Allowing Amendments in AIA Trials

Prolitec v. Scentair Tech (Fed. Cir. 2017) [ProlitecDecision]

In a one paragraph en banc order, the Federal Circuit has vacated the panel’s decision here and remanded to allow claim amendments. The court writes:

In light of this court’s en banc decision in Aqua Products, Inc. v. Matal, No. 2015-1177, 2017 WL 4399000 (Fed. Cir. Oct. 4, 2017) (en banc), the portions of the panel’s and Patent Trial and Appeal Board’s decisions in this case concerning Prolitec’s motion to amend are vacated, see Prolitec, Inc. v. ScentAir Techs., Inc., 807 F.3d 1353, 1362- 65 (Fed. Cir. 2015) (Majority Op. Part III); ScentAir Techs., Inc. v. Prolitec, Inc., IPR2013-00179, Paper No. 60, 2014 WL 2965704, at *15-17 (P.T.A.B. June 26, 2014) (Final Written Decision Part III), and this case is remanded to the Board for further proceedings consistent with Aqua.

Since this case raised the same issues as Aqua, the Federal Circuit had been sitting on the en banc petition for the past year awaiting outcome of that case.

I’ll note here that the decision by the Federal Circuit was unanimous.  Although many of the judges disagreed with the Aqua decision, they all now regard it as the law and binding precedent of the court.

IPR: Proving Patentability before Amendment

Do you get the Gist: Tracking Mail is an Abstract Idea

Secured Mail v. Universal Wilde (Fed. Cir. 2017)

The district court dismissed this case for failure to state a claim upon which relief can be granted – R.12(b)(6) – after finding that the claims of all seven asserted patents were ineligible under 35 U.S.C. 101.  On appeal, the Federal Circuit has affirmed.  U.S. Patent Nos. 7,814,032, 7,818,268, and 8,073,787 (“Intelligent Mail Barcode”); Nos. 8,260,629 and 8,429,093 (“QR Code”); and Nos. 8,910,860 and 9,105,002 (“Personalized URL”).

The patents all involve an mailer (i.e. package or envelope) with an identifier on the outside such as a barcode, QR code, or URL.  Once delivered, information is communicated (via computers) to the recipient about the contents and the sender.

As Patently-O readers understand, abstract ideas themselves are not patentable. Likewise a patent directed to an abstract idea is also unpatentable, unless the claims include an additional inventive concept that goes beyond the unpatentable idea to “transform the nature of the claim into a patent-eligible invention.” Alice.

The Alice two-step inquiry first asks whether the claims are directed to an abstract idea.  Here, the courts agreed that the claims “are directed to the abstract idea of communicating information about a [mailer] by use of a marking.”  Under Step Two, the appellate panel found that the claims merely recited “well known and conventional ways to allow generic communication between a sender and recipient using generic computer technology.”  Invalid.

I have included claim 1 of the ‘002 patent below (issued post-Alice):

 

1. A method for providing electronic data to a recipient of a mail object, comprising:

using an output device to affix a single set of mail ID data to said mail object, said single set of mail ID data including at least recipient data, said recipient data comprising a personalized network address associated with said recipient of said mail object;

submitting said mail object to a mail carrier for delivery to said recipient of said mail object;

receiving said recipient data from a reception device of said recipient via a network; and

providing by at least one processor said electronic data to said reception device via said network in response to receiving said recipient data, said electronic data comprising a sender’s web page that identifies said recipient of said mail object and includes data corresponding to a content of said mail object;

wherein said electronic data is configured to be displayed to said recipient via a web browser on a display of said reception device.

Note – the patentee has at least one additional patent issued in the family (US 9,390,394). However, that new patent does not appear to include any new inventive elements that go beyond the prior family members.

Read it and weep: [Federal Circuit Opinion]

I’ll note here that I believe the force behind the patentee is patent attorney Todd Fitzsimmons who also runs his own LA County patent firm.

 

Percent of US-Originated Patents That Claim Priority to a Provisional Application

ProvisionalApps

For the chart above shows the percentage of US-originated utility patents that claim priority to one or more provisional filings, grouped by year of issuance.   You’ll note the steady upward trend – each year more US utility patents rely upon provisional applications for that effective filing date.

Note – to find US-originated utility patents I simply excluded utility patents that included a priority claim to a foreign application filing.

Oil States and SAS arguments set for November 27

Oral arguments for both Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, No. 16-712 and SAS Institute Inc. v. Matal, No. 16-969, have been set for November 27, 2017.

