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Tag Archives: McKesson

En Banc Federal Circuit Eases Requirements For Induced Infringement Of Method Claims

Posted in Federal Circuit Decisions; Infringement; Personalized Medicine; Prometheus

On August 31, 2012, the Federal Circuit issued an en banc, per curiam opinion deciding both Akamai Technologies, Inc. v. Limelight Networks, Inc. and McKesson Technologies, Inc. v. Epic Systems Corp., which each relate to the requirements for establishing infringement when all of the steps of a method claim are not performed by a single party. The court overruled its 2007 decision in BMC Resources, Inc. v. Paymentech, L.P., and held that induced infringement can be found even if a single entity is not liable for direct infringement. While the cases before the court pertain to computer-related inventions, this decision will be important to patents in the field of personalized medicine, where a doctor, patient, and laboratory may be involved in various steps of a diagnostic or therapeutic method.

Direct Infringement Of Method Claims

The court did not disturb the principle that in order for “a party to be liable for direct patent infringement under 35 U.S.C. § 271(a), that party must commit all the acts necessary to infringe the patent, either personally or vicariously.” The court explained that, “[i]n the context of a method claim, that means the accused infringer must perform all the steps of the claimed method, either personally or through another acting under his direction or control.” Thus, “this court has rejected claims of liability for direct infringement of method claims in cases in which several parties have collectively committed the acts necessary to constitute direct infringement, but no single party has committed all of the required acts,” unless there was ”an agency relationship between the actors.”

Induced Infringement Of Method Claims

The court decided that induced infringement is best suited “to address the problem presented by the cases before us, i.e., whether liability should extend to a party who induces the commission of infringing conduct when no single ‘induced’ entity commits all of the infringing acts or steps but where the infringing conduct is split among more than one other entity.”

The court noted that to be liable for induced infringement, “the accused inducer [must] act with knowledge that the induced acts constitute patent infringement.” Moreover, “inducement gives rise to liability only if the inducement leads to actual infringement.” Revisiting and overruling its decision in BMC, the court reasoned:

Requiring proof that there has been direct infringement as a predicate for induced infringement is not the same as requiring proof that a single party would be liable as a direct infringer. If a party has knowingly induced others to commit the acts necessary to infringe the plaintiff’s patent and those others commit those acts, there is no reason to immunize the inducer from liability for indirect infringement simply because the parties have structured their conduct so that no single defendant has committed all the acts necessary to give rise to liability for direct infringement.

Applying the new interpretation to the cases before it, the court noted:

In the McKesson case, Epic can be held liable for inducing infringement if it can be shown that (1) it knew of McKesson’s patent, (2) it induced the performance of the steps of the method claimed in the patent, and (3) those steps were performed.

* * * * *

[In the Akami case,] Limelight would be liable for inducing infringement if the patentee could show that (1) Limelight knew of Akamai’s patent, (2) it performed all but one of the steps of the method claimed in the patent, (3) it induced the content providers to perform the final step of the claimed method, and (4) the content providers in fact performed that final step.

The court reversed the judgments of non-infringement in both cases, and remanded “for further proceedings on the theory of induced infringement.”

Judge Newman’s Dissent

Judge Newman dissented and criticized the court for failing to resolve the issue of divided direct infringement, and for expanding liability for induced infringement.

This en banc court has split into two factions, neither of which resolves the issues of divided infringement. A scant majority of the court adopts a new theory of patent infringement, based on criminal law, whereby any entity that “advises, encourages, or otherwise induces,” maj. op. 14, or “causes, urges, encourages, or aids the infringing conduct,” id. at 15, is liable for the infringing conduct. The majority further holds that only the “inducer” is liable for divided infringement, and that the direct infringers are not liable although the patent rights are “plainly being violated by the actors’ joint conduct.” Id. at 10. These are dramatic changes in the law of infringement.

