great advantage, but nobody to know what it is.” The examples put forward by the Supreme Court in Bilski approach that level: a process for maximising wealth by buying low and selling high, a method of resisting a corporate takeover and a method of avoiding tax.

When asked about the patentability of a method of teaching antitrust law that keeps 80% of students awake, Mr. Michael Jakes for the petitioners averred that there have been a number of patents for teaching methods, and that such a method is indeed patentable if defined as a process. Justice Breyer responded: “Now, suppose I reject that view, hypothetically, and suppose I were to take the view that this is way too far, that that is not the purpose of the statute… Have you any suggestion for me?” Justice Sotomayor asked: “How about if we say something as simple as patent law doesn't cover business matters …” Malcolm Stewart on behalf of the respondent found himself in difficulty in even defending State Street in the face of observations e.g. from Mr Justice Stevens: “I don't understand why that isn't just the application of a process, which is not itself patentable subject matter, to a particular machine that can use [that] process.”

As is well known, the EPC contains a prohibition on the patenting of business methods. The EPO Appeal Board has held in T 0931/95 that a computer programmed to carry out a business method is not caught by the prohibition, but that was a Pyrrhic victory because it went on to hold that claimed features of a non-technical nature should not be taken into account when evaluating inventive step, and the application was refused on that ground. It remains almost impossible in Europe to obtain grant of patents for inventions where novelty is confined to matters of business administration. It would appear that the position in the US may move at least partway towards that in Europe.

"INFORMATION PLEASE!" - BILSKI TAKES IT TO THE SUPREMES

2009-11-11T09:16:00.002-06:00

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. Particularly, Justice Breyer's first question was to ask whether or not a method of teaching antitrust law could be patentable subject matter [laughter]. Justice Sotomayor then mentioned "speed dating.” Bilski's counsel replied that, while the data itself is not patentable, "but if it is a series of steps,” it might be. Breyer demanded that counsel "make that balance in terms of information." Sotomayor asked "[Doesn't there have] to be something more substantive than the mere exchange of information; that it has to involve...'transformation'? [The Fed. Cir.] hasn't defined the outer limits of what it means by that." Counsel Jakes, "Yes."

Suddenly, I thought of a fairly obscure but interesting decision, In re Ngai, 367 F.3d 1336 (Fed. Cir. 2004). The claims in question were to a "kit" for amplifying RNA comprising certain known reagents and "instructions describing the [amplification] method of claim 1." In other words, the only "point of novelty" was the instructional material. The court affirmed the rejection below, and distinguished In re Gulack (where a sort of circular slide rule was claimed), stating:

As the Gulack court pointed out,"[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability." If we were to adopt Ngai's position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product. This was not envisioned by Gulack. Ngai is entitled to patent his invention of a new RNA extraction method, and claims covering that invention were properly allowed. He is not, however, entitled to patent a known product by simply attaching a set of instructions to that product."

"Hold on," you may say, "this is a section 102 rejection, not a section 101 decision." But I re-read this decision after being asked to opine about the potential patentability of claim in a published application. I will simplify it as follows: "A method of increasing the safety of drug x by providing instructions to a patient taking drug x to stop taking drug x if side effect y is observed." One of the other claims recited the further step of providing drug x to the patient and then providing the patient with the warning (label, most likely). But there was no step involving administering the drug or adjusting the dosage.

This is about as pure a claim to a transmittal of information between two people as I can think of, that does not come off as a judicial joke ("speed dating"). It might be categorized broadly as a method of medical treatment. As Justice Sotomayor questioned, "Do you think that there is some benefit to society from patenting a method to cure someone that just involves human activity, as opposed to some machine, substance or other apparatus to help that process?" The answer is "yes." In fact, there was some discussion before the Supreme Court relevant to the fact that pure surgical methods are patentable, even after Congress acted to limit damages for infringement.

The "warning claim" I summarized would also seem to be an attempt to answer this question affirmatively, and to patent "the mere exchange of information." Hopefully the Bilski Court will not attempt to resolve this question, as they deal with the "machine or transformation test" that is before them, but a number of the Justices are certainly interested in the broader issue a la the Metabolite Labs, dissent by Justice Breyer et al. Mr. Stewart for the PTO made it clear that he hoped that the S. Ct. would not muck around in "software innovations or medical diagnostic techniques." We can only hope.