Oil States challenges the AIA trial system at its most fundamental level — arguing that the Constitutional principles prohibits an administrative agency such as the USPTO from cancelling established property rights, such as those embodied by issued patents.

In SAS, the focus is on a narrow but important element of IPRs – whether the Board is “required to issue a final written decision as to every claim challenged by the petitioner.”  SAS is the IPR petitioner who challenged the claims of U.S. Patent No. 7,110,936 owned by ComplementSoft.  USPTO is also a respondent in the case (Matal) and is being represented by the US Solicitor General.

Both cases involve two private parties (patentee and challenger) as well as the government (USPTO) who intervened on appeal to support the PTAB’s decision-making.  In SAS, the PTO denied patentee ComplementSoft’s motion for divided arguments and at this point it is unclear to which Respondent will get to argue before the court.

SCOTUS

Application Pendency

AppPendency

The chart below shows the pendency timing for issued US patents — looking particularly at the time from priority filing (including foreign priority claims) until issuance of the US patent.  To smooth the chart a bit, I excluded the 0.2% of patents with the longest patent term — these were all > 20 year terms and had the tendency of substantially skewing the picture. The chart below shows the long tail skew for patents issued thus far in 2017.

DistributionPendency

Impact of the 15-year Design Patent Term

If I were preparing to file a design patent around early May 2015, I might have held-off a bit on the filing to pass the May 13, 2015 threshold.  Design patents stemming from applications filed on or after that date have a 15-year patent term (calculated from patent issuance) as opposed to a 14-year term for those filed prior to the threshold date.

When I looked at the numbers, I was surprised to find that the extra year did not capture the hearts of design patent filers as I might have expected. (See Chart below.) Yes, filings on the 13th of May were above average and the preceding two days were below average, but the first look here that few filers acted to game that extra year.

DesignPatents15Year

 

 

 

Regeneron v. Merus: En Banc Chances Rise

by Dennis Crouch

Prof. Hricik and I have both previously written about the Regeneron inequitable conduct decision.  The following short summary comes from Hricik:

[The] district court … held that people substantively involved in prosecution of the ‘018 Patent knew of but-for material references, which were not disclosed.  Although the district court had intended to hold a separate trial on intent to deceive, instead it held that the patentee’s discovery abuses (and other apparent misconduct) warranted an adverse inference of intent to deceive.  The discovery abuses were related to the inequitable conduct issue.  Accordingly, it held the patent unenforceable for inequitable conduct.

The panel split (Judge Newman dissenting), but affirmed 2-1, holding that the withheld art was in fact but-for material and that the district court had not abused its discretion by, under regional circuit law, imposing an adverse inference (more on that, the key and troublesome issue, below).

In my prior essay, I wrote that “[t]he case may be a wake-up-call for some litigators who will read through the list of misconduct and see it as only business-as-usual.”

Inequitable Conduct and Regeneron Pharmaceuticals, Inc. v. Merus N.V.: Trouble Waiting to Happen

Important Inequitable Conduct Case: Hybrid Prosecution/Litigation Misconduct

En Banc Petition: The patentee has petitioned for en banc rehearing — directly challenging the holding:

Questions Presented: (1) whether a district court may find that the patentee had specific intent to deceive the Patent and Trademark Office (PTO) based on misconduct by trial counsel, without relying on any actual evidence of intent to deceive the PTO; and (2) whether a district court has authority to eliminate the patent right as a sanction for litigation misconduct.

The petitioner’s primary argument is based upon prior Federal Circuit precedent that expressly bar courts from holding a patent unenforceable due to litigation misconduct. Aptix Corp. v. Quickturn Design Sys., Inc., 269 F.3d 1369, 1375 (Fed. Cir. 2001).  Note here that the majority attempted to distinguish Aptix by explaining that the court’s remedy for litigation misconduct was simply to infer a particular factual finding (intent to deceive), which turned out to be critical since materiality was also proven.  The question is whether this thin distinguishing point should be allowed to undermine the bulwark against inequitable conduct findings created by Therasense.

In a procedural order today, the Federal Circuit has given the patent-challenger a few extra weeks to draft its responsive brief (Now Due Nov. 2).

