Tag Archives: Supreme Court

Supreme Court Grants Cert in Already v. Nike

By Jason Rantanen

This morning the Supreme Court granted certiorari in Already, LLC dba Yums v. Nike, Inc., No. 11-982, an appeal carrying the potential for profound implications for patent law.  The question presented asks:

Whether a federal district court is divested of Article III jurisdiction over a party’s challenge to the validity of a federally registered trademark if the registrant promises not to assert its mark against the party’s then-existing commercial activities.

The Petition focused on a split between the Second and Ninth Circuit, but similar disagreements have simmered in the Federal Circuit.  Under controlling Federal Circuit precedent, it has long been the law that a patent holder can divest a federal court of Article III jurisdiction over the defendant's counterclaim for a declaratory judgment of patent invalidity by promising not to sue.  See Super Sack Mfg. Corp. v. Chase Packaging Corp., 57 F.3d 1054, 1059-60 (Fed. Cir. 1995).  A subsequent dissent by Judge Dyk, however, urged the abandonment of the Super Sack rule.  See Benitec Australia, Ltd. v. Nucleonics, Inc., 497 F.3d 1340, 1350-55 (Fed. Cir. 2007) (Dyk, J., dissenting). 

Should the Court agree with Petitioners, it thus would very likely spell the end of the so-called Super Sack covenant, making it harder for patent holders to withdraw their patents once placed into litigation. 

Notes:

Racing Procedures: Federal Circuit Refuses to Stay Reexam Appeal to Wait for Parallel District Court Appeal

by Dennis Crouch

Bunzl Processor Distribution v. Kappos (Fed. Cir. 2012) (nonprecedential order)

Bunzl and Bettcher are in a longstanding battle over the exclusive rights to make and sell a rotary knife blade used in meat processing. The patents include Bettcher’s Patent Nos. 7,000,325 and 8,074,363 and the pending lawsuits include three district court cases and an inter partes reexamination.

The ‘325 infringement lawsuit and the parallel inter partes reexamination were filed in 2008.  Bunzl recently filed a declaratory judgment action on the newly issued ‘363 patent.

Bettcher is winning the reexamination.  The USPTO Board of Appeals recently reaffirmed the examiner’s decision to confirm the patentability of the pending claims. Bunzl initially won the infringement lawsuit, but after being partially reversed on appeal, that case appears to be headed for a new trial in the near future. 

In light of the pending infringement trial, Bunzl asked the Federal Circuit to stay the reexamination appeal proceedings so that the whole case could be appealed at once.  In a short non-precedential opinion, Judge Newman has rejected that plea. She writes:

The power of the Court to stay proceedings is incidental to its inherent power to control the disposition of the cases on its docket. See Landis v. North Am. Co., 299 U.S. 248, 254 (1936). Here, we cannot say Bunzl has shown that staying proceedings for such a lengthy period of time is warranted.

Thus, the cases will continue in parallel. The appellate briefs will likely be due before the trial and jury verdict.  The appellate decision will then likely issue around the same time as the judge’s post-verdict order on the inevitable motions. There is a likelihood that the results from the two bodies will be inconsistent.  However, our system has a fairly consistent approach to determining the hierarchy of decision in patent cases.  

Parallel patent proceedings within the US have created a whole new set of litigation strategies and difficulties.  Of course, those strategies will change once again in the coming years as we implement the new post grant review proceedings of the AIA.

Note: In this order, Judge Newman was the sole decision maker acting in her role as motions judge for the month.

Patentable Subject Matter: Supreme Court Challenges Chief Judge Rader’s Broad Notion of Software Patentability

by Dennis Crouch

WIldTangent v. Ultramercial (Supreme Court 2012) Docket No 11-962

The Supreme Court has rejected another Federal Circuit patentable subject matter decision with a GVR and has ordered the appellate court to review its patentability decision with further consideration of Mayo Collaborative Services v.Prometheus Laboratories, Inc., 566 U.S. ___ (2012). In its standard GVR language, the Supreme Court wrote:

The petition for a writ of certiorari is granted [G]. The judgment is vacated [V], and the case is remanded [R] to the United States Court of Appeals for the Federal Circuit for further consideration in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___ (2012).

The patent at issue in this case claims a particular method for distributing copyrighted products over the Internet. Patent No. 7,346,545. The basic gist of the invention is that the consumer receives a copyrighted product in exchange for viewing an advertisement — and it all takes place over the internet and with a particular monetization scheme.

In its broadly written opinion, the Federal Circuit (Rader, C.J.) found the claimed invention patentable under Section 101 based upon the requirement that a computer be used to perform the method and the programming complexity required to carry out the claimed elements. The court wrote that while “the mere idea that advertising can be used as a form of currency is abstract, just as the vague, unapplied concept of hedging proved patent-ineligible in Bilski,…the ‘545 patent does not simply claim the age-old idea that advertising can serve as a currency. Instead, the ‘545 patent discloses a practical application of this idea.”

Following the Federal Circuit decision in Ultramercial, the Supreme Court decided Mayo v. Prometheus. In that case, the Supreme Court rejected the Prometheus patent as effectively encompassing an unpatentable law of nature. That revives the historic notion that the scope of knowledge held in the prior art is an important aspect of the Section 101 analysis.

The Supreme Court issued a parallel GVR in the gene-patent case of Myriad Genetics. Other pending 101 appeals include Fort Properties v. American Master Lease (en banc petition); Accenture Global v. Guidewire; Bancorp Services v. Sun Life; and others.

Claim one the ‘545 patent reads as follows:

1. A method for distribution of products over the Internet via a facilitator, said method comprising the steps of:

a first step of receiving, from a content provider, media products that are covered by intellectual-property rights protection and are available for purchase, wherein each said media product being comprised of at least one of text data, music data, and video data;

a second step of selecting a sponsor message to be associated with the media product, said sponsor message being selected from a plurality of sponsor messages, said second step including accessing an activity log to verify that the total number of times which the sponsor message has been previously presented is less than the number of transaction cycles contracted by the sponsor of the sponsor message;

a third step of providing the media product for sale at an Internet website;

a fourth step of restricting general public access to said media product;

a fifth step of offering to a consumer access to the media product without charge to the consumer on the precondition that the consumer views the sponsor message;

a sixth step of receiving from the consumer a request to view the sponsor message, wherein the consumer submits said request in response to being offered access to the media product;

a seventh step of, in response to receiving the request from the consumer, facilitating the display of a sponsor message to the consumer;

an eighth step of, if the sponsor message is not an interactive message, allowing said consumer access to said media product after said step of facilitating the display of said sponsor message;

a ninth step of, if the sponsor message is an interactive message, presenting at least one query to the consumer and allowing said consumer access to said media product after receiving a response to said at least one query;

a tenth step of recording the transaction event to the activity log, said tenth step including updating the total number of times the sponsor message has been presented; and

an eleventh step of receiving payment from the sponsor of the sponsor message displayed.

Federal Jurisdiction over Patent Malpractice Cases – Supreme Court Shows Interest in Gunn v. Minton

By Dennis Crouch

Gunn v. Minton, (on petition for Writ of Certiorari at the U.S. Supreme Court)

Vernon Minton developed a set of software that he leased to the Texas Int'l Stock Exchange (TISE) more than one year before filing a provisional patent application on the invention embodied by the product. The USPTO granted Minton U.S. Patent No. 6,014,643. However, in a later lawsuit against NASDAQ, the patent was invalidated via the on-sale bar of 35 U.S.C. § 102(b) and that invalidity finding was upheld on appeal. Minton v. Nat'l Ass'n of Sec. Dealers, Inc., 336 F.3d 1373 (Fed. Cir. 2003). In that decision, the Federal Circuit confirmed that the lease constituted a sale for 102(b). In a post-judgment motion, Minton asked the district court to consider whether the use by TISE was an experimental use. However, the court refused to consider that issue because of its untimely introduction.

