Tag Archives: Inequitable Conduct

Inequitable Conduct: Federal Circuit Places another Nail in the Coffin

Patent, ,

By Dennis Crouch

1st Media v. Electronic Arts (Fed. Cir. 2012)

In a strong opinion, the Federal Circuit has rejected a district court holding of inequitable conduct in a failure-to-submit case. The appellate court held that the defendant had failed to prove that the failure to submit was a deliberate fraud on the PTO under the standard outlined in the court’s 2011 en banc Therasense decision.

Individuals sufficiently involved with the prosecution of a patent application bears a “duty of candor and good faith dealing with the [USPTO], which includes a duty to disclose to the Office all information known to that individual to be material to patentability.” 37 C.F.R. § 1.56 (Rule 56). This duty is particularly applied to each inventor named in the application and “each attorney or agent who prepares or prosecutes the application.” A patent attorney’s failure to comply with the duty of candor can lead to disciplinary hearings by the USPTO’s office of enrollment and discipline (OED) and, as a rule, the USPTO refuses to grant patents “on an application in connection with which fraud on the Office was practiced or attempted or the duty of disclosure was violated through bad faith or intentional misconduct.”

The fiercely adversarial litigation system in the US is comparably quite good at rooting out (and thus discouraging) fraud. Whenever a patent is being enforced, accused infringers scour the records and available evidence to look for any way failures to comply with Rule 56. When those failures rise to intentional and material misconduct, a court has the equitable power to hold the patent (and its patent family) unenforceable due to inequitable conduct in the prosecution of the application. Of course, attorney fraud is a serious charge, and even false claims create difficulties for the accused wrongdoer. As such, the courts have taken some steps toward limiting those types of claims. The two key recent cases on this point are Excergen and Therasense.

Excergen: The Federal Rules of Civil Procedure (FRCP) as interpreted by the Excergen decision, inequitable conduct may only be alleged as a defense if it can be pled with particularity (as opposed to other types of claims that may be pled much more generally).

Therasense: Under Therasense, inequitable conduct requires proof that the alleged wrongdoing was deliberately and knowingly wrong and that the result of the wrongdoing during patent prosecution impacted the issuance of the eventual patent and that each element be proven with clear and convincing evidence. In the failure-to-disclose situation, the court writes that a defendant must prove “that the applicant knew of the reference, knew that it was material, and made a deliberate decision to withhold it.”

In 1st Media, the asserted patent was part of a family of applications that had been filed in various countries around the world. Three references used to reject the foreign applications were never submitted for consideration by the US examiners. Nevada district court Judge Mahan considered this issue and found that both the patent attorney and the listed inventor were at fault for failing to submit the references and held the patent unenforceable.

On appeal, the Federal Circuit reversed – making clear (again) that in a failure-to-disclose situation, the defendant must prove that individuals with a Rule 56 duty “made a deliberate decision to withhold” the references. Further, that deliberate decision element must be proven with clear and convincing evidence and that proof cannot be inferred from the fact that the individuals had knowledge of the references and their materiality.

A court can no longer infer intent to deceive from non-disclosure of a reference solely because that reference was known and material. Moreover, a patentee need not offer any good faith explanation for his conduct unless and until an accused infringer has met his burden to prove an intent to deceive by clear and convincing evidence.

In the bench trial, Judge Mahan found the explanations given by the inventor and his patent attorney to lacking. On appeal, the Federal Circuit made clear that the burden is on the defendant to provide clear and convincing evidence.

The court provided a nice quite for patent attorneys:

Moreover, it is not enough to argue carelessness, lack of attention, poor docketing or cross-referencing, or anything else that might be considered negligent or even grossly negligent. To sustain a charge of inequitable conduct, clear and convincing evidence must show that the applicant made a deliberate decision to withhold a known material reference. Whatever one might conclude about Lewis’s and Sawyer’s conduct and interactions relating to the Bush reference, and the nature of Sawyer’s practice at the relevant time, the record does not support the inference that Lewis and Sawyer deliberately chose to withhold Bush.

Because one element of the inequitable conduct charge is missing, the court concluded that it cannot be proven. Of course, “carelessness, lack of attention, [or] poor docketing” will still lead to malpractice claims.

Notes:

  • In its opinion, the Federal Circuit foreclosed any possibility for the defendants to re-open their inequitable conduct charges for a rehearing. However, the judge has not yet determined validity. Thus, if the withheld references are truly material then we’ll see the jury hold the asserted claims obvious.
  • Beginning September 16, 2012, patentees will also be able to request a supplemental examination at the USPTO to ensure that any references that had been previously withheld do not impact patentability. However, if the USPTO finds that the previously withheld references create a major patentability question then the Office will institute a reexamination.
  • We now have a situation where inequitable conduct is quite difficult to prove – meaning that patent owners will rarely be harmed by a violation of the duty of candor and good faith dealing. Consequently, patent attorneys will faced increased pressure to push the boundaries.

America Invents Act: One Year Later (pt. 2)

Patent, , ,

By Jason Rantanen

Liveblogging the America Invents Act: One Year Later conference at the Indiana University Mauer School of Law. Warning: Quality may vary.

Session 2: First to File/Supplemental Examination

I spoke during this panel, so wasn't able to take down any notes during Q&A

John Schaibley – Panel is going to discuss two changes under AIA: First to invent to First to File and Supplemental Examination.  Summarized the two changes.

Jay Thomas (Georgetown) – thanks Bob for his hard work on the AIA; but he won't necessarily agree with everything Bob said. 

When we teach 102, it's "the long march" – a lot of it is now gone.  Still going to be some complexity due to the prior user defense.  Also, what does "or otherwise available to the public."  What's the role of secret uses and sales prior to the date of filing. 

Remember two cases: Egbert v. Lipman(sp?): you can have a public of one; Metallizing Engineering: a trade secret use is patent defeating.  New section 102(a) still has the term "public use" in it.  Early legislative history indicated a continuity of meaning.  But things changed.  "or otherwise available to the public" was added.  Some legislative history that says that this has to be true for all prior art. Note that "public" is still pretty broad.  Just because it's technically publicly accessible doesn't mean that it's necessarily easy to find.

Also, keep in mind that these two cases were instances where the patent holder effectively tried to extend the date of filing.  Is it sound industrial policy to allow secret uses to not defeat patentability? 

International harmonization: tried to move in that direction, but didn't completely succeed.  Example: safe harbor under new 102 is different as between US and Europe and Japan. 

Short term issues: lots of filing before March 16, 2013.  Abolition of the Hilmer doctrine; lose ability to swear behind prior art references.  Storm surge is coming.  There's going to be a sharp distinction between old and new cases.  What to train the new examiners in?  Old and new or just new?  Constitutional challenges – probably dubious.  Employment assignment agreements – these will be important to look at.  And what about the technical corrections bill?  Likely to involve some huge changes of its own – dissatisfied parties are going to push for these. 

Dana Colarulli (USPTO) – Probably agrees with Bob on most of the things he said.  But legislation only gets us a good portion of the way there.  There's more to do.  Specifically, implementing the provisions in the appropriate way through rules. The PTO is really trying to get the implementation right. Very much looking for comments and feedback on the proposed rules.

International harmonization – huge step forward in restarting international harmonization discussions.  But doesn't go all the way there.  More work to be done. 

Impact of the law overall – this is the most significant change since 1836.  A lot of these changes have been percolating for far longer than the five years up to the AIA.  First to file really goes back to 1966 with a report from Lyndon Johnson, then a 1992 report that made the same suggestion.  2004 National Academies of Science recommended as well.  First to file is both international harmonization and a best practice. 

PTO's goals in drafting the rules.  Make the guidance clear and transparent.  Address examination issues raised by AIA up front. 

On grace period – this is a critical issue.  It's a unique feature of US law, but it's not the same grace period as we had before.  There are going to be questions about how narrowly the grace period is going to be read.  USPTO has interpreted the the grace period to be very narrow.  There are many views about this issue. 

Sales issue (ed. do they have to be public?) – legislative history conflicts.  Is Metalizing Engineering overturned or not? 

Visit the USPTO's AIA implementation page – lots of good material there. 

Nathan Kelley (USPTO) – How supplemental examination is supposed to work.  Purpose of supplemental examination is to immunize patentees against claims of inequitable conduct based on information that was not disclosed, inadequately disclosed, or incorrect information. 

Supplemental examination lets just about all issues of patentability to be raised.  Talked about the mechanics of supplemental examination.  If, for example, the issue raised by the supplemental examination is a written description issue, that's what will go into reexam. 