A set of amicus briefs support the petition:

  • Chicago IPLAC: “Finding inequitable conduct by the patent prosecution lawyer as a penalty for the tactics of subsequent litigation counsel is a departure from past jurisprudence of such gravity that this Court should consider this issue en banc.”
  • Seven Chicago Attorneys: A group led by Kevin Noonan argue that the district court “violated procedural due process” by failing to provide an opportunity to be heard on the question of specific intent to deceive the USPTO — noting that due process concerns are raised when dealing with lawyer misconduct accusations.
  • Hrick & Mccabe: The two leading Patent-Law Professional Responsibility gurus argue, inter alia, that the decision particularly harms the reputation of the prosecuting attorneys and inventors and the irrebuttable conclusions prevents any defense by those individuals.
  • NYIPLA: This group points out a deficiency in the opinion – although the majority agreed with the inference-of-intent penalty, the court did not particularly spell out that the inference was “the single most reasonable inference able to be drawn from the evidence” as required by Therasense.
  • Washington Legal Foundation: “Inequitable conduct claims are likely to proliferate as a result of the panel decision.”
  • BIO: If the holding stands, court should make clear that there must be a strong nexus between the litigation-misconduct and the misconduct during patent prosecution.

Documents:

Teaching Away: Only Counts if the Reference Teaches Away from All Embodiments of the Claim

Owens Corning v. Fast Felt Corp (Fed. Cir. 2017)

After being sued for infringing Fast Felt’s U.S. Patent No. 8,137,757, Owens Corning retaliated with a petition for inter partes review.  Although the PTO instituted the IPR, the PTAB eventually determined that the claims were not obvious — i.e., that “Owens Corning had failed to show obviousness of any of the challenged claims.”  On appeal, the Federal Circuit has reversed — holding that under a proper BRI claim construction, that the claims are obvious. (more…)

Are you Pat-Informed?  A new joint initiative of the research-based biopharmaceutical industry and WIPO wants you to be.

Guest post by Corey Salsberg, Vice President, Global Head IP Affairs, Novartis

The patent system depends on information to achieve its goal of promoting progress.  Published information defines the prior art.  Patents must disclose sufficient information to describe an invention and enable others to practice it.  And applications containing this information are published after 18 months, even if no patent issues.  Comparing patents to other intellectual property rights that also promote innovation—trade secrets, most notably—the system’s role in disseminating information is one of its most distinguishing features.

But “information is not knowledge,” as Einstein (and Frank Zappa) said.  Information isn’t anything if it isn’t accessible.  And it isn’t much use if those who can access it lack the ability or means to organize, process, and apply it to their work.

In the field of biopharmaceuticals, patent information is important to a wide variety of stakeholders.  Innovators use it to assess the state of the art, to secure freedom-to-operate, to seek out opportunities for in- or out-licensing, to identify partners for collaboration, or to learn from, improve, or advance the field of medicine.  Generics use it to plan product development, to design-around patents, craft strategies for patent challenges, and to help inform when and where they can proceed with generic product launches.  Both of these groups generally have access to patent lawyers and other professionals, and to private services that can “landscape” patents better than Bierstadt or Frederic Church.  But when it comes to something as important as patented medicines, there are other stakeholders that lack these resources, but who nevertheless would benefit from effective access to basic patent information.  These include health authorities, multilaterals, and a variety of NGOs engaged in the procurement of medicines, who need access to patent information to inform their decisions about how, when, where and from whom to obtain life-saving products for their constituents.  To be sure, granted patents, pending applications (at 18 months), and the information they contain are all public materials that are widely available through national patent offices, international organizations, and public search engines like Google Patents.  But accessing this information and processing it in a way that connects it to medicines can be challenging, burdensome, or for some even daunting.

To help take up this challenge, over the last couple of years the research-based pharmaceutical industry has been hard at work developing an industry-based platform that aims to make it easier for global drug procurement agencies to access a basic body of patent information that connects issued patents to marketed medicines.  Now under the joint sponsorship of the World Intellectual Property Organization (WIPO) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the platform, known as the Patent Information Initiative for Medicines, or “Pat-INFORMED,” is a voluntary endeavor comprised of a public database of patent information, and a platform for facilitating communication between procurement agencies and patent owners.  The database portion of Pat-INFORMED, hosted by WIPO, is modelled on the US “Orange Book,” and will provide the public with a searchable online gateway that, on a global basis, correlates granted patents to a company’s marketed medicines.  Information for the database will be supplied directly by participating companies like Novartis, and will be updated on a periodic basis.  Meanwhile, the communication platform will provide a channel for follow-on inquiries, to make it easier for procurement agencies to seek more detailed public patent information about a particular medicine.

