Tag: Intellectual property

Target Wins Rehearing of IPR Joinder Decision with Expanded Panel

Schwegman Lundberg Woessner

Last fall, the Patent Trial and Appeal Board (PTAB or Board) interpreted the IPR joinder provision, 35 U.S.C. § 315(c), to require joinder requests by a non-party to an ongoing proceeding.  (Target Corp. v. Destination Maternity Corp., IPR2014-00508 and IPR2014-00509.)  Prior to that decision,  the Board had interpreted § 315(c) to allow for issue joinder by the petitioner of the original proceeding (see, for example Microsoft v. Proxyconn, IPR2013- 00109).  Of course, joinder was decided on a case-by-case basis, but had not previously been denied because the request was made by the petitioner of the original proceeding.

Target Corp. filed rehearing requests in both affected IPR proceedings in an effort to have the Board reconsider its interpretation of  35 U.S.C. § 315(c) with an expanded panel.  Target’s arguments are quite clearly stated in its Motion for Rehearing.  The Board granted Target’s rehearing request.  In a 4:3 decision,  the majority agreed that § 315(c) had been overly narrowly interpreted in the prior decision:

Turning now to the merits of the Request for Rehearing, the contention at the heart of Petitioner’s request for rehearing is that the denial of its Motion for Joinder was “based on an erroneously narrow interpretation of 35 U.S.C. § 315(c).” Paper 22, 1. We agree with Petitioner.

The majority read § 315(c)’s reference to “any person who properly files a petition under section 311” in conjunction with § 311′s requirement that the petition filer not be the patent owner, to broadly interpret § 315(c) to include any person except the patent owner.  This interpretation is at odds with the dissent’s analysis, which reads § 315(c)’s reference to “may join as a party” to literally require a new party for joinder:

The statute under which Petitioner seeks relief provides:

(c) JOINDER.—If the Director institutes an inter partes review, the Director, in his or her discretion, may join as a party to that inter partes review any person who properly files a petition under section 311 that the Director, after receiving a preliminary response under section 313 or the expiration of the time for filing such a response, determines warrants the institution of an inter partes review under section 314.

35 U.S.C. § 315(c) (emphasis added). The statute does not refer to the joining of a petition or new patentability challenges presented therein. Rather, it refers to the joining of a petitioner (i.e., “any person who properly files a petition”). Id. Further, it refers to the joining of that petitioner “as a party to [the instituted] inter partes review.” Id. Because Target is already a party to the proceeding in IPR2013-00531, Target cannot be joinedto IPR2013-00531.

While the majority decision does align with panel decisions on joinder prior to Target, one must ask whether this issue is finally resolved by this expanded panel decision.  For example, what happens if another panel does not follow this interpretation § 315(c)?  Or suppose this decision is appealed; would the Federal Circuit reverse a Board decision on joinder as it relates to institution given its recent interpretation of 35 U.S.C. § 314(d) in In re Cuozzo Speed Technologies? (“We conclude that § 314(d) prohibits review of the decision to institute IPR even after a final decision. . . . Section 314(d) provides that the decision is both ‘nonappealable’ and ‘final,’ i.e., not subject to further review. 35 U.S.C. § 314(d).”)  Would a Federal Circuit appeal have to be in the form of a petition for writ of mandamus?  If so, how would that square with the mandamus decisions in In re Dominion Dealer Solutions, LLC, 749 F.3d 1379, 1381 (Fed. Cir. 2014)(mandamus relief not available to challenge the denial of a petition for IPR) and in In re Proctor & Gamble Co., 749 F.3d 1376, 1378–79 (Fed. Cir. 2014)(mandamus relief not available to provide immediate review of a decision to institute IPR)?

ARTICLE BY

Timothy Bianchi
OF
Schwegman, Lundberg & Woessner, P.A.

Practice Considerations Post Teva v. Sandoz

Sterne, Kessler, Goldstein & Fox P.L.L.C. - Attorneys at Law

In Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., No. 13-854, slip op. 574 U.S. __ (2015), the U.S. Supreme Court ruled that underlying factual issues resolved while formally construing a disputed patent claim term at the district court level are subject to a clear error standard of review as opposed to a de novo standard.

The Patent at Issue

The litigated patent claimed a method for manufacturing Copaxone, Teva’s multi-billion dollar a year drug used in the treatment of multiple sclerosis. Sandoz, as a generic pharmaceutical challenger under the Hatch-Waxman Act, attacked the patent as indefinite because it contained claim language describing an active pharmaceutical ingredient having a “molecular weight of 5 to 9 kilodaltons.” Although three accepted definitions1 exist in the relevant art to calculate “molecular weight,” the method of calculation to be used was not described in the claim, the patent specification, or the prosecution history. The district court took evidence on this issue, namely through extrinsic expert testimony, and ruled that “molecular weight” would have been calculated by determining the “peak average molecular weight.” Accordingly, the district court held the phrase to be definite and accepted the understanding advanced by Teva’s expert. The Federal Circuit, however, reversed and held that the claim was indefinite after reviewing the district court claim construction de novo.

