By:  Eric Caligiuri

On July 11, 2016, the U.S. Court of Appeals for the Federal Circuit ruled in a unanimous en banc decision in The Medicines Co. v. Hospira Inc., Federal Circuit case number 2014-1469, that to be “on sale” under pre-AIA 35 U.S.C. § 102(b), a product must be the subject of a commercial sale or offer for sale, and that a commercial sale is one that bears the general hallmarks of a sale pursuant to Section 2-106 of the Uniform Commercial Code.   If the product is “on sale” more than one year before the filing of an application for a patent, any issued patent is invalid and patent protection is lost.  The issue before the Court in Medicines Co. was whether a product is “on sale” under 35 U.S.C. § 102(b) when the product is produced by a third-party contract manufacturer. 01-Caliguri-Er-15EX-web

The two patents at issue, U.S. Patent Nos. 7,582,727 (“the ’727 patent”) and 7,598,343 (“the ’343 patent”), are FDA Orange Book listed as covering Angiomax, which is the trade name of a form of bivalirudin.  Bivalirudin is a synthetic peptide comprised of twenty amino acid residues. Bivalirudin drug products are used to prevent blood from clotting and are regarded as highly effective anticoagulants for use during coronary surgery.  However, the bivalirudin active pharmaceutical ingredient is too acidic for human injection without further processing.  Thus, the patented compounding process produces Angiomax by creating a bivalirudin solution and then adjusting the solution’s pH with a base while controlling the creation of impurities.  The ’727 patent and ’343 patent contain product and product-by-process claims for pharmaceutical batches of the improved bivalirudin drug product.

Critically, plaintiff Medicines Co. (“MedCo”) did not sell Angiomax to the public before filing for the patents, but instead used a third-party contract manufacturing organization, Ben Venue Laboratories (“Ben Venue”), to ensure the drug met U.S. Food and Drug Administration requirements.  Thus, the Federal Circuit’s opinion touched on an important issue in the patenting of pharmaceuticals and other products, such as semiconductors: the use of contract manufacturers and the manufacturing processes necessary to produce these products.

The dispute at issue here traces back to August 2010, when MedCo sued Hospira in the United States District Court for the District of Delaware, alleging that two of Hospira’s ANDA filings infringed certain claims of the ’727 patent the ’343 patent.  After a three-day bench trial in September 2013, the district court found the patents not invalid and not infringed.  In considering invalidity, the court had to determine whether the invention was sold or offered for sale before the critical date under § 102(b), i.e. was it subject to the on-sale bar.

Applying the two-step framework of Pfaff v. Wells Electronics, Inc., 525 U.S. 55 (1998), the district court found that the three batches Ben Venue manufactured for MedCo did not trigger the on-sale bar.  Pfaff’s two-step framework requires that the claimed invention was (1) the subject of a commercial offer for sale; and (2) ready for patenting.  The district court concluded that the first prong of Pfaff was not met because the claimed invention was not commercially offered for sale prior to the critical date.  The court reasoned that the transactions between MedCo and Ben Venue were sales of contract manufacturing services in which title to Angiomax always resided with MedCo.  The court also found that because the batches were for FDA “validation purposes,” the batches were not made for commercial profit, but were for experimental purposes, thus avoiding the on-sale bar.

On appeal, a panel of the Federal Circuit reversed the district court’s ruling regarding the applicability of the on-sale bar, finding MedCo “commercially exploited” the invention before the critical date, even if it did not transfer title to Angiomax.  The panel also found the experimental use exemption did not apply because the invention had already been reduced to practice, so MedCo could not have been experimenting.  At the request of MedCo, the Federal Circuit vacated the panel’s ruling to consider the case en banc.

Applying § 102(b) in light of Pfaff, the Federal Circuit en banc concluded that the transactions between MedCo and Ben Venue did not constitute a commercial sale of the patented product.  The full Court affirmed the district court’s conclusion that those transactions were not invalidating under § 102(b), and reversed the panel’s determination.  The Court reasoned that the sale of manufacturing services by a contract manufacturer to an inventor to create embodiments of a patented product for the inventor does not constitute a “commercial sale” of the invention.  MedCo did not market or release its invention by contracting with Ben Venue, but only paid the company to make batches of the drug because it did not have the manufacturing capabilities to do it in-house.  The Court saw no reason to treat MedCo differently than a company with in-house manufacturing capabilities.  “There is no room in the statute and no principled reason…to apply a different set of on-sale bar rules…depending on whether [a company] outsources manufacturing or manufactures in-house.”  Instead, the focus of the on-sale bar analysis should be on what makes a sale “commercial” in “the most well-understood sense of that term…as distinct from merely obtaining some commercial benefit from a transaction.”

