April 2012

Despite Therasense: Federal Circuit Finds Aventis Patent Unenforceable

Patent, , ,

by Dennis Crouch

This is an important case showing that inequitable conduct based upon failure to cite prior art will continue to be viable.

Aventis Pharma v. Hospira (Fed. Cir. 2012)

Aventis holds two patents that cover its branded chemotherapy drug Taxotere. According to the patent, the active drug is mixed with other ingredients to form a perfusion that can be injected intravenously without causing anaphylactic or alcohol intoxication symptoms.

In litigation to prevent Hospira from bringing a generic form to market, the district court ruled the patents unenforceable for inequitable conduct during prosecution of the patents. On appeal, the Federal Circuit has affirmed that holding. This case marks the first time that the appellate court has upheld an inequitable conduct finding since raising the standard of proof in the 2011 Therasense v. BD en banc decision.

Inequitable conduct occurs when a patent applicant intentionally and materially misleads the patent office. Both intent and materiality must be proven. In Therasense, the court additionally held that materiality is normally only satisfied if the misconduct was a “but-for” cause of the given patent being issued. (Caveat for egregious misconduct).

This case involves the most typical inequitable conduct allegation: failing to notify the USPTO of a known reference that impacts patentability.

Lets walk through the steps of materiality and intent:

Materiality: In addition to inequitable conduct, the court also held a few of the patent claims invalid as obvious – relying upon the withheld reference. According to the court, this fact alone proves materiality – since the reference rendered the claim invalid. Two procedural issues add to this conclusion: (1) Claims are (according to the law) more narrowly construed at trial than at the USPTO and therefore references that are material at trial would have definitely been material at the USPTO. (2) Invalidation requires clear and convincing evidence but proof of materiality for inequitable conduct only requires a preponderance of the evidence. As such, information that works to prove the higher standard would certainly work to prove the lower standard.

Intent: To win, the defendant must show that the defendant had specific intent deceive. This can be proven by inference, but only if that conclusion is the “single most reasonable inference able to be drawn from the evidence.” Here, the inventor testified that he saw the references as explaining failed experiments and therefore need not be disclosed to the PTO. However, the judge found that the inventor lacked credibility and that some evidence suggested the inventor had learned valuable information from the reference.

On appeal, the court confirmed that these elements were met and that the patents were therefore obtained through inequitable conduct.

The Impact of Mayo v. Prometheus: Three Weeks In

Patent,

By Dennis Crouch

It has been three weeks since the Supreme Court decided Mayo v. Prometheus, and in that time four additional decisions have been released that rely on the Supreme Court opinion.

  1. In Association for Molecular Pathology (AMP) v. Myriad Genetics, Inc., the Supreme Court granted certiorari, vacated the Federal Circuit decision and remanded for further consideration of patentability of Myriad’s claims to isolated DNA strands based upon the outcome of Mayo v. Prometheus.
  2. In SmartGene v. Advanced Biological Laboratories, a DC District Court relied upon Mayo v. Prometheus to invalidate a patent claiming a system and method using a computer program to guide the selection of therapeutic treatments. In that case, the court noted that the steps of the claims were invalid because they added nothing “specific” to the abstract idea of choosing a therapy “other than what is well-understood, routine, conventional activity, previously engaged in by those in the field.”
  3. In Nazomi Communications, Inc. v. Samsung Telecommunications, the patent claimed a method of “executing an instruction” that resolves a reference when needed and updates a data structure to indicate that the reference has been resolved. The N.D. California district court found that the claims do not violate the patentable subject matter limitation of Section 101 because they “do more than recite an abstract idea and say ‘apply it.'”
  4. In L.A. Printex Industries, Inc. v. Aeropostale, the Court of Appeals for the 9th Circuit was asked to determine whether a lower court had correctly dismissed a copyright infringement lawsuit over a floral fabric design. In a footnote, the court cited the Mayo decision in support of the notion that “ideas, first expressed by nature, are the common heritage of humankind” and not protectable as intellectual property rights.

Patent

by Dennis Crouch

I created a database of utility patents running up through April 8, 2012 and tallied the number of patents that list more than twenty claims. More claims tend to create a greater likelihood that at least one of the claims will be found both valid and infringed. On the other hand, more claims raise the cost of prosecution, increase the odds of the patent being held unenforceable, and correlates with greater prosecution time.

The underlying data is available here: https://docs.google.com/spreadsheet/ccc?key=0Avb15LgT1GHYdFVFQ19rajh6MkVIZ3FCTkRWM2pia2c. Feel free to use the data with acknowledgement.

Inter Partes Reexamination: Standard for Initiating Reexamination No Longer Requires “New” Issues

Patent,

The threshold standard for initiating an inter partes reexamination was changed on September 16, 2011 – the enactment date of the America Invents Act.  The revised law eliminates the old “substantial new question of patentability” standard and now requires “a reasonable likelihood that the requester would prevail with respect to at least 1 of the claims challenged in the request.”  This reasonable likelihood of prevailing (RLP) standard must now be met before the USPTO can initiate an inter partes reexamination.

In my initial review of the change, I wrote that the new standard is “stricter” than the old.  Certainly, a reasonable likelihood of success is more difficult to prove than simply raising a substantial question. However, I must add an important caveat — the old standard required that the substantial question be “new” while the revised standard does not have such a limitation. 

In a recent petition decision, the USPTO confirmed this analysis — indicating that the a reexamination request under the RLP standard can be based entirely upon issues previously addressed by the Office. In other words, “the determination of whether the question presented in the request are new is no longer a prerequisite of the determination of whether to order inter partes reexamination.” (Quoting from the petition decision) The USPTO wrote:

Whether the issue being brought forth for consideration has been addressed in a previous Office proceeding does not preclude reexamination under the current standard for ordering inter partes reexamination. Under 35 U.S.C. 312, the Office has the discretion to reconsider issues that have been addressed in the past, provided the estoppel provisions of 35 U.S.C. 317 do not apply.

In a footnote, the decision noted that the question of whether the raised objections to patentability are “new” is simply “not relevant to deciding this petition.”

File Attachment: Dismissal of Petition.pdf (210 KB).