Could apply to patents that have expired because the statute of limitations on a patent (enforceability period) is six years. 

Improper requests will not get into the PAIR system until they are granted. 

Items of information are anything, as long as they're written.  Videos/oral testimony must include a transcript.   Can't give more than twelve items of information in any one request.  But you can make more than one request.

Fees – about $5k for the request, plus upfront $16,000 for reexam that will be refunded if no ex parte reexam. 

(I spoke about inequitable conduct post-Therasense and the effect on supplemental examination)

During Q&A, question came up about PTO fraud enforcement.  PTO views supplemental examination as exactly that, not an inquiry into the intent of the parties.

The America Invents Act: One Year Later (conference)

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By Jason Rantanen

Liveblogging the America Invents Act: One Year Later conference at the Indiana University Mauer School of Law.   Warning and disclaimer: Quality may vary and these don't necessary reflect my opinions.

Session 1:

Mark Janis – opening remarks.  Hard to believe it's been a year act since AIA was signed.  Still at the beginning of understanding the AIA provisions.  Exciting times.  Lots of patent law thought leaders here today – Bob Armitage, Director K appos. 

Come back in ten days for the next conference.

Bob Armitage – wants to the the upbeat, inspirational speaker that we all need at 8:30 am. 

Some things that need to be done with the AIA in terms of legislative correction of errors.  Suggests that different constituencies in patent law work together on this goal in the immediate future – before the next election.

The AIA is the most profound change to the patent system since 1836 patent statute.  He's been involved in the process of patent reform for the last 30 years.  Shortly after he left law school, he realized that we had a law school that we had a patent system that didn't work very well.  Some of the things that we needed to do to improve the patent system was to eliminate first to invent, have a more transparent grace period, and eliminate recurring patent terms. 

Sees the AIA as major constituencies coming together to move the patent system in the direction of transparency and objectivity.  If the implementation of the AIA goes well, this is the patent system we'll have.  A more predictable patent system.  Much of this comes down to invalidity defenses – under the AIA these are much simpler. 

We were the last to the table in terms of modernizing our patent system.  Prior 1999, we really had a secret patent system. With the AIA, the patent system was opened up even further.  After AIA, there's no-fault correction of misnaming of inventors; the technical filing of an affidavit that mis-names the inventor is no longer a worry; best mode is no longer a concern for patent applicants; patent prosecutors are better off because of supplemental examination.  If they're deposed, and things arise, the patent holder can, in a pre-litigation context, go back to the patent office. (me: Query how this is viable, since depositions often arise during litigation.  Could make sense for a sequential litigant).

Other big changes: deceptive intent removed throughout the application process; patent owner can seek the patent as the applicant; no more supplemental oaths. 

Post-grant review: patents are now open to more challenges after the patent issues.  It's any issue of patentability that you can raise in court, you can raise in the PTO.  Why is this important?  This lets parties challenge patents the day patents issue, not six years down the road.  Challenging patents in court is expensive.  Post-grant review allows parties to resolve these issues in the matter of months, not years, at a fraction of the cost.

Sees the AIA as increasing transparency, objectivity, predictability, simplification of patent system.  Patent validity is reduced to just four objective legal standard: sufficient differentiation from prior public disclosures and earlier patent filings of others; sufficient disclosure to identify the claimed embodiments and enable them to be put to a specific practical, and substantial use; sufficient definiteness to differentiate subject matter; sufficient concreteness to avoid excessively conceptual or otherwise abstract subject matter.  That's all there is to the patent law.  These are objective standards that don't require you to know anything about what the inventor did, thought, etc. 

The national embarrassment of the first-to-invent system will now end. Example Gore-Tex case of why this was a problem.  Interference count practice was problematic.  It was an embarrassment and it's gone. 

The AIA is an attempt to be a codification of the way Congress wants the law, not a codification of what the law is. 102(b) was a colossal mess because of the attempt to codify existing law.  Under the AIA, there are no new AIA patent law doctrines.  Legislative history says "apply as written."  Example: 102 – only new phrase is "available to public."  Apply as written – this means that prior art is that art which is publicly accessible (comment: this issue is one of the most debated issues in the new AIA).

Who benefits from the AIA?  Those with the least resources, capital available.  It's a patent system optimized for small inventors, universities.  For those engaged in commerce of patents, supplemental examination allows for due diligence to be more effective, since it will allow the curing of inequitable conduct.

A Higher Written Description Standard for Negative Claim Limitations?

Patent, , ,

By Dennis Crouch

Santarus and the University of Missouri v. Par Pharma (Fed. Cir. 2012)

My employer (University of Missouri) owns several patents covering formulations of omeprazole proton pump inhibitors (PPIs). The patents are exclusively licensed to Santarus who markets the drugs under the brand Zegerid®. Par filed its request to make a generic version which prompted this infringement litigation.

The inventor, Dr. Jeff Phillips is a pharmacist at MU had the simple idea of combining omeprazole with baking soda (sodium bicarbonate). The baking soda helps the drug resist stomach acids long enough to be absorbed in the stomach wall. Although not a blockbuster drug, the approach has been successful for many patients with GERD and Santarus sales are about $40 million per year. (The reported deal is that MU receives about 5% of sales. As the inventor, Phillips receives a small cut from that.)

During litigation the patents were successfully attacked as obvious based upon a preliminary written description challenge.

Written Description Killing Priority and thus Nonobviousness: We know that patent applicants are allowed to narrow patent claims during the prosecution process. The vast majority of issued patent claims are not found in the originally filed patent application but instead are amended during prosecution. This is typically done by adding limitations into the claims as MU did here. The primary constraint on adding limitations is that the newly amended claim must be supported by the original application specification. Thus, a patentee cannot create limitations from thin-air, but must instead identify limitations found in the specification to be added into the claims. In the simple case, newly added claim limitations that are not supported by the specification are rejected for new matter at the USPTO and, once issued, can be invalidated for lacking written description under 35 U.S.C. § 112. The situation is a bit more confusing when the application claims priority to a prior patent filing. Of course, most issued patents do claim priority to a prior patent filing so the family member situation is quite important. In the patent family context, a child application might fully comply with the written description requirement if considered on its own. The child application can also be valid if new matter was added to the specification or claims at the time of filing. However, that new matter (if included within the claims) will mean that the patentee cannot claim priority to the parent application’s filing date. Where the parent case is published more than one year before the patent filing, that parent application can also serve as a prior art against the child application under 35 U.S.C. §102(b) unless priority can be established. (Query how this will works under the AIA?)

In this case, the generic challenger argued that one of the claimed limitations was not supported by the parent patent and, as a consequence, that parent patent serves as a critical piece of prior art that invalidates the claims.

One set of asserted claims were amended from the priority filing to included an exclusionary wherein limitation. In particular, the claims stated that “the composition contains no sucralfate.” The original specification had noted several reasons why omeprazole was preferable to sucralfate. In the same sentence, the specification also indicated that omeprazole is also preferable to sodium bicarbonate for those same reasons. Since sodium bicarbonate is actually an element of the invention, the district court held that the same sentence could not be used to particularly exclude sucralfate without further evidence that sucralfate is contraindicated. On appeal, the Federal Circuit rejected this reasoning – holding that preference statement in the specification was sufficient to justify addition of the exclusionary limitation and that the sodium bicarbonate inclusion (as a buffer) was justified by other portions of the specification.

Higher Bar for Negative Limitations?: The exclusionary limitation here is a negative limitation because it defines what the invention does not contain. Here, the invention does not contain sucralfate. The tradition in patent law has been to avoid negative limitations and, certainly, an invention cannot be wholly defined by negative limitations. However, negative limitations are allowed and are useful at times. It appears that the court sets a higher bar for the inclusion of negative limitations than it does positive elements of a claim. This is done by requiring that the specification include a reason for the exclusion in order to satisfy the written description requirement. The court writes here: “Negative claim limitations are adequately supported when the specification describes a reason to exclude the relevant limitation.” Ordinarily, such justification is not required for positive claim elements – although justifying explanations can be helpful in justifying greater claim breadth.

Although some reasoning is required, the patentee need not disclaim the element in the specification in order to add the exclusionary limitation in the claims. “Such written description support need not rise to the level of disclaimer. In fact, it is possible for the patentee to support both the inclusion and exclusion of the same material.”