More broadly, the Court explained that a commercial benefit alone is not enough to trigger the on-sale bar of § 102(b); the transaction must be one in which the product is “on sale” in the sense that it is “commercially marketed.”  As a general proposition, the Court instructed that one should look to the Uniform Commercial Code (“UCC”) to define whether a communication or series of communications rises to the level of a commercial offer for sale.  However, the Court also cautioned that while “[t]he UCC has been recognized as the general law governing the sale of goods, [it] is another useful, though not authoritative, source in determining the ordinary commercial meaning of” terms used by the parties.

Given that the en banc Federal Circuit had found that there was no commercial sale of the inventions in the ’727 and ’343 patents, the Court declined to reach a ruling on the experimental use finding.  However, the Court did make clear that the panel’s statement that there can be no experimental use after a reduction to practice is inaccurate.  Finally, the Court addressed the issue of “stockpiling” by an inventor and clarified that “stockpiling” by the purchaser of manufacturing services is not improper commercialization under § 102(b).

Both the panel and en banc Federal Circuit only considered whether the patents were invalid under the on-sale bar, and did not consider other issues related to claim construction, infringement, and invalidity on other grounds.  Thus, the case has been remanded back to the original Federal Circuit panel for further proceedings on these issues and is still far from over.

Scott-Hervey-10-web6/25/16-  At the 7th Annual  VidCon in Anaheim, CA , Weintraub Tobin Shareholder Scott M. Hervey and Rian Bosak, Head of Network Operations Full Screen, presented  “Fair Use and Youtube- A Creator’s Take” to a standing room only audience of digital media creators and industry professionals.  Check out their presentation below:

 

Up until now, it has been nearly impossible for a plaintiff to recover enhanced (up to treble) damages in patent infringement cases.  The current test for enhanced damages, set forth by the Federal Circuit Court of Appeals in 2007 in In Re Seagate Technology, LLC, 497 F.3d 1360 (2007), was so rigid that it essentially slammed the door on plaintiffs seeking enhanced damages.  On June 13, 2016, however, the Supreme Court decision changed all that, in a unanimous decision in Halo Electronics v. Pulse Electronics, 2016 U.S. LEXIS 3776 (June 13, 2016).  The Court opened the door for plaintiffs to recover enhanced damages – no one is sure yet how far – but it is clear that plaintiffs have been given a boost and would-be infringers a cause for anxiety.

In Halo, the Court made three rulings that affect patent infringement suits.  First, the Court changed the test for recovery of enhanced damages from a rigid test to a flexible one.  Second, the Court lowered the plaintiff’s burden of proof for enhanced damages.  Third, the Court eased the standard of appellate review of district courts’ decisions on enhanced damages, leaving the district courts with more discretion and making it more difficult for defendants to overturn awards of enhanced damages.Audrey Millemann Full

The patent laws permit a trial court, in its discretion, to award enhanced damages to a plaintiff who prevails in a patent infringement suit.  35 U.S.C. § 284.  In Seagate, the Federal Circuit held that in order to obtain enhanced damages under § 284, a plaintiff had to prove willful infringement.  The court established a two-part test for willfulness.  The first part is objective – the plaintiff must show that there was an objectively high likelihood that the defendant’s actions were infringing.  This part of the test, referred to as “objective recklessness,” is determined by the judge based on the record, and cannot be found if the defendant raises a substantial question during the litigation as to noninfringement or invalidity.  The second part of the Seagate test is subjective – the plaintiff must show that the defendant knew or should have known that its actions were risking infringement.  The Seagate court held that a plaintiff must prove both parts of the test by clear and convincing evidence.  In Seagate, the court also established three different standards for appellate review: de novo for objective recklessness, substantial evidence for subjective knowledge, and abuse of discretion for the decision to award enhanced damages.