To date, twenty leading global research-based biopharmaceutical companies, including founders Novartis, GSK, Pfizer and Merck KGaA, have committed to participate, and we anticipate more.  The initiative was formally announced last week at the WIPO General Assembly in Geneva, and is expected to be operational by mid-2018, with an initial wave of data for all small molecule medicines in the areas of oncology; hepatitis C, cardiovascular, HIV, diabetes, and respiratory disease, as well as any other products on the World Health Organization’s Essential Medicines List.  In a second phase, Pat-INFORMED will expand to all therapeutic areas and explore the inclusion of complex therapeutics.

As a founding member, we at Novartis view Pat-INFORMED as a great illustration of what can be accomplished when the private sector and multilateral organizations work together to improve the status quo and craft solutions to society’s challenges.

= = = = =

Notes

 

PatentlyO Bits and Bytes by Anthony McCain

Upcoming Events

The Power Of The PTAB: The New Authority In Patent Law

 Get a Job doing Patent Law                  

The Need for Legislative Reform: The Berkeley Section 101 Workshop

Assessing the Need for Legislative Reform of Patent Eligibility in the Mayo/Alice Era: Final Report of the Berkeley Center for Law & Technology Section 101 Workshop [Read the Full Report]

By Jeffrey A. Lefstin, Peter S. Menell, and David O. Taylor

CurrentStateOver the past five years, the Supreme Court has embarked upon a drastic and far-reaching experiment in patent eligibility standards. Since the founding era, the nation’s patent statutes have afforded patent protection to technological innovations and practical applications of scientific discoveries. However, the Supreme Court’s 2012 decision in Mayo Collaborative Services v. Prometheus Laboratories imposed a new limitation on the scope of the patent system: that a useful application of a scientific discovery is ineligible for patent protection unless the inventor also claims an “inventive” application of the discovery. The following year, the Court ruled that discoveries of the location and sequence of DNA compositions that are useful in diagnosing diseases are ineligible for patent protection. And in its 2014 Alice Corp. v. CLS Bank International decision, the Court ruled that software-related claims are ineligible for patent protection unless the abstract ideas or mathematical formulas disclosed are inventively applied.

These decisions sent shock waves through the research, technology, business, and patent communities. Medical diagnostics companies experienced a dramatic narrowing of eligibility for core scientific discoveries. Reactions within the information technology community have been mixed, with some applauding the tightening of patent eligibility standards on software claims and the opportunity to seek early dismissal of lawsuits, particularly those filed by non-practicing entities, and others criticizing the shift in patent eligibility. Several members of the Federal Circuit bluntly criticized the Supreme Court’s shift in patent eligibility standards on jurisprudential and policy grounds. Additionally, the Patent Office has struggled to apply the Supreme Court’s new and rapidly evolving standards.

As this sea change unfolded, many patent practitioners, scholars, PTO officials, and jurists hoped that the Supreme Court would provide fuller and clearer guidance on patent eligibility standards. In the aftermath of the Supreme Court’s rejection of the certiorari petition in Sequenom, Inc. v. Ariosa Diagnostics, Inc.—a case that many Federal Circuit jurists, scholars, and practitioners thought to be an ideal vehicle for clarifying patent eligibility standards, or for reexamining Mayo—we began planning a roundtable discussion among leading industry representatives, practitioners, scholars, policymakers, and retired jurists to explore the patent eligibility landscape and possible legislative solutions to the problems that have emerged.

We sought participants with significant knowledge and experience in the key industries affected by the shift in patent eligibility standards—principally the bioscience and software/information technology fields. To promote candid discussion among these participants, we established the following ground rules: (1) Participants would be free to use the information received, but neither the identity nor the affiliation of the speaker(s) could be revealed; (2) We would prepare a report describing the results of the workshop—and that report would not attribute statements or views to individuals (other than the co-convenors); and (3) The report would list the participants and be made available to the public through BCLT.

Our Report summarizes the presentations and discussions exploring the legal background and effects bearing on legislative action. Part I contains a lightly edited version of the background document circulated to participants prior to the workshop. Part II summarizes the four workshop sessions leading up to the discussion of legislative proposals: (A) legal background; (B) effects on research and development (R&D); (C) effects on patent prosecution; and (D) effects on patent assertion, litigation, and case management. Part III summarizes the discussion of legislative proposals and sets forth a framework for seeking compromise on reform legislation.

As explicated in the Report, a consensus emerged that the current state of patent eligibility jurisprudence is indefensible as a matter of legal principle and is seriously undercutting incentives in sectors of the biotechnology industry. The workshop revealed broad agreement that the Supreme Court’s patent eligibility jurisprudence has diverged from the Patent Act’s text and legislative history, as well as long-standing jurisprudential standards. The participants also agreed that the Supreme Court’s ostensible rationale for its § 101 jurisprudence lacks a sound foundation, and that its formulation of the inventive application standard is grounded on a profound misapprehension of key historical precedents.

