US Patent Application Filings for FY 2015

By Jason Rantanen

The USPTO recently released the data on the number of patent applications filed in Fiscal Year 2015 via its Data Visualization Center (i.e.: the Dashboard) page.

Based on this data, the number of patent applications hasn’t taken a nosedive.  Instead, applications have remained at the same level as the preceding year.  The number of UPR (Utility, Plant and Reissue) applications did drop by about 0.5% as compared with Fiscal Year 2014, but that’s a very small change, especially when compared with the growth in UPR filings over the past several years.  In addition, when Requests for Continued Examination are broken out (the PTO includes RCEs in its numbers of UPR filings on the Dashboard spreadsheet), the number of applications actually rose by about 1%.

Figure 1 depicts the numbers of UPR applications filed per fiscal year, with and without RCEs.  (Additional note: these numbers do not distinguish between applications that do not claim the benefit of an earlier U.S. application and those that do, such as continuations and continuations in part.  Also, historically plant and reissue applications have made up a de minimus proportion of the UPR applications (about a thousand of each per year).)

UPR - FY 2015To check whether there might have been a sudden drop at the end of the year that affected these results, I also plotted the cumulative numbers of applications filed on a monthly basis for each fiscal year from 2009-2015. Fiscal year 2015 really doesn’t look all that different from Fiscal Year 2014 when viewed on a monthly basis and there’s no sudden unexpected dropoff at the end.

Applications - Time Series (2015)

Finally, I graphed the numbers of design patent applications filed each fiscal year.  I was a bit surprised that design patent applications were essentially flat as compared to FY 2014, indicating that – so far at least – there hasn’t been a huge surge in these applications.

Design applications 2015

 

Life Tech v. Promega: Inducing with Yourself

InducingYourselfIn Life Technologies Corp. v. Promega Corp., the Supreme Court has asked for the views of the Solicitor General — greatly raising the likelihood that the high court will take the case.  The kicker will be how the US Gov’t responds.

The case centers around Life Technologies’ international sales of genetic testing kits.  A portion of the kit included Taq polymerase that was manufactured in the US and sent to the UK where it was combined with additional components to produce the infringing kit.  Of course, the UK manufactured kit isn’t infringing under ordinary U.S. patent law because it is being manufactured, sold, and used outside of the US.  However, Section 271(f) of the Patent Act provides a cause of action for infringement based upon export of components of a patented invention to be combined abroad.

This case focuses on Section 271(f)(1) that provides:

Whoever without authority supplies or causes to be supplied in or from the United States all or a substantial portion of the components of a patented invention, where such components are uncombined in whole or in part, in such manner as to actively induce the combination of such components outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.

The elements of infringement under Section 271(f)(1) appear to be:

  • Supply or cause to supply in or from the US;
  • A substantial portion of the components of a patented invention in uncombined form; and
  • In a way that actively induces the combination outside of the US in a manner that would infringe the patent if it had been combined within the US.

In finding for the patentee, the Federal Circuit made two interesting decisions:

  1. The exporter can induce itself to combine the components abroad.
  2. A single component (here the Taq polymerase) can serve as “a substantial portion of the components.”

In his essay on the decision, Jason Rantanen wrote that these holdings are “probably erroneous—doctrinal developments.”

Now, in its petition for certiorari, the adjudged infringer has followed Prof. Rantanen’s lead and asks the following questions:

  1. Whether the Federal Circuit erred in holding that a single entity can “actively induce” itself to infringe a patent under 35 U.S.C. § 271(f)(1).
  2. Whether the Federal Circuit erred in holding that supplying a single, commodity component of a multi-component invention from the United States is an infringing act under 35 U.S.C. § 271(f)(1), exposing the manufacturer to liability for all worldwide sales.

 

The basic arguments here stem from the Supreme Court’s prior statements that 271(f) should be interpreted narrowly.  In his amicus brief supporting the petition, Dean Tim Holbrook argues that the Federal Circuit “consistently fails to consider the presumption against extraterritoriality” and that important interpretive doctrine leads to the conclusion that the court went too far here.

Next step in the case will be a brief submitted by the US Government staking out its position as to whether export should count as infringement. Although I am sympathetic to Holbrook’s position, the US administration is active enough in patent cases so that it can be the one making the argument if the case so warrants.

Steed: Proving Conception

In re Steed (Fed. Cir. 2015)

This decision offers an example of failures of the first-to-invent regime. Basically, Steed (acting pro-se in a pre-AIA application) attempted to swear behind a 102(e) prior art reference.  However, prior conception, diligence, and reduction-to-practice all must be proven with documentary evidence. Here, the applicant submitted a Section 131 declaration attempting to show prior conception, diligence, and reduction to practice, but the evidence submitted was ultimately found lacking.

Through a series of cases, the courts have defined invention more as a process than a point in time.  This process is triggered and begins with an inventor’s (or inventors’) conception of the invention that includes a “definite and permanent idea of the complete and operative invention,” including all of the elements of the eventually claimed invention.  Although conception seemingly occurs in the mind of inventors, the evidentiary requirements demand written proof of conception.  Although invention is triggered by conception the process is not deemed complete until the idea has been actually reduced to practice (RTP).  Today, few patent applicants actually reduce their idea to practice prior to filing (certainly not covering all of the claimed arrangements), however, the the courts have deemed the filing of a patent application satisfying the patentability requirements to be a constructive reduction to practice.   In essence, the courts have noted that the elements of invention were not actually completed, but we will close our eyes and simply assume the legal fiction.