The Supreme Court’s Halo decision is a single decision issued in two cases:  Halo Electronics v. Pulse Electronics and Stryker Corp v. Zimmer, Inc.  In the Halo case, plaintiff Halo and defendant Pulse competed in electronic components.  Halo owned patents for electronic packages with transformers used to attach to circuit boards.  Halo offered Pulse the opportunity to license the patents.  Pulse declined and continued to sell the accused products, after deciding that the patents were not valid.  Halo sued Pulse.  The jury found that Pulse had infringed the patents and that the infringement was likely willful.  Halo sought enhanced damages, but the district court denied the request on the grounds that Pulse had asserted a defense at trial that was not baseless, such that the first part of the Seagate test could not be met.  On appeal, the Federal Circuit affirmed.

In Stryker, Stryker and Zimmer competed in the sale of an orthopedic surgical device.  Stryker sued Zimmer for patent infringement, and won a jury verdict of $70 million for willful infringement.  The willfulness was based on evidence that Zimmer had flagrantly decided to copy Stryker’s products.  The district court awarded an additional $6.1 million in damages and trebled the award, for a total of over $228 million.  On appeal, the Federal Circuit affirmed the finding of infringement, but reversed the award of treble damages, relying on the same rationale as in the Halo case, that the defendant had presented reasonable defenses at trial, such that the first part of the Seagate test could not be met.

The Supreme Court explained that § 284 provides a district court with discretion to award enhanced damages and does not specifically limit that discretion.  Halo, at *14.  However, the Court emphasized that the district court’s discretion should only be exercised in “egregious” cases.  Id. at *15.  Egregious cases are those in which the defendant’s conduct is “wanton, malicious, bad-faith, deliberate, consciously wrongful, flagrant, or . . . characteristic of a pirate.”  Id. 

In tossing out the Seagate test, the Court said that the first part of the Seagate test – objective recklessness – is wrong because it excludes defendants who wantonly infringe a patent, but later, during litigation, assert a defense that they may not even have known existed at the time of the infringement.  Id. at *16-17.  According to the Court, “someone who plunders a patent – infringing it without any reason to suppose his conduct is arguably defensible – can nevertheless escape any comeuppance under §284 solely on the strength of his attorney’s ingenuity.”  Id. at *17.  The Court found no basis under §284 for a threshold requirement of objective recklessness, holding that a defendant’s culpability should be “measured against the knowledge of the actor at the time of the challenged conduct.”  Id.  The Court further found that the high burden of proof of clear and convincing evidence was inappropriate and not consistent with § 284.  Id. at *20.

The Court set forth the proper test for enhanced damages, at *19:

“[C]ourts should continue to take into account the particular circumstances of each case in deciding whether to award damages, and in what amount.  Section 284 permits district courts to exercise their discretion in a manner free from the inelastic constraints of the Seagate test.  Consistent with nearly two centuries of enhanced damages under patent law, however, such punishment should generally be reserved for egregious cases typified by willful misconduct.”

Thus, in discarding the Seagate test, the Court did not replace it with a new test.  Instead, the Court simply held that the Seagate test is “unduly confining” and that district courts should “be guided by sound legal principles developed over nearly two centuries of application and interpretation of the Patent Act . . . [and limit] the award of enhanced damages to egregious cases of misconduct beyond typical infringement.”  Id. at *24.

Lastly, the Court changed the standard of review of a district court’s decision on enhanced damages.  The Court held that because the district court has full discretion to award enhanced damages, its discretion should be subject to a single standard of review, abuse of discretion.

Halo has significant ramifications for patent owners and potential infringers, and for patent litigation itself.  Among them are:

  • Because the test is now more flexible and because the plaintiff’s burden of proof is lower, there may be more patent infringement cases filed.
  • Because the accused infringer may face allegations of willfulness that will likely survive to trial, cease and desist letters from patent owners to accused infringers may carry more weight.
  • Because the test is now determined by the defendant’s conduct at the time of the infringing acts, plaintiffs may conduct more extensive discovery into the defendant’s knowledge and when the defendant had that knowledge.
  • Without the benefit of the objective recklessness part of the Seagate test, defendants will have a more difficult time obtaining summary judgment of no willfulness; thus, the issue of willfulness and the plaintiff’s supporting evidence of the defendants willfulness will be presented at trial.
  • Because defendants will not want to risk evidence of willfulness at trial and an award of enhanced damages, settlement discussions will become more important, and more cases may settle before trial.
  • Because the “new” test is more flexible and because the burden of proof on the plaintiff is lower than under Seagate, plaintiffs may be more likely to recover enhanced damages at trial.
  • Because the test is now determined by the defendant’s conduct at the time of the infringing acts, companies developing new technology may become more diligent in conducting early infringement and invalidity analyses of key patents in their industry.
  • For the same reason, defendants may become more cautious in how they conduct themselves during the development of new technology, and in the written records of their conduct.

While most view Halo as very favorable to patent owners, its effect will not be known until the district courts start applying the test and the Federal Circuit rules on their decisions.  Until that time, potential infringers may not really know what type of conduct will result in enhanced damages, and should act accordingly.

 

Patent litigators and prosecutors have been waiting to hear whether the U.S. Supreme Court would require the United States Patent and Trademark Office (“USPTO”) to apply the same claim construction standard as the district courts.  The answer is “No.”JDC-Portrait-20141222-07e

For over 100 years, the USPTO has used the “broadest reasonable construction” standard to interpret patent claims.  But the district courts apply a different standard, which gives claims their ordinary meaning as understood by a person of skill in the art.  Questions have arisen to whether it makes sense for these standards to be different.  In its ruling on June 20, 2016, the U.S. Supreme Court addressed this question as it relates to an inter partes review (“IPR”), which is a procedure created by the America Invents Act, 35 U.S.C. §100 et seq.   The IPR procedure allows someone other than the patent owner to petition the USPTO to review claims of an issued patent and cancel claims that are found to be unpatentable in light of prior art.  The Patent Trial and Appeal Board (“PTAB”) handles IPR petitions and reviews at the USPTO.

In 2012, Garmin International, Inc., and Garmin USA, Inc., filed an IPR petition seeking to invalidate the claims of Cuozzo Speed Technologies, LLC’s patent relating to speedometers that alert drivers when they exceed the speed limit.  Among other requests, Garmin asked the USPTO to review claim 17 in light of three prior art patents.  Claim 17 depended from claims 10 and 14.  While Garmin had not expressly challenged claims 10 and 14, the USPTO granted the petition as to all three claims explaining that claims 10 and 14 were implicitly challenged.  The PTAB concluded that these claims were obvious in light of the prior art, denied Cuozzo’s motion to amend the claims as futile, and cancelled the claims.  Cuozzo appealed to the Court of Appeals for the Federal Circuit arguing 1) the PTAB improperly applied the “broadest reasonable construction” standard instead of the district courts’ standard, and 2) the USPTO improperly instituted review of claims 10 and 14 because Garmin had not challenged those claims “with articularity.”  The Federal Circuit rejected both arguments.  The Supreme Court granted certiorari and affirmed.  The Court found that the USPTO has the authority to issue a reasonable rule specifying the standard for claim construction and that the broadest reasonable construction standard is a reasonable rule.  Further, the Court found that 35 U.S.C. §314(d) precludes appeal of the USPTO’s decision to institute review of claims 10 and 14.

In considering the claim construction standard, the Court considered Cuozzo’s argument that the USPTO did not have the authority to issue a regulation instructing that in inter partes review, the PTAB “shall [construe a patent claim according to] its broad­est reasonable construction in light of the specification of the patent in which it appears” 37 CFR §42.100(b)(2015).  Cuozzo argued that the PTAB should be required to apply the same claim construction standard used by the district courts.  The Supreme Court, however, disagreed citing §316(a)(4) of the statute, which grants the USPTO authority to issue “regulations … establish­ing and governing inter partes review.”  The Court explained that the statute contains a gap because it does not unambiguously tell the USPTO what claim construction standard to use.  Where a statute is ambiguous or leaves a gap, the Court pointed out that it typ­ically interprets the statute “as giv­ing the agency leeway to enact rules that are reasonable in light of the text, nature, and purpose of the statute.”

The Court was not persuaded by Cuozzo’s argument that Congress must have designed IPR proceedings as a “surrogate for court proceedings,” and thus must have intended the USPTO to use the same standard as the district courts.  The Court reasoned that in other ways IPR proceedings are more like a specialized agency proceeding than a judicial proceeding.  For example, parties initiating the proceedings do not have to have a stake in the outcome, petitioners may lack constitutional standing and need not remain in the proceeding, and the Patent Office may intervene in a later judicial proceeding to defend its decision.  In addition, the burden of proof to cancel claims in an IPR is preponderance of the evidence, whereas in district court, a challenger must prove invalidity by clear and convincing evidence, which is a higher standard.  Further, “neither the statutory language, its purpose, or its history suggest that Congress considered what standard the [USPTO] should apply … in inter partes review.”  Therefore, the Court found that the USPTO has the authority to enact reasonable rules specifying the claim construction standard to fill this gap in the statute.

The Court then turned to the question of whether the rule is a reasonable exercise of that authority.  The Court noted that “the broadest reasonable construction helps to protect the public.”  It encourages patent applicants to draft claims narrowly, which promotes “precision while avoiding overly broad claims” and “helps prevent a patent from tying up too much knowledge” while helping the public “draw useful information from the disclosed invention and better understand the lawful limits of the claim.”  The Court also noted that past practice at the USPTO supports use of the broadest reasonable construction.

Cuozzo argued that there is a critical difference between the initial examination of a patent and the examination during an IPR that supports use of the district courts’ standard.  In an initial examination, the examiner applies the broadest reasonable construction, and if claims are rejected, the applicant can amend them as a matter of right.  In contrast, there is no absolute right to amend claims during an IPR.  Instead, amendment requires a motion, which has rarely been granted.  But the Court did not find this argument persuasive.  Instead, the Court found that use of the broadest reasonable construction was not unfair in any obvious way because there is an opportunity to amend during an IPR, albeit rarely granted, and the “original application process may have presented several additional opportunities to amend” the patent claims.

Cuozzo also argued that the use of one standard in IPR proceedings before the PTAB and a different standard in district courts “may produce inconsistent results and cause added confusion.” A district court could find a patent claim valid, and then the USPTO could later cancel the claim in its review.  The Court noted that that possibility “has long been present in our patent system, which provides different tracks … for the review and adjudication of patent claims.”  Given that inter partes review imposes a different burden of proof than that of the district courts, “the possibility of inconsistent results is inherent to Congress’ regulatory design.”  Further, the USPTO uses the broadest reasonable construction in other proceedings, which may be consolidated with inter partes review.  Thus, the Court could not find it unreasonable that the patent office prefers “a degree of inconsistency between the courts and the [USPTO] rather than among [USPTO] proceedings.”

Therefore, according to the Supreme Court, the PTAB and district courts can continue to apply different standards for interpreting patent claims.  Thus, when seeking to invalidate claims, patent challengers will likely continue to favor IPRs because of the broadest reasonable construction standard and the lower burden of proof.

In a high-profile case, a jury recently found that Google’s use of portions of Oracle’s Java software code was allowable under the fair use doctrine and thus did not constitute copyright infringement.  Oracle sought as much as $9 billion in damages from Google for incorporating approximately 11,000 lines of Oracle’s Java software code into Google’s Android software.  Not only were billions of dollars in monetary damages at stake in this dispute, but also a controversial legal concept that could have repercussions for the entire software industry.01-Caliguri-Er-15EX-web

The issue is whether Oracle can claim a copyright on Java APIs and, if so, whether Google infringes these copyrights by implementing them into their Android software.  APIs, or Application Programming Interfaces, are a set of routines, functions, specifications, etc., that allow software programs to communicate or interact with each other.  APIs are one of the most common ways technology companies integrate software and applications with each other and allow for third-party developers to write programs (i.e. Apps) to run on their products.  Google, and those on its side, said an Oracle victory would stifle software innovation by discouraging third-party programmers and developers from using APIs.  Oracle, and those on its side, said a Google victory hurts innovation by weakening intellectual-property protections for software and discouraging companies from creating new software platforms.

The dispute itself traces back to 2010 when Oracle sued Google in United States District Court for the Northern District of California, case number 3:10-cv-03561, for both patent infringement and copyright infringement.  Oracle alleged that Google’s Android software illegally used key pieces from Java that related to 37 APIs created to help programmers more easily write in Java.  Java was originally developed by Sun Microsystems beginning in 1991.  Oracle purchased Sun in January 2010, and continued the Java platform.  Google first released a beta version of its Android mobile phone operating system in 2007, and noted from the beginning that it would incorporate some Java pieces.  Google wrote its own version of Java for Android, but in order to allow third-party developers to write programs for Android, Google also used the same names, organization, and functionality as the Java APIs.

In May 2012, a jury found that Google did not infringe any asserted claim of Oracle’s two patents-in-suit, but the jury did find that Google had copied the “structure, sequence and organization” of parts of the 37 Java APIs.  “Structure, sequence and organization” is a legal term used to define a basis for comparing one software work to another in order to determine if copyright infringement has occurred when one software code is not a literal copy of the other.  However, District Court Judge William Alsup overturned the jury finding on copyright infringement and ruled that the structure of the Java APIs used by Google was not copyrightable.  Judge Alsup reasoned that “so long as the specific code used to implement a method is different, anyone is free under the Copyright Act to write his or her own code to carry out exactly the same function or specification of any methods used in the Java API.”

Oracle appealed Judge Alsup’s copyright ruling to the Court of Appeals for the Federal Circuit, which had appellate jurisdiction instead of the Ninth Circuit Court of Appeals because the District Court case also contained patent claims.  The Federal Circuit reversed the District Court on the copyright issue, holding that the “structure, sequence and organization” of an API could be copyrightable. The Federal Circuit acknowledged that Oracle’s APIs were somewhat functional, but that does not “automatically” put them beyond the scope of copyright law.  Google petitioned for review from the United States Supreme Court, but the Supreme Court denied Google’s request in June 2015, and the case was remanded back to the district court for the current proceedings on the fair use defense and damages.

Trial in the current case began on May 9, again in front of Judge Alsup in the Northern District of California, on whether Google’s use of the APIs was protected by the fair use doctrine and therefore exempt from copyright infringement.  The fair use doctrine is a defense or exemption to copyright infringement that allows the incorporation of copyrighted material in another’s work if a four-factor balancing test is met.  In determining whether the use made of a work in any particular case is a fair use, the factors to be consider are: (1) the purpose and character of the use, including whether the use is commercial or for nonprofit/educational purposes and whether it is transformative; (2) the nature of the copyrighted work; (3) the amount used in relation to the copyrighted work as a whole; and (4) the effect of the use on the potential market for or value of the copyrighted work.  Per the jury instructions, Google had the burden of proof to show fair use.

During the trial, Google argued that its use of the Java APIs was transformative under the first factor because it used the Java APIs as part of a new platform for mobile devices.  Google argued under the second factor, the nature of the work, that APIs rank low on the creativity scale because they are more functional in nature.  Under the third prong, Google argued that it used only a small amount of the overall code that was necessary to effectively use the open-source Java language, and that the 11,000 lines of Java code it used was less than 0.1% of Android’s 15 million lines of code.  Finally, under the fourth prong, Google argued there was little market harm to Oracle because no one was using the APIs for mobile devices at the time.

Oracle argued under the first prong that the Java APIs were already being licensed and adapted by Sun at the time for mobile devices, and that the use by Google was commercial anyway. As to the second and third factor, Oracle argued the APIs represent a lot of skill and creativity, and that Google did not have a right to use exact lines of Java code or the overall structure, sequence, and organization of the 37 APIs.  In addition, Oracle argued, 11,000 lines of code is still a significant amount of code.  For the fourth factor, Oracle argued that the success of Android shows harm to the market because Oracle would have been able to license its Java code in the mobile space if Google had not copied its APIs without permission.

On May 26, after three days of deliberations, the jury came back with a unanimous verdict in favor of Google, finding Google’s use of the Java APIs in Android to constitute fair use.  Regardless, the case is still far from over as Oracle has already said it will appeal to the Federal Circuit.  Oracle’s appeal will likely focus on the District Court’s jury instructions and how closely those instructions capture the Federal Circuit and Ninth Circuit’s application and analysis of fair use.  Moreover, no matter which way the Federal Circuit goes, we can expect the losing party to ask the Supreme Court to review the issue.  So, while the current result is a big win for Google and other supporters of open-source software, the road to final resolution of this issue is still a long one.