Furthermore, the workshop revealed a consensus that it is unlikely that the Supreme Court will reconsider the patent-eligibility issue in the foreseeable future. Conferees also doubted that the Federal Circuit will confront the core concerns surrounding patent eligibility. The USPTO has tended to be reactive only, or has adopted what some conferees viewed as unduly rigid interpretations of the case law.

Thus, legislative reform will be necessary to effect significant change in patent eligibility standards. Participants largely agreed that legislation would be necessary to address the problems that have emerged for bioscience researchers. Nonetheless, there was disagreement on the need for legislative reform of patentable subject matter relating to software and information technology. Moreover, there was a lack of agreement on the best solution to problems, and none of the current legislative proposals garnered consensus.

While nearly all of the conferees recognized that this state of the law poses serious concerns for bioscience research and development, there existed substantial reluctance on the part of some software industry representatives about pursuing legislative reform that could increase patent assertion activity and raise defense risks and costs in the software field. Some participants also thought that the courts should be given time to develop an appropriate screen for the eligibility of software patents and saw some progress in the developing case law.

This suggests to the workshop convenors and authors of the report (the three of us) that the most fruitful approach to reform legislation would restore the traditional patent eligibility standard at least for bioscience advances—that is, establishing that conventional applications of scientific discoveries are eligible for patent protection—while addressing concerns about cumulative creativity and abusive patent assertion. Such additional provisions could include the following: (1) an expanded experimental use exception at least for doctors and medical researchers; (2) exclusion of non-technological subject matter, notably pure business methods (a technological arts test); (3) a mechanism to encourage courts to consider 12(b)(6) motions directed to § 112 issues (as opposed to § 101 issues) early in patent case management; (4) fee-shifting aimed at discouraging nuisance value patent lawsuits; (5) higher thresholds for enhanced damages in the software field; and/or (6) shorter duration for algorithm-based inventions—i.e., where the point of non-obviousness is a computer-implemented algorithm. We further note that compromise legislation might also address distinctive issues relating to affected industries that lie outside of the patent field, such as reimbursement policies relating to medical diagnostics.

Jeffrey A. Lefstin is Professor of Law and Associate Academic Dean at the University of California Hastings College of Law. Peter S. Menell is Koret Professor of Law and Co-director of the Berkeley Center for Law & Technology at the University of California at Berkeley School of Law. David O. Taylor is Associate Professor of Law and Co-Director of the Tsai Center for Law, Science and Innovation at the SMU Dedman School of Law. The full report is available at: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3050093

Patent Attorney DIY: ModustrialMaker

I really enjoy Patent Attorney Mike Clifford’s high quality YouTube channel modustrialmaker – highlighting his “modern industrial DIY projects.” The channel now has more than 30,000 subscribers and 1 million views.

The video below shows his latest work – a white concrete table with a live-edge maple inlay.  After watching the video, I do feel enabled to make and use the same without undue experimentation.

Great work!

 

Patent Jobs and the Myth of the Employment Hypothesis

Prof. Ken Port along with Lucas Hjelle and Molly Rose Littman have an interesting new draft article titled: Patent Jobs and the Myth of the Employment Hypothesis. Although it is not as easy as it used to be, the article explains that:

[F]or one easily identifiable group, the legal job market is strong and growing: job prospects for Mechanical, Electrical, Chemical, and Computer Engineers (hereinafter, “MECC Engineers”) are quite positive. However, despite these positive job prospects, the number of MECC Engineers coming to law school is at near-record lows. The decrease in the number of MECC Engineers enrolled in law schools far exceeds the decrease in non-patent-bar-eligible law students.

The article argues that “this fact will have a deleterious effect on the United States economy.”

 

No Vaccines Before the Next Zika Outbreak?: A Case for IP Preparedness

The following is a guest post from Ana Santos Rutschman, the Jaharis Faculty Fellow in Health Law and IP at DePaul.  I invited Prof Santos Rutschman to write about her work on Vaccine Preparedness and IP. Her new article titled IP Preparedness for Outbreak Diseases is forthcoming in UCLA Law Review. – DC.

In September 2017, the development of the US Army’s Zika vaccine—once a leading candidate in the Zika vaccine race—came to a halt after almost all federal funding for Zika R&D was cut short. This happened less than a year from the end of the global public health emergency. Funding will now resume only if the Zika epidemic re-emerges.