The present lawsuit arose when Minton then sued his patent litigation counsel (who have now joined the Fulbright & Jaworski firm). The crux of the malpractice claim is that the litigation counsel failed to timely plead the experimental use question. Minton sued in Texas state court and lost on a pretrial motion based upon the trial court's judgment that Minton had failed to present "a scintilla of proof . . . to support his claims." That no-damages judgment was affirmed by the Texas court of appeals. However, the Supreme Court of Texas took an orthogonal view and held that Texas courts lacked subject matter jurisdiction over case. In particular, the Texas Supreme Court held that Minton's malpractice claim required resolution of a substantial question of patent law and therefore fell within the exclusive "arising under" jurisdiction of the federal courts and, eventually, the Court of Appeals for the Federal Circuit. This ruling gives Minton another shot at winning the case – this time in federal district court.

The 5-3 Texas Supreme Court decision followed the lead set by the Federal Circuit in Air Measurement Tech., Inc. v. Akin Gump Strauss Hauer & Feld, L.L.P., 504 F.3d 1262 (Fed. Cir. 2007) and Immunocept, L.L.C. v. Fulbright & Jaworski, L.L.P., 504 F.3d 1281 (Fed. Cir. 2007). In those cases the Federal Circuit gave a broad interpretation to arising under jurisdiction based upon the court's congressionally mandated goal of national uniformity in the patent system. Both the Akin Gump and the Fulbright Jaworski cases were decided on the same day by the same panel and both penned by then Chief Judge Paul Michel. (Judges Lourie and Rader joined the panels). Although the Texas court did not treat the Federal Circuit decisions as binding precedent, the court chose to adopt the logic of those decisions. The dissent argued that the State of Texas has a strong interest in (and a regulatory scheme in place for) ensuring that Texas attorneys maintain a high level of quality and that federalism concerns suggest that many of these cases should be adjudged at the state court level. In a non-patent case, the Supreme Court approved of this more nuanced analysis of arising under jurisdiction in the case of Grable & Sons Metal Products, Inc. v. Darue Eng'g & Mfg., 545 U.S. 308 (2005).

The lawyer defendants have now appealed to the U.S. Supreme Court – asking that court to provide its verdict on the breadth of arising under jurisdiction for non-patent cases that require interpretation of a patent law issue. Gunn presents the following question:

Did the Federal Circuit depart from the standard this Court articulated in Grable & Sons Metal Products, Inc. v. Darue Eng'g & Mfg., 545 U.S. 308 (2005), for "arising under" jurisdiction of the federal courts under 28 U.S.C. § 1338, when it held that state law legal malpractice claims against trial lawyers for their handling of underlying patent matters come within the exclusive jurisdiction of the federal courts? Because the Federal Circuit has exclusive jurisdiction over appeals involving patents, are state courts and federal courts strictly following the Federal Circuit's mistaken standard, thereby magnifying its jurisdictional error and sweeping broad swaths of state law claims – which involve no actual patents and have no impact on actual patent rights – into the federal courts?

This may be surprising to some, but in most cases the respondent does not actually file any response to a Supreme Court petition for writ of certiorari. The Supreme Court tends to only hear important cases that are well represented on both sides. The lack of response is intended to suggest that the case should not rise to that threshold level of importance. Here, Minton declined to respond to the petition. However, in a recent order, the Supreme Court has asked for Minton's response. This judicial action suggests interest in the case, and that interest may be prompted that may be further spurred by the recent spate of decisions showing some disagreement within the Federal Circuit on the very issue. In a supplemental filing in support of its petition, Gunn argued that "[t]he Federal Circuit, which created the jurisdictional morass at issue in this case, is thus split within itself regarding whether to abandon the misguided and overly-broad jurisdictional standard it articulated in Air Measurement Tech., Inc. v. Akin Gump Strauss Hauer & Feld, L.L.P., 504 F.3d 1262 (Fed. Cir. 2007) and Immunocept, L.L.C. v. Fulbright & Jaworski, L.L.P., 504 F.3d 1281 (Fed. Cir. 2007)."

If the Supreme Court takes the case, argument will likely be scheduled for late 2012.

Federalism and Patent Law: Courts Split on Scope of Federal Circuit Arising Under Jurisdiction

In a trio of decisions, the several members of the Federal Circuit have expressed their disagreement with the court’s expansion of appellate jurisdiction to cover attorney malpractice cases that involve patent law issues.

  • Landmark Screens, LLC v. Morgan Lewis & Bockius, LLP (Fed. Cir. 2012)(O’Malley, J., concurring);
  • Byrne v. Wood, Herron & Evans, LLP (Fed. Cir. 2012)(O’Malley, J., joined by Wallach, J., dissenting from denial of the petition for en banc rehearing); and
  • USPPS, Ltd. v. Avery Dennison Corp. (Fed. Cir. 2012)(O’Malley, J., joined by Mayer, J., concurring).

Attorney malpractice is a state law claim, but the Federal Circuit has (and thus the Federal Courts have) claimed exclusive jurisdiction over many patent prosecution related malpractice claims if the well-pled complaint requires the determination of a substantial issue of patent law.

In Minton v. Gunn, 355 S.W.3d 634 (Tex.2011), the Texas Supreme Court agreed with the Federal Circuit’s extension of jurisdiction, but made an interesting and important statement that Texas courts “are not bound by the holdings of the Federal Circuit.” This situation sets up the need for Supreme Court review. Minton was a 5-3 decision. The dissenting justices argued that state courts should maintain jurisdiction over the case based on its application of the 2005 US Supreme Court case of Grable & Sons Metal Prods., Inc. v. Darue Eng’g & Mfg., 545 U.S. 308 (2005). In that case, the US Supreme Court held that federalism principles require a cautious and balanced approach to the removal of traditional state court claims to federal court.

The dissent in Minton wrote:

The Federal Circuit’s focus on this mandate [of uniformity] is understandable, but uniformity in patent law is not the be-all and end-all of jurisprudence. It must give way to the contours of federal question jurisdiction provided by the Supreme Court. See Grable. In turn, this Court has its own mandate, of at least equal importance to that of the Federal Circuit. We owe a duty to the people of this state to exercise the judicial power, see Tex. Const. art. V, §§ 1, 3, and that duty includes vital matters such as ensuring consistency and certainty in the civil law of the state, see Tex. Gov’t Code § 22.001, and regulating the practice of law, id. § 81.011(c). Accordingly, we should not risk the confusion and inconsistency that will result from having two sets of binding precedent in Texas legal malpractice law—one stemming from this Court and the other courts of this state, and another, entirely outside of our control after today’s opinion, developing under the direction of the Federal Circuit, largely uninformed by the deep roots of Texas jurisprudence and the requirements of the Texas Constitution.

This Court should not be quick to follow Federal Circuit case law that fails to follow the test set forth by the Supreme Court. Because this case fails to meet three of the four elements required by the Supreme Court for federal-element “arising under” jurisdiction, the court of appeals was correct when it held that exclusive federal patent jurisdiction does not lie here. I therefore respectfully dissent.

In a parallel 2011 case, an Illinois state appellate court held that Magnetek’s claim against Kirkland & Ellis for deficient representation in a patent litigation lawsuit did not arise under patent law. In that case, the court wrote that the largest patent law issue – whether the patent was enforceable or not – had already been decided by a separate court and therefore was not at issue in the case. Magnetek, Inc. v. Kirkland and Ellis, LLP, 954 N.E.2d 803 (Ill.App. 2011).

A petition to the Supreme Court is likely in at least one of these cases.

Supreme Court: District Courts must Review PTO Factual Findings De Novo in Cases Challenging Board Decisions

By Dennis Crouch

Kappos v. Hyatt (Supreme Court 2012)

This case involves a patentee’s right to a file a civil action in district court challenging the USPTO’s refusal to grant a patent. 35 U.S.C. § 145. In a unanimous decision, the Supreme Court has affirmed the Federal Circuit ruling that the patent applicant’s presentation of new evidence to the district court requires that court to make de novo factual findings that consider both the new evidence and the administrative record. The USPTO had asked that the court to apply a higher standard of deference to agency factual findings.