The Supreme Court’s Decision

In the majority opinion, authored by Justice Breyer, the Court explained that claim construction may involve both legal and factual elements that could necessitate differing levels of appellate scrutiny. Specifically, if a patent claim term is construed based upon the intrinsic evidence alone (i.e., patent claims, specification, and prosecution history), the determination is exclusively one of law, subject to de novo review. However, if the intrinsic evidence is not dispositive of the meaning of a claim term, then extrinsic evidence can be consulted (e.g., expert testimony, technical dictionary definitions, etc.) to better understand the meaning of the term. It is these underlying “facts” relating to extrinsic evidence that are reviewed according to the clear error standard. The Court reasoned that the District Judge, having presided over the entire proceeding, has a comparatively greater familiarity with the “specific scientific problems and principles” than the appellate court and should be afforded deference on factual findings. While the new scheme announced by the Court changes the standard of review for subsidiary factual matters, the ultimate issue of claim interpretation will still be reviewed de novo.

What is the Significance of Teva v. Sandoz?

The holding in Teva could have broad-ranging implications for clients in the procurement and enforcement of their patent rights. Below are a few examples of how the decision could impact current patent practice.

As an initial matter, patent owners should pay particular attention to the sufficiency of the disclosure with regard to key elements of the claims and consider specifically defining these elements in the specification through, for example, the use of a glossary. Such a strategy could help avoid protracted battles of the experts that could result in claim terms being redefined in ways never intended by the patent owner. While this approach has the potential to narrow claim scope, and may require additional time and expense during patent prosecution, it could result in a stronger, more effective patent less susceptible to post-Teva based challenges.

In the context of litigation, the Teva decision could provide motivation for litigants to create “factual issues” that are determinative of claim construction. Patentees, for example, may be tempted to try and broaden the scope of their claims by creating ambiguities in claim language in order to advance constructions that were never originally intended but may now be supported by extrinsic evidence. Alternatively, accused infringers may attempt to create as many factual disputes as possible with regard to the meaning of a claim in an effort to lock the patent owner into an unfavorable finding. Regardless of the motivations of the parties, district courts will likely become more attentive to these issues knowing their claim construction determinations could be afforded a higher standard of review. It is possible that the Teva decision could even result in broader acceptance among district court judges of “trial-like” Markman hearings with submission of expert testimony and extrinsic evidence at the claim construction stage.

Finally, in light of the changing claim construction standard of review in federal courts, parties (petitioners) should consider how this will impact the use and significance of inter partes review (IPR) proceedings. For example, IPR proceedings provide petitioners with a “broadest reasonable interpretation” standard for claim construction, while also allowing petitioners to submit an expert declaration in support. Since patent owners are typically not given an opportunity to submit a rebuttal expert declaration before the Board institutes trial, this can provide a preliminary advantage for petitioners attempting to secure a favorable construction, as an initial finding on claim construction is usually made as part of the institution process. Moreover, the patent owner may find it difficult to overturn the initial claim construction inertia, whether during the postinstitution phase or on appeal after a final decision on the merits has been made by the Board.

Many questions remain in the wake of Teva, as patent owners and challengers alike will be faced with new claim construction strategy scenarios relying on extrinsic evidence.

ARTICLE BY

Daniel E. Yonan
Jon E. Boljesic
OF
Sterne, Kessler, Goldstein & Fox P.L.L.C.

 1 The three accepted definitions to determine “molecular weight” included a (1) peak average molecular weight; (2) number average molecular weight; or (3) weight average molecular weight.

US Supreme Court Holds that Juries Should Decide the Issue of Trademark Tacking

Mintz Levin Law Firm

In the first substantive trademark decision it has issued in a decade, the US Supreme Court, in  Hana Financial, Inc. v. Hana Bank, case number 13-1211 (January 21, 2015), affirmed the Ninth Circuit by holding that whether two marks may be tacked for purposes of determining priority is a question for the jury.

The case involved two organizations providing financial services to individuals in the United States. The Respondent Hana Bank had been operating under that name in Korea since 1991, and first began to advertise its services to Korean expatriates in the US in 1994. Advertisements for those services in the US first appeared in Korean and in English under the name “Hana Overseas Korean Club,” and included the name “Hana Bank” in Korean. In 2000, it changed the name of “Hana Overseas Korean Club” to “Hana World Center,” and in 2002 began operating a bank in the United States under the name “Hana Bank.” This latter enterprise was its first physical presence in the United States.

Petitioner Hana Financial was established in 1994 as a California corporation and began using that name and an associated trademark in 1995. In 1996, it obtained a federal trademark registration for a logo design incorporating the name “Hana Financial” for use in connection with financial services.

In 2007, Hana Financial sued Hana Bank alleging trademark infringement. Hana Bank denied infringement by claiming that under the tacking doctrine it had priority of use of the mark “Hana” for financial services in the United States. The trial jury found in favor of Hana Bank and the Ninth Circuit affirmed that decision on appeal. Since there was a split among the federal circuit courts as to whether tacking should be decided by juries or judges, the Supreme Court granted Hana Financial’s writ of certiorari.

So what is “tacking”? The general rule is that use of two marks may be “tacked together” for purposes of establishing priority of use when the original mark and the revised mark are “legal equivalents.” Marks are “legal equivalents” when they “create the same, continuing commercial impression” so that consumers “consider both as the same mark.” There is no dispute that the commercial impression that a mark conveys must be viewed through the eyes of the consumer. Thus, Justice Sotomayor, writing for a unanimous Court, stated that pursuant to long recognized doctrine, “when the relevant question is how an ordinary person or community would make an assessment, the jury is generally the decisionmaker that ought to provide the fact-intensive answer.” Accordingly, the Court held that when the facts do not warrant entry of summary judgment or judgment as a matter of law on the question of tacking, the question of whether tacking is warranted must be decided by a jury.

The lesson here for trademark owners is to ensure that archival records of your use of your marks over time are diligently maintained. This will help ensure that in the event the mark is changed in any way for purposes of modernization or otherwise, you have sufficient evidence to prove your earliest date of first use of the “legally equivalent” mark to defend against claims of infringement.

ARTICLE BY

Susan Neuberger Weller
OF
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

The “Top Ten” Intellectual Property Stories of 2014 (Most “Definitely”)

Schwegman Lundberg Woessner

I don’t think I can recall a more action-packed year for intellectual property law in my career, much less during the almost six years that I have been writing this blog. I am trying to write this while in transit, so there will be few footnotes or cites, but they are easy enough to find in my past posts, or online. I am not even sure that I outlined ten stories before I started typing, but here goes — in no particular order.

1,2,3 and 4. Mayo meet Alice meet Myriad – The Tortuous Path of s.101.

Although only Alice was decided in 2014, the excitement really started with the unexpected release of the PTO “Life Sciences” Guidelines in March (No. 1 Story). The draft Guidelines directed Examiners to reject claims to products of nature unless they were significantly different in structure from the products in their natural states, and declared that simple “If A, then B” diagnostic claims were patent-ineligible as attempts to patent natural phenomena.

The Guidelines were continuously criticized as based on a misreading of the earlier Mayo and Myriad S.Ct. decisions and were released in a revised form in December (No. 2 Story) via publication for comment in the Fed. Reg. The revised Guidelines recognized that the standards for claiming diagnostic tests were in flux but permitted consideration of functional differences in resolving the PE of natural products.

However, only a few days later, in U. of Utah Res. Fndn v. Ambry, (No. 3 Story) the Fed. Cir. held that primers could not be patented if not structurally changed from their natural sequence. Judge Dyk, writing for the panel, simply misread Myriad as holding that no isolated product of nature — as opposed to no naturally occurring DNA — could be patented unless it was markedly different than in its natural state. This decision followed the earlier invalidation of the claims to Dolly the cloned sheep in In re Roslin in which Judge Dyk, declared that no naturally-occurring living organism is patentable. The Utah panel also held that claims to comparing a subject’s DNA sequence to a reference sequence, wherein the claim also recited PCR amplification or probing, did not escape the Mayo requirement for an additional inventive concept in additional to the abstract idea of comparing sequences. This decision is ripe for rehearing en banc, if only to correct Judge Dyk’s manifest misreading of Myriad (and to keep the PTO Guidelines under some judicial control).

The title of this “news story” is meant to point up the tsunami-like “abstract idea” judicial exception to s. 101 patent-eligibility (PE). The Mayo v. Prometheus decision only mentions “abstract idea” once, and it is to cite to an earlier decision. The S. Ct. in Mayo reversed the Fed. Cir., holding that a claim reciting a natural phenomenon was required to recite some further inventive concept in order to be “significantly more” than a claim preempting use of the phenomenon. In Bilski, the Fed. Cir. fashioned the “machine or transformation test”. Judge Rader’s dissenting argument that a claim to hedging commodity risk was no more than an attempt to claim an abstract idea. The S. Ct. agreed with Judge Rader.

In Alice Bank, (No. 4 Story) the S. Ct. managed to marry the Mayo “test” for PE to the abstract idea exception of Bilski. The Court applied a two-step test. First, decide if a claim involves an abstract idea and then examine the claim to see if it contains significantly more than elements that are conventional and routine in the relevant art. Now, enter Utah Res. Foundation (Myriad) v. Ambry. While Ambry argued that the diagnostic claims were no more than an attempt to claim a natural phenomenon (mutations in DNA), the Fed. Cir. took a different tack and looked to itsMyriad decision for guidance.

And, lo and behold, at the Fed. Cir. level, Judge Lourie wrote that the DNA comparison claims were not PE, since they were directed to an abstract idea(!) So the Fed. Cir., simply applied the Mayo test as articulated in Alice and invalidated the method claims asserted by Myriad as attempts to claim an abstract idea, albeit with a bit of window dressing (PCR and probing). In the coming year, I can only hope that the PE of a simple “If A, then B” diagnostic claim will be resolved. And I also hope that Judge Breyer is not writing for the majority.

5. Kimble v. Marvel. The S. Ct. granted cert. to revisit the question of whether or not a requirement that a licensee pay post-expiration date royalties for a patent license is per se illegal (as it is presently).

6. Nautilus v. Biosig. While the S. Ct. tried to raise the bar for meeting s. 112(b) by requiring that claim elements be defined with “reasonable certainty,” rather than by the Fed. Cir.’s requirement that the meaning of the element not be “insolubly ambiguous” or “amenable to construction.” It is not at all clear where the new bar has been set.

7. Teva v. Sandoz. The S. Ct. granted cert. to resolve the question of whether or not it is proper for the Fed. Cir. to conduct de novo review of the district courts’ factual findings during claim construction. By the way, what is a mixed question of law and fact and how is a court to review them separately? Appeal to the Fed. Cir. and find out!

8. American Calcar v. American Honda Motors. This convoluted case stands for the observation that the inequitable conduct defense has risen from the grave of legal doctrines, to which it had been consigned by many commentators. Still, to prevail on this defense, a defendant is greatly assisted by the presence of a single (or perhaps two) “bad actors” who do things like try to patent a competitor’s drug — which, remarkably was the factual posture of two cases before the Fed. Cir. last year. You can advocate with vigor; just don’t lie.

9. Commil v. Cisco. Although the question present in the granted petition for cert. seems narrow (To what extent can evidence of a good faith belief in non-infringement negate the element of intent required to induce infringement?), this appeal is evidence that the S. Ct. is not yet tired of the challenges posed by Title 35.

10. Progress in Regulations Affecting Bringing Biosimilars to Market. In August, the FDA released its “Purple Book” listing approved reference products and actually accepted an application for a biosimilar “generic”. While some commentators feel that it will be more effective to re-conduct phase III trials than to try to navigate the hostile regulatory hurdles thrown up by the agency, the availability of biosimilar drugs seems inevitable.

ARTICLE BY

Warren Woessner
OF
Schwegman, Lundberg & Woessner, P.A.

The USPTO’s New Guidance Simplifies Prosecution by Clarifying Subject-Matter Eligibility of Patents

Armstrong Teasdale Law firm

The U.S. Patent and Trademark Office (PTO) issued new guidance on Dec. 8, 2015 that provides improved clarity to those prosecuting patent applications in the computer-implemented and biochemical arts. Although many questions remain on the issue of subject matter eligibility, this guidance will be a useful tool to move prosecution of such applications past rejections under 35 U.S.C. § 101. It is available here.

The Interim Guidance on Patent Subject Matter Eligibility (the “Guidance”) will be available to examiners for prosecution immediately. This long-awaited document aims to provide better clarity on the subject matter eligibility of computer-implemented patents and patents in the biological, chemical and biochemical arts. For the past several months, navigating the eligibility of such patent applications has been difficult, in part due to unclear PTO rules and procedures following the Supreme Court decisions of Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014) and Mayo Collaborative Serv. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012).

The Guidance primarily focuses on adding details to the two-step subject matter eligibility test of Alice Corp. and Mayo. The first step of this test is to “determine whether the claim is directed to a law of nature, a natural phenomenon, or an abstract idea.” Here, the Guidance affirms the PTO’s broad power to find claims pending before the office as being directed to such judicially created exceptions.

Although the Guidance provides several examples of abstract ideas and natural phenomenon, it is clear that these examples are non-limiting. As such, the Guidance confirms the substantial discretion that has been used by examiners, courts and the Patent Trial and Appeal Board (PTAB) to find that claims are directed to abstract ideas or laws of nature. In light of this broad discretion, applicants should avoid only arguing that their claims are not directed to such exceptions. Such arguments will likely fail, therefore applicants should not rely solely on this approach.

The second step is to “determine whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exception.” The Guidance provides applicants with new methods of showing “significantly more” than previously provided.

First, the Guidance re-affirms the validity of the “machine or transformation” test. Specifically, “applying the judicial exception with, or by use of, a particular machine” and “effecting a transformation or reduction of a particular article to a different state or thing” both can constitute “significantly more” than the abstract idea, law of nature or natural phenomenon. Second, the Guidance states that “adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application” may also constitute “significantly more”.  This language appears to give PTO examiners significant latitude to overcome rejections under 35 U.S.C. § 101.

The Guidance also clarifies that “extrasolution activity” and “linking the use of the judicial exception to a particular technological environment or field of use” will not constitute “significantly more”, resolving an open question since Alice Corp. It also specifies that when a claim recites “a plurality of exceptions,” failing to find “significantly more” for any one of those exceptions will cause the claim to fail subject matter eligibility.

Additionally, the Guidance provides a new option for applicants with claims that “clearly do not seek to tie up any judicial exception such that others cannot practice it.” Though the meaning of this statement is unclear, the PTO has offered an option of “streamlined eligibility analysis” for such claims.

There are some notable limitations to the Guidance. First, the Guidance does not constitute substantive rulemaking and lacks the force of law. As a result, examiners are not formally required to follow it. (Practically, however, we anticipate it will be used by most examiners.) Second, the Guidance is not binding on or applicable to litigation proceedings or proceedings at the Patent Trial and Appeal Board (PTAB). Third, these are truly “interim” guidelines.

We anticipate that final rules and laws are still in development and this area of law will continue to change over the coming months. More information on the Interim Guidance can be found here.

© Copyright 2014 Armstrong Teasdale LLP. All rights reserved

Post Holiday Trademark Sale!!!!!!!

Giordano Halleran Ciesla Logo

The USPTO announced that they are having a sale.  You can save $50 per class on all new trademark registration applications and $100 on all renewals.  The Final Rule issued on December 16, 2014 announced that trademark filing fees will be reduced.

Small Print:  Unfortunately, the discounts will not be effective in time for the holidays.  The new discounted fees don’t kick in until January 17, 2015.  In the good news department, the discounts will continue thereafter!

ARTICLE BY

Kurt E. Anderson
OF
Giordano, Halleran & Ciesla, P.C.

USPTO Issues New Subject Matter Eligibility Examination Interim Guidelines – Abstract Idea Guidance

Sterne Kessler Goldstein Fox

On December 15, 2014, the USPTO issued Interim Guidance for examination of subject matter eligibility under 35 U.S.C. § 101. These new guidelines largely follow the previous interim guidelines issued on June 25, 2014, in view of CLS v. Alice (2014), with some additional details. The new guidelines have also combined that earlier guidance for claims reciting abstract ideas with the March 4, 2014, guidance for claims reciting natural phenomena/laws of nature.

Under the new guidelines, the examiner will first determine whether the claim is directed to one of the four accepted statutory categories. If it does, examiners are instructed to apply the 2-part patent-eligibility analysis, as articulated by the Supreme Court in Alice. Examiners are instructed to apply the 2-part analysis to the broadest reasonable interpretation of the claims when analyzed as a whole. Importantly, the Guidance also confirms that “[e]very claim must be examined individually, based on the particular elements recited therein, and should not be judged to automatically stand or fall with similar claims in an application.”

Analysis for Software/Business Method Claims – Abstract Idea Guidance

To evaluate software and business method claims, the “abstract idea” analysis laid out in the Guidance will be the most relevant. To determine whether a claim recites an abstract idea, the 2-part Alice test is as follows: 1) determine whether the claims are directed to an abstract idea, and if they are, then 2) determine whether the claims recite additional elements that amount to significantly more than the abstract idea.

Part 1

In accordance with Alice, the Interim Guidance notes that fundamental economic practices, certain methods of organizing human activities, an idea ‘of itself,’ and mathematical relationships/ formulas are recognized as abstract ideas. Citing previous cases, the Interim Guidance provides examiners with specific examples of abstract ideas:

  • mitigating settlement risk (Alice);

  • hedging (Bilski);

  • creating a contractual relationship (buySAFE);

  • using advertising as an exchange of currency (Ultramercial);

  • processing information through a clearinghouse (Dealertrack);

  • comparing new and stored information and using rules to identify options (SmartGene);

  • using categories to organize, store and transmit information (Cyberfone);

  • organizing information through mathematical correlations (Digitech);

  • managing a game of bingo (Planet Bingo);

  • the Arrhenius equation for calculating the cure time of rubber (Diehr);

  • a formula for updating alarm limits (Flook);

  • a mathematical formula relating to standing wave phenomena (Mackay Radio); and

  • a mathematical procedure for converting one form of numerical representation to another

    (Benson).

Part 2

If no abstract idea is found in Part 1, then Part 2 need not be addressed. But if Part 1 identifies an abstract idea in the claims, Part 2 is considered. The Guidance stresses the importance of considering the claim as a whole, rather than addressing individual elements on their own.

The Guidance provides examples of limitations that may be enough to qualify as “significantly more” when recited in a claim. These examples include:

  • improvements to another technology or technical field;

  • improvements to the functioning of the computer itself;

  • applying the abstract idea with, or by use of, a particular machine;

  • effecting a transformation or reduction of a particular article to a different state or thing;

    • adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application; and

    • other meaningful limitations beyond generally linking the use of the abstract idea to a particular technological environment.

      These examples are consistent with the recent Federal Circuit Decision in DDR Holdings, LLC. v. Hotels.com (DDR).