Robert Frame had argued on behalf of petitioner that the new RLP standard should be interpreted as SNQ+.  Frame pointed to the House Report on the AIA that stated:

The threshold for initiating an inter partes review is elevated from ‘significant new question of patentability’ -a standard that currently allows 95% of all requests to be granted — to a standard requiring petitioners to present information showing that their challenge has a reasonable likelihood of success.

As discussed above, that approach was rejected by the USPTO (CRU).

The patent being reexamined is No. 8,028,491 and covers a particular type of tactile warning surface units used to warn visually impaired individuals of a hazard (such as a curb).  The design allows the surface units to be wet-set (in concrete) and also replaceable.  This type of device is required in many situations in order to comply with requirements of the ADA.

In 2011, the patent holder (ADA Solutions) filed suit against several alleged infringers. On that same day, several of the accused infringers filed this reexamination request. (The parties are litigating other patents as well).

Unenforceable Patents

Patent,
By Jason Rantanen
Although the en banc Federal Circuit raised the bar for establishing inequitable conduct in Therasense v. Becton Dickinson, findings of inequitable conduct are still possible as illustrated by the district court's decision on remand in that case last week.  Given that the harsh consequence of a finding of inequitable conduct remain unchanged by Therasense, it remains a very real risk for patent holders asserting their patents in litigation.  What, then, are the characteristics of patents that historically have been the subject of an inequitable conduct finding? 

In a recently released draft paper, Lee Petherbridge, Polk Wagner, and I discuss the results of a study in which we empirically examined patents that were determined to be unenforceable due to inequitable conduct and compared them to litigated patents.  We report evidence that unenforceable patents are different from litigated patents.  Unenforceable patents have significantly longer pendency, more parent applications, and contain more claims.  Unenforceable patents also cite fewer U.S. patent references.  Surprisingly, we found no evidence that patents with foreign inventors are more likely to be unenforceable and no evidence that the subject matter of a patent associates with an inequitable conduct determination.  Using these observations, we hypothesize about why inequitable conduct happens, how inequitable conduct relates to patent policy, and what – if anything – practitioners who are concerned about an inequitable conduct determination might take as potential warning signs.

We are still grappling with what our results might teach about why inequitable conduct happens. As this is a working draft, we welcome any comments about that or any other aspects of the study.  The paper can be downloaded here: http://papers.ssrn.com/abstract=2031173.

Patent

In 2011, the USPTO issued a record number of utility patents – just shy of 225,000 issued patents.  My indicators are that the 2012 figure will be around 6–10% greater.  On April 3, the USPTO issued 5,176 utility patents — once again a new record and fully 200 more than the previous record set in March of this year.

USPTO Director Dave Kappos took office in August of 2009.  The record number of grants on a single day prior to that was 4,418 – set in 1999 under the leadership of Q. Todd Dickinson who heads the the AIPLA.

Punishing Prometheus: Part V – The Long Punt and the Improbable Return

Patent, , ,

Guest Post by Robert R. Sachs of Fenwick & West LLP
Read Part I; Part II; Part III; and Part IV.

The Bilksi decision punted on the question of what is an abstract idea, leaving it the Federal Circuit to devise a test. Judge Rader and Judge Dyk proposed different versions of an “I know it when I see it” test. Sadly, the Prometheus decision is of a piece with Judge Dyk’s approach—boiling the claim down to a point where the court can say it’s nothing more than _____  [pick at least one: abstract idea, law of nature, natural phenomena].

But interestingly the Court punted even more deeply in Prometheus—and perhaps, just perhaps, gave inventors and us crafty patent attorneys an out, a chance for a long return. A key premise of the Court’s analysis is that all of the claim elements, apart from the alleged law of nature, were “well­ understood, routine, conventional activity.” This not the normal state of affairs, either before the USPTO or before a court in patent litigation. The Court thus held out for another day:

We need not, and do not, now decide whether were the steps at issue here less conventional, these features of the claims would prove sufficient to invalidate them.

This sentence, a model of clarity, not it is.  It seems to suggest that had the other steps been “unconventional,” that is non-obvious, the claim would have stood a chance. This is how the Court rationalized the Diehr decision, noting that the steps of “installing rubber in a press, closing the mold, constantly determining the temperature of the mold, constantly re- calculating the appropriate cure time through the use of the formula and a digital computer, and automatically opening the press at the proper time” were “nowhere suggested” as being “obvious, already in use, or purely conventional.” But of course the Diehr court never “suggested” that because the novelty and obviousness of that process was not before the Court then, and it (wisely) did not frame the discussion in that way, no less because it has already stated that it was not going to dissect the claim into old and new parts.  To position Diehr in this way is highly disingenuous of the Court.  Moreover, I have a very strong feeling that even 54 years ago in 1968, putting rubber in mold, putting the mold in the oven, and taking it out of the oven when it was done was pretty well known in the art. 

In any event, if this hint is correct, then there remains a path to patent eligibility, one that seems both relatively straight forward and fraught with complexity, much like any long punt return: just run the ball all the way down the field.  On our playing field, you need only (!) make sure that there are at least some elements that “apply” whatever law of nature is in your claim in an “unconventional” manner.  

Surely, good advice. Alas, there are several problems with such a facile rule. First, once you start dissecting a claim and evaluating each element by itself, it becomes very easy to map each element onto some prior art. That is after all, what many patent examiners do; I’m just sayin’.

Second, some claims, like those in Prometheus, are by designed to reflect the business operation of the inventor and his company, and avoid problems such as multi-actor infringement. For example, had Prometheus added more “unconventional” limitations to the claims, in particular reciting steps relating to the manner of treating the patient based upon the thiopurine level, the claim would have had significantly less commercial value, if any, since Prometheus was in the business of testing for diseases, not in the business of treating them.

This is, of course, something for which the Court does not evidence an understanding or a concern. But it is something that the Court should both understand and care about—since the entire purpose of the patent law is to encourage innovation through economic incentives.  If that is the theory, then the incentives to patent must be aligned with the value proposition that the innovator seeks to exploit.  It follows that reducing the value of the incentive should reduce the level of innovation. (I’m not saying here that in fact this is true; I’m merely stating this as hypothesis).