This ruling has two major caveats:

  • Deference will be given to PTO factual findings if the applicant fails to present any new contradictory evidence at the trial.
  • Although it must undertake a de novo review, a court can give less weight to newly presented evidence based upon its consideration of “the proceedings before and findings of the Patent Office.”

In its brief, the USPTO argued that the standard employed here would “encourage patent applicants to withhold evidence from the PTO intentionally with the goal of presenting that evidence for the first time to a nonexpert judge.” The Supreme Court rightfully rejected that scenario as “unlikely” in most cases. There are two reasons for this: (1) as the Court notes, this strategy would serve to undermine their chances of directly obtaining a patent from the USPTO based upon the speculative strategy of having a court find the invention patentable; and (2) in my estimation, some amount of new evidence (such as expert testimony and test results) can always be obtained after trial. This is especially true because of the limited manner in which testimony can be presented to an examiner or in an ex parte appeal to the Board.

In this particular case, however, Hyatt has some reason to sandbag because his application was filed pre-1995 and covers basic building blocks of the modern computer. The delay in issuance likely means additional revenue sources that may persist for 17 years from the issue date.

This result here is appropriate in our current world where ex parte appeals to the PTO Board have become a standard and regular aspect of patent prosecution. Those appeals have become somewhat commodified and many firms offer a fixed price. This makes business sense under Hyatt because the applicant still has a chance to fully press its case and present additional evidence after losing at the Board.

Justice Thomas penned the majority opinion.

In a concurring opinion, Justice Sotomayor (joined by Justice Breyer) offered some thought as to particular times when a district court may offer less weight to evidence presented only at trial. Justice Sotomayor primarily discussed the 1927 deliberate suppression case of Barrett Co. v. Koppers Co., 22 F. 2d 395, 396 (3rd Cir. 1927). In that case, the patent applicant refused to allow their witnesses to answer questions from the chief examiners. The appellate court in that case ruled that the applicant was estopped from later introducing evidence that it had purposely withheld. Learned Hand wrote in a later case that estoppel should not apply when the suppression was merely negligent. Relying on these cases, Justice Sotomayor wrote her suggestion that

when a patent applicant fails to present evidence to the PTO due to ordinary negligence, a lack of foresight, or simple attorney error, the applicant should not be estopped from presenting the evidence for the first time in a §145 proceedings.

Although not expressly stated, I suspect that the purpose of “keeping costs low” would fall within Justice Sotomayor’s category of permissible suppression. Of course, these suggestions from Sotomayor are not part of the majority opinion, which did not cite Barrett or the Learned Hand decision of Dowling v. Jones, 67 F. 2d 537 (2nd Cir. 1933).

In application of this rule to the facts here, Justice Sotomayor began with the presumption that new evidence should be allowed and found that the USPTO had not (yet) met its burden to show wrongful suppression.

Supreme Court: Generic Pharma Manufacturer Has Standing to Pursue FDA Mis-Label Claim against Patentee

By Dennis Crouch

Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, (Supreme Court 2012)

This decision only slightly shifts balance of power in the pharmaceutical industry away from patentees toward generic manufacturers. The case may serve as a good example a complex issue that the Supreme Court appears to understand and deal with in a nuanced fashion.

The FDA maintains a listing of approved drug treatments and any patents that cover the treatment. The listing – known as the Orange Book – is essentially managed by the individual patentee-manufacturers who regularly provide the FDA with updated information of new listings and de-listings. Patentees receive a number of benefits from listing patents in the Orange Book, including constructive standing to sue based upon a generic company's filing of an abbreviated new drug agreement (ANDA) as well as an up-to-30-month stay of FDA approval of any generic versions.

Although the diabetes drug repaglinide has three FDA approved uses, Novo's listed patent covers only one of those methods of use. Relying upon that limitation of coverage, Caraco filed an ANDA application requesting permission to sell the drug for the other two uses but carving out the patented use from its application. Novo then changed its Orange Book listing to indicate that its patent actually covered all three approved uses.

In the ensuing litigation, Caraco filed a counterclaim seeking an order to force Novo to amend its use-code listings. The Federal Circuit, however refused to allow the counterclaim.

In a unanimous decision penned by Justice Kagen, the Supreme Court has reversed, holding that a generic drug manufacturer may employ the counterclaim provision of the Hatch-Waxman Act to force correction of a use code that inaccurately describes the brand's patent as covering a particular method of using a drug.

The Federal Circuit had given the statute a highly technical reading – noting that such a counterclaim for correction was only available if "the patent does not claim … an approved method of using the drug." 21 U. S. C. §355(j)(5)(C)(ii)(I). Since the patent did cover one approved method, the appellate panel majority reasoned that there was no standing to correct the two incorrect listings.

The Supreme Court rejected that analysis as counter to the context surrounding the provision in the law.

The statutory counterclaim we have considered enables courts to resolve patent disputes so that the FDA canfulfill its statutory duty to approve generic drugs that do not infringe patent rights. The text and context of the provision demonstrate that a generic company can employthe counterclaim to challenge a brand's overbroad use code. We accordingly hold that Caraco may bring a counterclaim seeking to "correct" Novo's use code "on the ground that" the '358 patent "does not claim . . . an approved method of using the drug"—indeed, does not claim two.

Reversed.

Justice Sotomayor penned a short concurring opinion calling for further reform to the statute and within the FDA to better ensure that generic drugs can become quickly available for uses that are not covered by any valid patent. The concurring opinion calls the agency to task for failing to exercise its authority in regulating listings in the Orange Book.

Supreme Court to Hear International Copyright Exhaustion Case

By Dennis Crouch

Kirtsaeng v. John Wiley & Sons, Inc. (Supreme Court 2012)

The Supreme Court has granted certiorari in another international copyright exhaustion case. Previously, in Omega v. Costco, the court stalled in a 4-4 tie and left the case without an opinion. Copyright exhaustion – also known as the “first sale doctrine” – is codified under 17 U.S.C. § 109(a) and allows the holder of a copy of a work “lawfully made under this title” to sell or otherwise dispose of the copy without the copyright holder’s permission. Without this doctrine, such a sale could be considered a violation of the copyright holder’s exclusive distribution rights under section 106(3). The question in this case is whether the exhaustion doctrine applies to authorized copies manufactured outside of the US and then imported. Copyright holders argue that exhaustion does not apply because the foreign copies were not “lawfully made under this title,” but instead were lawfully made in a region not subject to US copyright law. A win for the copyright holders would support a system of price discrimination that would allow a rights-holder to block third-party imports of legitimate (non-counterfeit) products into the US. The rule would also tend to encourage foreign manufacture.

The question presented:

How do Section 602(a)(1) of the Copyright Act, which prohibits the importation of a work without the authority of the copyright’s owner, and Section 109(a) of the Copyright Act, which allows the owner of a copy “lawfully made under this title” to sell or otherwise dispose of the copy without the copyright owner’s permission, apply to a copy that was made and legally acquired abroad and then imported into the United States?

The case is expected to be argued this fall.

Exclusive Rights of Importation: The particular facts of the case are interesting. John Wiley sells textbooks at a reduced rate in Thailand. Kirtsaeng imported eight Wiley books and resold them in the US. Although Wiley had profited from the original sale in Thailand, the company argued that the importation also violated US law because the foreign sale did not exhaust the copyright and that, therefore, Wiley maintained exclusive rights of importation and distribution. A jury awarded Wiley statutory damages of $75,000 per copy for a total of $600,000 for the eight books. The Second Circuit affirmed that judgment.

Patent Law: Patent law’s exhaustion doctrine is not based upon a statute but does run roughly parallel to the copyright law as outlined above. In the Jazz Photo cases, the Federal Circuit ruled that international sale does not exhaust US patent rights. If the Supreme Court reverses in Kirtsaeng, this will likely be seen as an implicit reversal of Jazz Photo and its progeny. Thus, the case will obviously impact patent law. The AIPLA filed a brief in support of the petition – focusing on the need for resolving the circuit split.