      Limitations that do not qualify as “significantly more” include:

    • adding the words “apply it” (or an equivalent) with the abstract idea, or mere instructions to implement an abstract idea on a computer;

    • simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the abstract idea, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry;

    • adding insignificant extrasolution activity to the abstract idea, e.g., mere data gathering in conjunction with the abstract idea; and

    • generally linking the use of the abstract idea to a particular technological environment or field of use.

      2-Part Analysis Not Always Necessary

      According to the Interim Guidance, examiners do not need to perform the complete 2-part analysis when eligibility is self-evident. A full analysis may not be needed where the claims clearly do not preempt the abstract idea in such a manner that others cannot practice it. For instance, the interim guidelines note that a claim directed to a complex manufactured industrial product or process that recites meaningful limitations along with an abstract idea may sufficiently limit its practical application so that a full eligibility analysis is not needed. As an example, a robotic arm assembly having a control system that operates using certain mathematical relationships is not an attempt to tie up use of the mathematical relationships and would not require the examiner to perform the full 2-part analysis to determine eligibility.

    The Interim Guidance is effective on December 16, 2014 and is not legally binding. The USPTO is seeking public comments on this Interim Guidance along with additional suggestions on claim examples by March 15, 2015.

Federal Circuit’s Sandoz Decision Increases Importance of Post-Grant Proceedings to Biosimilar Developers

Sterne Kessler Goldstein Fox

On Friday, December 5, the U.S. Court of Appeals for the Federal Circuit rendered its decision in Sandoz v. Amgen, No. 2014-1693, a case with major implications for the emerging U.S. biosimilars industry. The decision addresses when and how a party seeking to launch a biosimilar product in the U.S. can initiate litigation to challenge the brand company’s potential blocking patents. This is the first instance in which the Federal Circuit has had the opportunity to address the scope and applicability of the Biologics Price Competition and Innovation Act (BPCIA), which established a formal pathway for biosimilar approval in the US.

Background

At issue in Sandoz is a litigation Sandoz, Inc. initiated against Amgen, Inc. and Hoffman-La Roche Inc. on June 24, 2013. Sandoz’s complaint seeks a declaratory judgment (DJ) that two patents owned by Roche and exclusively licensed to Amgen are invalid, unenforceable, and would not be infringed by the commercial marketing of Sandoz’s biosimilar version of Amgen’s blockbuster biologic product Enbrel® (etanercept). The patents at issue extend Amgen’s protection around etanercept an additional 15 years past the original patents. Sandoz filed its complaint against Amgen prior to filing any application with the FDA for approval to market its biosimilar etanercept product, which is currently in Phase III clinical trials. Sandoz will not file with the FDA until the Phase III trial is complete, and of course will not be able to market its version of etanercept in the US without FDA approval. At the time of suit, Amgen had not alleged Sandoz was currently doing anything that exposes it to liability for infringing Amgen’s patents rights around Enbrel®.

The District Court Decision

Amgen moved to dismiss Sandoz’s complaint, asserting that the court lacked jurisdiction to hear the case because no immediate and real controversy between the parties exists. In a brief order, the court granted Amgen’s motion to dismiss on two separate grounds. First, the court ruled that its discretion to enter a DJ in the case is subject to the provisions of the BPCIA, which sets specific limitations on the timing and conduct of any litigation arising from the filing of an application for approval to market a biosimilar. The court concluded that “neither a reference product sponsor, such as Amgen, nor [a biosimilar applicant] such as Sandoz, may file a lawsuit unless and until they have engaged in a series of statutorily–mandated exchanges of information” related to patents potentially in dispute. In this case, Sandoz had not complied with the exchanges as it had not even started the process by filing its application with the FDA.

Second, the court found that Sandoz had not established jurisdiction under traditional grounds because it had not established a real and immediate injury or threat of future injury caused by Amgen. The court noted that Amgen had never advised Sandoz that it intended to sue Sandoz, and that the mere allegation by Sandoz that it intended to file an application for FDA approval in the future was not sufficient to create a case on controversy. Sandoz appealed the district court order dismissing the action.

The Federal Circuit Decision

On appeal, Sandoz argued that the litigation provisions of the BPCIA only govern the statutory patent infringement litigation authorized by the Act after a biosimilar application is filed with the FDA, and do not apply to DJ actions in general. Sandoz further argued that nothing in the BPCIA can be construed to bar or limit in any way the ability to bring DJ actions to resolve patent disputes prior to filing a biosimilar application. Finally, Sandoz argued that the district court erred in concluding that Sandoz had not adequately demonstrated a sufficient actual case or controversy sufficient to allow the DJ action to proceed.