With these notions in mind, the court held that the statements in the specification were sufficient to support the exclusionary limitation in this case. “The claim limitation that the Phillips formulations contain no sucralfate is adequately supported by statements in the specification expressly listing the disadvantages of using sucralfate.” And, as a consequence, the parent patent is not a proper prior art reference against those claims supported by the original specification.

Patent with Multiple Priority: In cases with a complex family structure, patent priority is actually determined on a claim-by-claim basis. As discussed above, the Federal Circuit held that some of MU’s claims properly claim priority to the original specification filed with the USPTO. On appeal, the patentee implicitly agreed that some of the other patent claims are not supported by the original specification. For those cases, the original filing qualifies as prior art against the no-priority claims under section 102(b). The question then is whether the newly added material is sufficiently different to avoid invalidation on obviousness.

Without going into detail, the Federal Circuit found that some of the patent claims that qualified for priority were also nonobvious and thus should be treated as valid and enforceable.

Need one to win: In the end, this appears to be a win for Mizzou since a patentee only need a court to find one of its claims is infringed and enforceable.

Notes:

  • Although I am employed by the University of Missouri, the university is not my client and I have not spoken with any of the university counsel about this case.
  • Par also appealed the district court’s finding of no inequitable conduct. The Federal Circuit affirmed that holding based upon a lack of clear and convincing evidence of intent deceive the USPTO.

Patently-O Bits & Bytes by Lawrence Higgins

Patent, , , ,

USPTO Patent Review Processing System Preview

  • The United States Patent and Trademark Office (USPTO) will preview the new electronic filing system for the trials established under the Leahy-Smith America Invents Act. The preview will take place from 10 am – noon on Thursday, September 6, 2012. Representatives from the Patent Trial and Appeal Board will demonstrate the new Patent Review Processing System (PRPS) and show how to register to use the system, to file a petition seeking a trial, to pay petition fees, to join the proceeding as a patent owner and to file motions and other documents. The preview will be helpful for any practitioners or administrative personnel who anticipate filing documents in the new proceedings beginning September 16, 2012 (inter partes review, post-grant review, and the transitional program for covered business methods). There will also be an opportunity to ask questions. You may attend electronically or in person. [Link]

Patent Jobs:

  • Stevens & Showalter is seeking a patent attorney/agent with at least 2 years of experience and a background in EE or CS to work at their Dayton, Ohio office. [Link]
  • Connolly Bove Lodge & Hutz is looking for patent attorneys with 3-5 years of experience to work at their Wilmington, DE office. [Link]
  • Faegre Baker Daniels is searching for a patent associate with a Ph.D. in the life sciences and 2-4 years of experience to work at their Indianapolis office.[Link]
  • Westerman, Hattor, Daniels & Adrian is seeking a electrical attorney/agent with 1-3 years of experience to work at their D.C. office. [Link]
  • Maquet is looking for a patent attorney with a minimum of 3 years of patent prosecution experience to work at their Wayne, N.J. office. [Link]
  • Drinker Biddle & Reath is searching for a patent agent with 3+ years of experience and a degree in EE to work at their Chicago or D.C. office. [Link]
  • Hiscock & Barclay is seeking a patent attorneys/agents with 3-5 years of experience to work at in their upstate NY office. [Link]
  • Bass, Berry & Sims is looking for IP associates with 1-4 years of experience to work at their Nashville office. [Link]
  • Trop, Pruner & Hu is seeking associates with EE/CS backgrounds to work at their Austin or Houston office. [Link]

Upcoming Events:

  • U.S. Patent Commissioner Speaks: Current Developments in Patents event/webinar will be held on September 13. U.S. Commissioner for Patents, Margaret Focarino, will comment on current developments in patents, especially those occurring at the U. S. Patent and Trademark Office, and participate in questions and answers. [Link] [Webinar]
  • ACI's FDA Boot Camp conference is scheduled for September 20-21, in Boston. ACI's FDA Boot Camp has been designed to give products or patent litigators, as well as patent prosecutors, industry in-house counsel, and life sciences investment and securities experts, a strong working knowledge of core FDA competencies. [Link] (PatentlyO readers register for with PO 200 for a discount)
  • C5s 3rd EU Pharma Regulatory Law conference is scheduled for September 25-26 in Brussels, Belgium. 2012 is set to be a critical year for EU pharma regulation with the implementation of the pharmacovigilance rules, proposals to amend the data protection and clinical trials directives and the new falsified medicinal products directive. [Link] (PatentlyO readers register with PO 10 for a discount)
  • The 13th Annual Maximizing Pharmaceutical Patent Lifecycles is scheduled for October 10-11 in New York. The conference will feature, Presentations from key representatives from the USPTO who will provide you with direct insights and the logic of this agency on some of most pressing life cycle management strategies that the industry is facing today, Analyses of recent critical cases affecting patent life cycle planning including: Caraco (use codes); Prometheus (subject matter eligibility); Sun Pharma (double patenting); Ariad (patentability); and Therasense (inequitable conduct) – and strategies for using these cases to your advantage and many more topics. [Link] (PatentlyO readers register for with PO 200 for a discount)
  • The University of Akron School of Law's Center for IP & Technology will host the 6th Annual IP Scholars Forum on October 26, 2012, from 9:00AM – 2:00 PM. The Forum's purpose is to bring together a small group of prominent scholars for intensive, high-level discussions on cutting-edge issues of common interest. This year's Forum will discuss "The Impact of IP on Public Health." Guest include: Frank Pasquale, Andrew Torrance, Jim Chen Jay Dratler, Jr., Katherine Van Tassel, and many others. [Link]

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

Patently-O Bits & Bytes by Lawrence Higgins

Patent, , , ,

USPTO Patent Review Processing System Preview

  • The United States Patent and Trademark Office (USPTO) will preview the new electronic filing system for the trials established under the Leahy-Smith America Invents Act. The preview will take place from 10 am – noon on Thursday, September 6, 2012. Representatives from the Patent Trial and Appeal Board will demonstrate the new Patent Review Processing System (PRPS) and show how to register to use the system, to file a petition seeking a trial, to pay petition fees, to join the proceeding as a patent owner and to file motions and other documents. The preview will be helpful for any practitioners or administrative personnel who anticipate filing documents in the new proceedings beginning September 16, 2012 (inter partes review, post-grant review, and the transitional program for covered business methods). There will also be an opportunity to ask questions. You may attend electronically or in person. [Link]

Patent Jobs:

  • Stevens & Showalter is seeking a patent attorney/agent with at least 2 years of experience and a background in EE or CS to work at their Dayton, Ohio office. [Link]
  • Connolly Bove Lodge & Hutz is looking for patent attorneys with 3-5 years of experience to work at their Wilmington, DE office. [Link]
  • Faegre Baker Daniels is searching for a patent associate with a Ph.D. in the life sciences and 2-4 years of experience to work at their Indianapolis office.[Link]
  • Westerman, Hattor, Daniels & Adrian is seeking a electrical attorney/agent with 1-3 years of experience to work at their D.C. office. [Link]
  • Maquet is looking for a patent attorney with a minimum of 3 years of patent prosecution experience to work at their Wayne, N.J. office. [Link]
  • Drinker Biddle & Reath is searching for a patent agent with 3+ years of experience and a degree in EE to work at their Chicago or D.C. office. [Link]
  • Hiscock & Barclay is seeking a patent attorneys/agents with 3-5 years of experience to work at in their upstate NY office. [Link]
  • Bass, Berry & Sims is looking for IP associates with 1-4 years of experience to work at their Nashville office. [Link]
  • Trop, Pruner & Hu is seeking associates with EE/CS backgrounds to work at their Austin or Houston office. [Link]

Upcoming Events:

  • U.S. Patent Commissioner Speaks: Current Developments in Patents event/webinar will be held on September 13. U.S. Commissioner for Patents, Margaret Focarino, will comment on current developments in patents, especially those occurring at the U. S. Patent and Trademark Office, and participate in questions and answers. [Link] [Webinar]
  • ACI's FDA Boot Camp conference is scheduled for September 20-21, in Boston. ACI's FDA Boot Camp has been designed to give products or patent litigators, as well as patent prosecutors, industry in-house counsel, and life sciences investment and securities experts, a strong working knowledge of core FDA competencies. [Link] (PatentlyO readers register for with PO 200 for a discount)
  • C5s 3rd EU Pharma Regulatory Law conference is scheduled for September 25-26 in Brussels, Belgium. 2012 is set to be a critical year for EU pharma regulation with the implementation of the pharmacovigilance rules, proposals to amend the data protection and clinical trials directives and the new falsified medicinal products directive. [Link] (PatentlyO readers register with PO 10 for a discount)
  • The 13th Annual Maximizing Pharmaceutical Patent Lifecycles is scheduled for October 10-11 in New York. The conference will feature, Presentations from key representatives from the USPTO who will provide you with direct insights and the logic of this agency on some of most pressing life cycle management strategies that the industry is facing today, Analyses of recent critical cases affecting patent life cycle planning including: Caraco (use codes); Prometheus (subject matter eligibility); Sun Pharma (double patenting); Ariad (patentability); and Therasense (inequitable conduct) – and strategies for using these cases to your advantage and many more topics. [Link] (PatentlyO readers register for with PO 200 for a discount)
  • The University of Akron School of Law's Center for IP & Technology will host the 6th Annual IP Scholars Forum on October 26, 2012, from 9:00AM – 2:00 PM. The Forum's purpose is to bring together a small group of prominent scholars for intensive, high-level discussions on cutting-edge issues of common interest. This year's Forum will discuss "The Impact of IP on Public Health." Guest include: Frank Pasquale, Andrew Torrance, Jim Chen Jay Dratler, Jr., Katherine Van Tassel, and many others. [Link]

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

Eight Points to Know about September 16, 2012: Post-Grant Transitions and Deadlines

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by Dennis Crouch

September 16, 2012 is a big date for parties considering a post-grant challenge to someone else’s patent.  Eight things that your clients should know:

  1. End of Inter Partes Reexamination: September 15, 2012 is the last date to request inter partes reexamination under the old system.  That is to say, inter partes patent reexamination filings will no longer be accepted on September 16, 2012.  Parties who understand and find the current system valuable may want to accelerate their filing timeline accordingly. 
  2. Beginning of Inter Partes Review: The new inter partes review system begins on September 16, 2012 and applies to any issued patent that has been issued for at least 9–months.
  3. Inter Partes TRIAL: Despite the similar name, the procedures involved with an inter partes review will be quite different from inter partes reexamination.  In short, the review will be more like a trial and heard by a tribunal of administrative patent judges rather than being considered by an examiner.
  4. $$$ Inter Partes Expense $$$: The trial features will certainly make inter partes reviews significantly more expensive based on greater attorney fees. In addition, the fee for filing an inter partes review petition is $27,200 (plus $600.00 for each claim over 20). Current inter partes reexamination fee is $8,800.
  5. $$$ Ex Parte Reexamination $$$: The AIA barely changes the ex parte reexamination process.  Those reexaminations can still be requested by third parties.  The major change, however, is that the fee for ex parte reexamination will jump on September 16, 2012 from $2,520 to  $17,750.  What is $15k worth to your client?
  6. Post Grant Review: Except for “covered business methods,” the post grant review system (with its broad-base of potential challenges) is on hold until 2013.  In particular, PGR will only be available to challenge granted patents that are filed as applications after the March 16, 2013 first-to-file changeover
  7. Business Method Post Grant Review: The PGR system does open on September 16, 2012 to challenge “covered business methods.”  These challenges are limited by the statute to only patents that cover some sort of financial data processing and that do not involve a novel technological feature or solution.
  8. Supplemental Examination:  Although perhaps out of place on this list (b/c not a third party challenge), supplemental examination also becomes available on the 16th of September 2012. This process can cure inequitable conduct that committed during the original ex parte prosecution.  

Judge Richard Linn to take Senior Status

Patent,

Judge Richard Linn has announced his intention to take “senior status” effective November 1, 2012. Judge Linn has been sitting as a circuit court judge on the Court of Appeals for the Federal Circuit since January 1, 2000. Judge Linn is a longtime patent attorney and began his patent law career as an examiner at the United States Patent & Trademark Office in 1965 – working while also attending Georgetown University Law Center. He holds a degree in electrical engineering from Rensselaer Polytechnic. In recent years, Judge Linn has been instrumental in developing an alliance of intellectual property focused inns of court known as the “Linn Inn Alliance.”

On the bench, Judge Linn has always been skeptical of novel legal theories. It is fair to place him on the “pro-patentee” side of the bench – especially based upon his notion of broad subject matter eligibility and a high bar for inequitable conduct findings. Judge Linn authored almost 300 patent decisions and his voice of reason will certainly be missed.

Judges on senior status continue to hear cases, but typically with a reduced docket. Those judges are also allowed under the law to move outside of the DC area. Of key importance, his senior status will open a seat on the 12-member bench for an additional nominee. The seat created by Chief Judge Michel’s 2010 retirement also remains open. Edward DuMont was originally nominated for the slot by President Obama, but that nomination rescinded after the Senate failed to even schedule a hearing. In November 2011, President Obama nominated Richard Taranto for the slot. The Senate is expected to eventually confirm the Taranto nomination, but that work might be delayed until after the November election.

Judges Newman, Lourie, Bryson, and Dyk are all eligible to take senior status.

Upcoming Patent Law Conferences at Indiana-Bloomington

Patent,

By Jason Rantanen

The Center for Intellectual Property Research at Indiana University Maurer School of Law is sponsoring three conferences this fall on the state of patent law.  At the first conference, coming up in just two weeks, I'll be speaking about inequitable conduct in the wake of Therasense v. Becton Dickinson and the way the new supplemental examination rules are likely to impact patent law.  That conference features a panel discussion about what the AIA accomplished involving heavyweights in both academia (Mark Janis, John Duffy & Rochelle Dreyfuss) and industry (Mark Chandler, Gary Griswold, Doug Norman, and John Vaughn). 

Full details on each conference are available by following the links.

September 13-14:
The America Invents Act: One Year Later
Keynote Speakers:
David Kappos, Director, USPTO
Robert Armitage, General Counsel, Eli Lilly and Company
 
September 24: 
The State of Patent Litigation: A Conversation with the Federal Circuit
Keynote Speakers:
Hon. Randall Rader, Chief Judge, U.S. Court of Appeals, Federal Circuit
Hon. S. Jay Plager, Circuit Judge, U.S. Court of Appeals, Federal Circuit
(In cooperation with the Federal Circuit Bar Association)
 
November 2-3: 
The Future of Design Protection Law
Mark D. Janis, Robert A. Lucas Chair of Law, IU Maurer School of Law
Graeme Dinwoodie, Professor of Intellectual Property and
Information Technology Law, Oxford University
(Held at Oxford University)

Are the Courts Correct in Their Assumption that a Patent Issued on Non-patentable Subject Matter is Invalid?

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By David Hricik, Mercer University School of Law. (Note – this is an update of the essay posted last week on the Patent Ethics site.)

I forget when I first thought about this, but it’s been a while. With all the discussion of Prometheus (sadly, the case, not the film, which was great), I figured this was a good time to raise it. At minimum, there’s a litigable question here, and assumptions that a patent issued on non-patentable subject matter is invalid need examination. I’d love to be wrong about this, but I don’t think I am.

Some History.

I have not scorched the earth, but from what I can tell no court has squarely addressed the question of whether the Patent Act allows a court to deny enforcement (on any ground) of a patent granted on subject matter that is not within Section 101. Instead, what the cases showed me was that law developed in the context of challenges to the USPTO’s denial of a patent have been used to invalidate issued patents – without analyzing the statutory authority to do so.

Let’s take a look at what most people assume is the law and see if we can get there: does the Patent Act allow a court to invalidate a patent that does not claim patentable subject matter?

Section 282

The starting point is 35 USC 282. It provides in pertinent part:

The following shall be defenses in any action involving the validity or infringement of a patent and shall be pleaded:

(1) Noninfringement, absence of liability for infringement, or unenforceability,

(2) Invalidity of the patent or any claim in suit on any ground specified in part II of this title as a condition for patentability,

(3) Invalidity of the patent or any claim in suit for failure to comply with any requirement of sections 112 or 251 of this title,

(4) Any other fact or act made a defense by this title.

Federico’s commentary, often relied on to indicate Congressional intent, doesn’t help at all, but here it is:

The defenses which may be raised in an action involving the validity or infringement of a patent are specified in general terms, by the second paragraph of section 282, in five numbered items. Item 1 specifies “Noninfringement, absence of liability for infringement, or unenforceability” (the last word was added by amendment in the Senate for greater clarity); this would include the defenses such as that the patented invention has not been made, used or sold by the defendant; license; and equitable defenses such as laches, estoppel and unclean hands. The second item specifies “Invalidity of the patent or any claim in suit on any ground specified in Part II of this title as a condition for patentability”; this would include most of the usual defenses such as lack of novelty, prior publication, prior public use, lack of invention. The third item specifies “Invalidity of the patent or any claim in suit for failure to comply with any requirement of section 112 or 251 of this title”; the first section mentioned would include the defense of insufficient disclosure, and the second sentence mentioned would include reissue defenses. The fourth item merely specifies “Any other fact or act made a defense by this title.” All the defenses usually listed in textbooks on patent law may be placed in one or another of the enumerated categories, except a few which are no longer applicable in view of changes in the new statute.