That R&D on diseases like Zika is not attractive to pharmaceutical companies is a well-known phenomenon. It usually takes a major public health crisis to shake up the playing field. With Ebola, for instance, funding for R&D increased 258% in 2015. The Zika outbreak had the same effect, and so will future outbreaks of similar diseases.

But funding spikes triggered by outbreaks are short-lived. They fuel an accelerated R&D race, with multiple pharmaceutical companies and research institutions jumping in. As soon as the fear factor begins to decline, so does the support for R&D. The looming possibility of another outbreak guarantees that some drug development will still occur, but only at a residual level.

The relationship between outbreaks and R&D funding has long been a feature of our vaccine development cycles—from diphtheria and polio in the 1920s and 1950s to Ebola and Zika more recently. But Zika is teaching us something new about the role of IP in the development of vaccines through outbreak-spiked funding: we need to look at IP well beyond the realm of patents operating as incentives to prospective R&D players. Transfers of IP rights between R&D entities, if poorly designed, can hinder the development and the availability of new vaccines (and of drugs in general).

We are seeing the consequences of such a bad licensing deal right now. The Army’s Zika vaccine was once considered a top candidate in the Zika vaccine race. Its initial development was supported during the early stages of the outbreak by the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA), an office under the umbrella of the Department of Health and Human Services. In 2016, the Army brought in a private-sector company, Sanofi, to help with the clinical development of the vaccine. Shortly thereafter BARDA awarded the company $43.2 million for phase II clinical trials. Then, in late 2016, the Army announced that it intended to license the vaccine to Sanofi on an exclusive basis.

Two provisional patents covered the Army’s vaccine—one encompassing methods of production, and another encompassing methods of preparation. Having been developed through government funding, the vaccine is subject to §207-§209 of the Patent Act, which regulate the transfer of federally owned inventions. §207 allows an agency to grant both exclusive and non-exclusive licenses. §209, however, establishes that an agency can only grant an exclusive license if exclusivity is “a reasonable and necessary incentive” to bring the innovation to the public. The fact that Sanofi had already received a substantial amount of government money to develop the vaccine makes it doubtful that exclusivity was needed in this case.

Even more troubling was the fact that, when prompted to disclose the main terms of the license, the Army indicated that no pricing provisions had been agreed upon with Sanofi. Exclusive licenses, per §209, must “promote the invention’s utilization by the public.” The lack of an affordable pricing clause, or of tiered pricing categories, seems to be at odds with this goal. Sanofi, incidentally, has a record of drug overcharging, having recently paid $19.8 million to resolve claims brought by the Department of Veterans Affairs with regard to two different contracts.

Now that federal funding for Zika R&D is over, the problems posed by the existence of a sole licensee become more acute. Even with last year’s $43.2 million boost in federal funding, Sanofi has chosen to stop all work on the vaccine. Meanwhile, several competitors across the globe keep developing other candidates. But the damage is done. All the outbreak-induced R&D at the Army is put to simmer and won’t likely be rekindled until there is a new outbreak (at which point, for all we know, the Zika virus might have mutated and the Army’s vaccine technology rendered ineffective). All the money poured into this project—including the portion of federal funding that subsidized Sanofi’s R&D—will yield no vaccine to help prevent the next outbreak.

Over the past few years, I have been studying IP inefficiencies in the context of outbreaks and outbreak-spiked vaccine R&D. The case of the Zika vaccine is not unique, but rather emblematic of the current lack of IP preparedness to support the development of drugs for outbreak diseases. Much in the same way that health systems struggle to cope with outbreaks, our IP regime works poorly when it comes to making the most out of the R&D funding brought about by an outbreak. As a consequence, we will miss out on vaccines and life-saving drugs before other public health crises arise.

Now that we are seemingly in an inter-outbreak period, it would be timely to address these problems. Here are a few simple solutions to the licensing problem: we can create a limited list of diseases that are ineligible for §207 exclusivity (with neglected tropical diseases coming immediately to mind); we should amend the disclosure requirements in §209 and have agencies disclose all terms of proposed licenses involving federally funded vaccines; and we should make the incorporation of pricing provisions mandatory in §209 exclusive licenses (at least for outbreak-related technologies).

International Commercial Arbitration of Patent Cases

One of the more powerful new petitions for writ of certiorari is the case of Dow AgroSciences, LLC v. Bayer CropScience AG, Docket No. 17-372.  Although the question presented – focusing on arbitration of patent cases – does not strike to the core of patent law doctrine, it is one of the more likely to be granted certiorari.