Bilski Transcript.pdf

OUTSIDE OPINIONS ARE STILL KEY TO AVOIDING WILLFUL INFRINGEMENT

2009-11-05T08:48:00.003-06:00

By A. J. Nelson

The October 29th IPO summary reports on the Senate version of the bill (attached below) regarding willful infringement:

SENATE BILL CODIFIES SEAGATE STANDARD FOR WILLFUL INFRINGEMENT AND IMPOSES ADDITIONAL LIMITATIONS ON FINDING WILLFULNESS -- Section 4 of S. 515, the patent reform bill that was reported out of the Senate Judiciary Committee on April 2, 2009, at p. 30 amends 35 U.S.C. §284 on willful infringement. The section continues the statutory provision that allows a court to increase damages up to triple the normal amount for willful infringement and adds extensive language to define “willfulness.” The section incorporates the “objective recklessness” standard of the Federal Circuit’s 2007 Seagate opinion and prescribes requirements for notice of infringement. Other permitted grounds for willfulness include intentional copying with knowledge of the patent and a second infringement finding. Willfulness cannot not be found if there was an informed, good faith belief of patent invalidity, unenforceability or no infringement. Willfulness cannot be pleaded until after a finding of infringement. IPO POSITION: IPO believes that in light of the Federal Circuit’s 2007 opinion in the Seagate case, patent reform legislation should not include any provision on willful infringement.

The bill 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.

Of course, the IPO, aka The Patent Owners Organization, opposes because the somewhat vague recklessness guideline promulgated by the Court can be seen as permitting very little Due Diligence and FTO work before a product is launched. The business owner can say in that instance "I had no idea that patent was out there. I was not reckless because my technical researchers said I was okay. They know the art. That is my good faith belief. After all, my researchers are at the forefront of this business."

Many in the business of litigation currently subscribe to the allegedly smart view that the approach of little or no FTO work and no prior formal opinions preserves as much flexibility as possible for patent infringement litigation and does not commit to positions before litigation occurs. Is it smart business, however, to spend thousands or millions of dollars on development of a product without knowing whether or not a U.S. patent may stop sales cold in their tracks?

s.515.pdf

Who Owns First? Stanford University v. Roche Molecular Systems

2009-10-28T17:23:00.002-05:00

Attached is an article written by Ron Schutz of Robins, Kaplan, Miller and Ciresi and is posted with his permission.

APaTS Who Owns First.pdf

SECOND PAIR OF EYES REVIEW - IS THE WICKED WITCH REALLY DEAD?

2009-10-23T14:47:00.002-05:00

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?

Director Kappos apparently does not think so. In his address to the members of AIPLA at their recent annual meeting in Washington, DC, he explicitly called for reform of the present "count system" (which I hear is undergoing reform right now) and implicitly criticized SPOE review, by stating that a system that attempts to measure quality after allowance (that is, after an initial determination of "quality") was not tenable. As noted above, the very existence of such a system caused Examiners to err on the side of rejection, and the SPOE reviewers necessarily felt pressured to reverse a certain number of Examiners in any case (or why should they be quality reviewers in the first place?). Since then, I have asked many practitioners if SPOE has been terminated. The answers were all ambiguous but seem to add up to a qualified "yes." Apparently the program will continue to operate at a reduced level to try to control rogue Examiners who issue too few or two many applications (Yes, Virginia, there are Examiners in the latter group). So as Halloween looms, perhaps one of the scariest PTO innovations in a long time will not be stalking our claims much longer.

(I want to thank posts by E. B. Chen, NC Jolt Online Ed. and Gene Quinn in IPWatchdog.com for some background material I used in this note.)

JUDGE RADER DEFENDS THE FUTURE OF IP

2009-10-16T16:55:00.001-05:00

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?"

While the title of the talk was "Trolls and Other Creatures of the Night," Judge Rader spent relatively little time on that topic. He dismissed the definition of patent troll as one who holds patents but does not practice them (commercially) as unfairly including universities and other research institutions. He said that the proper definition is "anyone who asserts a patent far beyond its value" and that the power of trolls can be limited if district court judges can develop procedures to properly value IP early in the litigation process, where they must be the "gatekeepers of damages."

In addition, Judge Rader acknowledged the role of patent litigation in setting the fence lines of IP, and urged us to consider that "Good fences make good neighbors."

As lunch speeches go, this was no rubber chicken, and I applaud Judge Rader for getting AIPLA's new business year (and new President, Alan Kasper) off to a good start.

TALKING WRITTEN DESCRIPTION REQUIREMENT BLUES - ARIAD WOBBLES

2009-10-12T12:16:00.004-05:00

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."

The questions to be resolved en banc, however, are 1) Does s. 112(1) contain a WDR separate from the enablement requirement, and 2) If it does, what is its scope and purpose? The Ariad brief answers "no" to question 1 but seems to retract its "no" in answering question 2. As part of its short answer to question 2 on page 1 of the brief, Ariad asserts: "Properly interpreted, the statute itself requires the specification to describe (i) what the invention is, and (ii) how to make and use it." At pages 43-46 of the Brief (the only parts you need to read if you are conversant with the debate), Ariad argues:

"[I]t necessarily follows that the statute provides no scope or purpose for a separate written description requirement. Properly interpreted, the written description requirement of s. 112(1) requires, first, that the specification describe (identify) what the invention is and second, that the specification teach how to make and use the invention...Identifying the invention is necessary for enablement, since a specification that does not teach one of ordinary skill what to make and use does not enable the skilled artisan to make and use the unidentified subject matter."

What a minute! This seems like ascribing an "identifying function" to the WDR that is separate from the enablement requirement. A sentence later, Ariad tries to ascribe this function to the claims, stating: "However, original claims necessarily identify the subject matter that they define; since they are part of the disclosure at the time of filing and 'constitute their own description’”.

This argument is akin to taking the position that claims that meet s. 112(2) also satisfy the "description function" of s. 112(1), but Ariad must have felt that statutory redundancy was not much of an argument, even though paragraph 2 of 112 requires "The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention."

If Judge Lourie has been the Big Bad Wolf leading the pack who supports a heightened WDR to police biotechnology, he should be licking his legal chops over arguments like this. As soon as Ariad concedes that the WDR of s. 112(1) requires the specification to describe "what the invention is," the Pandora's box filled with descriptors has been flung wide open; the courts are left to grapple with "How much description of the invention should the specification contain?" Well, how about "a precise definition, such as by structure, formula, chemical name, or physical properties." Lilly, 119 F.3d at 1566. Again, it bears repeating that adequate claims do not need to contain this level of description, e.g., they can describe the invention functionally or with mixed structural/functional terminology in some cases. For example, "An antibody that binds specifically to cytokine hBAD." Such a claim will still be weighed against the enablement requirement of s. 112(1), but a specification that adequately teaches how to "make and use" such an antibody should meet s. 112(1) without more.

As I wrote in early 2003, "the legal battle lines are sharply drawn. One camp of judges, led by Judge Rader, believes that the WDR is no more than a semantic test for the 'right to use' the claim language in question. If the claim language is supported by the specification, the WDR is satisfied. Enablement is a separate issue that is to be resolved by the very specific Wands factors. ... The camp led by Judge Lourie expects a lot more from the WDR; along with the enablement requirement, it now imparts or denies the 'right to claim' the invention at issue. That is nearly as equitable a doctrine as that assigned to the doctrine of equivalents."

At pages 46-50, the Ariad brief contains a rather confusing discussion of two cases decided in the 1850's that is supposed to convince the Fed. Cir. that Supreme Court precedent illustrates "[t]he proper approach to the enabling-description requirement of s. 112(1)". In my next post on Ariad, I review a hypothetical fact situation based on two biotech inventions that is a bit more modern. Eventually, we may even reach the merits of the case.
Ariad v Lilly Brief.pdf