Section 101.

Section 101 is relied upon as the basis for invalidating patents. It states: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

While clearly granting power to the USPTO to issue patents on “new and useful” processes, it obviously also limits the USPTO’s power to do so.

The question here is not patentability, but validity. Simply, suppose the USPTO makes a mistake, and issues a patent on non-patentable subject matter. Is this a defense to infringement?

In my view, the answer is “no.”

Analysis.

Let’s start with the two specific subsections, because they make us focus on the text and show some very deliberate choices by Congress that easily could have gone the other way had Congress intended 101 to be a defense.

The second subsection of 282 is probably the most important: “Invalidity of the patent or any claim in suit on any ground specified in part II of this title as a condition for patentability.”

Section 102 and 103 are “conditions of patentability.” They say so in their titles, and they are substantive legal conditions (technically, I’d call them “conditions of unpatentability” given the burdens of proof, but this works). The fact that 101 is not a condition of patentability is to me is very important: Congress chose in 282(2) to specify that only those things denominated as “conditions of patentability” are bases for invalidity. It then chose to label 102 and 103 as conditions, but not 101. Those are deliberate choices. In my view, a patent issued on non-patentable subject matter is not “invalid” under the second provision.

Subsection 3 of Section 282 is easy to apply to this question, but it is important because it also adds to the evidence that 101 is not a defense. Patentable subject matter is in 101, not 251 or 112. So that part’s easy: 282(3) doesn’t list 101.

But the important point, again, is that Congress deliberately thought about what should be invalidity defenses, and what should not, and left out 101 not just as a “condition of patentability,” but also in this specific paragraph, where it “caught” some strays. It left out 101. That says a lot.

Two down, two to go.

Now we’re left with arguing that, although it thought about what should be invalidity defenses in two different places, nonetheless we should imply that Congress meant to include it in some amorphous language in the other two subsections. We’re fighting uphill.

Let’s go to the first catch-all type subsection: “Noninfringement, absence of liability for infringement, or unenforceability.” Logically, I can’t make patentable subject matter fit, at all. Before explaining why, let’s be clear on the consequences of saying that Section 101 is within this section: it would be that the patent is valid but there would be no infringement.

“Unenforceability” is the easy one. The cases and legislative history I’ve read show this was designed to capture equitable doctrines like patent misuse and, arguably, inequitable conduct (long diversionary story there). We’d be straining to put 101 there.

Federico’s statements that the defendant hadn’t made the product, or had a license to do so, show that “infringement” means what we think it means. A licensed patent is valid, but “not infringed.” A patent that the defendant never violated is valid, but not infringed. So, I can’t make “noninfringement” logically work or work without giving words a very unnatural meaning.

Now the only arguable catch-all, subsection 4: “Any other fact or act made a defense by this title.” Here we are, trying to read it into the catch-all that, even Federico says, “merely” specifies things in the statute that are made defenses. But, section 101 is not made a defense by this title. Instead, it specifically points to other requirements and conditions. Again, if this were easy and clear, Congress would have put in 101 “it shall be a defense to patent infringement that…” or put 101 in Section 282.

So, tell me why I am wrong.

Let me get rid of some easy ones: no court I’ve found has ever addressed this issue. I think it’s pretty simple, but there you go. Second, don’t conflate patentability with infringement defenses. There are lots of things that can affect patentability that aren’t in 282. Third, 282 is exclusive: if you want so suggest that it’s not, you (a) have to say “Congress enacted a specific statute laying out defenses, but it’s just a guide” which is not in my view defensible; and (b) it says “shall be defenses,” not “may include” or some-such. Third, this is a relatively new “defense.” I can’t say I’ve scorched the earth, but in looking at CAFC cases it has only been raised a few times.

Meyer v. Bodum: A Waste of Public and Private Resources?

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Meyer Intellectual Properties Limited v. Bodum, Inc. (Fed. Cir. 2012) Panel: Dyk (concurring), Moore, O'Malley (author) Download 11-1329

At its heart, Meyer v. Bodum is essentially an obviousness case, although for reasons having to do with the procedural posture, the court never gets to the merits of that issue, instead remanding the case for further proceedings based on numerous errors committed by the district court, which the opinion portrays as misguided and lacking an understanding of the basics of patent law.  

Judge Dyk's concurrence, reproduced in its entirety at the end of the post, goes even further, concluding that "this case is an example of what is wrong with our patent system…Such wasteful litigation does not serve the interests of the inventorship community, nor does it fulfill the purposes of the patent system."  Slip Op. at 46-47.

BodumBackground: Frank Brady was an independent sales representative for Bodum from 1986-1996, during which time he marketed and sold products including Bodum's French press coffee makers.  In the mid-1990's, Brady came up with the idea of a milk frother that used aeration instead of steam, and in 1996, he filed a patent application directed to a "Method for Frothing Liquids" that led to two issued patents, Nos. 5,780,087 and 5,939,122.  The claims essentially involve four steps: "(1) providing a container that has a height to diameter aspect ratio of 2:1; (2) pouring liquid (e.g., milk) into the container; (3) introducing a plunger that includes at least a rod and plunger body with a screen; and (4) pumping the plunger to aerate the liquid."  Slip Op. at 5. Brady also sold milk frothers through his company, BonJour, which was subsequently sold to Meyer. 

Bodum2In 1999, Bodum began selling the first generation of its accused milk frothers.  The figures  accompanying this post are the opinion's comparisons of Bodum's Version 1 frother with the '087 patent. Shortly after Meyer filed an infringement suit in 2006, Bodum changed its designs, removing the spring element holding the screen against the inside wall of the container and replacing it with an O-ring.  The O-ring was later removed to create the Version 3 frother. 

Following a jury trial in which the jury held the patents to be valid and willfully infringed, awarding $50,000 in damages, the district court trebled the damages, declared the case exceptional, and awarded Meyer its attorney fees of $756,487,56.  Bodum appealed, alleging a panopoly of errors by the district court.  The Federal Circuit agreed. 

Infringement: The CAFC vacated the district court's grant of summary judgment of infringement due to a lack of any evidence of direct infringement in the record.  Rather, the district court relied only on assumptions of direct infringement.  "We find it troubling that the district court based its direct infringement analysis on what it assumed happened, rather than on actual evidence of record. This assumption contradicts our well-established law that a patentee must prove infringement by a preponderance of the evidence."  Slip Op. at 26.

Evidentiary Rulings: Prior to and during trial, the district court made a number of evidentiary rulings that sharply limited Bodum's ability to present its case.  In an uncommon move, the Federal Circuit concluded that the district court had abused its discretion in these rulings, holding that (1) the district court erroneously limited the scope of prior art to only two references (one of which was subsequently excluded), despite sufficient disclosure of several additional references; (2) the district court  erroneously excluded Bodum's expert from testifying despite a report containing a sufficiently detailed statement of his opinions and the bases for his conclusions, especially given the non-complex nature of the technology; and (3) the district court erroneously precluded lay witnesses from testifying to authenticate one of the two allowed prior art references.  The CAFC thus remanded for a new trial on obviousness.

Inequitable Conduct: The CAFC also held that the district court erred by dismissing Bodum's inequitable conduct claims on a motion in limine.  Under Seventh Circuit law, "a motion in limine is not the appropriate vehicle for weighing the sufficiency of the evidence."  Slip Op. at 41-42.  The district court thus "erred in addressing the sufficiency of Bodum's inequitbale conduct defense on an evidentiary motion." Id. at 42. 

Willful Infringement and Enhanced Damages: Because the CAFC remanded the case for a new trial on infringement and invalidity, it vacated the wilfulness verdict and enhanced damages award.  In doing so, it suggested that the district court use Bard Peripheral Vascular, Inc. v. W.L. Gore & Associates, Inc., 682 F.3d 1003 (Fed. Cir. 2012) (in which the Federal Circuit held that threshold "objective prong" of the willfulness inquiry is a question of law) as a starting point.

Judge Dyk's Concurrence: Writing in concurrence, Judge Dyk questioned why this patent issued in the first place and why it was not found obvious on summary judgment: 

While I agree with and join the thorough majority opinion, in looking at this case from a broader perspective, one cannot help but conclude that this case is an example of what is wrong with our patent system. The patents essentially claim the use of a prior art French press coffee maker to froth milk. Instead of making coffee by using the plunger to separate coffee from coffee grounds, the plunger is depressed to froth milk. The idea of frothing cold milk by the use of aeration rather than steam is not new as reflected in the prior art Ghidini patent.  Under the Supreme Court’s decision in KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 420 (2007), and its predecessors, it would be reasonable to expect that the claims would have been rejected as obvious by the examiner, and, if not, that they would have been found obvious on summary judgment by the district court. But no such thing. The parties have spent hundreds of thousand of dollars and several years litigating this issue, and are invited by us to have another go of it in a second trial. Such wasteful litigation does not serve the interests of the inventorship community, nor does it fulfill the purposes of the patent system.

Judge Dyk specifically refers to the private costs of this litigation – the hundreds of thousands (at least a million, if both parties' costs are taken into account) of dollars spent by the parties on legal fees.  The public, too, has spent a substantial amount of resources on this case: the district court's time and resources, the jury's time (and perhaps a future second jury), and the Federal Circuit's own time spent correcting the errors – as evidenced by its thorough 44-page opinion.  Beyond these monetary costs, Judge Dyk's concurrence hints at an even greater public cost: the undermining of public confidence in the ability of the patent office and the courts to get patentability decisions on even relatively technologically simple inventions right.

Supplemental Examination Final Rules

Patent

By Jason Rantanen

As Dennis writes below, tomorrow the USPTO will publish five final rules packages for implementing the America Invents Act.  This post focuses on the Supplemental Examination Rules, available here.  In large part, the Final Supplemental Examination Rules mirror the proposed rules, which I discussed in a previous post. 

The biggest change from the proposed rules relates to the elimination of some of the specific content requirements. Originally, the rules articulated several very specific categories of information that the requestor was required to provide.  The final rules are more streamlined, paralleling the content requirements for submitting an ex parte reexamination. They do, however, retain the requirement of a "A separate, detailed explanation of the relevance and manner of applying each item of information to each claim of the patent for which supplemental examination is requested." 37 C.F.R. § 1.610. (This requirement parallels the ex parte reexamination requirement of 37 C.F.R. § 1.510(b)(2).)

The PTO considered other potential changes, but in each case decided either to retain the original rule or concluded the change was mooted by its change to the content requirements.  It slightly bumped up the limit on the number of items of information that could be submitted from 10 to 12.

The cost for filing a supplemental examination request remains steep: $5,140 for the initial request plus $16,120 for the ex parte re-examination fee. Both must be paid at the time of initial request, and the $16,120 will be refunded if no re-examination is ordered.  The rules also finalize the substantial increase in the fee for filing a request for ex parte reexamination: $17,750.  Initially the small- and micro-entity reductions will not apply to these fees, although the PTO's proposed fee structure under Section 10 of the AIA do allow for such reductions. (USPTO fee website).

Given these costs, together with the realities of how patent litigation actually works and how inequitable conduct claims are generally developed, I remain highly skeptical of the PTO's projection that it will receive about 1,430 requests for supplemental examination annually.  Indeed, I suspect this number will actually be much, much smaller.  Most information that might be submitted in a supplemental disclosure request will be discovered too late for supplemental examination to matter.    For similar reasons, I am dubious of the PTO's prediction that supplemental examination will reduce the number of district court patent infringement cases in which inequitable conduct is plead as a defense. 

Monsanto wins $1b verdict on RoundUp Ready Seed Patent

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Dr. EvilBy Dennis Crouch

The PACER entry is compelling:

JURY VERDICT For: Plaintiffs Against: Defendants In the Amount of: One Billion Dollars. (Entered: 08/02/2012)

In his August 6 order, Judge Webber confirmed the jury verdict that DuPont/Pioneer willfully infringe Monsanto's GMO roundup-ready seed patent. The jury rejected the defendants' claims that the asserted patent was invalid; that the patent had been finally obtained through inequitable conduct; and that the reissue patent improperly expanded the scope of the original claims. The judge also confirmed the jury's reasonable royalty damage award of "One Billion Dollars ($1,000,000,000)."

The asserted patent was Monsanto's reissue No. RE 39,247 and the accused product was DuPont's Optimum GAT soybean line that has never been released to the public. Rather, thus far DuPont's use of the patent has been for research purposes. No matter – the US has only a de minimis research defense that certainly does not apply here. See Madey v. Duke. Thus, unlicensed use of the Monsanto genetically modified soybean seed counts as infringement, even if that use was only for the development of a commercial product.

There is no question that this innovation was groundbreaking and has transformed the landscape of American agriculture. The genetic modification makes crops tolerant to the herbicide glyphosate. Although far from organic, glyphosate (RoundUp) has a much smaller negative environmental impact than other herbicides. In addition, the use of glyphosate has allowed for no-till farming that greatly reduces topsoil runoff and energy demands. In his press release, Monsanto's General Counsel David Snively wrote that the verdict "highlights that all companies that make early and substantial investments in developing cutting edge technology will have their intellectual property rights upheld and fairly valued." Snively's remarks are perhaps overstated, but at least have some kernels of truth.

The damages theory was interesting. Since the accused product was not yet on the market, Monsanto did not seek any lost profit. Rather, Monsanto demanded a reasonable royalty for the research-use made by the defendants. Monsanto argued that the use of Monsanto's invention in DuPont's labs and Pioneer's test fields gave those companies an "improper head start" in making the GM seeds. The judge and jury agreed – if those companies wanted to build upon the invention then they should have first obtained a license. In the pharmaceutical world, 35 U.S.C. § 271(e) offers a research exemption for this type of activity. However, that exception does not apply here because of the low level of regulation over genetically modified food-products. The patent is set to expire in 2014. The patentee's right-to-exclusive-research supported by this case means that the 2014 date offers a starting-date for follow-on competitive research. Any actual products building directly upon the patented invention will arrive on the market sometime later.

I sat-in on one day of the jury trial that was held in St. Louis, Missouri. The eight-member jury were largely attentive as they listened to DuPont's technical expert explain DNA and problems with the patent. I smiled at seeing the jury members walk in wearing t-shirts and carrying notepads. Their attitude and attire was a severe contrast to the room full of two-dozen attorneys and experts (each charging hourly). Although I'm sure that Judge Webber could have ably decided the case himself, the jury of individual citizens gave me a bit more confidence in our system and, in my mind, offers the ultimate reality check for this type of case. At least some of the jury members appear to be fans of Dr. Evil.

The level of damages, claim construction, and other issues will be the subject of an appeal the Court of Appeals for the Federal Circuit.

Denial of Summary Judgment Arguing No Inequitable Conduct

Ethics

In Bristol-Myers Squibb Co. v. Teva Pharma. USA, Inc. (D. Del. Civ. A. No. 10-805-RGA, July 19, 2012), the patentee moved for summary judgment against an inequitable conduct defense. The court denied the motion.  The alleged information concerned compound 2'-CDG.  The patentee argued that there was no similarity between that compound and the claimed invention, entecavir, and so the information was not material. However, the court denied the motion. In part the court stated:

The inventor is one of several people credited with an article which contains a statement about 2'-CDG's "structural similarity" to entecavir. The inventor, when questioned about the article, said he had neither written nor read it before it was published.  Such a statement at least raises a credibility concern. I do not think making the credibility decision on summary judgment in this case is appropriate.  

The court went on to state, however:

I have also considered that the issue here involves the state of mind of three individuals abouttwentyyearsago. Itisoftendifficulttoprovesomeone'sstateofmindaboutsomething thepersondidyesterday. Toprovebyclearandconvincingevidencethatapersonintendedto deceive the PTO twenty years ago, in the absence ofany direct evidence that he did so, is about as difficult as climbing Mt. Everest. I cannot say, however, as a matter of law that it cannot be done. See Aventis Pharma SA. v. Hospira, Inc., 675 F.3d 1324, 1334-37 (Fed. Cir. 2012) (affirming a finding of an inventor's intent to deceive in 1990). 

 

Introducing David Hricik

Patent

By Dennis Crouch

I am happy to introduce Professor David Hricik as a new Patently-O contributor. Hricik is likely the most well-known and well-respected expert on U.S. patent lawyer ethics and so it makes sense that his focus on Patently-O will also be on patent law ethics, patent lawyer malpractice, and inequitable conduct. His two-volume treatise on patent ethics (co-authored with Mercedes Meyer) is published by Oxford University Press and has become a required reference for patent attorneys dealing with our regularly arising ethical questions. Hricik has been working in patent law for almost 25 years: The first 14 as a (patent) litigator and the last ten as a law professor.

Hricik will be blogging at: www.patentlyo.com/hricik. We’ve added a new tab at the top of the page that links to Hricik’s site.

His first three posts are up, including Best Mode, the AIA, and Conflicts of Interest.

Welcome David Hricik.

Predicting En Banc Issues

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By Jason Rantanen

Dissenting opinions are generally considered to be good predictors of en banc review.  On one level, this is largely indisputable: most appeals that the Federal Circuit takes en banc involve a divided panel decision, and appellate practitioners are well aware that the chances of getting en banc review of an opinion that contains a dissent are much better than persuading the full court to review a unanimous opinion.  Of course, knowing that dissenting opinions are the more likely candidates for en banc review isn't particularly helpful by itself, since Federal Circuit judges pen more than thirty patent-related dissents each year. 

There's an extension of this theory, however, based on the idea that a high number of dissents on a particular patent law issue is a signal that the court may take that issue en banc in the near future.  There are several reasons why this extended theory is plausible: dissents may indicate that the court is cognizant of the importance of a particular legal issue; they may demonstrate awareness by the court of an intra-circuit split that it needs to resolve; they may also represent a pre-en banc dialogue between the judges.  Dissents are not costless, after all – sometimes they can be as much work or more as writing the majority opinion, and most judges do not write them as a matter of course. 

Empirical observations support this theory, at least for some grants of en banc review.  In the two years prior to the Federal Circuit's grant of en banc review of inequitable conduct in Therasense v. Becton Dickinson, for example, there were four dissents on the issue of inequitable conduct.  On the other hand, in the two years prior to the grant of en banc review in In re Seagate there were no dissenting opinions on the issue of willful infringement.  Thus while there may be value in keeping an eye on areas where dissents are common, it's by no means a perfect predictor.

With that caveat, I read through the patent-related dissents for the past two years to assemble a picture of recent Federal Circuit dissents.  All together, there were 64 of these dissents in panel opinions.  The following chart depicts the authors of those dissents.

Dissents by Judge
The next chart depicts the issues addressed by those dissents that arose with a frequency of greater than 1.  Note that there were four dissents that involved two issues.  In order to prepare the chart below based on dissenting opinions, I included only the first issue, but the second issue would also be relevant.  Those second issues were joint infringement(1), infringement(3), inequitable conduct(2), and doctrine of equivalents(2) (totals dissents addressing this issue in parentheses).

Dissents by Subject Matter

One nuance that is not conveyed by this chart is the degree to which the judges dissent on specific issues.  Two are noteworthy: Judge Dyk wrote four of the dissents on claim construction, while four separate judges (Bryson, Moore, Plager and Mayer) wrote the dissents on the issue of subject matter patentability.  Judge Newman wrote on a variety of issues.

The final chart depicts the issues that the Federal Circuit declined to consider en banc with at least one judge dissenting from that decision.  Note that for several of the issues included in the previous chart (state law malpractice claims, assignment, claim construction, and preliminary injunctions), the court has also declined to consider those issues en banc over the views of at least one judge.

Petitions with Dissents
These statistics hardly tell the whole story, of course.  Both litigation and appeals – let alone en banc review – are rare events, and thus attempting to divine highly predictive information is difficult.  Furthermore, two judges (Judges Newman and Dyk) together wrote almost half of the dissents.  Nevertheless, when combined with other insights, the above data may be helpful.  Claim construction and obviousness are hot topics (although last fall the CAFC declined to take claim construction en banc).  There is also significant disagreement among the judges on subject matter patentability, although they may not be willing address that issue through an en banc court given the Supreme Court's substantial interest in the topic.  In addition, my own sense is that there is more disagreement among the judges on the issue of the standard for preliminary injunctions than is apparent from the statistics alone.  It would not surprise me if the court were to grant en banc review on this issue – although admittedly it declined to do so recently.

What are your views on the next issue that the Federal Circuit reviews en banc?

For more on predicting en banc review generally, see Tracey E. George, The Dynamics and Determinants of the Decision to Grant En Banc Review, 74 Wash. L. Rev. 213 (1999).  For a discussion of Federal Circuit en banc practice, see Christopher A. Cotropia, Determining Uniformity within the Federal Circuit by Measuring Dissent and En Banc Review, 73 Loyola Los Angeles L. Rev. 801 (2010) (available at http://digitalcommons.lmu.edu/cgi/viewcontent.cgi?article=2720&context=llr).

Edit: minor correction to charts. 

Patently-O Bits & Bytes by Lawrence Higgins

Patent, ,

2012 Jefferson Medal recipient

  • The New Jersey Intellectual Property Law Association (NJIPLA) will award the 2012 Jefferson Medal to the Honorable Garrett E. Brown, Jr. (Ret.), Chief Judge, United States District Judge for the District of New Jersey. Following a 60 year tradition, the NJIPLA presents the Jefferson Medal annually to someone who has made exceptional contributions to the field of intellectual property law. Former Medalists include judges, members of Congress, Patent and Trademark Office officials and leaders of the intellectual property bar. Chief Judge Brown will be presented with the Jefferson Medal on June 8, 2012 at the annual Jefferson Medal Dinner at The Hilton at Short Hills, Short Hills, NJ.

    Chief Judge Brown recently joined the JAMS panel after a distinguished judicial and legal career. He served twenty-six years as United States District Judge for the District of New Jersey, the last six as Chief Judge, where he led the court-wide effort to provide prompt, efficient justice to civil litigants, and to implement new local patent rules. Prior to appointment to the federal judiciary, he served two years as Chief Counsel to the U.S. Maritime Administration. While in private practice, he concentrated on federal commercial litigation, including antitrust, employment, construction, environmental, banking, intellectual property, and securities matters. [Link]

Will Singapore Become a Patent Hotspot?

  • Singapore wants foreign IP attorneys and professionals to relocate there. A Patents Bill was introduced to the parliament, which will allow foreign patent professionals to practice in Singapore without going through the long process of passing exams and doing an internship with a local law firm, which is currently required. However, foreign attorneys will only be allowed to engage in work from other countries. The intention behind the proposed changes is that highly skilled IP professionals from across Asia and beyond will relocate to Singapore, where they will be ideally located to handle patent work for the whole Asia region. [Link] Patent Act

Patent Jobs:

  • Faegre Baker Daniels is seeking a patent associate with 2-6 years of experience and a degree in EE, ME, or ChemE to work at their Minneapolis office. [Link]
  • Klarquist Sparkman is looking for a patent attorney/agent with an advanced degree in organic chemistry and 3+ years of experience to work at their Portland office. [Link]
  • Klarquist Sparkman is searching for a patent attorney with 1-4 years of experience and an EE, CS, or physics degree to work at their Portland office. [Link]
  • Bacon & Thomas is seeking a patent attorney with 1-3 years of experience and a background in ME, EE, or similar to work at their Alexandria, VA office. [Link]
  • Klein, O'Neill & Singh is looking for a patent attorney/agent with 2-5 years of experience and a degree in EE, CS, or physics to work at their Irvine, CA office. [Link]
  • Buchanan Ingersoll & Rooney is searching for a trademark associate with 2-4 years of experience to work at their Alexandria, VA office. [Link]
  • TransTech Pharma is seeking an IP Counsel with 5+ years of experience and a science degree to work at their High Point, NC location. [Link]
  • Baker & Hostetler is looking for patent attorneys with 2+ years of experience with a degree in ME, EE, or materials to work at their Cincinnati office. [Link]
  • Solazyme is searching for a patent agent with 3-5 years of experience and a degree in bio sciences to work at their San Francisco location. [Link]
  • Trop, Pruner & Hu is seeking associates with an EE or CS backgrounds and a minimum of 2 years of experience to work at their Houston or Austin office. [Link]
  • A law firm in Cupertino has multiple openings for patent attorneys/agents with an Electrical or mechanical background. [Link]
  • NSIP LAW is looking for associates with a minimum of 4 years of experience in patent prosecution and an EE, CE, or CS degree to work at their Washington, DC office. [Link]
  • Myers Wolin is seeking a partner level patent or trademark attorney or small practice group with portables to join their firm located in Morristown, NJ. [Link]
  • Kilpatrick Townsend is searching for a student associate or patent agent with a degree in EE, CS, or physics to work at their Washington, DC office. [Link]
  • Los Alamos National Lab is looking for an experienced patent attorney with 8 years of experience and a technical background to work at their Los Alamos, New Mexico location. [Link]
  • Nagoya International Patent Firm is seeking a US patent attorney with 2-5 years of experience to work in Japan. [Link]
  • Banner & Witcoff is searching for lateral associates with EE or CS backgrounds to work at either their Washington, DC or Chicago office. [Link]
  • The Webb Law Firm is looking for a senior litigation attorney with a minimum of 7 years of experience to work at their Pittsburgh location. [Link]
  • The Webb Law Firm is seeking a patent litigation associate with a minimum of 3 years of experience to work at their Pittsburgh location. [Link]
  • The Webb Law Firm is searching for associates with a degree in CS, CE, or EE and a minimum of 3 years of experience to work at their Pittsburgh location. [Link]
  • Perkins Coie is looking for a patent associate with a minimum of 3 years of experience and a degree in EE, physics, or CS to work at their Seattle office. [Link]
  • Fiala & Weaver is seeking patent attorneys/agents with 1+ years of experience and a degree in EE, CS, or physics. [Link]
  • FLSmidth is searching for a patent attorney with at least 5 years of experience to work in Salt Lake City. [Link]
  • Hamilton, Brook, Smith & Reynolds is looking for electrical associates with 3-5 years of patent pro or IP litigation experience to work at their Concord, Massachusetts office. [Link]
  • Sandia National Labs is seeking a patent attorney with 4-8 years of experience and a degree in physics, EE, ChemE or relevant field to work at their Albuquerque location. [Link]
  • Solazyme is searching for an IP paralegal with 2-5 years of experience to work at their San Francisco location. [Link]
  • Senniger Powers is looking for an associate attorney with a minimum of 2 years of experience and a degree in EE, CE, or CS to work at their St. Louis office. [Link]
  • Harness, Dickey & Pierce is seeking an IP litigation associate with 2-4 years of experience to work at their St. Louis location. [Link]
  • Hoxie & Associates is searching for an experienced patent prosecution paralegal to work at their Millburn, NJ office. [Link]
  • Faegre Baker Daniels is looking for a Biotech/Biochem/Chemical patent agent with at least 2 years of experience and a Ph.D. to work at their Denver office. [Link]
  • Schwegman, Lundberg & Woessner is seeking attorneys with 1+ years of experience and a degree in software/Electrical engineering, organic chemistry (Ph.D.), chemical/polymer engineering, and ME. [Link]
  • Telesign is seeking an IP analyst with at least a bachelor's degree to work at their Marina Del Rey, CA location. [Link]
  • The Michaud-Kinney Group is seeking 2 IP attorneys with at least 3 years of experience: 1 with a background in chemistry or biology and the other with a background in mechanical or electrical technologies. [Link]
  • AdvantEdge Law Group is looking for patent attorneys/agents with a degree in EE, CE, or CS and 2-5 years of experience to work at their South Jordan, Utah location. [Link]
  • Schwabe, Williamson & Wyatt is searching for a patent associate with a background in CS and/ or EE and 4 years of experience to work in either their Seattle or Portland office. [Link]
  • NXP is seeking a Sr. patent attorney, IP and licensing with 10-15+ years of experience to work at their San Jose location. [Link]
  • Steptoe & Johnson is searching for IP associates with a minimum of 2 years of experience in patent litigation and a background in EE to work at in their DC office. [Link]
  • Harrity & Harrity is looking for patent attorneys/agents with a minimum of 2 years of experience and a background in EE, CS, or physics to work in their Fairfax, VA office. [Link]
  • Turner, Padget, Graham, and Laney is seeking a patent attorney 3-5 years of experience in drafting and litigating patents to work in their Greenville, SC office. [Link]
  • Weaver Austin Villeneuve & Sampson is searching for a patent attorney/agent with a EE and/or CS background and 3-5 years of experience to work in their Oakland office. [Link]

Upcoming Events:

  • The Los Angeles Intellectual Property Law Association invites you to join us for the 2012 LAIPLA Spring Seminar at the beautiful Lodge at Torrey Pines in La Jolla, California, on June 8-10, 2012. The Spring Seminar features nine hours of panel discussions and presentations on the latest developments in intellectual property law, provides excellent networking opportunities at the cocktail receptions and dinners, and allows sufficient time for relaxation and enjoyable outdoor activities, including a golf tournament at the Torrey Pines Golf Course, home of the 2008 U.S. Open. Speakers and panelists include federal judges, practitioners (including in-house attorneys), and academics. [Link]
  • The Louisville Bar Association, IP Section, is hosting a half-day CLE program covering various topics in patent law, including patent-eligible subject matter in light of Mayo, patent claim interpretation, joint and distributed infringement, and inequitable conduct. The CLE will be held on June 12 from 9 AM until 12 PM at the LBA office in downtown Louisville, Kentucky. Speakers include Donald S. Chisum, author of Chisum on Patents, and Janice M. Mueller, author of Patent Law, Third Edition. [Link]
  • A free webinar on Improving Decision-Making with Patent Claims Analytics hosted by IPVision will take place June 12, 2012 at 1 pm EST/10 am PST. Those who attend will receive a free claims analysis. Sign up here: [Link]
  • The C5's 11th Annual International Conference on Maximising Pharma Patent Lifecycles conference will be held June 20-21 in London. Patent lifecycle management is becoming more crucial for pharmaceutical companies with the cost of research and drugs continually rising and companies constantly trying to obtain the maximum financial benefit from existing patent terms. In addition to protecting existing IP rights and seeking methods to extend current patent lifecycles, pharmaceutical companies are faced with the challenge of inventing new drugs and diversifying portfolios to replace sales on older and generic drugs. [Link]
  • AIPLA's 4th Annual Trademark Bootcamp will be held in Alexandria, VA on June 22. Learn the trademark basics from top trademark practitioners. This day-long course provides a complete overview of the trademark prosecution process from start to finish, with sessions including: pre-filing considerations, the application process, the examination process, and many more. [Link]
  • The ACI 3rd annual Hatch-Waxman Boot Camp will be held June 25-26 in San Diego. Topics to be covered include: the organization, jurisdiction of the FDA and the PTO and their interplay in the patenting of drugs and biologics, how the approval process for drugs and biologics is connected to the patenting of these products, how the Hatch-Waxman Act established the paradigm for market entry of generic small molecule drugs – and how biosimilar and many others. [Link]
  • IP Dispute Resolution 2012 will take place June 28-29 in London. Hear experiences from Kraft Foods, Nokia, Ericsson, Proctor & Gamble, RIM, Google, Unilever…Discuss current litigation issues, procedures & remedies in all relevant jurisdictions. Guest speakers include: Mialeeka Williams, Ignacio de Castro, Michael Bishop, Richard Vary, Kevin Cranman, and many others. [Link] (PatentlyO readers receive a 10% discount)
  • The AUTM annual meeting will take place July 23-25 in Oklahoma City. There will be many intriguing sessions and lectures to attend. Guest speakers include: Dennis Crouch, Kevin Noonan, Todd Sherer, and many more. [Link]
  • ACI's Freedom to Operate conference is scheduled for July 30-31, 2012 in Philadelphia, PA. Freedom to operate searching and analysis, always a critical component of any patent counsel's profession, is undergoing its biggest shake-up in a generation. Expansion of the obviousness standard, the America Invents Act provisions now requiring a truly global search, and other developments have left patent attorneys and business development professionals perplexed as they try to protect valuable IP in an increasingly competitive global environment. [Link] Register for with PO 200 for a discount.
  • Earn Advanced Patent Law CLE in Spectacular Seattle This Summer: The Chisum Patent Academy is now accepting registrations for its 4th annual summer seminar in Seattle, July 30 – August 1, 2012. Their uniquely insightful, interactive seminars are limited to 10 participants. All sessions are taught by Donald Chisum and Janice Mueller. For further details on seminar coverage and registration information, see http://www.chisumpatentacademy.comor e-mail mailto:info@chisum.com
  • IP Law Summer School will be held August 13-17 in Cambridge, UK. The only residential conference for Intellectual Property lawyers who want to get ahead… an unrivalled resource for the consolidation of, or initiation into all of the central concepts in IP, presented in the context of the latest developments in the industry. [Link] (PatentlyO readers receive a 10% discount)

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