The petition begins: International arbitration of federal statutory claims poses a threat to U.S. public policy that can be mitigated only by independent judicial review. [DowBayerPetition].

The case here involves a set of crops genetically modified to be resistant to the herbicide glufosinate.  Some of the crops include additional genetically modified resistance in a “molecular stack” with additional herbicide resistant genes such as aad-12 (2,4-D herbicide tolerance) and dmmg.

Bayer sued Dow for infringement, but a prior agreement forced to the case to arbitration and a $455 arbitration award for Bayer that was affirmed by the Federal Circuit.

Affirming Arbitration Award

Now, Dow has petitioned the Supreme Court with the following question presented:

The United Nations Convention on the Recognition and Enforcement of Foreign Arbitral Awards (the “New York Convention”), as incorporated into Chapter 2 of the Federal Arbitration Act (“FAA”), 9 U.S.C. 201 et seq., authorizes a U.S. court to decline recognition and enforcement of an arbitral award that “would be contrary to the public policy” of the United States.

Here, recognition and enforcement of a $455 million arbitral award based on duplicative and expired patents is contrary to the U.S. public policy that patents are granted only for “limited Times.” But the Federal Circuit held that award enforceable, ruling that a court may not entertain a public-policy challenge in the absence of a prior judicial decision on nearly identical facts.

The question presented is:

Whether a federal court must independently determine whether recognition and enforcement of an arbitral award under the New York Convention would be contrary to the public policy of the United States.

Dow AgroSciences, LLC v. Bayer CropScience AG, 2017 WL 4022790.

Unlike many areas of law, the Patent Act includes a particular provision recognizing voluntary arbitration of patent dispute. 35 U.S.C. 294. The provision indicates that the Federal Arbitration Act (Title 9) should be followed “to the extent such title is not inconsistent with this section.”  The statute particularly provides that the ordinary defenses to patent infringement “shall be considered by the arbitrator if raised.”

 

Commenting on Patently-O (Add your Photo)

Patently-O comments include lots of good information, but any site with over 300,000 comments will have their share of problematic ones.  I’d like to refer everyone back toward my 2014 post: Moving Toward a Better Patently-O Ecosphere.

Tech Update: If you want to customize your commenting-photo, the process is to first create an account with WordPress (wordpress.com) and then go to https://wordpress.com/me to manage details.

Moving Toward a Better Patently-O Ecosphere

A bill to abrogate the sovereign immunity of Indian tribes as a defense in inter partes review of patents

My Senator (McCaskill) has introduced S. 1948 titled “A bill to abrogate the sovereign immunity of Indian tribes as a defense in inter partes review of patents.”  [TribalImmunity]

The Bill provides one simple statement as follows:

Notwithstanding any other provision of law, an Indian tribe may not assert sovereign immunity as a defense in a review that is conducted under chapter 31 of title 35, United States Code.

As discussed previously, Tribal Nation Sovereign Immunity is not Constitutionally protected and may be eliminated by particular acts of Congress.  Thus, this Bill would seem to be effective to eliminate the ongoing concern regarding tribal immunity assertions.  The proposal does lack an effective date and so the only missing element would be whether the Bill would retroactively veto pre-enactment claims of immunity.

More on Tribal Immunity: Is a Tribal-Owned Patent Immune from IPR Challenge?

Allergan: Creating Sovereign Immunity with Tribal Pass-Through

 

 

 

Federal Circuit: Antibody-Exception to Written Description Does Not Exist

AmgenFig17

By Dennis Crouch

Amgen v. Sanofi (Fed. Cir. 2017).  The Delaware district court sided with Patentee Amgen and awarded permanent injunctive relief barring Sanofi from selling its injectable drug product Praulent (alirocaumab) – a human monoclonal antibody used to reduce low-density lipoprotein (LDL) cholesterol – covered by U.S. Patent Nos. 8,829,165 and 8,859,741.

On appeal, the Federal Circuit has vacated the injunction – holding that the district court made reversible errors with regard to written description and enablement.  Before walking through the decision, I’ll note here that the Federal Circuit panel here – made up of Chief Judge Prost, Judge Taranto and Judge Hughes – would not be identified as overly pro-patentee.

 

The drug at issue works by inhibiting the protein PCSK9 from binding with LDL Receptor (LDL-R), thus leading to a reduction of blood LDL.  Basically, the claimed antibody binds to a particular residue (amino acid) of the PCSK9 molecule in a way that blocks the PCSK9 from then binding and promoting LDL-R. Representative claim 1 of the ‘165 patent is as follows:

An isolated monoclonal antibody,

wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, … or S381 of SEQ ID NO:3, and

wherein the monoclonal antibody blocks binding of PCSK9 to LDL-R.