The Federal Circuit panel affirmed the district court’s dismissal of Sandoz’s complaint, concluding that Sandoz had not alleged an injury of sufficient immediacy and reality to create subject matter jurisdiction. The Federal Circuit noted that “a case of actual controversy” is a prerequisite to exercising declaratory judgment jurisdiction. The test for determining whether a case or controversy exists is whether “ there is a substantial controversy . . . of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.” The Federal Circuit, however, declined to address the lower court’s interpretation of the BPCIA as barring a lawsuit by either the reference product sponsor or the biosimilar applicant unless and until the parties have engaged in the statutorily-mandated patent information exchanges.

In concluding that Sandoz’s complaint does not present a case or controversy, the Federal Circuit panel noted that there was no prior decision in which the Federal Circuit had found a case or controversy to exist when the only activity that would create exposure to potential infringement liability was a future activity requiring FDA approval that had not yet been sought. The court found the immediacy requirement lacking where the conclusion of Sandoz’s Phase III trial, which was a prerequisite for filing for FDA approval, was still several years away when Sandoz filed suit. The court refused to assume that the Phase III trial would be successful, and noted that the trial could in fact uncover issues with Sandoz’s product that could push the application filing date back even further. Alternatively, the clinical trial could fail resulting in Sandoz never seeking FDA approval, or Sandoz could modify its proposed product and file for approval on the modified product. The court also noted that Sandoz’s complaint lacked specificity as to how Amgen’s patents read or don’t read on Sandoz’s product; and instead relies on prior general assertions by Amgen that the patents at issue cover Enbrel, that Amgen will assert the patents against products that compete with Enbrel, and that Sandoz intends to market a competing product at some point in the future. Ultimately, the court concluded that the events allegedly exposing Sandoz to infringement liability may not occur as anticipated or may not occur at all. The court found that Sandoz also had not shown that it would suffer any “immediate and substantial adverse impact” from not being able to seek or secure a patent adjudication before filing its application for FDA approval.

Unanswered Questions

The Federal Circuit specifically stated that its decision was limited to the particular facts before it, and does not address whether Sandoz would be able to seek declaratory judgment jurisdiction once it files its FDA application, or whether the BPCIA forecloses declaratory judgment actions outside of the statutorily-mandated patent information exchange once the application is accepted by the FDA. The decision also did not clarify the additional issue disputed by the parties concerning what constitutes sufficient “notice of commercial marketing,” which the BPCIA states must be provided by the biosimilar applicant prior to launch.

Increased Important of Post-Grant Proceedings before the USPTO

Although the Sandoz court made a point to limit the scope of its decision to the facts before it, the decision casts substantial doubt on the ability of any biosimilar developer to bring a district court action challenging the reference product sponsor’s patents prior to filing a biosimilar application with the FDA and triggering the patent information exchange provisions of the BPCIA. At the same time, the decision elevates the importance to biosimilar developers of post-grant challenges before the U.S. Patent and Trademark Office, such as inter partes review (IPR) and post-grant review (PGR), as means for obtaining some degree of early patent certainty before initiating the FDA approval process. IPRs in particular have proven to be a potent weapon for generic drug manufacturers in the context of ANDA litigation. The lower standard of proof required to show invalidity, the expedited pace of the proceedings, and the decreased cost in comparison to district court litigation coupled with the extremely high rate in which patent claims are being invalidated provide generic manufacturers with tremendous leverage to obtain favorable settlements with brand companies. We expect that the Sandoz decision should only increase the speed with which post-grant proceedings are adopted in the biosimilar arena.

ARTICLE BY

Timothy J. Shea, Jr., PhD.
Paul A. Calvo
OF
Sterne, Kessler, Goldstein & Fox P.L.L.C.

U.S.-Centered Negotiations for Product Made and Sold Outside United States Do Not Constitute Sale or Offer for Sale in United States

Mcdermott Will Emery Law Firm

Halo Elecs., Inc. v. Pulse Elecs., Inc. and Pulse Elecs. Corp.

In a case exploring the limits of what constitutes a sale or offer for sale “within the United States” under 35 U.S.C. § 271(a), the U.S. Court of Appeals for the Federal Circuit found that sales were carried out outside of the United States and, even though they were partially negotiated in the United States, did not constitute an infringement of U.S. patent rights under § 271(a).  Halo Elecs., Inc. v. Pulse Elecs., Inc. and Pulse Elecs. Corp., Case Nos. 13-1472; -1656 (Fed. Cir., Oct. 22, 2014) (Lourie, J.) (O’Malley, J., and Hughes, J., concurring).

Halo accused Pulse of infringing its patents related to surface mount electronic packages containing transformers for mounting on a printed circuit board.  Pulse’s products were manufactured in Asia and the majority of its products were delivered to customers in Asia.  Pulse received the purchase orders for these products abroad.  However, Pulse engaged in pricing negotiations with its customers in the United States, and Pulse’s U.S.-based employees had to approve prices quoted by its agents when those prices fell beneath a threshold.  The district court granted Pulse summary judgment of non-infringement finding that its activities for these sales were insufficient to constitute a sale or offer for sale “within the United States.”  After a trial finding that the same products that did enter the United States infringed Halo’s patents, the district court found Pulse’s substantial invalidity defense negated the objective prong of willfulness under In re Seagate.  Halo appealed.