Judge Linn’s Dissent

Judge Linn’s dissenting opinion was joined by Judges Dyk, Prost, and O’Malley. These judges disagree with the court’s decision that liability for induced infringement can exist independently of liability for direct infringement:

On this unsound foundation, the majority holds that in the present appeals there has been predicate “infringement” even though § 271(a)’s requirements are not satisfied. On that basis, the majority vacates the contrary judgments of the district courts and remands for further proceedings concerning liability under § 271(b). In my view, the plain language of the statute and the unambiguous holdings of the Supreme Court militate for adoption en banc of the prior decisions of the court in BMC … and Muniauction … , which hold that liability under § 271(b) requires the existence of an act of direct infringement under § 271(a), meaning that all steps of a claimed method be practiced, alone or vicariously, by a single entity or joint enterprise.

Impact On Personalized Medicine Claims

Barring a Supreme Court decision that reverses or refines this holding, the Federal Circuit’s decision in Akami may make it easier to obtain patents in the personalized medicine space that both satisfy 35 USC § 101 as interpreted by the Supreme Court’s Prometheus decision, and that are enforceable against a single infringer or inducer. As I wrote previously, certain aspects of the Prometheus decision encourage method steps that would be carried out by different actors, such as one or more doctors, a testing laboratory, and/or the patient. While it is possible that an agency relationship could link those parties, the holding in Akami may make it easier to assert such patents against an inducer who encourages others to commit some or all of method steps that constitute infringement, even where the parties performing individual steps are acting independently.

Help The USPTO Reduce The Paperwork Burdens Of Patent Prosecution

Posted in Duty of Disclosure; USPTO Proposed Rule Changes

As announced in a recent Federal Register Notice, the USPTO is soliciting public comments on its information collection requirements, in accordance with the Paperwork Reduction Act. This is an important opportunity to highlight requirements that are unnecessarily burdensome and that may go beyond requirements authorized by statute. While my main paperwork concerns relate to the IDS rules, the Notice highlights other areas where the USPTO may be underestimating the burdens of its regulations. The USPTO will consider written comments received by May 21, 2012. Continue reading this entry

USPTO Tweaks Patent Term Adjustment Rules To Accomodate McKesson-Type IDS Submissions

Posted in Patent Term Adjustment; USPTO Proposed Rule Changes

In a Federal Register Notice issued December 1, 2011, the USPTO issued a final rule that tweaks the patent term adjustment rules to permit applicants to promptly file McKesson-type Information Disclosure Statements (IDSs) without incurring a patent term adjustment deduction. The rule change took effect on December 1, 2011.

(The Federal Register Notice indicates that previously proposed changes to the calculation of patent term adjustment when the USPTO reopens prosecution after a Notice of Appeal are being revised and will be published for comment separately.) Continue reading this entry

Will The USPTO Use The New CCD Tool To Lessen The IDS Burden?

Posted in Duty of Disclosure; International Patent Practice; Patent Office Practice

I know that the USPTO is busy studying the America Invents Act and drafting its implementing regulations, but it is disappointing that nothing has been done to address the inefficiencies of the current Information Disclosure Statement (IDS) rules. This inaction is even more egregious now that the Trilateral Patent Offices (EPO, JPO, USPTO) have launched the Common Citation Document Application (CCD) to provide easy access to references identified in search reports.

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Revisiting IDS Guidlines? While You’re At It . . .

Posted in Patent Office Practice

As I noted last week, the USPTO is revisiting its guidance on the Duty of Disclosure in the wake of the Federal Circuit’s en banc decision in Therasense. While the USPTO is reviewing the substantive requirements of the Duty of Disclosure, I hope that it also takes this opportunity to ease the procedural burdens associated with Information Disclosure Statements (IDSs).

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Revising U.S. Patent Regulations

Posted in USPTO Proposed Rule Changes

If Director Kappos would grant you three wishes to revise the USPTO’s regulations (37 CFR), what would they be? This is not a fairy tale. Last week, the USPTO announced its “preliminary plan to review its existing significant regulations in response to the President’s Executive Order 13563 on Improving Regulation and Regulatory Review.” The USPTO is soliciting public input on how it should undertake this process and specific rules that should be reviewed, and will accept written comments received before April 21, 2011.

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Beware The IDS Of March

Posted in Duty of Disclosure

The oracle told Julius Caesar to “beware the ides of March,” but patent practitioners have more cause for concern about the IDSs they will have to file in March.

The McKesson Problem

Federal Circuit decisions such as McKesson indicate that there can be a duty to disclose information from co-pendng U.S. applications, including Office Actions and cited references. However, the USPTO’s current IDS rules do not provide an efficient framework for citing information from a co-pending U.S. application that is undergoing parallel examination. As a result, applicants are forced to submit copies of documents already in the hands of the USPTO. 

I have proposed three changes to the MPEP and USPTO regulations that the USPTO could adopt to alleviate the burdens of complying with the duty of disclosure in this context. I have pointed out that the required refiling of documents that the USPTO already has burdens the USPTO as well as applicants. I have noted that “McKesson IDS” is one of the most common search topics that bring people to this blog.

The IDS of March

The “IDS of March” is an IDS that caught my attention as symbolizing the wastefulness imposed by the current IDS rules that require applicants to file copies of documents in one application that the USPTO already has in connection with another (identified) application.

IDS2-28.jpg

There has to be a more efficient way to get this information in front of examiners without needlessly burdening applicants, the USPTO and the environment.

Do you have a McKesson-type IDS that should be featured as an IDS of March?

Leave a comment and I will follow-up with you.

USPTO Takes the MPEP to the Wikisphere

Posted in Patent Office Practice

As the USPTO begins the process of updating the Manual of Patent Examining Procedure (MPEP) and the Trademark Manual of Examining Procedure (TMEP), it is inviting public comment on specific sections through new “online discussion tools.” I am encouraged by the USPTO’s interest in public input on these guidance materials, and hope that members of the patent community take advantage of this opportunity to provide meaningful comments and suggestions on the procedural and substantive guidance they provide.

According to the USPTO’s press release, the tools will facilitate discussion and feedback by:

  • Encouraging readers to post comments about the current text, on a section-by-section basis, to point out errors, suggest clarifications, and suggest examples of interpretations.
  • In some circumstances, posting preliminary content and encouraging the community to comment on the preliminary content before it becomes official.
  • Periodically summarizing and following up on the comments on each section to ensure that meritorious suggestions are acted upon while streamlining the comment process.
  • Providing a forum for the community to discuss and debate topics such as how to interpret recent court decisions.

As set forth on the Terms of Participation page:

The ultimate objective is to create an MPEP that will enable practitioners and examiners to find information quickly, get accurate and complete guidance, and ensure that all patent applications comply with the laws and regulations governing the patent system.

The first MPEP chapters open to this process include:

  • Chapter 500 – Receipt and Handling of Mail and Papers
  • Chapter 600 – Parts, Form, and Content of Application

The “tools” are in essence discussion forums where members of the public can submit comments, read and comment on other comments, and “vote” on comments with a “thumb up” (“I agree”) or “thumb down” (“I disagree”). 

Those interested in reviewing or contributing comments can access the MPEP tool here and the TMEP tool here. No registration is required to review the comments, but registration (name, email address, and password) is required to provide any input.

Although the USPTO seems to be kicking off this effort with non-controversial sections of the MPEP, there already are some interesting comments on the ”requirements” for patent application abstracts. There also is a comment asking for guidance on McKesson-type Information Disclosure Statements that I promise I didn’t write, but I do hope that the USPTO understands and addresses the serious burden associated with these IDSs.

How Much Do IDS’s Contribute to the USPTO’s Patent Process Problems?

Posted in Patent Office Practice

In a recent post on his blog, Director Kappos discussed the progress the USTPO has made towards improving patent processes.  He reports that in fiscal year 2010 the USPTO "[e]ntered more than 2.9 million documents." Now, he doesn’t categorize these documents, but I wonder how many include Information Disclosure Statements that submit copies of references or Office Actions that the Patent Office already has in the electronic files of other patent applications. Yes, I am referring to the McKesson IDS problem again!

One of my first blog articles proposed three easy solutions to the McKesson IDS problem. I understand that this problem is not a major prioirty for the USPTO, but I was hopeful that it would make the agenda after Director Kappos wrapped up his first year leading the USPTO.

When the EPO waived its new disclosure requirements for applications where it could readily obtain the information itself, I thought that the USPTO would take notice. How can the USPTO require US applicants to submit in one application copies of references and Office Actions from another application, when the EPO has decided that applicants with US priority applications do not have to submit copies of US Office Actions, because the EPO can obtain those documents itself from the USPTO’s PAIR website? 

Now, Director Kappos has shined a spotlight on the overwhelming number of documents the USPTO must process on a yearly basis. If the USPTO has not investigated what portion of these documents is made up of Information Disclosure Statements, and what portion of Information Disclosure Statements submit copies of documents that the USPTO already has on file in association with another application, it should. And, if it has looked at those numbers, it should share them with the public.

The current IDS processes waste applicant resources, USPTO resources, and paper:

If we recieve an Office Action in one application, we may decide (pursuant to McKesson) to cite it (and any newly cited references) in an IDS in a copending application. Even though the USPTO already has a copy of the Office Action and the references from the first application, the current IDS rules require us to submit copies in the second application in order to have them considered by the examiner.

If the IDS includes a large number of documents or lengthy documents, we are likely to file hard copies, because copying documents is faster than scanning and uploading them one by one to PAIR.

When the USPTO receives the hard copies, it then scans them into its own electronic files to be indexed in PAIR with the second application.

Thus, the current rules require the same documents to be processed three times:

  1. First, when the USPTO issues the first Office Action and provides copies of non-patent references. 
  2. Second, when the applicant copies the Office Action and references for the IDS in the copending application.
  3. Third, when the USPTO scans the Office Action and references from the IDS for the electronic file of the copending application.

Even if only a small fraction of the 2.9 million documents processed by the USPTO in 2010 are McKesson-type IDSs, it is clear that the USPTO could realize signficant process improvements if it at least waived the requirement to submit copies of documents already in its possession. As the number of pending applications continues to grow year over year, the number of IDSs will only increase. The USPTO’s failure to address this issue will undermine its efforts to improve its internal processes and could delay the overall patent process if examination is delayed while IDS documents are entered into the USPTO’s system.

New Duty of Disclosure for European Patent Applications

Posted in Duty of Disclosure; International Patent Practice

European patent applications filed on or after January 1, 2011 will be subject to a new disclosure requirement designed to support international worksharing efforts. The new rule will require applicants to submit copies of search results received from the national patent office of the priority country (the Office of First Filing, or OFF). Failure to comply with the new requirement can result in abandonment of the European patent application, but the EPO plans to implement steps to facilitate compliance.

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Will The Federal Circuit’s Therasense Decision Solve The McKesson Problem?

Posted in Duty of Disclosure; Federal Circuit Decisions; Inequitable Conduct

This week the Federal Circuit heard oral arguments in its en banc rehearing of Therasense, Inc. v. Becton, Dickinson & Co. As reflected in the en banc order, the court took this case en banc in order to reconsider—and hopefully reform—the law of inequitable conduct. The court’s decision could solve the McKesson problem and rein in the threat of inequitable conduct charges that drives practitioners to submit references even when they are not believed to be relevant to patentability. 
 

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Next on the Agenda: Fixing the McKesson IDS Problem?

Posted in Duty of Disclosure; Patent Office Practice

David Kappos has wrapped up his first year as Director of the USPTO. As noted in his blog, he has implemented a number of new programs and rolled out several new initiatives. Perhaps most importantly, he has fostered an atmosphere of cooperation between the USPTO and the stakeholder community. With that in mind, I again urge the USPTO to take action to solve the McKesson Information Disclosure Statement (IDS) problem. I am not the only one concerned with this issue. One of the most common search topics that bring people to this blog relate to "McKesson" and "IDS." Clearly, stakeholders are burdened by this problem and are looking for guidance and solutions.

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Three Easy Solutions to the McKesson Problem

Posted in Duty of Disclosure; Patent Office Practice

Federal Circuit decisions such as McKesson Information Solutions, Inc. v. Bridge Medical, Inc., 487 F.3d 897 (Fed. Cir. 2007), indicate that there can be a duty to disclose information from co-pendng U.S. applications, including Office Actions and cited references. However, the USPTO’s current IDS rules do not provide an efficient framework for citing information from a co-pending U.S. application that is undergoing parallel examination. As a result, applicants are forced to submit copies of documents already in the hands of the USPTO and to undertake the costly and time-consuming process of filing Requests for Continued Examination (RCEs) in order to comply with the current IDS rules. 

Now that it has been three years since the McKesson decision was issued, the time for the USPTO to relieve the burden of these decisions is long overdue. Here are three simple solutions that the USPTO could adopt:

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