What is the Law?

The Court has spliced together disparate, essentially contrary opinions into a legal virus, a self-validating meme that cannot be defeated by logic or example. I said earlier that the Court’s analysis was “not even wrong.”  The Court’s reliance on claim dissection, on hand waving rules of “is it enough?” and “does it add something significant?”; its confusing of statistical relationships with “natural laws;” and its shear daftness in believing that Section 101 must lord over Sections 112, 102 and 103 all combine to create a powerful “means for” invalidating any patent, now extant or in the future.  Give me any patent claim, and I can craft an argument using the Court’s Prometheus analysis that it is invalid. And like any theory that is not falsifiable—that is not even wrong—you could not logically defeat my argument: for I could always say: “it’s not enough.” 

Zeus punished Prometheus for stealing fire—knowledge—from the gods of Mount Olympus and giving it to Man: chaining him to a rock so his innards may be eaten by a bird of prey. So too has the Court sat in judgment of the modern Prometheus, for “stealing” a small bit of knowledge from the equivalent—and equivalently false—god, the laws of nature. Like their namesake, this Prometheus has had its innards exposed for the taking, and its discovery is now available for anyone to feast upon.

There may or may not be laws of nature. Even Einstein’s theory of relativity is not immune to criticism. But there is a law which is universal, immutable and everlasting, a law that will be confirmed yet again by this decision: The law of unintended consequences. 


 

Patently-O Bits & Bytes by Lawrence Higgins

Patent, , ,

Are Companies Acting as Government Contractors Immune From Patent Infringement Suits?

  • The CAFC, in Zoltek Corp. v. United States, No. 2009-5135 (Fed. Cir. Mar. 14, 2012), Zoltek was the assignee of a patent for manufacturing carbon fiber sheets with controlled surface electrical resistivity. The carbon fiber at issue was used by Lockheed Martin to build the F-22 fighter jet, pursuant to a government contract. The manufacturing of the fibers started in Japan, and thereafter imported into the US, where the fibers were processed into sheets and used for F-22.

    The court held that when the US is subject to suit under 28 USC 1498(a) for alleged infringement of a patent by a contractor acting by and for the US, the contractor by law is rendered immune from individual liability for the alleged infringement. The court further held that, when a product of a patented process is… imported into the US by or for the US, there is direct infringement under a 1498 action. (In addition the US waives sovereign immunity) Opinion

    28 USC 1498

    • (a) Whenever an invention described in and covered by a patent of the United States is used or manufactured by or for the United States without license of the owner thereof or lawful right to use or manufacture the same, the owner's remedy shall be by action against the United States in the United States Court of Federal Claims for the recovery of his reasonable and entire compensation for such use and manufacture.
    • (c)The provisions of this section shall not apply to any claim arising in a foreign country.

USPTO Will Admit 10 Additional Schools into its Patent Law Clinic Certification Pilot Program

  • The Pilot Program started began in 2008 with 6 schools and expanded in 2010 to 16 schools. Students in the patent program can expect to draft and file a patent application and respond to an office action. Each law school clinical program must meet and maintain the requirements for USPTO certification in order for student practitioners to practice before the USPTO. The program provides real-world experience to students interested in the field of IP. Submissions will be accepted through June 1, 2012. [Link]

Patent Jobs:

  • Hoffmann & Baron is seeking a patent attorney/agent with a minimum of 3-5 years of experience in the areas of computers and business methods to work in their Parsippany, NJ office. [Link]
  • Faegre Baker Daniel's is searching for a patent agent with a degree in EE or CS and patent experience to work in their Chicago office. [Link]
  • Larson Newman is looking for patent attorneys with an EE degree and 3-5 years of experience to work in their Austin office. [Link]
  • Akerman Senterfitt is seeking a chemical patent associate with 1-3 years of experience to work in their Denver office. [Link]
  • Gilead Sciences is searching for patent litigation counsel with a BS in life sciences and 5-8 years of experience to work at their Foster City, CA office. [Link]
  • Carlson, Gaskey & Olds is looking for a patent attorney with 4-8 years of patent litigation experience to work at their Birmingham, MI office. [Link]
  • Klarquist Sparkman is seeking a litigation associate with 1-2 years of experience to work in their Portland office. [Link]
  • Klarquist Sparkman is seeking a patent attorney/agent with an advanced degree in organic chemistry and 3+ years of experience to work in their Portland office. [Link]
  • Cardinal Intellectual Property is looking for a patent search professional with a JD degree and a technical degree to work remotely. [Link]
  • Berkeley Lab is searching for a patent attorney with at least 5 years of experience as a patent attorney/agent. [Link]
  • Faegre Baker Daniels is seeking a trademark litigation associate with 2-3 years of trademark and copyright litigation experience to work in their Minneapolis office. [Link]
  • Cardinal Intellectual Property is looking for a patent search attorney to work at their Evanston, IL location. [Link]
  • Wellstat Management Company is searching for a patent attorney/agent with at least 5 years of experience and a background in biomedical or mechanical engineering to work at their Gaithersburg, MD location. [Link]
  • Stroock
  • Faegre Baker Daniels is looking for a junior patent litigation associate with 1-2 years of experience to work in their Denver or Boulder office. [Link]
  • Nixon & Vanderhye is searching for a patent attorney/agent with experience drafting and prosecuting patent applications to work in their Arlington, VA office. [Link]
  • The DuPont Company is seeking patent agents with experience in preparing and prosecuting patent applications under USPTO TC1600 to work at their Wilmington, DE location. [Link]
  • Covidien is looking for an IP attorney with 4-6 years of experience to work at their New Haven, CT location. [Link]
  • Hagens Berman is searching for a patent litigation attorney with 3+ years of experience to work at their Seattle office. [Link]
  • The USPTO is seeking patent examiners with an engineering degree to work at their Alexandria or Detroit locations. [Link]

Upcoming Events:

  • On April 10th join the United States Patent and Trademark Office Managers, Design Examiners, Design Patent Practitioners and Industrial Designers from across the country in a lively and thought-provoking discussion at the USPTO. They will discuss rules and techniques relating to proper graphic descriptions of design patent claims, confer on best practices aimed at the broadest protection of industrial designs in the United States, and hear from members of the design community on the importance of strong industrial design protection in an increasingly design-conscious world. [Link]
  • The IP Section of the Atlanta Bar Association and Georgia State University Law School will hold its 8th annual SpringPosium at the Barnsley Gardens resort on April 13 &14. Some example seminars will include: the new America Invents Act, Federal Court best practices, IP law and life practice management, and recent developments in damages law. Guest speakers include: Clerk of Court and Chief Deputy Clerk of the US Court of Appeals for the Federal Circuit, Jan Horbaly and Pamela Twiford and Clerk of Court of the US District Court for the North District of Georgia, James Hatten.
  • The European Generic Medicines Association is hosting the 10th EGA International Symposium regarding Biosimilar Medicines on April 19-20 in London. Greenblum & Bernstein is providing a pre-symposium workshop on April 19, 2012 titled: Biosimilars In America: IP Strategy and Due Diligence. The workshop will explore the mechanics of the Biologics Act with an emphasis on how the Act relates to the involved intellectual property and how the intellectual property may impact the biosimilar applicant's strategy for entering the market. [Link]
  • The University of Colorado School of Law will hold a conference on April 24th. The conference, Patents on the Range or Wild Frontier, will discuss the future of patent policy. Guest speakers include: David Kappos, Don Rosenberg, John Thorne, Paul Ohm, Bernard Chao, and many others. [Link]
  • ACI will hold its 6th Annual Paragraph IV Disputes conference on April 24-25 in New York City. The conference will cover topics such as: the impact of the AIA on Hatch-Waxman litigation, claim construction, prior art obviousness and obvious-type double patenting, and many other topics. (Patently-O readers register with PO 200 for a discount). [Link]
  • The World Research Group is holding its 4th Annual Corporate IP Counsel Forum on May 16-17 in NYC. The Corporate IP Counsel Forum will address key issues and uncover latest developments related to IP in the form of case studies and panel discussions. Some of the topics include, but are not limited to: The America Invents Act and its impact on patent litigation and prosecution, IP monetization strategies for small and mid-size companies, Patent valuation, The top 10 most influential court cases in IP this year, Patent eligibility, Invention mining, Divided infringement, Best practices for combating non-practicing entities, Appeals to the U.S. Court of Appeals for the Federal Circuit, Copyright infringement. [Link]
  • The Annual DRI Business Litigation and Intellectual Property Seminar will be held May 16-18, 2012, in New York City. Attendees will learn trial and appellate advocacy skills in business litigation get up-to-date on the last trends in intellectual property and business litigation, and network with in-house counsel, business and intellectual property trial lawyers and experts from across the country. Speakers include: Former ABA President, Dennis W. Archer, Dennis Archer PLLC, and David Leitch, VP and General Counsel of Ford Motor Company. [Link]
  • The San Francisco Intellectual Property Law Association is hosting its annual seminar in Healdsburg, the center of one of California's best wine regions, from June 1-3. Speakers include Hon. Margaret A. (Peggy) Focarino, USPTO Commissioner of Patents, Hon. Robert Stoll, former USPTO Commissioner of Patents, Hon. Gerard F. Rogers, Chief Administrative Trademark Judge of the TTAB, Hon. Randy R. Rader, Chief Judge of Federal Circuit, Hon. Susan Illston, Judge of N.D.CA, Hon. Edward J. Davila, Judge of N.D.CA, as well as professors and leading practitioners. [Link]
  • On May 21-22 Ronald Slusky will hold a seminar in Chicago, the seminar teaches a comprehensive approach to analyzing inventions and capturing them in a sophisticated set of patent claims. The seminar is based on Ronald's book, Invention Analysis and Claiming: Patent Lawyer's Guide. [Link]
  • ACI will hold a Biosimilars conference May 22-23 in New York, NY. The conference will focus on the legal, regulatory, and commercial realities of biosimilars. [Link]

Contact Lawrence.Higgins@patentlyo.com with leads for future Bits and Bytes.

Patently-O Bits & Bytes by Lawrence Higgins

Patent, , ,

Are Companies Acting as Government Contractors Immune From Patent Infringement Suits?

  • The CAFC, in Zoltek Corp. v. United States, No. 2009-5135 (Fed. Cir. Mar. 14, 2012), Zoltek was the assignee of a patent for manufacturing carbon fiber sheets with controlled surface electrical resistivity. The carbon fiber at issue was used by Lockheed Martin to build the F-22 fighter jet, pursuant to a government contract. The manufacturing of the fibers started in Japan, and thereafter imported into the US, where the fibers were processed into sheets and used for F-22.

    The court held that when the US is subject to suit under 28 USC 1498(a) for alleged infringement of a patent by a contractor acting by and for the US, the contractor by law is rendered immune from individual liability for the alleged infringement. The court further held that, when a product of a patented process is… imported into the US by or for the US, there is direct infringement under a 1498 action. (In addition the US waives sovereign immunity) Opinion

    28 USC 1498

    • (a) Whenever an invention described in and covered by a patent of the United States is used or manufactured by or for the United States without license of the owner thereof or lawful right to use or manufacture the same, the owner's remedy shall be by action against the United States in the United States Court of Federal Claims for the recovery of his reasonable and entire compensation for such use and manufacture.
    • (c)The provisions of this section shall not apply to any claim arising in a foreign country.

USPTO Will Admit 10 Additional Schools into its Patent Law Clinic Certification Pilot Program

  • The Pilot Program started began in 2008 with 6 schools and expanded in 2010 to 16 schools. Students in the patent program can expect to draft and file a patent application and respond to an office action. Each law school clinical program must meet and maintain the requirements for USPTO certification in order for student practitioners to practice before the USPTO. The program provides real-world experience to students interested in the field of IP. Submissions will be accepted through June 1, 2012. [Link]

Patent Jobs:

  • Hoffmann & Baron is seeking a patent attorney/agent with a minimum of 3-5 years of experience in the areas of computers and business methods to work in their Parsippany, NJ office. [Link]
  • Faegre Baker Daniel's is searching for a patent agent with a degree in EE or CS and patent experience to work in their Chicago office. [Link]
  • Larson Newman is looking for patent attorneys with an EE degree and 3-5 years of experience to work in their Austin office. [Link]
  • Akerman Senterfitt is seeking a chemical patent associate with 1-3 years of experience to work in their Denver office. [Link]
  • Gilead Sciences is searching for patent litigation counsel with a BS in life sciences and 5-8 years of experience to work at their Foster City, CA office. [Link]
  • Carlson, Gaskey & Olds is looking for a patent attorney with 4-8 years of patent litigation experience to work at their Birmingham, MI office. [Link]
  • Klarquist Sparkman is seeking a litigation associate with 1-2 years of experience to work in their Portland office. [Link]
  • Klarquist Sparkman is seeking a patent attorney/agent with an advanced degree in organic chemistry and 3+ years of experience to work in their Portland office. [Link]
  • Cardinal Intellectual Property is looking for a patent search professional with a JD degree and a technical degree to work remotely. [Link]
  • Berkeley Lab is searching for a patent attorney with at least 5 years of experience as a patent attorney/agent. [Link]
  • Faegre Baker Daniels is seeking a trademark litigation associate with 2-3 years of trademark and copyright litigation experience to work in their Minneapolis office. [Link]
  • Cardinal Intellectual Property is looking for a patent search attorney to work at their Evanston, IL location. [Link]
  • Wellstat Management Company is searching for a patent attorney/agent with at least 5 years of experience and a background in biomedical or mechanical engineering to work at their Gaithersburg, MD location. [Link]
  • Stroock
  • Faegre Baker Daniels is looking for a junior patent litigation associate with 1-2 years of experience to work in their Denver or Boulder office. [Link]
  • Nixon & Vanderhye is searching for a patent attorney/agent with experience drafting and prosecuting patent applications to work in their Arlington, VA office. [Link]
  • The DuPont Company is seeking patent agents with experience in preparing and prosecuting patent applications under USPTO TC1600 to work at their Wilmington, DE location. [Link]
  • Covidien is looking for an IP attorney with 4-6 years of experience to work at their New Haven, CT location. [Link]
  • Hagens Berman is searching for a patent litigation attorney with 3+ years of experience to work at their Seattle office. [Link]
  • The USPTO is seeking patent examiners with an engineering degree to work at their Alexandria or Detroit locations. [Link]

Upcoming Events:

  • On April 10th join the United States Patent and Trademark Office Managers, Design Examiners, Design Patent Practitioners and Industrial Designers from across the country in a lively and thought-provoking discussion at the USPTO. They will discuss rules and techniques relating to proper graphic descriptions of design patent claims, confer on best practices aimed at the broadest protection of industrial designs in the United States, and hear from members of the design community on the importance of strong industrial design protection in an increasingly design-conscious world. [Link]
  • The IP Section of the Atlanta Bar Association and Georgia State University Law School will hold its 8th annual SpringPosium at the Barnsley Gardens resort on April 13 &14. Some example seminars will include: the new America Invents Act, Federal Court best practices, IP law and life practice management, and recent developments in damages law. Guest speakers include: Clerk of Court and Chief Deputy Clerk of the US Court of Appeals for the Federal Circuit, Jan Horbaly and Pamela Twiford and Clerk of Court of the US District Court for the North District of Georgia, James Hatten.
  • The European Generic Medicines Association is hosting the 10th EGA International Symposium regarding Biosimilar Medicines on April 19-20 in London. Greenblum & Bernstein is providing a pre-symposium workshop on April 19, 2012 titled: Biosimilars In America: IP Strategy and Due Diligence. The workshop will explore the mechanics of the Biologics Act with an emphasis on how the Act relates to the involved intellectual property and how the intellectual property may impact the biosimilar applicant's strategy for entering the market. [Link]
  • The University of Colorado School of Law will hold a conference on April 24th. The conference, Patents on the Range or Wild Frontier, will discuss the future of patent policy. Guest speakers include: David Kappos, Don Rosenberg, John Thorne, Paul Ohm, Bernard Chao, and many others. [Link]
  • ACI will hold its 6th Annual Paragraph IV Disputes conference on April 24-25 in New York City. The conference will cover topics such as: the impact of the AIA on Hatch-Waxman litigation, claim construction, prior art obviousness and obvious-type double patenting, and many other topics. (Patently-O readers register with PO 200 for a discount). [Link]
  • The World Research Group is holding its 4th Annual Corporate IP Counsel Forum on May 16-17 in NYC. The Corporate IP Counsel Forum will address key issues and uncover latest developments related to IP in the form of case studies and panel discussions. Some of the topics include, but are not limited to: The America Invents Act and its impact on patent litigation and prosecution, IP monetization strategies for small and mid-size companies, Patent valuation, The top 10 most influential court cases in IP this year, Patent eligibility, Invention mining, Divided infringement, Best practices for combating non-practicing entities, Appeals to the U.S. Court of Appeals for the Federal Circuit, Copyright infringement. [Link]
  • The Annual DRI Business Litigation and Intellectual Property Seminar will be held May 16-18, 2012, in New York City. Attendees will learn trial and appellate advocacy skills in business litigation get up-to-date on the last trends in intellectual property and business litigation, and network with in-house counsel, business and intellectual property trial lawyers and experts from across the country. Speakers include: Former ABA President, Dennis W. Archer, Dennis Archer PLLC, and David Leitch, VP and General Counsel of Ford Motor Company. [Link]
  • The San Francisco Intellectual Property Law Association is hosting its annual seminar in Healdsburg, the center of one of California's best wine regions, from June 1-3. Speakers include Hon. Margaret A. (Peggy) Focarino, USPTO Commissioner of Patents, Hon. Robert Stoll, former USPTO Commissioner of Patents, Hon. Gerard F. Rogers, Chief Administrative Trademark Judge of the TTAB, Hon. Randy R. Rader, Chief Judge of Federal Circuit, Hon. Susan Illston, Judge of N.D.CA, Hon. Edward J. Davila, Judge of N.D.CA, as well as professors and leading practitioners. [Link]
  • On May 21-22 Ronald Slusky will hold a seminar in Chicago, the seminar teaches a comprehensive approach to analyzing inventions and capturing them in a sophisticated set of patent claims. The seminar is based on Ronald's book, Invention Analysis and Claiming: Patent Lawyer's Guide. [Link]
  • ACI will hold a Biosimilars conference May 22-23 in New York, NY. The conference will focus on the legal, regulatory, and commercial realities of biosimilars. [Link]

Contact Lawrence.Higgins@patentlyo.com with leads for future Bits and Bytes.

Self-Replicating Inventions: Supreme Court asks for Government’s Views in Monsanto Patent Exhaustion Case

Patent, ,

By Dennis Crouch

Bowman v. Monsanto (Supreme Court Docket No. 11-796, 2012)

In 2011, the Federal Circuit again affirmed that Monsanto’s genetically modified seeds patents can be used to stop farmers from saving and replanting the GM seeds. The farmer, Vernon Bowman, then petitioned the Supreme Court asking for a writ of certiorari – presenting the following question:

Patent exhaustion delimits rights of patent holders by eliminating the right to control or prohibit use of the invention after an authorized sale. In this case, the Federal Circuit refused to find exhaustion where a farmer used seeds purchased in an authorized sale for their natural and foreseeable purpose – namely, for planting. The question presented is:

Whether the Federal Circuit erred by (1) refusing to find patent exhaustion in patented seeds even after an authorized sale and by (2) creating an exception to the doctrine of patent exhaustion for self-replicating technologies?

In its brief-in-opposition, Monsanto reformulated the question as follows:

Whether the Federal Circuit correctly ruled that Monsanto’s patent rights in biotechnology related to genetically modified plants (here, patented technologies that make soybeans resistant to glyphosate-based herbicides) are independently applicable to each generation of soybeans embodying the invention, such that a grower who, without authorization from Monsanto, creates a new generation of genetically modified soybeans infringes Monsanto’s patents.

CVSG: Now, the Supreme Court has invited the Solicitor General to file briefs expressing the views of the United States in the case. This is a significant step toward grant because it shows some interest in the case. Typically a call for the views of the Solicitor General (CVSG) requires the vote of at least four justices. However, those votes appear to be easier to obtain than a vote to grant certiorari or a vote to reverse the lower court. A study of 30,000 petitions reported that a petition on the paid docket is four times more likely to be granted once the Court calls for a response. Thompson and Wachtell, An Empirical Analysis of Supreme Court Certiorari Petition Procedures: The Call for Response and the Call for the Views of the Solicitor General, 16 George Mason L. Rev. 237 (2009). In his study of patent cases, Professor Duffy found that the SG’s opinion is extremely important in predicting whether the Supreme Court decides to hear a case on the merits. John F. Duffy, The Federal Circuit in the Shadow of the Solicitor General, 78 Geo. Wash. L. Rev. 518 (2010).

DOJ – USPTO – FTC – ETC.: The USPTO would almost certainly agree with the Federal Circuit’s opinion and recommend against a grant of certiorari. Of course, the Supreme Court is not asking the opinion of Raymond Chen (USPTO Solicitor General), but rather the opinion of Solicitor General of the United States (acting on behalf of the US). In the power struggle, the USPTO is only one voice and may well lose-out here to other interests (as it has in other recent cases). In 2005, the SG (then Paul Clement) filed a brief in the parallel case of McFarling v. Monsanto recommending that the petition be denied. The McFarling petition did not focus on exhaustion. However, in a footnote the SG brief noted that “whether (and, if so, to what extent) the patent-exhaustion doctrine applies to restrictions on the use of a materially identical patented product that was produced by the patented product sold by the patentee” is “novel.”

Mark Walters of Frommer Lawrence & Haug is lead counsel for Bowman. Seth Waxman is counsel of record for Monsanto.

London Masterclass: The Real, Dramatic and Ongoing Changes to United States Patent Law and their Impact on the Practice of Patent Law

Patent

London_underground_logo
By Dennis Crouch

This summer, I will be leading a professional summer course (masterclass) on U.S. Patent Law at the University College of London (UCL) Faculty of Laws. The event is sponsored by UCL and chaired by the Rt Hon Prof. Sir Robin Jacob. In three two-hour sessions, we will look at recent changes to the US patent law and their impact on the practice of law – with a particular focus on issues involving UK and European patent law professionals and their clients.

The three sessions are as follows:

  • Monday 18 June – 6-8pm: Changes in the Way Patents are Prosecuted in the US.
  • Thursday 28 June – 6-8pm: US Patent Litigation Structure and Changes to the Process.
  • Wednesday 4 July – 6-8pm: Litigating at the USPTO (Pre and Post-Grant); Subject Matter Eligibility.

The course is geared toward patent law professionals, experienced users of the patent system, and others considering entering the field. I am looking forward to meeting you there and perhaps the pub after.

UCL is offering an early-bird special for those who sign-up early:

Guest Post: Prometheus v Mayo – A European view

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Guest post by Paul Cole, European Patent Attorney, Lucas & Co.

How is the Prometheus invention viewed by the EPO, and what are the differences between the reasoning of EPO appeal boards and of the US Supreme Court concerning patent eligibility?

An indication is that the EPO granted EP-B-1114403 (Seidman) which corresponds to US 6355623 and has a main claim that reads:

An in vitro method for determining efficacy of treatment of a subject having an immune-mediated gastrointestinal disorder or a non-inflammatory bowel disease (non-IBD) autoimmune disease by administration of a 6-mercaptopurine drug, comprising

determining in vitro a level of 6-thioguanine in a sample from said subject having said immune-mediated gastrointestinal disorder or said non-inflammatory bowel disease (non-IBD) autoimmune disease,

wherein said treatment is considered efficient if the level of 6-thioguanine is in the range of about 230 pmol per 8×108 red blood cells to about 400 pmol per 8×108 red blood cells.

The above claim is not an outlier. The forward references of the '633 patent include US 7524851, whose equivalent EP-B-1695092 has a main claim that reads:

A method for monitoring azathioprine therapy in an individual, said method comprising

measuring the level of 6-thioguanosine diphosphate and 6-thioguanosine triphosphate in a sample from said individual, and

calculating a concentration ratio of 6-thioguanosine triphosphate to 6-thioguanosine triphosphate and 6-thioguanosine diphosphate,

wherein a concentration ratio greater than 0.85 is indicative of superior clinical responsiveness to azathioprine therapy, and wherein a concentration ratio less than 0.85 is indicative of inferior clinical responsiveness to azathioprine therapy.

In a communication dated 26 October 2007 and available in the EPO's online file the Examining Division decided that the '851 claim was novel and inventive based on the technical effect of improved therapeutic efficiency. In accordance with EPO practice, from that effect a technical problem based on the Seidman disclosure as starting point could be reconstructed which was to provide an improved method of monitoring azopurine therapy.

If the '403 patent had been challenged e.g. in an opposition the EPO would have been bound to follow established case law and hold that the claimed method was patent-eligible firstly because it is carried out on a sample from the subject and secondly because an in vitro measurement is made, see the Enlarged Appeal Board decision in G 3/08 PRESIDENT'S REFERENCE in which the long-standing practice of the Appeal Boards was approved. An argument that the "wherein" features should be disregarded for assessment of novelty or inventive step taking into account the exclusions under art. 52 EPC as a mere discovery or mere presentation of information would have been likely to fail because, as seen above, improvement in therapeutic efficiency is treated at least at first instance as a technical effect.

The CAFC in its opinion on remand of 17 December 2010 reasoned in broadly similar terms to what would be expected from an EPO Appeal Board dealing with patent-eligibility. It held that treatment and optimization formed part of an inherently patent-eligible treatment protocol (opinion, page 20) and continued:

We agree with the district court that the final "wherein" clauses are mental steps and thus not patent-eligible per se. However, although they alone are not patent-eligible, the claims are not simply to the mental steps. A subsequent mental step does not, by itself, negate the transformative nature of prior steps. Thus, when viewed in the proper context, the final step of providing a warning based on the results of the prior steps does not detract from the patentability of Prometheus's claimed methods as a whole. The data that the administering and determining steps provide for use in the mental steps are obtained by steps well within the realm of patentable subject matter; the addition of the mental steps to the claimed methods thus does not remove the prior two steps from that realm.

As to the overall significance of the "wherein" clauses in the context of the claim as a whole, the CAFC appears to have accepted that they helped define a technical result (opinion at pp.22-23):

Although the wherein clauses describe the mental processes used to determine the need to change the dosage levels of the drugs, each asserted claim as a whole is drawn to patentable subject matter. Although a physician is not required to make any upward or downward adjustment in dosage during the "warning" step, the prior steps provide useful information for possible dosage adjustments to the method of treatment using thiopurine drugs for a particular subject. Viewing the treatment methods as a whole, Prometheus has claimed therapeutic methods that determine the optimal dosage level for a course of treatment. In other words, when asked the critical question, "What did the applicant invent?," Grams, 888 F.2d at 839 (citation omitted), the answer is a series of transformative steps that optimizes efficacy and reduces toxicity of a method of treatment for particular diseases using particular drugs.

From a European standpoint the key ruling of the Supreme Court is that the reasoning of the CAFC and the EPO Appeal Boards should not be followed. Its reasons are set out in the slip opinion pp. 20-21:

Third, the Government argues that virtually any step beyond a statement of a law of nature itself should transform an unpatentable law of nature into a potentially patentable application sufficient to satisfy §101's demands… The Government does not necessarily believe that claims that (like the claims before us) extend just minimally beyond a law of nature should receive patents. But in its view, other statutory provisions—those that insist that a claimed process be novel, 35 U. S. C. §102, that it not be "obvious in light of prior art," §103, and that it be "full[y], clear[ly], concise[ly], and exact[ly]" described, §112—can perform this screening function.

This approach, however, would make the "law of nature" exception to §101 patentability a dead letter …

What role would laws of nature, including newly discovered (and "novel") laws of nature, play in the Government's suggested "novelty" inquiry? Intuitively, one would suppose that a newly discovered law of nature is novel. The Government, however, suggests in effect that the novelty of a component law of nature may be disregarded when evaluating the novelty of the whole… But §§102 and 103 say nothing about treating laws of nature as if they were part of the prior art when applying those sections. Cf. Diehr, 450 U. S., at 188 (patent claims "must be considered as a whole").

If the CAFC/EPO approach is to be abandoned, what is the alternative? The rule followed by the Supreme Court is that the claimed combination of features must amount to significantly more than the natural law itself and that limiting the law to a particular technological environment or adding insignificant post-solution activity does not suffice. The Court was aware of the need for caution and warns in its opinion:

The Court has recognized, however, that too broad an interpretation of this exclusionary principle could eviscerate patent law. For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.

In effect the Mayo rule corresponds to the "contribution approach" suggested at first instance in the UK in Merrill Lynch's Application [1988] R.P.C. 1 which was to consider whether the inventive contribution resided only in excluded matter. That approach also has its difficulties and it was rejected by the UK Court of Appeal in Genentech's patent [1989] R.P.C. 147 where it was observed that:

Such a conclusion, when applied to a discovery, would seem to mean that the application of the discovery is only patentable if the application is itself novel and not obvious, altogether apart from the novelty of the discovery. That would have a very drastic effect on the patenting of new drugs and medicinal or microbiological processes.

The Supreme Court acknowledges that the rule ought not to be interpreted to cover newly discovered first or subsequent medical indications for a known substance (slip opinion at page 18):

Unlike, say, a typical patent on a new drug or a new way of using an existing drug, the patent claims do not confine their reach to particular applications of those laws.

It is, however, less than clear by what logic new drugs escape the rule in Mayo but the Prometheus test is caught by that rule. For example, nitroglycerin was first synthesized in 1847 and was used as an explosive. In 1878 it was introduced as a treatment for angina by Dr William Murrell. Suppose Dr Murrell had claimed a pharmaceutical composition for the treatment of angina or other heart conditions comprising nitroglycerin and a pharmaceutically acceptable carrier or diluent. The anti-angina activity of nitroglycerin could be regarded as a mere phenomenon of nature "though just discovered", the reference to treatment of cardiac disorder could be a mere limitation to a particular technological environment and formulation into tablets or other forms for convenient administration to the patient could be regarded as an insignificant post-solution activity since the incorporation of active ingredients into tablets or other dosage forms was well known long before 1878. The pharmaceutical composition claim which is in standard form for a first medical indication would block research into further formulations and further medical indications for nitroglycerin. Indeed, blocking further development was an objection raised in the 1790's to James Watt's patent for a steam engine. It might be said that the hypothetical Murrell claim confines the reach of what has been discovered to the particular application of pharmaceuticals but it might equally be said that the Prometheus claim confines the reach of what has discovered to the particular application of a blood test for metabolites of drugs of a particular family. If there is a distinction, arguably it is no more than pragmatism.

Such a conclusion is consistent with the arguments of Robert Sachs in Part III of his Guest Post, where he singles out relative terminology and conclusory statements. A question expressed as "doing significantly more" or "adding enough" is a matter of degree rather than of kind, and provides no unequivocal forward guidance. Indeed the Supreme Court accepted the limitations of its guidance (slip opinion at page 24) where it said:

In consequence, we must hesitate before departing from established general legal rules lest a new protective rule that seems to suit the needs of one field produce unforeseen results in another.

Perhaps the wisest course is to take the opinion at its word and accept that beyond disapproving the CAFC/EPO approach Mayo makes no new rule and does nothing positive to explain what is patent-eligible and what is not.

Paul Cole wrote more on the topic in a recent guest post on Warren Woessner's blog Patents4Life.

 

Means-Plus-Function: Invalid as Indefinite

Indefinite, Patent, ,

by Dennis Crouch

Ergo Licensing v. CareFusion 303 (Fed. Cir. 2012)

In a split opinion, the Federal Circuit has affirmed a lower court ruling that Ergo's asserted claims are invalid. Judge Moore explains in her opinion, that the claims are indefinite under 35 U.S.C. § 112 (2) because the means-plus-function limitations are not supported by any corresponding structure disclosed in the specification.  Judge Linn joined Judge Moore's opinion.  Judge Newman dissented. 

Describing, Enabling, and Defining: 35 U.S.C. § 112 (1) requires that a claimed invention be fully described and enabled. In addition, the claims must be drafted in a manner that particularly identifies the scope of rights being claimed.  35 U.S.C. § 112 (2).  Although overlapping, these three requirements—written description, enablement, and definiteness—are separate and distinct requirements. Thus, a claim may fail the definiteness requirement even though the invention sought to be patented was fully described in the original specification in "full, clear, concise, and exact terms" and in a way that "enables any person skilled in the art … to make and use the same."

Means-Plus-Function: Patent claims ordinarily recite particular "structure, material, or acts" as elements that both provide for the inventive step and limit the scope of rights. 35 U.S.C. § 112 (6) allows a patentee to alternatively draft limitations as "a means or step for performing a specified function without the recital of structure, material, or acts in support thereof." To a lay reader, these means-plus-function claims appear quite broad. For instance a claimed "means for connecting elements A and B" seemingly covers any method or structure that accomplishes the claimed function. However, the statute itself require that means-plus-function claims be given a much more limited scope. Under § 112 (6), a means-plus-function claim "shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof." Thus, to know the meaning of a claimed "means for connecting," we must look to the patent specification to see what particular connecting means were disclosed and the scope of the claim would be limited only to those disclosed structures and their equivalents. The result here is that means-plus-function claims typically have a scope that is much narrower than one might expect on the initial reading.

Undefined Means: In recent years, a number of means-plus-function claims have been invalidated as lacking definiteness under § 112 (2). (I.e., invalid as indefinite). Courts follow the following approach: (a) The statute requires that a means-plus-function element be defined according to corresponding structure found in the specification. (b) If no corresponding structure is found then the term cannot be defined and (c) is therefore invalid as indefinite.

This case offers yet another example of claims being held invalid based upon means-plus-function claim elements that lack corresponding structure in the specification. The claims recite a "control means for controlling [an] adjusting means." The patentee argued that its disclosure of a general purpose computer was sufficient structure because a computer would be able to accomplish the task-at-hand. On appeal, the court rejected the patentee's argument and affirmed that such a computer was insufficient structure since a general purpose computer could not accomplish the function required by the claim. The court wrote that the patentee could have satisfied the requirement by additionally including the algorithm that the computer would use to accomplish its task."

If special programming is required for a general purpose computer to perform the corresponding claimed function, then the default rule requiring disclosure of an algorithm applies. It is only in the rare circumstances where any general-purpose computer without any special programming can perform the function that an algorithm need not be disclosed.

Thus, the means-plus-function limitation has no corresponding structure in the specification because "there is no algorithm described in any form for the function of 'controlling the adjusting means.'" As a result, the claim is invalid as indefinite.

In an extended dissent, Judge Newman argued that the ruling amounts to a formalistic technicality that is unfair to patentees – especially when the enablement and written description tests are not offended by the claim.

Disfavored by Patentees: Because of their narrow scope and high-likelihood of invalidity, "means for" claiming has been on a steady decline for the past two decades. The chart below shows a time series of the percent of patents that include at least one "means for" claim limitation. (Note – my search was for "means for" and so some MPF claims are not counted). These days, the only ones being caught in this trap are either (1) being poorly advised or (2) attempting to improperly extend the scope of their patent beyond what was actually invented. In my view, prudent patent applicants today never rely on MPF claims as their broadest or strongest claims. However, many still find some role for those claims and it is important to recognize that means-plus-function claim scope varies dramatically on the international level.

Device for: The majority opinion suggests the next frontier of challenge – patent claims that rely heavily on functional language but that do not use the magic "means" language. Here, the court at least suggests that an equivalent claim drafted as a "device for controlling" would have been invalid under the same analysis. The court wrote "The [hypothetical] recitation of 'control device' provides no more structure than the term 'control means' itself, rather it merely replaces the word 'means' with the generic term 'device.'"