On appeal, the Federal Circuit panel affirmed that Pulse’s U.S.-based activities for its products manufactured and sold in Asia were not sales or offers for sale “within the United States.”  The Court noted that while a sale is not necessarily limited to the place of transfer of the tangible property, but may also be determined by the place where agreement to such a transfer takes place, extraterritorial applications of U.S. patent law were disfavored.  The Court found it was undisputed that the products at issue were manufactured, shipped and delivered abroad; that the purchase orders were received abroad; that the negotiations that occurred in the United States did not constitute a firm agreement to buy and sell; and that Pulse was paid abroad for its products.  Based on these facts, the Court found it need not reach Halo’s argument that the place of formation of a contract can be determinative of whether a sale has occurred “within the United States.”  The Court further explained that for an offer to sell to constitute infringement, the offer must be to sell a patented invention within the United States, and that Pulse’s actions therefore did not constitute an offer for sale cognizable under the Patent Act.  Finally, the panel affirmed the district court’s finding of no willfulness, agreeing that Pulse’s presentation of a substantial invalidity defense at trial negated the objective prong of the willfulness test.

Practice Note: In a concurrence, Judge O’Malley and Judge Hughes, while agreeing with the finding of no willfulness under current case law, urged the full court to reexamine its enhanced damages jurisprudence in light of the Supreme Court of the United States’ decisions in Highmark v. Allcare Health Management Sys., and Octane Fitness v. ICON Health & Fitness.  Specifically, the concurrence urged reconsideration of the two-part subjective/objective test required under Seagate; the requirement that willfulness be proven by clear and convincing evidence; whether de novo review is the appropriate standard on appeal; and whether willfulness must be decided by the court as a matter of law.

ARTICLE BY

Christopher L. May
OF
McDermott Will & Emery

Antares Pharma Bolsters the “Original Patent” Rule for Reissued Patents

Michael Best Logo

On November 17, the Federal Circuit decided Antares Pharma, Inc. v. medac Pharma Inc., holding reissued patent claims invalid for failing to comply with the “original patent” requirement of 35 U.S.C. § 251. The court’s decision casts a spotlight on the original patent rule and reinvigorates the little-used doctrine as an invalidity defense against reissued patent claims.

In Antares Pharma, the plaintiff alleged infringement of U.S. Patent RE44,846. Specifically, the plaintiff asserted four claims that had been added through reissue proceedings to broaden the original patent. The original claims were directed to various embodiments of a jet injection device, and the asserted reissue claims covered particular safety features for any injection device. The patentee sought a preliminary injunction, which the district court denied. The court found substantial questions of validity regarding whether the reissued claims impermissibly recaptured subject matter surrendered during prosecution to obtain the original claims.

On appeal, the Federal Circuit declined to address the recapture issue. The court instead decided the case by invoking the original patent rule, an issue that had been argued but not resolved below.

Section 251, which governs reissue applications, states in pertinent part that where a patentee has by error claimed more or less that it had a right to claim in a patent, the Patent Office will “reissue the patent for the invention disclosed in the original patent.” The italicized provision had previously been applied in a manner analogous to the written description requirement to require that reissue claims found adequate support in the disclosure of the original patent. In Antares Pharma, however, the Federal Circuit turned to Supreme Court precedents dating back as far as 1854 to read a more stringent standard into the “original patent” provision of § 251. In particular, the court held that whether or not the written description requirement was satisfied, “the specification must clearly and unequivocally disclose the newly claimed invention as a separate invention.”

Applying that standard to the reissue claims on appeal, the court not only affirmed the denial of a preliminary injunction, but also held the asserted reissue claims invalid as a matter of law. The court concluded that the safety features claimed during reissue were never described separately from the jet injector or disclosed in the particular claimed combinations. Because the original specification lacked “express disclosure” of the exact embodiments recited in the reissue claims, those claims failed to satisfy the original patent requirement.

The Antares Pharma decision provides guidance to potential reissue applicants and offers a significant new weapon for parties accused of infringing a reissued patent. For patentees, the decision expands the risks associated with using a reissue application to seek supplemental or complementary patent protection—the reissue applicant not only risks intervening rights and undesirable modification or loss of previously issued claims, but now faces a heightened requirement, not applicable to continuing applications, for clear and unequivocal disclosure of the newly claimed subject matter as a separate invention. To the extent practical, new applications should clearly set forth each potential invention with detailed examples. For parties accused of infringement, the exacting Antares Pharma standard will provide an additional, robust basis for validity challenges against asserted reissue claims during litigation.

ARTICLE BY

Andrew T. Dufresne
Marshall J. Schmitt
OF
Michael Best & Friedrich LLP