Here, the patent applicants had a number of documents showing that they were working on a variety of ideas. However, nothing submitted was sufficient to show that the applicants had conceived of the whole idea (with the claim limitations being sought) prior to the critical prior-art date.

The point here is that it is hard to prove a prior invention date unless you have kept very good records enough to prove an early conception date of the invention that you are now claiming.

= = = = =

An odd aspect of the case involved the PTO’s argument that the pro-se inventors had waived their arguments associated with proving an early date of actual reduction to practice. Basically, in briefing the applicants had stated that their evidence showed a prior constructive reduction to practice even though it was clear that the applicants were attempting to prove prior actual reduction to practice.  Since the applicants had used the wrong word, the PTO solicitor argued that the applicant waived their right to argue actual reduction to practice. On appeal, the Federal Circuit rejected the waiver argument, but ultimately found that the applicants had not proven actual reduction to practice.

= = = = =

One take-away from this case is the importance of relying upon highly qualified patent counsel. Although the AIA has largely eliminated the particular issues in this case, a large number of pitfalls remain to trap the unwary.

 

Federal Circuit Operating Procedure: Affirm PTO Decisions Without Opinion

The Federal Circuit released two more “Rule 36” from the Federal Circuit: Hill-Rom Services, Inc. v. Stryker Corporation; and First Quality Baby Products v. Kimberly-Clark Worldwide, Inc. Both of these cases involved the patentee appealing PTAB obviousness determinations during reexamination proceedings.

The Federal Circuit’s local Rule No. 36 provides:

Rule 36. Entry of Judgment – Judgment of Affirmance Without Opinion

The court may enter a judgment of affirmance without opinion, citing this rule, when it determines that any of the following conditions exist and an opinion would have no precedential value:

(a) the judgment, decision, or order of the trial court appealed from is based on findings that are not clearly erroneous;

(b) the evidence supporting the jury’s verdict is sufficient;

(c) the record supports summary judgment, directed verdict, or judgment on the pleadings;

(d) the decision of an administrative agency warrants affirmance under the standard of review in the statute authorizing the petition for review; or

(e) a judgment or decision has been entered without an error of law.

Since January 2015 (10 1/2 months), the court has issued 101 precedential opinions.

Although the two cases here do seemingly turn on factual questions, they also deal with obviousness – which is the key issue in the vast majority of Patent Office decisions.

Over the past year, the Federal Circuit has decided a large number of Patent Office appeals with R.36 judgments or non-precedential opinions.  Looking at Federal Circuit decisions since January 1, 2015 that stem from Patent Office appeals: approximately 20% are precedential opinions; 20% are non-precedential opinions; and 60% are Rule 36 affirmances without any opinion at all.

IPO Executive Director: Mark Lauroesch

Mark LauroeschI wanted to take a moment to welcome Mark Lauroesch as the new Executive Director of the Intellectual Property Owners Association (IPO) following the retirement of longtime director Herb Wamsley.  Lauroesch was previously in house counsel with Corning for 20 years, including 10 years as VP and General IP Counsel.  Congratulations on the new role! 

Phil Johnson (J&J) remains president of the IPO Board of Directors with Carl Horton  (GE) as VP and Kevin Rhodes (3M) as treasurer.

Federal Circuit Summarily Affirms Apple v. Samsung judgment without Merits Briefing

Apple v. Samsung (Fed. Cir. 2015) (SamsungSummaryAffirm)

Most recently in the patent battle between Apple and Samsung, district court Judge Koh awarded $550 million to Apple for based largely upon design patent infringement findings.  That awarded followed immediately after the Federal Circuit’s 2015 remand to Judge Koh “for immediate entry of final judgment.”  Samsung is again appealing the damages ruling, but meanwhile there remains the question of whether Samsung needs to go ahead and pay the money or can stay execution of the judgment.

The Federal Rules of Civil Procedure allow a party to stay payment of money damages (but not injunctive relief) pending appeal of a final judgment and upon payment of a “supersedeas bond.”

Fed. R. Civ. Pro. 62(d): Stay with Bond on Appeal. If an appeal is taken, the appellant may obtain a stay by supersedeas bond…. The bond may be given upon or after filing the notice of appeal or after obtaining the order allowing the appeal. The stay takes effect when the court approves the bond.

Here, Samsung requested that Judge Koh accept $600 million as the bond, but Apple objected – arguing that Samsung’s substantive appeal is frivolous.  Because Judge Koh had not ruled on the bond request, Samsung filed an emergency appeal to have the Bond accepted.  As part of its briefing, Apple also requested “Summary Affirmance” of the district court’s final judgment regarding the half-billion-dollar judgment.

In the appeal, the Federal Circuit has sided with Apple – not only refusing to grant the bond but also summarily affirming Judge Koh’s damages award (that was already subject to a prior appeal).

Summary affirmance is appropriate when “the position of one party is so clearly correct as a matter of law that no substantial question regarding the outcome of the appeal exists.” Joshua v. United States, 17 F.3d 378, 380 (Fed. Cir. 1994). We have reviewed the parties’ arguments and conclude that summary affirmance is appropriate.

The Federal Circuit had granted a temporary stay of execution of the award and indicated that the stay would continue for seven days and by that time Samsung must have paid the money or be in contempt of court (absent action from the en banc Federal Circuit court or the Supreme Court).

In all likelihood, Samsung will immediately (today or tomorrow) file a request for rehearing and the en banc court may agree with the adjudged infringer that the summary affirmance shortcut was too quick.  In its briefing, Samsung wrote:

A motion for approval of a supersedeas bond is not … the proper vehicle to decide or even address the merits of an appeal. Indeed, Apple cites no decision permitting such an inquiry in this context, let alone one disapproving a supersedeas bond based on such an inquiry.

If it ever reached the merits, Samsung has indicated its planned appeal strategy on the following questions:

  1. Whether the PTO’s final decision* invalidating a patent-in-suit is entitled to collateral estoppel effect in a pending federal court case.
  2. Whether a district court my enter a partial final judgment that does not satisfy Fed. R. Civ. Pro. 54(b).

Absent en banc rehearing, those issues will not be addressed in this case.

= = = = = =

* The “PTO Final Decision” raised by Samsung refers to one of Apple’s infringed patents – No 7,844,915.  That patent has been working its way through the third-party-requested ex parte reexamination process since 2012.  Most recently, the examiner issued a final rejection of the asserted claims and that judgment was affirmed by the PTAB and Apple’s request for rehearing denied.  The patent covers the “pinch-to-zoom” feature of Apple’s iPhone.

Pending Cases at the Supreme Court

As we sit here today, there are no pending patent cases before the Supreme Court where the court has granted certiorari.  That said, there are a large number of pending petitions.  These include Cuozzo & Pulse that I have previously discussed. WilmerHale has been covering these, but is a few months behind.

The following are a few recently filed petitions:

Teva Follow-On: FiveTech v. SouthCo: (1) Can the Federal Circuit limit the role of the intrinsic evidence in construing patent claims under the exacting “lexicography and disavowal” standard; (2) Does the “lexicography and disavowal” standard improperly circumscribe the objective standard of the person of ordinary skill in the art in construing claim terms.

Teva Follow-On: Chunghwa Picture Tubes v. Eidos: Whether a district court’s factual finding(s) underlying its construction of a patent claim term must be reviewed for clear error under Rule 52(a)(6) as this Court held in Teva, or is an exception created to clear error review where the appellate court finds the intrinsic record clear after a de novo review of that record, as the Federal Circuit held in this case.

Attorney Fees in Copyright:

Kirtsaeng v. John Wiley (Kirtsaeng II): What is the appropriate standard for awarding attorneys’ fees to a prevailing party under § 505 of the Copyright Act?

Omega v. Costco (Costco II): (1) Can Copyright attorney fees be based on a finding that petitioner engaged in copyright misuse when the issue of misuse was appealed but left undecided on appeal? (2) Can the pursuit of a claim of copyright infringement constitute “copyright misuse” when the allegedly infringing copy is a “pictorial, graphic, or sculptural work” that is reproduced in a “useful” article.

Inter Partes Review Challenges:

Automated Merchandising v. Michelle Lee: (1) Must the federal judiciary await the substantive conclusion of an agency proceeding before it can evaluate whether an express statutory limitation on that agency’s jurisdiction requires that agency to terminate its proceeding? (2) Did the Federal Circuit err in refusing to order the USPTO to terminate the subject inter partes reexaminations under 35 U.S.C. § 317(b)?

Luv N’ Care v. Munchkin: Did the Federal Circuit err by affirming a PTAB administrative judgment based on new issues raised sua sponte by the PTAB at the Final Hearing, thus depriving the patent owner of notice and a meaningful opportunity to respond?

ANDA Loophole Cases:

Mylan v. Apotex:  (1) Whether Article III’s case or controversy requirement can be satisfied by a suit which seeks a judgment of non-infringement of a disclaimed patent. (2) Whether Congress can create Article III jurisdiction by imposing statutory consequences that turn on obtaining a judgment of non-infringement of a disclaimed patent.

Daiichi Sankyo v. Apotex: Whether an action seeking a declaration judgment of non-infringement presents a justiciable case or controversy under Article III of the Constitution where the patent at issue was previously disclaimed and thus cannot be enforced.

Design Patent Summary Judgment: Butler v. Balkamp: Is summary judgement proper in a District Court when a factual dispute exists in a Design Patent action and the District Court substitutes its own opinion for that of the ordinary observer?

Reasons to Combine and Obviousness: Arthrex v. KFX Medical: (1) Is the “reason to combine” inquiry a subsidiary question of fact, subject to deferential review on appeal, or a legal question for the court, and reviewed de novo. (2) Should the ultimate legal issue of obviousness be resolved by the court rather than submitted to the jury for resolution.

Trans Pacific Partnership IP Chapter

The final draft document for the Trans Pacific Partnership (TPP) agreement intellectual property chapter has apparently been provided by Julian Assange at WikiLeaks.

Some highlights:

Article QQ.E.1:

  1. Subject to paragraphs 3 and 4, each Party shall make patents available for any invention, whether a product or process, in all fields of technology, provided that the invention is new, involves an inventive step, and is capable of industrial application.
  2. Subject to paragraphs 3 and 4 and consistent with paragraph 1, each Party confirms that patents are available for inventions claimed as at least one of the following: new uses of a known product, new methods of using a known product, or new processes of using a known product. A Party may limit such processes to those that do not claim the use of the product as such.
  3. Each Party may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to nature or the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law. Each Party may also exclude from patentability: diagnostic, therapeutic, and surgical methods for the treatment of humans or animals; animals other than microorganisms; and essentially biological processes for the production of plants or animals, other than non-biological and microbiological processes.
  4. Each Party may also exclude from patentability plants other than microorganisms. However, consistent with paragraph 1 and subject to paragraph 3, each Party confirms that patents are available at least for inventions that are derived from plants.

Article QQ.E.11: {Publication of Patent Applications}

  1. Recognizing the benefits of transparency in the patent system, each Party shall endeavor to publish unpublished pending patent applications promptly after the expiry of 18 months from the filing date or, if priority is claimed, from the priority date.
  2. Where a pending application is not published promptly under paragraph 1, Parties shall publish such application or the corresponding patent as soon as practicable.
  3. Each Party shall provide that an applicant may request the early publication of an application prior to the expiry of the period mentioned in paragraph 1.

Remedies:

6. Each Party shall ensure that its judicial authorities shall have the authority to order a party at whose request measures were taken and who has abused enforcement procedures with regard to intellectual property rights including … patents, copyright and related rights, and industrial designs, to provide the party wrongfully enjoined or restrained adequate compensation for the injury suffered because of such abuse. The judicial authorities shall also have the authority to order the applicant to pay the defendant expenses, which may include appropriate attorney’s fees.

The provisions on Pharma, Ag, Biotech Data Protection, and Trade Secrets need further analysis.

– DC

The Concentrated Market of Patent Jurisdictions

The chart below shows the relative distribution of new patent lawsuit filings (complaints) over the past decade.  I included the top four most popular jurisdictions (E.D.Tex., D.Del., C.D.Cal., and N.D.Cal.) and also a catch-all category for the sum of the other 90 or so districts in the country.  LawsuitDistribution

You’ll note that E.D.Tex. has been the leading district almost every year for the past decade, but that growth has increased since the AIA (2011) and even further increased in 2014 and 2015.  Part of ramp-up comes from the fact that the E.D.Tex. cases already had more defendants-per-patent and the joinder provisions of the AIA could be seen as a natural expression of that phenomenon.  However, the rise in 2015 can’t be so easily explained.

If you calculate the HHI, this now looks like a very concentrated market.

Trans Pacific Partnership

The Trans-Pacific-Partnership is now much closer to reality with substantive agreement between the 12 member nations that include the US, Canada, Mexico, Japan, Australia, et al. (but not China).  The new multilateral trade agreement has not been made public, but reportedly includes a number of intellectual property elements with special protections against copyright theft for the US entertainment industry and generic competition for the branded pharmaceuticals.  Congress will need to approve the agreement to make it effective in the US, but is likely to do so if Republicans get their act together.

A final version of the text should be available in November.

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Cuozzo Takes IPR Challenge to the Supreme Court

Cuozzo Speed Tech v. Lee (Supreme Court 2015)

Cuozzo lost its petition for en banc rehearing in a 6-5 split of Federal Circuit judges.  Now, the patentee has raised is challenge to the IPR process to the Supreme Court – asking two questions:

  1. Whether the [Federal Circuit] erred in holding that, in IPR proceedings, the Board may construe claims in an issued patent according to their broadest reasonable interpretation rather than their plain and ordinary meaning.
  2. Whether the [Federal Circuit] erred in holding that, even if the Board exceeds its statutory authority in instituting an IPR proceeding, the Board’s decision whether to institute an IPR proceeding is judicially unreviewable.

Answers to these questions will fundamentally alter the inter partes review system. The petition does a good job of walking through the importance of the case and then separately explaining their legal argument.

I’m sure that we’ll cover this case more as the briefing moves forward – amici have 30 days to file.  Meanwhile, read the petition here: Cuozzo Speed Technologies LLC v Michelle K Lee Petition for a Writ of Certiorari

The Cuozzo petition was filed by a rising star in Supreme Court practice – Jeffrey Wall, who is partner at Sullivan & Cromwell.  Wall was a clerk for Justice Thomas and was an Assistant to the Solicitor General for five years. He also has the distinguishing mark of being my law school classmate (as well as Prof. Rantanen).

 

Guest Post: The Blurring Of §§ 101 and 103—A Double-Edged Sword that Cuts the Other Way

Guest post by Ben Roxborough.  Mr. Roxborough is one of a few dual citizens who have completed federal court clerkships in both the United States and Australia. He has clerked in the U.S. for three years and practiced in Australia for five years, writing articles on how Australian courts developed a workable doctrine for patentable subject matter. He earned an LL.M. degree at Stanford Law School, specializing in intellectual property. This is not legal advice, and he welcomes any comments or criticisms: ben.roxborough@gmail.com

To say that the sands have been shifting with respect to Section 101 jurisprudence would severely understate the seismic change that it has experienced in recent years; ever more so in recent months. The consequence is that the lines between sections 101, 102 and 103 have been blurred. This consequence appears to stem from statements in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289, 1304 (2012), where Justice Breyer suggested that the inquiries “overlap.” Indeed, three years later, the Federal Circuit panel in Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1347 (2015), went as far as saying that a “pragmatic analysis of § 101 is facilitated by considerations analogous to those of §§ 102 and 103.”

Because the lines have blurred, defendants have been able to rely on 102/103 arguments to invalidate patents on 101 grounds. These arguments, which defendants tend to advance at the second step of the Mayo/Alice framework, generally state that the additional steps—beyond the putative ineligible subject matter—are conventional because they can be found in the specification or are so ubiquitous that the court can treat them as routine and well understood by those in the scientific community. In Mayo, 132 S. Ct. at 1298, for example, Justice Breyer cited admissions in the specification that the processes for determining the level of metabolites in a patient’s blood were “well known in the art.” The patent lacked inventive concept because of this. Relying on Mayo, among other cases, defendants now make a simple argument. The argument may be summed up as: “Your Honor, if you combine what’s described in the specification and prior art with the ineligible subject matter, you’ll find that the patent claims are routine and conventional and do not meet the 101 threshold.”

In effect, the 101 ineligibility defense has become a de facto 103 defense, targeting primarily combination patents. But putting aside the fact that this de facto argument reflects a conclusion (rather than any real analysis), the argument is extraordinary because prior art in the specification is used against the patentee. No evidence other than the specification is being proffered to support the defendant’s position (which may mean that the prior art in the specification is an admission, but no patentee would say that the combination of the prior art elements were well known in the art at the time of the invention). And although some district courts have acknowledged this paradox, the argument tends to be successful as it was in McRO, Inc. v. Namco Bandai Games Am., Inc., No. CV 12-10327-GW, 2014 WL 4749601, at *11 (C.D. Cal. Sept. 22, 2014).

But it doesn’t end there: the patentee’s perilous position is only compounded further when the defendant seeks dismissal of the claim pursuant to Federal Rule of Civil Procedure 12(b)(6) because the patentee generally cannot proffer evidence outside the four corners of the complaint (and patent) that could undercut the defendant’s position. This seems unfair from not only a procedural perspective, but also a substantive one. When looking at a combination patent, what courts most want to know (or should want to know) is: “Who would have thought to combine the elements of the invention in the first place, and why?”

These basic concerns are central in the 103 context. But they should be equally relevant in the 101 context. Defendants have had a field day eviscerating patent after patent since Alice using ‘obviousness-like’ arguments to show that the patent lacks inventive concept. What is required in response to these developments is judicial recognition of ‘obviousness-like’ arguments that cut the other way. The article I am writing seeks to develop these themes, so to place plaintiffs and defendants on equal footing under Section 101. They are summarized here (and, admittedly, are far from fully developed):

  1. THE SKILLED ARTISAN: To provide the 101 analysis with an objective baseline, courts need to define who the skilled artisan is—and what she knew at the time of the invention. Sometimes a plaintiff is precluded from presenting such evidence because courts now decide a significant number of 101 cases at the Rule 12(b)(6) stage. To guard against early Rule 12(b)(6) motions, the skilled artisan’s background should be described in the complaint (or even the patent itself). Or, the Defendant should be required to show ineligibility within the confines of Rule 12(b)(6). This is less of a problem at the Rule 56(a) stage because the patentee has a chance to present skilled artisan’s common general knowledge. Critically, however, in those cases now on appeal—where the district court has not properly articulated the skilled artisan’s background—the Federal Circuit should be remanding such decisions for further factual development of the record. Placing greater emphasis on the skilled artisan can only make the 101 analysis a more balanced one.
  1. SOLVE THE PROBLEM: Defendants are using the specification against the patentee. But what is referenced in the specification can actually help the patentee demonstrate that the additional steps beyond the ineligible subject matter constitute inventive concept. Specifically, plaintiffs should turn the tables and point to the specification to demonstrate the problems faced by those in the field—and why the invention provides a “new and useful” solution. 35 U.S.C. § 101. Taking a problem-solution approach to define what is “new and useful” is precisely the type of analysis that Judge Chen applied in DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014), though it has its roots in Diamond v. Diehr, 450 U.S. 175, 188 (1981) and the Supreme Court’s more recent holding in Alice also reflects this approach.
  1. TEACHING AWAY: This analysis typically applies in the 103 context. But what stops it from being relevant in the 101 context? To this point, the recent BRCA1 decision has opened the door for its application. In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig., 774 F.3d 755, 764 (Fed. Cir. 2014). Just as Justice Breyer tethered the notion of what was “well known in the art” by referring to the specification for 101 purposes, the Federal Circuit in BRCA1 has tethered that same notion to “techniques that a scientist would have thought” to use when deciding to engage in experiments that were directed to the invention. But if inventors engage in activities that run counter to scientific thought, those activities can hardly be considered routine and conventional in a 101 sense, correct? While some may say that teaching away analysis should be reserved for § 103 (and to do so would otherwise conflate § 101 with §103), several reasons militate against this position. First, as stated above, the Supreme Court and Federal Circuit have said that § 101 is facilitated by considerations analogous to those of § 103. Second, teaching away analysis should not be monopolized by § 103. In fact, evidence that teaches away is already relevant to enablement (§ 112) to show that “a significant amount of experimentation would have been necessary to practice the claimed invention.” Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 1379-79 (Fed. Cir. 2007). Because teaching away analysis is transferable between different sections in the statute, there would seem no reason why it could not be extended to § 101 to determine whether a combination of steps is routine and conventional.
  1. HINDSIGHT: Given that Alice requires that courts look at patented elements as a whole, the concern of hindsight bias should have as much relevance to a § 101 challenge as it does a § 103 challenge. For when each of the elements of a claimed invention do not exist in the prior art, or even the ordered combination, how can a defendant rationally argue that the combination is routine and conventional without some degree of hindsight bias kicking in? Princeton Biochemicals, Inc. v. Beckman Coulter, Inc., 411 F.3d 1332, 1337 (2005). Indeed, in Mayo, 132 S. Ct. at 1298-99, Justice Breyer explained that the invention in Diehr was patentable because the “ordered combination” of the steps of the claimed invention as a whole were “nowhere suggested” to be “in context obvious, already in use, or purely conventional.” And while the Supreme Court made no express mention of hindsight in its 101 holdings, it was, at the very least, an underlying rationale in Diehr. Footnote 12 of that opinion is exemplary. Alice, too, reinforces this point when it spoke of looking at combination patents as “whole.”
  1. PREEMPTION & PIONEER PATENTS: Plaintiffs do appear to be pressing preemption arguments more heavily in recent months. The Sequenom case illustrates this: Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (2015) But, sadly, the Federal Circuit panel got it wrong when it was not prepared to consider evidence that demonstrated that the invention did not foreclose the use of the discovery. The saying what’s good for the goose is good for the gander seems apt. Because of this, it will be left to the Federal Circuit en banc, or other panels to address how preemption should factor into the 101 calculus. In any case, those decisions should take a liberal approach to Mayo’s dicta and allow preemption to play a tie-breaking fact role in close cases—e., a role similar to that of secondary indicia in the 103 calculus as evidence providing a tipping point in favor of a non-obviousness determination. To this end, and in the preemption context, the patentee should be entitled to show that there are different ways of achieving the goal to which the patent is directed—not just one (preemptive) way.

In addition, the Mayo decision also spoke of “how much future innovation is foreclosed relative to the contribution of the inventor.” Mayo, 132 S. Ct. at 1303. Does this mean that a pioneer patent should be given more latitude in a 101 context than a patent that provides a mere incremental improvement? I think it does. But a workable doctrine must emerge—much like one emerged with respect to the doctrine of equivalents in the infringement context. The article will address this.

  1. DRAFT JURY 101 INSTRUCTION: Given that some 101 cases are predicated on underlying factual findings, much like 103, the article will conclude with an appendix that includes a draft jury instruction. That will be addressed in more detail later.

Australia Rejects Isolated-DNA Patents

Australian_Coat_of_Arms[1]D’Arcy v. Myriad, [2015] HCA 35

The High Court of Australia (HCA) has determined that Myriad’s claims to isolated DNA are not patent eligible — finding that the creation of this category of important rights is best left to “legislative determination.”

Australia’ patent statute is still keyed to the 1624 English Statute of Monopolies that allows for patents on “any manner of new Manufactures.”  Australia takes those “ancient” words and then applies a common law approach to determine its scope.  In general, Australian patent rights can only be granted on “something brought about by human action.”

The court here writes:

Although it may be said in a formal sense that the invention as claimed, referring to isolated nucleic acids, embodies a product created by human action, that is not sufficient to support its characterisation as a manner of manufacture. The substance of the invention as claimed and the considerations flowing from its substance militate against that characterisation. To include it within the scope of a “manner of manufacture” involves an extension of that concept, which is not appropriate for judicial determination. Further, to include this class of claim within that concept would not contribute to coherence in the law. . . Nor do Australia’s international obligations and the differently framed patent laws of other jurisdictions, which were referred to earlier in these reasons, support the conclusion that this class of claim should fall within the concept.

In reaching its decision, the court reviewed US, UK, Korean, Japanese, and Chinese patent law to consider where beneficial harmonization may occur.

D’Arcy v Myriad Genetics Inc (S28-2015) [2015] HCA 35.

No Motivation to Make a Worse Product – Therefore Patentable?

by Dennis Crouch

Spectrum Pharma and the University of Strathclyde v. Sandoz Inc. (Fed. Cir. 2015)

In this case the Federal Circuit shoots down two fairly silly arguments, but not without first giving them full credence and consideration.  Although the patentee lost here, the Federal Circuit appears to agree with the patentee that its less-pure compound could have been patentable over a purer version identified in the prior art even though the added impurities provided no benefit, functionality, or synergy — PHOSITA simply would not have been motivated to make the less-pure version.

Background: The ANDA lawsuit here centers around Strathclyde’s patent (licensed to Spectrum) covering the the drug Fusilev aka l-leucovorin and Sandoz’s related generic drug application.  The drug leucovorin was found to be effective at treating iron deficiency that can occur with 5-FU cancer treatment. Later, researchers discovered that it was actually one isomer of leucovorin (6S) that was effective and the other isomer (6R) was just along for the ride. The patentee here substantially purified the 6S isomer and attempted to patent it as part of a therapeutic composition.  Claim 1 requires “a mixture of (6S) and (6R) diastereoisomers and consists of at least 92% by weight of the (6S) diastereoisomer, the balance of said compound consisting of the (6R) diastereoisomer.”  It turns out that years earlier a researcher had manufactured a pure form of the 6S isomers and the 50/50 mixture of 6S/6R isomers was known as well. By the time of the invention in question here it was also known that the 6S isomer was the effective one. Later studies proved that the substantially pure form was clinically no better than the 50/50 mixture having the same effective amount of  the 6S isomer.

Obviousness:

A patent claim is invalid as obvious if an alleged infringer proves that the differences between the claims and the prior art are such that “the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art.” 35 U.S.C. § 103(a) (2006) (pre-AIA). Obviousness is ultimately a conclusion of law premised on underlying findings of fact, including the scope and content of the prior art, the differences between the claimed invention and the prior art, and the level of ordinary skill in the pertinent art. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007); Graham v. John Deere Co., 383 U.S. 1 (1966). “The presence or absence of a motivation to combine references in an obviousness determination is a pure question of fact.” Alza Corp. v. Mylan Labs., 464 F.3d 1286 (Fed. Cir. 2006). In addition to common knowledge or teachings in the prior art itself, a “design need or market pressure or other motivation” may provide a suggestion or motivation to combine prior art elements in the manner claimed. Rolls Royce, PLC v. United Techs. Corp., 603 F.3d 1325 (Fed. Cir. 2010);

Here, the patented mixture could be made by simply mixing the known pure 6S isomer with the 50/50 mixture so as to reach the claimed 92% ratio.  The patentee argued that there would have been no motivation to combine these references — going from a pure substance to a less-pure substance. The Federal Circuit sees merit in that argument:

[I]f the pure material is known, no reason has been shown why one would want to have an impure material. Although one may not be motivated to obtain an impure material and, in effect, it therefore can be argued to have been nonobvious—which is Spectrum’s position here, that the 92–95% pure material was nonobvious over the known pure material.

 

 

The Federal Circuit ultimately rejected that argument “despite its superficial appeal” by looking at the patent from the starting point of a 50/50 mixture – and finding that there would have been a motivation to improve its purity.  The court also noted that the new mixture offered no “unexpected advantages over the prior art pure material, the less-than-pure material, and any others of similar concentration.”  In essence, this case is can be seen as very much parallel to KSR – where a combination of two known elements, with each element being used as expected, is unlikely to be patentable absent some unexpected results or synergy.

Objective Post-Invention Evidence Showing Obviousness: Of interest, the Federal Circuit approved of two additional bits of evidence that occurred post-invention that helped prove obviousness. The first was evidence that several other researchers were able to obtain the 92% isomer concentration shortly after the patentee obtained its results — that appears have provided some evidence of obviousness.  Secondly, the court relied upon post-invention studies showing no benefit of the pure drug to negate any synergy  argument.

Infringement by Importation: A second set of claims included a limitation that the composition was provided in “a quantity at least sufficient to provide multiple doses of said mixture of (6S) and (6R) diastereoisomers in an amount of 2000 mg per dose.”  Although Sandoz was planning to sell drug in single-use vials of ~200 mg per dose, the patentee argued that Sandoz did plan to import the drug in larger shipments and, at that importation would be infringing.  The Federal Circuit rejected that argument – finding that the ANDA infringement inquiry under 271(e)(2) “focuses on a comparison of the asserted patent claims against the ANDA product that is likely to be sold following FDA approval.” Thus, the fact that Sandoz plans bulk-imports does not create liability.

On this front, it seems that the Federal Circuit may have left open the possibility that Sandoz imports may still infringe under 271(a) once the generic maker begins imports.

Doctrine of Equivalents: The patentee had argued for infringement under the DOE even though it had narrowed the very amount element during prosecution.  Its argument was that the amendment should not count as narrowing because other claims in the patent were still broader.  That argument fell on deaf ears:

[B]y claim amendments and distinguishing statements on the prior art during prosecution, Spectrum is now estopped from invoking the doctrine of equivalents to prove infringement. When submitting an amendment with the application claims that eventually issued as claims 5–9, the applicants asserted that the newly added claims “include specific limitations as to quantities of materials,” and distinguished the prior art by pointing to the “quantities of these specific mixtures specified in the claims.” Those claims were also added following an office action rejecting the previous original claims as obvious in view of Rees. The applicants again explicitly highlighted the significance of the dosage limitation during an appeal to the Board, their brief stating that the claims “require a minimum of four grams,” the “quantity limitations set forth in the claims” which “define an aspect of the invention that is of great practical significance.” The applicants unequivocally argued that Rees, which allegedly only produced experimental quantities, “do[es] not teach, suggest, or otherwise render obvious the claimed compositions in the quantity specified” in the application claims that became claims 5–9. Those statements are clear and unmistakable expressions of the applicants’ intent to surrender coverage of quantities of the compound in lower doses.

Thus, Sandoz wins here on all fronts.

 

Patent Market Tracker

John Martin and his team at Innography have released their bi-annual update on the patent market. LINK. Their primary finding: Alice v. CLS Bank “hasn’t affected the volume of US patent sales, which continues its roughly 10% per year increase over the last several years.”  The short report hits a number of highlights, including recent deals by Porsche, Google, LinkedIn, and others. Although the report does delve into particularly technological issues, its tracking remains in terms of quantities rather than valuation.

Patent Trolls and Great Inventors

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The announcement to my upcoming Mizzou event with Prof Holte is exciting, but so is our topic.  Discussion will center around Holte’s case-study article: Trolls or Great Inventors: Case Studies of Patent Assertion Entities.

Holte’s abstract:

There has been much debate about the economic harms caused by patent infringement lawsuits filed by patent holders who do not make or sell products covered by their own patents — entities pejoratively referred to as “patent trolls.” This debate has thus far been largely theoretical or based on broad industry-wide data. The purpose of this Article is to present a focused empirical report that has previously been lacking — detailed information regarding the inventors themselves, the patent assertion entities (PAEs) that represent them, and the stories behind their patents. The research for this Article centers on two instructive case studies: (1) MercExchange, L.L.C., the prominent PAE whose seminal patent infringement action against eBay continued to the Supreme Court in eBay Inc. v. MercExchange, L.L.C., 547
U.S. 388 (2006); and (2) Capital Security Systems, Inc., a lesser-known PAE that has sued some of the largest banks in the world on its patented electronic check processing technology. This Article explores the stories behind the inventors, the patented inventions, and the entities asserting the patents in order to develop a more complete contextualized picture of PAEs and their economic impact. Based on this more complete picture, the Article then assesses whether these patent holders warrant the “patent troll” moniker, lurking under the bridge of innovation waiting to harass and extort innovators attempting to pass, or whether they instead resemble the great American vision of a Horatio Alger novel protagonist, laboring to build that bridge of innovation brick-by-brick and eventually reaping a reward for their hard effort. The Article concludes that, while additional studies are needed, the two PAEs studied herein fall squarely into the latter honest laborer category.

 

Shukh v. Seagate: Fired Inventors and their Former Employers

Alexander Shukh v. Seagate (Fed. Cir. 2015)

Mr. Shukh sued his former employer Seagate asking for a correction of inventorship under 35 U.S.C. § 256 as well as breach of contract and discrimination associated with his firing.

Because Shukh had already assigned-away his ownership rights to the patents, the District Court ruled that the Shukh’s standing for the inventorship claim hung on his alleged reputational harm due Seagate’s failure to list him as a co-inventor on six different patents. The district court also dismissed the state law allegations for failure to state a claim. At the close of discovery, the district court then dismissed the case on summary judgment – finding that Shukh had not produced evidence to prove the reputational harm.

On appeal, the Federal Circuit has vacated the lower court’s summary judgment –

Today, we hold that concrete and particularized reputational injury can give rise to Article III standing. As we noted in Chou, “being considered an inventor of important subject matter is a mark of success in one’s field, comparable to being an author of an important scientific paper.” 254 F.3d at 1359. We reasoned that “[p]ecuniary consequences may well flow from being designated as an inventor.” Id. This is particularly true when the claimed inventor is employed or seeks to be employed in the field of his or her claimed invention. For example, if the claimed inventor can show that being named as an inventor on a patent would affect his employment, the alleged reputational injury likely has an economic component sufficient to demonstrate Article III standing.

We find that there is a question of material fact as to whether Dr. Shukh’s omission as a named inventor on the disputed patents caused him reputational injury. Dr. Shukh presented evidence such that a trier of fact could conclude that this omission injured his reputation in at least two ways: first, it harmed his reputation as an inventor in the field of semiconductor physics, and second, it contributed to his reputation for poor teamwork due in part to his accusations that others were stealing his work. Moreover, Dr. Shukh presented evidence from which a trier of fact could conclude that these reputational harms had economic consequences—namely, that Dr. Shukh was unable to find employment after he was terminated from Seagate.

This case highlights a troubling issue for inventors. The difficulty for inventors is that an inventor does not automatically have standing to sue for being improperly excluded from being listed as an inventor. Rather, the inventor must be able to allege additional cognizable harm before the court will hear the case.

Hereby Assign: Shukh’s employment contract with Seagate included a statement that he “hereby assign[s]” his future invention rights to Seagate. Although these contracts are generally interpreted by state-law, the Federal Circuit issued a 1991 patent-specific ruling that this clause results in an automatic assignment of rights. Filmtec Corp. v. Allied-Signal, Inc., 939 F.2d 1568 (Fed. Cir. 1991). The Filmtec outcome should be contrasted with agreements where employees “agree to assign.” In the agreement-to-assign case, legal title does not shift until the inventor actually does assign after inventing. In his appeal, Shukh asked the Federal Circuit to overrule Filmtec – which it refused to do here on stare decisis grounds. “[W]e cannot overrule that holding without en banc action.”

The suggestion for en banc action has some strong backers. In his dissenting opinion in Stanford v. Roche, Justice Breyer challenged the Federal Circuit rule. Relying upon history and tradition, Justice Breyer wrote that the initial “hereby-assign” employment contract as creating equitable title in the invention whose legal title does not automatically transfer.

Given what seem only slight linguistic differences in the contractual language, this reasoning seems to make too much of too little. Dr. Holodniy executed his agreement with Stanford in 1988. At that time, patent law appears to have long specified that a present assignment of future inventions (as in both contracts here) conveyed equitable, but not legal, title. See, e.g., G. Curtis, A Treatise on the Law of Patents for Useful Inventions §170, p. 155 (3d ed. 1867) (“A contract to convey a future invention . . . cannot alone authorize a patent to be taken by the party in whose favor such a contract was intended to operate”); Comment, Contract Rights as Commercial Security: Present and Future Intangibles, 67 Yale L. J. 847, 854, n. 27 (1958) (“The rule generally applicable grants equitable enforcement to an assignment of an expectancy but demands a further act, either reduction to possession or further assignment of the right when it comes into existence”).

Under this rule, both the initial Stanford and later Cetus agreements could have given rise only to equitable interests in Dr. Holodniy’s invention. And as between these two claims in equity, the facts that Stanford’s contract came first and that Stanford subsequently obtained a postinvention assignment as well should have meant that Stanford, not Cetus, would receive the rights its contract conveyed.

In 1991, however, the Federal Circuit, in FilmTec, adopted the new rule quoted above—a rule that distinguishes between these equitable claims and, in effect, says that Cetus must win. The Federal Circuit provided no explanation for what seems a significant change in the law. Nor did it give any explanation for that change in its opinion in this case. The Federal Circuit’s FilmTec rule undercuts the objectives of the Bayh-Dole Act. While the cognoscenti may be able to meet the FilmTec rule in future contracts simply by copying the precise words blessed by the Federal Circuit, the rule nonetheless remains a technical drafting trap for the unwary. It is unclear to me why, where the Bayh-Dole Act is at issue, we should prefer the Federal Circuit’s FilmTec rule to the rule, of apparently much longer vintage, that would treat both agreements in this case as creating merely equitable rights.

The majority in Stanford v. Roche did not particularly address the issue.

Non-Transitory Patent Claims

by Dennis Crouch

I was surprised when I ran these numbers and found that 4% of recently issued patents include a non-transitory claim limitation. (95% of these are in what I term computer-related arts).  For the most part, these are software patent claims.  However, because “software” per se is usually not considered patent eligible, patent attorneys moved toward claiming a computer-readable-medium having the software instructions stored therein.  More recently, the PTO concluded that those claims – when broadly interpreted – would encompass transitory signals which are not patent eligible under Section 101.  The PTO suggested that applicants amend their claims “by adding the limitation ‘non-transitory’ to the claims.”

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Open question – how many of these cases have written description support for the new non-transitory limitation?