John Wiley’s cases are still pending against various patent law firms for failing to obtain a license to make copies of prior art documents before making copies and submitting those to the USPTO as required by law. The defendant law firms are expected to file their answers later this month.

Supreme Court Looks to Take Trademark Standing Case Following Covenant-not-to-Sue

by Dennis Crouch

Already (YUMS) v. Nike (SCT 2012)

Nike sued YUMS back in 2009 alleging trademark infringement, unfair competition, and dilution under both federal and NY state law.  The complaint included the image below comparing YUMS brand shoes with Nike’s federal trademark registration number 3,451,905.  The design is related to Nike’s Air Force 1 shoe that was first released in 1982. The Yums intentionally retro look is apparently fashionable for skaters and freestyle BMX riders. [Buy the shoes here] (The image does not show the shoes’ creative soles.)

PatentlyO136

After being sued, YUMS counterclaimed — seeking to cancel the registration.  However, before the court could reach a decision on the merits, Nike’s attorneys at Banner & Witcoff provided YUMS with a covenant-not-to-sue on the AF1 design rights. In the document, Nike wrote that YUMS brand “no longer infringe or dilute the Nike Mark at a level sufficient to warrant the substantial time and expense of continued litigation."

The covenant was limited to YUMS current shoes as well as ‘colorable imitations’ of current lines. In particular, Nike promised to:

refrain from making any claim(s) or demand(s), or from commencing, causing, or permitting to be prosecuted any action in law or equity, against [Yums] or any of its [successors or customers], on account of any possible cause of action based on or involving trademark infringement, unfair competition, or dilution, under state or federal law in the United States relating to the [Nike eAir Force 1 Mark] based on the appearance of any of [Yums]’s current and/or previous footwear product designs, and any colorable imitations thereof, regardless of whether that footwear is produced, distributed, offered for sale, advertised, sold, or otherwise used in commerce before or after the Effective Date of this Covenant.

YUMS was apparently happy with the document, but not fully satiated.  Rather, YUMS maintained its declaratory judgment lawsuit — arguing that the Nike Mark continued to improperly chill its innovative marketing efforts.  However, the district court dismissed the case — finding that it lacked subject matter jurisdiction because there was no ongoing case or controversy.  Important for its ruling, YUMS had not taken any “meaninful steps” toward developing a new potentially infringing product not covered by the covenant-not-to-sue.

On appeal, the Second Circuit affirmed, holding specifically that the cancelation power under 15 U.S.C. § 1119 does not provide federal courts with an independent basis for jurisdiction absent an actual case-or-controversy between the parties.

Supreme Court: Now, YUMS has appealed to the US Supreme Court — relying upon the expertise of Jim Dabney and Prof John Duffy (of KSR fame) to bring their case. They raise the simple question: “Whether a federal district court is divested of Article III jurisdiction over a party's challenge to the validity of a federally registered trademark if the registrant promises not to assert its mark against the party's then-existing commercial activities.”  The complaint raises a circuit split between the Second Circuit here and the Ninth Circuit, which is much more friendly to DJ trademark actions in this type of situation. In addition, the petition highlights Supreme Court precedent that suggest broad jurisdiction should be available to challenge the validity of suspect intellectual property rights. See Lear, Inc. v. Adkins, 395 U.S. 653 (1969), MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), Cardinal Chem. Co. v. Morton Int'l, Inc., 508 U.S. 83 (1993), and Scott Paper Co. v. Marcalus Mfg. Co., 326 U.S. 249 (1945).

The Supreme Court has now asked Nike to respond to the petition – due May 4.  This move greatly increases the odds that the petition will eventually be granted.

Of interest, a key element of the Myriad gene patent case is whether the ACLU and AMP have standing to sue.  This case may shed further light on that outcome.

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

By Dennis Crouch

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

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

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

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

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

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

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

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

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

Supreme Court: Solving Claim Construction?

032312_0335_ClaimConstr1
by Dennis Crouch

Retractable Techs., Inc. v. Becton, Dickinson & Co. (on petition for certiorari 2012)

As its company name suggests, Retractable Technologies makes safety syringes that retract after completing a drug injection. Retractable sued BD for patent infringement and won $5 million in damages and permanent injunctive relief. This was the second time that Retractable had filed a lawsuit to enforce its patent. In both cases, the district court interpreted the claim term syringe "body" as encompassing a body "composed of one or multiple pieces." (In the first case, the accused infringer agreed to stop making its product and to pay a $1 million settlement).

On appeal here, BD was able to convince a two-member majority of its Federal Circuit panel to modify the claim construction in a way that limits the "body" element to a "one-piece body." (Majority opinion by Judges Lourie and Plager). The appellate panel narrowly construed the term based upon its reading of the patent specification and the notion that the claims should be limited to what "the inventor actually invented." In dissent, Chief Judge Rader argued that the majority had improperly confined claim scope to the specific embodiments of the invention." Chief Judge Rader also argued in favor of giving more weight to the doctrine of claim differentiation. Here, some of the non-asserted claims in the patent included an explicit "one-piece body" limitation – suggesting that the asserted claim without the "one-piece" limitation must be broader.

After losing the appeal, Retractable filed a petition for rehearing and rehearing en banc. The petition was denied, but Judges Moore and O'Malley each filed dissents.

Supreme Court Petition: Retractable has now filed a petition for writ of certiorari to the United States Supreme Court. The petition raises two questions:

1. Whether a court may depart from the plain and ordinary meaning of a term in a patent claim based on language in the patent specification, where the patentee has neither expressly disavowed the plain meaning of the claim term nor expressly defined the term in a way that differs from its plain meaning.

2. Whether claim construction, including underlying factual issues that are integral to claim construction, is a purely legal question subject to de novo review on appeal.

First Question Goes Nowhere: In my view, the first question presented is not well stated. Of course a court can use context to provide meaning to claim language. A formalistic and restrictive view of patent doctrine was rejected by the Supreme Court in virtually every recent decision, including Mayo, Bilski, KSR, eBay, and MedImmune. Further, many members of the Supreme Court have identified a problem with vague and over-broad claim limitations, and the majority opinion here provides a simple tool for limiting scope: interpret the claims within the context of what was demonstrably understood by the inventor and the examiner and by what would have been known by a reasonably skilled artisan.

Use Specification to Narrow (or Broaden): There are times when the context of the specification is used to broaden the scope of a claim term beyond its ordinary meaning. However, the Federal Circuit judges appear to believe that greater reliance on the specification will usually result in a narrowing of claim scope. Thus, the debate on the role of the specification in claim construction is at least partially a proxy for the debate on whether patents should be given a broad scope or narrow scope. I would again criticize the petition – this time for wholly agreeing that reliance on the specification results in a narrowed scope. Retractable frames the debate on trying to understand "the circumstances in which the language of the specification should narrow the plain meaning of a claim term."

The Second Question is more well framed, although I would have tweaked it slightly to ask: "Whether claim construction, including underlying factual issues that are integral to claim construction, is a purely legal question [that is therefore] subject to de novo review on appeal." The tweak here is important because Retractable is not challenging the Supreme Court's Markman decision but rather challenging the Federal Circuit's Cybor decision. In Markman, the Supreme Court recognized the reality that claim construction includes a number of factual determinations – calling the process a "mongrel" of fact and law. However, the court ruled that claim construction should be treated as an issue of law to be decided by a judge. In Cybor, the Federal Circuit applied its usual formalistic if-then approach to rule that appellate review must be de novo because claim construction is an issue of law. From the petition:

In Markman, this Court held that, for purposes of the Seventh Amendment, the task of construing patent claims falls to trial judges rather than juries. Markman did not decide the standard of review that an appellate court should apply to a district court's claim construction. The Court noted, however, that the process of construing a claim is a "mongrel practice," that "falls somewhere between a pristine legal standard and a simple historical fact." In holding that trial judges are "better suited" for this task than juries, the Court recognized that claim construction requires trial judges to exercise a "trained ability to evaluate the testimony in relation to the overall structure of the patent." Accordingly, the Court held that "there is sufficient reason to treat construction of terms of art like many other responsibilities that we cede to a judge in the normal course of trial, notwithstanding its evidentiary underpinnings." Thus, Markman recognized that claim construction involves underlying factual questions, and said nothing to indicate that the Federal Circuit should displace the district court's resolution of those questions.

There are lots of doctrines that receive de novo review that do not have a reversal rate anywhere near that of claim construction. I think that everyone agrees that claim construction is inherently difficult. Claim construction rulings do not provide a yes-no answer like you might find in an obviousness judgment. Rather, a judge is required to identify the best interpretation of all possible interpretations of each contested claim term. And, unlike statutory interpretation, we do not have the benefit of the scope being developed over time through a series of cases. Rather, in most instances, a court's construction is in the first instance. In addition to the inherent difficulty, claim construction is made more difficult because of the open panel dependence of claim construction decisions. For many years the Federal Circuit refused to admit any panel dependence in its decision making, that has changed.

Where to Focus Assurances?: District court judges complain about claim construction because of the high likelihood that their decisions will be reversed on appeal. Giving deference to district court judgments would likely mean fewer reversals. This approach gives us certainty earlier in the process, but only once the district court issues a final claim construction. That date still seems very late. The scope of patent claims is of critical importance to almost all patent monetization transactions. However, very few of those transactions take place in conjunction with a district court claim construction decision. We need a process for substantially understanding claim scope at a much earlier stage and without relying on a federal court.

One answer for an early understanding of claim scope: Define terms during prosecution. If applicants fail to define terms, examiners should provide their own definitions as part of the office action. In the short-term, the focus should be on terms that are (1) frequently debated in court (such as "server" or "coupled to"; (2) used in the specification in a way that is in tension with the ordinary meaning of a term; or (3) inherently imprecise (such as "about").

Notes

Punishing Prometheus: The Supreme Court’s Blunders in Mayo v. Prometheus

Guest Post by Robert R. Sachs of Fenwick & West LLP

“Not even wrong.” So said Wolfgang Pauli about a proposed analysis by a young physicist, meaning that the arguments were not subject to falsification, the basic tool of scientific analysis. So too it can be said about the Supreme Court’s decision in Mayo v. Prometheus. The Court’s analysis creates a framework for patent eligibility in which almost any method claim can be invalidated. Like so many pseudo-sciences in which every phenomenon can be rationalized and in which there is no test that can show the theory to be incorrect, under Prometheus seemingly anything can be “explained” as being unpatentable subject matter.

Let me say at the outset that I’ve been a student of patent law, and patent eligibility in particular, since 1993. My clients have frequently been those whose inventions bumped up against the boundaries of patentable subject matter—in software, e-commerce, finance, business operations, user interfaces, and bio-informatics to name a few—so I have become intimately acquainted with both the legal and practical implications of this question. As such my personal reaction to this decision is very strong, and I will be quite blunt in what follows.

Over the next several days I will address just some of the logical and legal errors in the Court’s decision.

What’s a Law of Nature?

The first critical mistake is the Court’s assumption that Prometheus’ claims recited a “law of nature:” “The claims purport to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage will be ineffective or induce harmful side-effects.” The facile assumption that this relationship is a “law of nature” is incorrect, and potentially the most damaging misstep by the Court.

First, let us assume for the moment that there are in fact such things as “laws of nature.” What would their characteristics be? A first approximation would suggest that a law of nature is immutable and universal, that it is not subject to change, and it applies in all circumstances. See, Evidence Based Science. Thus, gravity and the speed light apply to you and me equally, and under all conditions. (I’m purposely using these two examples, for reasons that will become clear.)  However, this is not the case with the toxicity of any drug, including thiopurines, as acknowledged by the Court: the amount of a toxic dose varies between individuals for two reasons. First, different people metabolize at different rates, thereby producing different metabolite levels for a given dose. Second, individuals have differential responses to a given amount of the metabolites; a given level of the metabolites may be toxic in one person and not toxic in another. Thus, while the patent sets forth metabolite levels for toxicity and effectiveness, these levels are necessarily probabilistic, as some patients could experience toxicity at levels below or above those specified in the patent claims. This is inherent in the way toxicity is determined using a median lethal dose, LD50. This is exactly the same reason that one person can be drop dead drunk after five drinks and another can be stone cold sober at the same level. Indeed, Mayo’s test used a higher threshold for toxicity—evidence that there is no “law of nature” as to what is a toxic dose of thiopurine in all humans.

The “natural relation” that Prometheus claims is, itself, not immutable in an even deeper sense. This relationship is a byproduct of human (or perhaps more generally mammalian) biology, which from a logical point of view is a contingent relationship that could have been otherwise: we could have evolved in such a way that the toxicity range was higher or lower, or the drug was entirely ineffective. That is, it’s an arbitrary and contingent fact that humans evolved so that thiopurine drugs were effective at all for treating immune-mediated gastrointestinal disorders, or that we metabolize them in a manner that makes them toxic at specific dosing ranges. Indeed, given that humans are not exposed to thiopurine in nature, it is hard to understand how it can even be argued that it is a “natural law” that these drugs have a specific range of toxic or effective dosages at all. That these drugs are effective (or toxic) is a classic discovery in the truest sense of the term.

At best, the relationship between the dosage and toxicity level may be a “natural phenomenon.” Let us assume that is the case. Natural phenomena are a different class of things than laws of nature. Lightning, mirages, tornadoes, superconductivity, rainbows, these are natural phenomena: events that take place in nature (or in the lab) under specific and contingent conditions. While these events are of course dependent on the laws of nature, they are different from them in kind. The prohibition of patent claims in this regard is for claims on the phenomenon itself, not on the specific application of a phenomenon. Indeed, most patents in the chemical, biological, and electrical arts are based precisely on this distinction, being able to induce, apply, or control a natural phenomenon for a particular purpose. For example, there are thousands of patents that expressly claim a particular use of the Hall effect, natural phenomena discovered in 1879. The Court’s failure to appreciate this distinction puts many patents that harness natural phenomena at risk.

In short, the relationship of thiopurine dosage to toxicity is a contingent, empirical fact and subject to discovery. Like other empirical facts, it is precisely the type of subject matter that has been patented in this country since the very first patent issued by the USPTO: Samuel Hopkins’ patent on an improved method for making potash, based on the discovery that burning the raw ashes a second time increased their carbonate production. Hopkins’ discovery is no different in kind from Prometheus’ discovery: in both cases empirical “scientific” facts about the world.

But let us return to the core assumption: that there are laws of nature in the first instance. The Court makes the obvious reference to Einstein’s E=mc2 equation as an example. But the great scientist would have readily dismissed this appellation, knowing full well that what he set forth was a theory, a model, a description that was subject to falsification. Indeed, Einstein’s work has been criticized as being incomplete, or valid only in limited circumstances.

The view that there are laws of nature reflects an 18th century view of the world, based no doubt upon the classical, Newtonian view of a reality of absolute space and time governed by the three “laws of motion”—laws that were thought to be immutable and universal—and which Einstein among others showed not to be “laws” at all.

Most modern scientists do not view reality as defined by “laws”—indeed, the very idea that we could “know” what the “laws” are itself begs the very questions that philosophers since Plato have struggled with, the questions of epistemology (what is knowledge, what can we know) and ontology (what exists).

In several places, the Court lumps laws of nature together with “abstract ideas,” for example by leaning on the analysis in Bilski and Benson. But again, this is a category error: abstract ideas are very different from laws of nature, and must be treated separately. “Ideas,” classically speaking, are the “impressions in your head” when you think about something—the thing you think about is a “concept.” When you think about concepts that have instances in the world—cats, dogs, and thiopurine—you are thinking of “concrete” concepts, and your ideas are “concrete.”  Even when you think of a unicorn or a flying purple people eater, you are thinking of a concrete concept because it could have an instance in the world. However, when you think about concepts that do not (or could not) have instances in the world—justice, eternity, infinitesimal, invisible green four sided triangles—or metaphors—All the world’s a stage, and all the men and women merely players—the “idea” in your head is “abstract.” (Of course, I know that this is (1) a gloss, and (2) subject to debate as much as anything else in philosophy. Arguably, there are no “abstract” concepts at all. I’ll leave that debate for another day).

To wit: the abstract idea of say, immortality, is clearly not a “law of nature,” describing something that by definition cannot have examples in the world, since nothing can be immortal (there could be unicorns however, thus the concept of “unicorn” is concrete). Conversely, Ohm’s Law—that the current through a conductor between two points is directly proportional to the potential difference across the two points—describes something inherently and entirely physical and real. Ohm’s Law is a description of the world (and it turns out, not always correct). That the Court attempts to put these two square pegs in the same round hole reveals just how little the Court understands the nuances of science, philosophy and language—let alone the patent law itself.

Tomorrow:  What’s a Claim? and Patent-Eligibility vs. Patentability

 

 

Scholarship Cited by the Supreme Court in Mayo v. Prometheus

Supreme Court: No Move Yet on Denying Human Gene Patents

The Supreme Court is in the midst of deciding whether to grant the Ass’n of Molecular Pathology’s petition for a writ of certiorari in the Myriad gene patent case. The petition, led by public interest patent attorney Dan Ravicher, poses a simple question to the court: “Are human genes patentable?” Petitioners also ask the Supreme Court to provide more latitude for public interest groups to challenge patents even in the absence of any personal or direct threat of an infringement action – arguing that the Federal Circuit is not following the Supreme Court’s guidance set forth in MedImmune.

In addition to the party briefs, ten amici briefs were filed with the court from a variety of medical associations, hospitals, and professors – all in support of the petitioners. None of the major patent law associations filed briefs in the case.

The briefs were complete and distributed to the Justices on January 25 in preparation of a February 17 conference. In patent cases, the typical result of the conference is that the court either (1) grants certiorari; (2) denies certiorari; (3) invites comments from the Solicitor General; or (4) does nothing until the next conference. We learned today that the Supreme Court is following path number 4 – no action until next time. At some point before the close of term, the Supreme Court will revisit the case and announce that it is following one of the other paths. In an e-mail, Hal Wegner noted that the Supreme Court is scheduled to release new orders three times during next five weeks.

The delay may well be related to the fact that the Court is in the midst of drafting a merits decision in another § 101 patent-eligibility case of Mayo v. Prometheus. Although the Mayo case focuses on medical methods rather than genes per se, there is still a good chance that outcomes will be linked.

Other Denials: The court today did deny certiorari in several patent cases, including Janssen Biotech, Inc. v. Abbott Laboratories; Hynix Semiconductor v. Rambus; and Eastman Chemical Co. v. Wellman, Inc.

In Janssen Biotech, the patentee unsuccessfully challenged the de facto heightened written description standard that the court has placed on biotechnology focused patents. In Hynix, the accused infringer unsuccessfully asked the Supreme Court to follow principles of equity in preventing infringement claims over industry-standard products by a patentee who had concealed its pending patent applications from the standard setting organization and had amended its claims during prosecution to cover the agreed-upon standard. In Eastman Chemical, the Supreme Court refused to consider whether the Federal Circuit should add some teeth to the indefiniteness doctrine codified in 35 U.S.C. §112(2).

Supreme Court Affirms Broad Congressional Authority to Offer Intellectual Property Rights for Public Domain Works

By Dennis Crouch

Golan v. Holder (Supreme Court 2011)

As widely expected, the Supreme Court today affirmed a lower court ruling that the "Copyright Clause" of the U.S. Constitution does not prevent Congress from providing copyright protection to public domain works. As also expected, Justice Breyer (joined by Justice Alito) dissented from the 6-2 decision.

The case was filed after Congress restored the copyrights to a thousands of foreign-authored works that had fallen into the public domain based upon the authors' failures to observes pre-Berne Convention formalities such as registration and notice ©. Many of the restored works had been known to be in the public domain for decades before the 1994 passage of the statute – the Uruguay Round Agreements Act. (Picasso's 1937 Guernica painting reproduced without a license below is an example of a work whose copyright was restored by the statute). The Supreme Court opinion is written as a further extension of the 2003 Eldred decision that affirmed Congressional power to extend copyright by an additional 20-years as part of the Sonny Bono Copyright Term Extension Act (CTEA). I had suggested to my students last semester that the best conceivable outcome for petitioners would be that the Court would determine that heightened scrutiny should apply to adjudge the free speech impact of the expansion of copyright law. However, the court also rejected that path.

The Supreme Court opinion authored by Justice Ginsburg rejected the three primary arguments made by petitioners:

  1. The Court held that allowing works from the public domain to be later copyrighted does not result in the potential for perpetual copyright in violation of the "limited terms" language of the Constitution. In its opinion, the court rejected any notion that the public has a "vested" right in works from the public domain. "Once the term of protection ends, the works do not revest in any rightholder. Instead, the works simply lapse into the public domain."
  2. The purpose of copyright law – to "promote the Progress of Science" – should be broadly interpreted to include both promotion of the creation of new work as well as promotion of knowledge and learning more generally. And, inducing of the dissemination of existing works is a permissible means to promote science. In addition, providing for access to foreign markets by acceding to treaty obligations can also provide an incentive for creation of new works and therefore promote the progress.
  3. In Eldred, the free speech rights embodied by the First Amendment to the U.S. Constitution do not limit Congress from modifying copyright law within its "traditional contours." Petitioners argued that the removal of elements from the public domain was outside of these traditional contours and that, under Eldred, the Supreme Court should use a heightened level of scrutiny to determine whether the new law offends free speech concerns. The Court rejected that analysis based upon its conclusion that Congress has, on several occasions, removed elements from the public domain and that, therefore, this action is within the traditional contours of copyright policy. In addition, the Court held that the impact of the particular law at issue was simply to place the foreign works in the copyright position that they would have occupied if the current copyright regime had been in place at the time. From that perspective, the new law fits well within the traditional contours of copyright law.

Impact on Patent Law: Copyright and patent share the same constitutional underpinnings and each is purposed to "promote the Progress" of their respective fields. This leads me to the conclusion that the reasoning in Golan would be equally applicable to Congressional expansions of patent law. In its decision, the Court explicitly refers to historic patent restoration bills as "informing" the inquiry into the scope of the clause as it applies to copyright. The converse should also be true. Thus, perhaps Congress would have authority to extend patent terms based upon a patentee's provision of data additional testing data or its promise to manufacture the product in the US.

An interesting caveat comes from the Court's 1996 Graham decision. That opinion includes the line that "Congress may not authorize the issuance of patents whose effects are to remove existent knowledge from the public domain, or to restrict free access to materials already available." In distinguishing that line, the Court wrote that the passage does not speak "to the constitutional limits on Congress' copyright and patent authority" but instead it addresses "an invention's very eligibility for patent protection." (quoting Eldred). The seeming distinction here is that Congress has more latitude in determining patent (and copyright) term or duration and less latitude in determining subject matter eligibility.

In dissent, Justice Breyer wrote, inter alia, that the "newness" requirement has always been a necessary and fundamental element of intellectual property (copyright and patent) protection. This newness requirement is offended by allowing copyright protection to be offered for works created long ago and already known to be in the public domain.

The political setup of this case is somewhat interesting because the government's pro-property position could be conceived as the conservative approach while Golan's more liberal position is suggesting that anyone should be able to use these works without payment to the creator. At the same time, the liberal Golan's legal argument was based upon the traditionally conservative suggestion of strong Constitutional limits on the powers of the federal government.

Note:

  • At several points in this article I would have linked to Wikipedia, but the site is not generally available today because of its ongoing protest against an expansion of intellectual property law that would require services such as Wikipedia and Google to remove links to sources of pirated material.

Patentable Subject Matter and the Supreme Court Myriad Preview

Myriad's patent claims are directed, inter alia, to several isolated human DNA molecules that represent the BRCA1 and BRCA2 genes. These gene mutations are associated with an increased risk of developing breast and/or ovarian cancer. Because women with these gene mutations are much less likely to survive into old-age, many choose to undergo extensive preventive surgery in an attempt to avoid the risk. In other words, the genetic information and testing technology is important. 

Fundamentals of Patentability: Most patentability decisions focus on either an invention's obviousness or a patent's failure to properly disclose the invention. The Myriad case looks at something more fundamental – whether isolated human DNA is, in general, the type of thing that should be patentable.

Product of Nature: In this case, all the parties agree that the claimed DNA molecules are "compositions of matter" that nominally fall within the statutory guidelines of patentable subject matter found in 35 U.S.C. § 101. The disagreement comes from the common law gloss that the Supreme Court has added to the statute. Namely, the Supreme Court has repeated stated that, regardless of the novelty of the invention, neither products of nature nor natural phenomena qualify for patenting. The big issue in this case boils down to whether the claimed molecules fall within this product of nature exception.

Human-Made Inventions: According to the Court, "human-made inventions" sit at the opposite end of the spectrum from products of nature. To be distinguishable from products of nature, a human made invention must be "markedly different" or express "distinctive" characteristics from what is found in nature.

Patenting Isolated cDNA: Myriad's patent also claim cDNA molecules that are synthesized in the lab using the naturally occurring enzymes reverse transcriptase and DNA polymerase.  cDNA differs from native DNA in that the cDNA typically (and in this case) represents only the information for a single gene and with unnecessary (intron) information removed. Native DNA is typically part of a large single molecule (a chromosome) that includes lots of genes and lots of introns intermixed between and within gene coding. The human body has a natural process for accessing and using the particular gene when it is needed. To do this, enzymes are able to create an RNA strand that mirrors the DNA information and that removes the introns. In the human, that RNA is then used to create a protein used by the body. For Myriad, the RNA is instead transcribed back into DNA (now called cDNA because it is [c]omplementary to the RNA).

To be clear, Myriad did not claim to invent any of this process or to invent cDNA in general. Rather, Myriad invention is that it created a cDNA molecule that holds the exact same information as the naturally occurring BRCA1/BRCA2 RNA.  Certainly, cDNA is chemically different from RNA — it is preferred in the lab because it is double-stranded and typically more stable.   An additional difference here is that the claimed cDNA is isolated from the cell and the living organism so that it it can be tested and used in different ways.  

Holding: cDNA is Markedly Different from That Found in Nature: The Federal Circuit considered these arguments, but decided to take a different perspective — focusing on differences instead of similarities. In holding the claims patentable, the court reasoned that: 

  1. The claimed cDNA is a molecule that is not found in nature.
  2. The claimed cDNA is quite different from a native chromosomal DNA.
  3. Human intervention of cleaving and/or synthesizing is necessary to make the cDNA.
  4. Because the molecule is changed, it cannot be said to be merely "purified."
  5. Judge Moore goes on to explain that the cDNA sequence is "completely different than the corresponding RNA."

Insignificant Extra-Solution Modification: In a number of cases, the Supreme Court has worked to conflate the issues of patentable subject matter with issues of obviousness and novelty.  Thus, for instance, courts have repeatedly noted that insignificant extra-solution modifications of an invention cannot whitewash an otherwise unpatentable invention.   Here, potential conflation has a strong foothold because the real breakthrough at the time was discovery of the genetic sequence itself.  It took tremendous effort and ingenuity to discover that transcription map and that map was the key to their discovery as outlined in the inventors 1994 Science article.  However, in 1994 (the time of the invention) once a sequence was known, almost any trained molecular biology lab technician could manufacture the isolated cDNA with effort but without much necessary ingenuity. If the discovered map itself was unpatentable as merely information and the process to create the isolated DNA was already known, then where is the invention? This type of analysis is outside of mainstream Federal Circuit decisions, but if the Supreme Court takes the case, the interplay between what was invented and what was already known may well be an important element in to the court's discussion of patentable subject matter.  

   

   

   

Supreme Court takes Two More Patent Cases

The Supreme Court has granted writs of certiorari in two pending patent cases. 

In Kappos v. Hyatt, the Supreme Court will decide (1) whether a patent applicant who files a Section 145 civil action has a right to present new evidence to the Federal District Court that could have been (but was not) presented during the proceedings before the USPTO and (2) when new evidence is presented, whether the court may decide the related factual questions de novo and without deference to prior PTO findings.  An en banc Federal Circuit previously sided with the applicant, Hyatt, and held that the district court must allow new evidence and that factual conclusions affected by the new evidence must be decided de novo even if previously determined by the PTO. Judge Kimberly Moore penned the en banc opinion after dissenting from the original panel that had arrived at the opposite conclusion. This is Hyatt’s second case at the Supreme Court.  He won the first against the State of California who was attempting to tax his receipts from patent licensing awards.  Hyatt’s patents are related to computer micro-controller designs and claim a 1975 priority date.

Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S is a brand versus generic pharmaceutical dispute involving the scope of a generic company’s right to counterclaim against the brand based upon a brand’s overbroad description of claim scope submitted to the FDA.  The Federal Circuit held that the Hatch-Waxman Act only allows for deleting of improperly listed patents while the petitioner here argues that the Act also allows for correction of misstatements for patent scope.

The Supreme Court today also decided two personal jurisdiction  that could have some impact on how foreign entities are treated in US patent cases. In  J. McIntyre Machinery v. Nicastro, the court held that a the “stream of commerce” theory of personal jurisdiction was being taken too far and that the foreign manufacturer (Nicastro) could not be subject to courts located in New Jersey because it had not engaged in activities in that state that “revealed an intent to involde or benefit from the protection of the [New Jersey] laws.”  In Goodyear Luxembourg Tires v. Brown, the court held that courts located in North Carolina did not have general jurisdiction over Goodyear’s foreign subsidiary.

Supreme Court to Revisit Patentable Subject Matter Eligibility

Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Supreme Court 2011)

by Dennis Crouch

The Supreme Court has agreed to hear Mayo’s petition on the patentable subject matter eligibility of medical diagnostic methods.  The issue raised on appeal is stated as follows: 

Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve “transformations” of body chemistry.

The claims asserted by Prometheus are directed toward a method of “optimizing therapeutic efficacy” by first administering an active drug (6-thioguanine) to a subject and then using the subject’s metabolite blood-level to adjust future doses of the drug.  (U.S. Patents 6,355,623 and 6,680,302). Thus, most of the claims are centered around three ordered-steps of:

  1. administering the drug to the subject;
  2. determining the amount of drug in the subject’s blood; and
  3. re-calibrating the drug dosage based on step-2.

A broader claim (claim 46 of the ‘632 patent) eliminates the administering step of claim 1 above.

The district court found the claims invalid as lacking patentable subject matter under 35 U.S.C. 101.  On appeal, the Federal Circuit reversed — holding that the steps of “administering a drug” and “determining the level of 6-thioguanine” were both sufficiently transformative of “a particular article into a different state or thing.”  That Federal Circut decision was based on the court’s machine-or-transformation test that was subsequently discredited by the Supreme Court in Bilski v. Kappos (2010).  In the wake of its Bilski decision, the Supreme Court vacated the Federal Circuit’s Prometheus decision and remanded for a new opinion.  On remand, the Federal Circuit again affirmed that the Prometheus claims are eligilble for patent protection. [See Rantanan’s post]

Microsoft v. i4i: Supreme Court Affirms Strong Presumption of Patent Validity

Microsoft Corp. v. i4i Limited Partnership (Supreme Court 2011)

The patent act indicates that issued patents are “presumed valid.” 35 U.S.C. § 282. In this case, Microsoft challenged the strength of that presumption — arguing that a low “preponderance” standard for proving invalidity should be sufficient rather than the higher “clear and convincing” standard required by the Court of Appeals for the Federal Circuit. In straightforward language, the Supreme Court writes: “We consider whether §282 requires an invalidity defense to be proved by clear and convincing evidence. We hold that it does.” Microsoft will now likely be forced to pay the $250+ million judgment for infringing i4i’s patents.

With unanimous agreement, the Supreme Court has rejected Microsoft’s argument and affirmed the Federal Circuit’s strong presumption of proof. Justice Sotomayor delivered the opinion for seven of the justices. Justice Breyer joined the majority but also wrote a concurring opinion that was signed by Justices Scalia and Alito; Justice Thomas concurred, but based upon his own unique historical reasoning. Chief Justice Roberts recused himself. With the absence of Justice Stevens, the court appears to now be tilted to the right on core patent issues. (I.e., toward patents as property rights and away from a more policy-based regulatory paradigm).

The court’s opinion rests largely on its 1934 RCA opinion that required “clear and cogent evidence” to overturn an issued patent and a conclusion that the 1952 patent act intended to codify the common law holding of RCA.

[B]y the time Congress enacted §282 and declared that a patent is “presumed valid,” the presumption of patent validity had long been a fixture of the common law. According to its settled meaning, a defendant raising an invalidity defense bore “a heavy burden of persuasion,” requiring proof of the defense by clear and convincing evidence. That is, the presumption encompassed not only an allocation of the burden of proof but also an imposition of a heightened standard of proof. Under the general rule that a common-law term comes with its common-law meaning, we cannot conclude that Congress intended to “drop” the heightened standard proof from the presumption simply because §282 fails to reiterate it expressly.

The Supreme Court similarly rejected Microsoft’s alternative proposal that the presumption of validity be weakened for validity challenges that were not considered by the USPTO during prosecution of the application. However, the Court did agree with Judge Rich’s American Hoist opinion that “new evidence” of invalidity likely carries more weight than evidence that had been previously considered and rejected by the Patent Office. In what may become the most litigated aspect of the decision, the Supreme Court writes:

Simply put, if the PTO did not have all material facts before it, its considered judgment may lose significant force. And, concomitantly, the challenger’s burden to persuade the jury of its invalidity defense by clear and convincing evidence may be easier to sustain. In this respect, although we have no occasion to endorse any particular formulation, we note that a jury instruction on the effect of new evidence can, and when requested, most often should be given. When warranted, the jury may be instructed to consider that it has heard evidence that the PTO had no opportunity to evaluate before granting the patent. When it is disputed whether the evidence presented to the jury differs from that evaluated by the PTO, the jury may be instructed to consider that question. In either case, the jury may be instructed to evaluate whether the evidence before it is materially new, and if so, to consider that fact when determining whether an invalidity defense has been proved by clear and convincing evidence. Although Microsoft emphasized in its argument to the jury that S4 was never considered by the PTO, it failed to request an instruction along these lines from the District Court. Now, in its reply brief in this Court, Microsoft insists that an instruction of this kind was warranted. That argument, however, comes far too late, and we therefore refuse to consider it.

In its opinion, the court acknowledged policy arguments both for and against a strong presumption of validity (Citing Lemley & Lichtman), but in the end decided that it was bound to follow Congress and the common law precedent.

In his concurring addendum, Justice Breyer attempted to cabin-in the decision by indicating that the clear and convincing evidence standard of proof “applies to questions of fact and not to questions of law.” He suggested that jury instructions should include detailed interrogatories that separate-out factual determinations made by a jury from the legal conclusions. That distinction is extremely important in the patent landscape because the ultimate question of obviousness is a legal conclusion based upon a set of facts generated by following the process set out in Graham v. John Deere. If Justice Breyer’s prescription is followed, it creates a major loophole in the strong presumption because the most difficult and debatable aspect of the obviousness analysis is the leap from the factual underpinnings to the ultimate conclusion. As an aside, Justice Breyer suggests in his opinion that “novelty” is a question of law while the Federal Circuit has long held that to be a factual conclusion.

Justice Thomas agreed that the standard for proving invalidity should be did not agree with the majority that the standard was “codified” in the Patent Act of 1952 but rather that the common law clear and convincing evidence standard was left unchanged by the Act.

Supreme Court: Inventors Can Retain Rights Even for Federally Funded Inventions

StanfordImageStanford v. Roche, 563 U. S. ____ (2011)

In a 7-2 decision, the Supreme Court has ruled that a federally funded contractor does not necessarily own the patent rights to inventions resulting from funded projects. Here, the Board of Trustees of the Leland Stanford Junior University unsuccessfully argued that such rights automatically vest under the Bayh-Dole Act of 1980.

Ownership of patent rights and inchoate pre-filing rights are somewhat confusing because they involve a mixture of federal patent law and state laws of contracts, employment, and trade secrets. Here, the majority led by Chief Justice Roberts has held that US patent rights have always (since 1790) initially vested in “the inventor” and that the non-specific language of the Bayh-Dole Act does nothing to change the original setup.

The Bayh-Dole Act has revolutionized the way that universities look at technology and innovation by allowing research institutions to “elect to retain title” to inventions generated through federal funding. 35 U.S.C. § 202(a). Today, most major research universities hold dozens if not hundreds of patents and have extensive licensing offices. The Association of University Technology Managers (AUTM) now boasts more than 3,500 members.

This case involves a Stanford researcher (Mark Holodniy) who was under a prior contractual duty to assign invention rights to Stanford but who actually assigned rights to Cetus. When Stanford sued Roche (Cetus’ successor in interest) for patent infringement, Roche’s defense was that a co-owner could not be held liable for patent infringement. The Court of Appeals for the Federal Circuit agreed with Roche — holding that Holodniy’s duty to assign rights to Stanford did not block him from actually assigning rights to Cetus and that Roche therefore held rights in the invention.

At the Supreme Court, Stanford argued that the contractual rights did not matter and instead that its statutory right to “elect to retain title. . . any invention of the contractor” conceived or reduced to practice under a federally funded agreement gave it precedence over Cetus/Roche. The court rejected Stanford’s argument as both against the tradition of patent law and not in accord with the statute.

Stanford’s reading of [the Statute] is plausible enough in the abstract; it is often the case that whatever an employee produces in the course of his employment belongs to his employer. No one would claim that an autoworker who builds a car while working in a factory owns that car. But, as noted, patent law has always been different: We have rejected the idea that mere employment is sufficient to vest title to an employee’s invention in the employer. Against this background, a contractor’s invention—an “invention of the contractor”— does not automatically include inventions made by the contractor’s employees.

This case is largely a moot point because the Federal Circuit has established a particular federal-patent-law interpretation of employment agreements that allows contracting parties to choose language that optionally includes either a promise to cooperate and assign rights or else an automatic assignment that occurs constructively at the moment of invention. If Stanford had chosen the more stringent automatic assignment language for its employment contract, then it would have automatically taken rights. The only problem, of course, is whether Universities have the bargaining power to require its employees to sign the more stringent contracts.

At the same time, however, the decision here offers some cause for caution in relying fully on the Federal Circuit’s usurpation of exclusive jurisdiction over this employment and contract law issue. In Footnote 2, the Supreme Court noted that, in this decision, the court had “no occasion to pass on the validity of the lower court’s construction of those agreements.” As discussed below, Justice Breyer explicitly criticized the Federal Circuit’s contract interpretation.

In dissent, Justice Breyer wrote:

Ultimately, the majority rejects Stanford’s reading (and the Government’s reading) of the Act because it believes that it is inconsistent with certain background norms of patent law, norms that ordinarily provide an individual inventor with full patent rights. But in my view, the competing norms governing rights in inventions for which the public has already paid, along with the Bayh-Dole Act’s objectives, suggest a different result.

Breyer also challenged the Federal Circuit rule distinguishing between a promise to transfer and an automatic transfer agreement. Relying upon history and tradition, Justice Breyer saw the initial contract as creating equitable title in the invention and then looked to old decisions historically did not enforce contracts to automatically transfer of legal title to patent rights.

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.

Justice Breyer realized that his argument regarding equitable title had not been briefed by the parties and therefore indicated his preference to remand for briefing of that issue.