Looking at the claim – it basically covers all isolated monoclonal antibodies capable of performing the required binding function – and the basic issue in the case is whether that broad claim is sufficiently supported by the specification. On point, the specification describes a number of example antibodies; the screening process that the inventors used to find those examples; and 3D structure of two of the known antibodies, including the antibody that serves as the patentee’s actual drug product (Repatha).

The Written Description and Enablement requirements are both stem from the same sentence in 35 U.S.C. 112:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.

Written description focuses on whether the original patent disclosure conveyed evidence that the patentee – at the time of filing – had “possession” of the claimed invention. Ariad.  Most written description challenges arise from post-filing amendments to the patent claim scope, however in Ariad the Federal Circuit made clear that originally-filed claims may lack sufficient written description if the claim covers a wide genus of embodiments and the specification fails to disclose “a representative number of species.”

Post-Priority Evidence: The extent of required written description disclosure depends upon the number of potential species.  However, the district court refused to allow the accused-infringer attempted to introduce such evidence unless it reflected a pre-priority understanding of the science. On appeal, the Federal Circuit rejected that approach – holding that “the use of post-priority-date evidence to show that a patent does not disclose a representative number of species of a claimed genus is proper.”  Note here, the rule here is distinct from the limitation that only pre-priority date evidence is permissible for showing state-of-the-art at filing.

Enablement also focuses on sufficiency of disclosure, but asks the slightly different question of whether, after considering the specification, a skilled practitioner would be enabled to make and use the invention.

Under the enablement requirement, “the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361 (Fed. Cir. 1997).

As with written description, the focus is on enablement at the time the application was filed, however here the court also allows post-priority-date evidence to show that the accused infringers here “engaged in lengthy and potentially undue experimentation to enable the full scope of the claims.” The court writes:

Such evidence could have been relevant to determining if the claims were enabled as of the priority date and should not have been excluded simply because it post-dated the claims’ priority date.

Thus, the district court’s exclusion of such evidence was improper.

= = = = =

In addition to improperly excluding evidence, the Federal Circuit also ruled that the district court antibody-antigen jury instruction relating to written description was also improper. In particular, the jury instructions included the following explanation of the law:

In the case of a claim to antibodies, the correlation between structure and function may also be satisfied by the disclosure of a newly characterized antigen by its structure, formula, chemical name, or physical properties if you find that the level of skill and knowledge in the art of antibodies at the time of filing was such that production of antibodies against such an antigen was conventional or routine.

According to the appellate court, this instruction is wrong because it allows a patentee to satisfy the description-of-use portion of written description by relying upon the level of skill in the art. Rather written description requires an actual written description showing possession of the invention, including express instructions on how to make and use the invention.

The essential problem with the jury instruction given in this case is that it effectively permitted the jury to dispense with the required finding of a written description of the invention. . . .  A jury would naturally understand the instruction to permit it to deem any antibody within the claim adequately described merely because the antibody could easily be “produc[ed]” (and, implicitly, used as an antibody).

 

The decision here repudiates statement to the contrary from Enzo that are here characterized as dicta.  On remand, the jury will likely also be asked to consider whether – in this particular case – “the chemical structure of an antigen [provides] structure-identifying information about the corresponding antibodies.

 

 

Carani on Design Rights: International Functionality and Scope

Christopher Carani_(9789041188649)_Final coverThe past week I have included a few design patent law updates on Patently-O.  While on the topic, I should mention the new book edited by (and substantially authored by) Christopher Carani titled Design Rights: Functionality and Scope Protection ($200 from WK).

The book walks through design protection available the various global regions – US, Europe, Japan, China, India, S.America, etc – and is designed to help practitioners both understand the law and get started on strategy. From the book-blurb:

This book, while providing a solid foundation of the law regarding the protection and enforcement of design rights, focuses on the ever-present, and always contentious, issue of functionality in the context of design rights. While there is considerable harmonization on the fundamental principle that design rights regard aesthetic appearance and not underlying technical function, courts and legislatures the world over have long struggled with determining whether to permit, and how to interpret the scope of, design rights directed at products whose appearance may, partially or completely, be the result of functional consideration.

At 700 pages, the design-focused tome may also help sculpt your biceps as you read.

First Post-Samsung Design Patent Damages Verdict

Design Patents 2017

New IP reading from law professors: