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The University of Amsterdam’s Institute for Information Law recently announced its essay competition: “Science Fiction and Information Law.”

Authors in both ‘genres’ dedicate a considerable share of their time speculating about how [new] technologies may evolve. Most importantly, science fiction authors, as well as information law scholars, ponder what the implications will be for society, markets and the values that we cherish and seek to protect. . . .

We welcome essays that reflect on our possible data-driven future, where data has been firmly established as an economic asset and new, data-driven smart technologies can change the way we live, work, love, think and vote. How will AI change politics, democracy or the future of the media? What will life be like with robot judges and digital professors? What is the future of transportation in the wake of drones, the autonomous car and perfect matching of transportation needs? Is there a life beyond the ubiquity of social media: Is there bound to be an anti-thesis and if so, what will the synthesis look like? What will happen when social media corporations start fully-fledged co-operation with the police? Or unleash the power of public engagement to solve or prevent crime by themselves? How would crime respond to all this? What could be the true implications of the ‘data economy’ and if we really can pay our bills with our data? How will future information law look like in the age of AI?

The essays will be read and judged — the top five will receive awards, published in the Internet Policy Review, and the authors invited to Amsterdam for a public symposium.

Rules:

  • 8000-15000 words in English.
  • Authors might already be sci-fi authors, but might come from any realm.
  • Essay emailed to Prof. Helberger n.helberger@uva.nl by December 15, 2018.
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by Dennis Crouch

The new petition for writ of certiorari in Ariosa raises the questions of what “counts” as prior art — what is disclosed or what is claimed?  The petition asks:

If a patent discloses but does not claim an invention, does that disclosure qualify as prior art as of the date of the application in which it was first made, such that no one else may patent the same invention based on a later-filed application?

[Ariosa Diagnostics Inc. v. Illumina Inc. – cert. petition].  Here, the prior art statute at issue is pre-AIA 102(e), whose equivalent is in the post-AIA 102(a)(2).  The statute seems to squarely answer the question above — a disclosure in an issued US patent will count as prior art as of its filing date regardless of whether the all features of the disclosure were actually claimed in the patent.

102 A person shall be entitled to a patent unless (e) the invention was described in . . . (2) a patent granted on an application for patent by another filed in the United States before before the invention by the applicant for patent.

In the simple case outlined above, the courts all agree that the disclosures found in an issued patent or published application  count as prior art as of the patent’s filing date.  The difficulty comes when we bring priority-claims into play (such as priority to a provisional application).

In this case, the Federal Circuit ruled that a published application can count as prior art as of its provisional filing date — but only as to features actually claimed in the application.  According to the court, features disclosed in the provisional but not claimed in the published application will only be prior art as of their date of public disclosure.

The patent challenger argues that this interpretation is wrong — and particularly that the effect of the priority claim should be governed by 35 U.S.C. §§ 119(e)(1) and 120, which provide for applications properly claiming priority back to an earlier filing “shall have the same effect, as to such invention, as though filed on” the earlier date.  On the other side – the statutory hook for the Federal Circuit’s limitation here is the fact that the statute gives priority for “the invention” — i.e., the claimed invention — but not for the disclosure as a whole. In addition Sections 119 and 120 develop the rules for patents claiming priority — not for prior art.

In the petition, the patent challenger offers the following question:

Question presented: Do unclaimed disclosures in a published patent application and an earlier application it relies on for priority enter the public domain and thus become prior art as of the earlier application’s filing date, or, as the Federal Circuit held, does the prior art date of the disclosures depend on whether the published application also claims subject matter from the earlier application?

There are several important prior cases on-point:

  • Alexander Milburn Co. v. Davis-Bournonville Co., 270 U.S. 390 (1926) (judicially establishing the precursor to 102(e)).
  • Hazeltine Research, Inc. v. Brenner, 382 U.S. 252 (1965)
  • In re Wertheim, 646 F.2d 527 (C.C.P.A. 1981)
  • Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375 (Fed. Cir. 2015)

The petition cites my Patently-O commentary on the situation in which I argue that a disclosure’s prior art status should not depend upon what is claimed.

A leading commentator has observed that “[a]nyone who works with prior art knows that this setup is an oddball way to address the situation. A patent’s disclosure for prior art purposes should not depend upon what was claimed or not but instead should focus on what was disclosed.” Dennis Crouch, Federal Circuit Backtracks (A bit) on Prior Art Status of Provisional Applications and Gives us a Disturbing Result; see also id. (“The result here is silly—and somewhat disturbing—that under the first-to-invent rule the second inventor gets a patent.”).

Although it is unclear, I don’t believe that the AIA will be seen to have changed the statute in a way that changes the rule here.  Thus, the outcome of this case will likely bind post-AIA cases as well.

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Patently-O by Dennis Crouch - 4d ago

Earlier in 2018, the Office of the US Trade Representative (USTR) imposed a 25% added-value tariff on a set of particular Chinese-made products expected to valued at about $34 billion per year.  A prior notice indicated a plan to increase the 25% tariff to $50 billion worth of goods (an additional $16 billion on Chinese goods ).  Doing the math here – the US is planning here to collect $12.5 billion in tax revenue from the Chinese goods entering into the US. Although a tariff already applied to most Chinese imports, the rate is usually less than 5%.

As expected, in response to the US tariffs, China imposed increased duties on US goods.

The USTR has now proposed upping the bet — this time “in the form of an additional 10 percent ad valorem duty on products of China with an annual trade value of approximately $200 billion.” [FR Notice].   Easy math: the new 10% tax should raise an additional $20 billion in general revenue for the U.S. Government.

China cannot match this added tariff in direct parallel fashion – Since the U.S. only exports about $130 billion to China per year.  However, China could instead collect the $20 billion with a higher duty; impose quotas; or apply some other non-tariff countermeasure (such as by adjusting IP rights owned by US entities).

In addition to each country’s unilateral measures, both countries (as well as our other global trading partners) have taken their cases to the World Trade Organization (WTO) asking for enforcement of the rules of The General Agreement on Tariffs and Trade (GATT) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

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LexMachina has released a new report on Trade Secret litigation in Federal Court.

The basics: Federal Trade Secret litigation is up about 30% following enactment of the Defend Trade Secrets Act (DTSA) in 2016.  (1134 cases filed in 2017). The DTSA created a federal cause of action for trade secret litigation and resulting original jurisdiction in federal court for the federal claims. Prior to the DTSA, state-law trade secret claims found their way into federal court either via supplemental jurisdiction (typically linked to an a federal IP claim) or via diversity jurisdiction (parties from different states).

The vast majority of trade secret actions include additional causes of action — most often breach of contract or other commercial law claim.

[Report here – Registration Required]

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Endo Pharms. Sols., Inc. v. Custopharm Inc., — F.3d —, 2018 U.S. App. LEXIS 19265 (Fed. Cir. 2018).

by Dennis Crouch

Endo’s injectable testosterone Aveed is listed in the Orange Book as being covered by Bayer’s U.S. Patent Nos. 7,718,640 and 8,338,395.  Endo and Bayer sued Custopharm after it submitted an Abbreviated New Drug Application (ANDA) to produce a generic version. (Under 35 U.S.C. 271(e), submission of the ANDA is an act of infringement).

On appeal, the Federal Circuit has sided with the patentee — affirming the district court judgment of validity.

The claimed invention here requires the use of testosterone undecanoate (TU) at a concentration of 250 mg/ml in a vehicle containing a mixture of about 40% castor oil and 60% benzyl benzoate. (Claim 1 of the ‘640 patent). Three key prior art references are all research articles that report using the same concentration of TU and also the castor oil.  The prior-art articles do not, however, actually report that benzyl benzoate was used — it turns out though that the researchers (including one overlapping listed inventor here) used the same 40/60 split of castor oil and benzyl benzoate.  The asserted claim 2 adds a limitation that 750 mg TU is injected — the articles describe the use of 1000 mg.

A primary question on appeal was whether the prior art articles inherently taught the benzyl benzoate concentration. “Custopharm contends that the Articles inherently describe the vehicle formulation (40% castor oil and 60% benzyl benzoate).”

The inherency doctrine has been quite limited by the Federal Circuit — Under the law, a prior art reference inherently discloses a claim limitation only when “the
limitation at issue necessarily must be present, or [is] the natural result of the combination of elements explicitly disclosed by the prior art.” Par Pharmaceutical, Inc. v. TWI Pharmaceutical, Inc., 773 F.3d 1186 (Fed. Cir. 2014).

In this case, we know that 60% benzyl benzoate concentration was actually present in the prior art experiments, but that knowledge was not expressly part of the prior art. Thus, the court focused on whether the existence of benzyl benzoate was necessary based upon the prior art itself. From that frame of reference, the elements were not inherently disclosed by the prior art.

The district court reasonably found that this was not enough “to establish [with clear and convincing evidence] that the Articles barred the possibility of an alternative vehicle being used in the prior art compositions” to meet the rigorous standard of inherency.

Prior Publications Compared with Prior Uses or Sales: I believe that this case could have come out differently if the challengers had been able to rely upon the uses in the experiments as prior sales or public uses. In those circumstances, the question would focus on what was actually in the injection rather than what was publicly known or disclosed about the injection. My conjecture here appears to be based upon alternative facts since the articles in-question stem from research studies and so were likely sufficiently protected by secrecy and experimental use limitations.

The other question here is what to do about the fact that Bayer (or its predecessor) was involved with the prior art articles.  Here, Doris Hübler is the first named inventor on the patents at issue and also one of the authors of the prior art article and that Bayer provided the TU ampules used for the testing.  I believe that the answer here is that Bayer only runs into trouble here if (1)the experiments count as commercialization under cases such as Metallizing Engineering or (2) Bayer somehow abandoned the invention. Neither of these appear appear to fit here.

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Claim construction continues to hold focus as the centerpiece of contested patent cases — both in court and in administrative AIA trials (primarily, Inter Partes Review proceedings) before the Patent Trial and Appeal Board (PTAB).  One element of current practice is that the USPTO applies a different standard for construing claims than do courts or the USITC in infringement litigation. (Compare Broadest Reasonable Interpretation with Phillips / Ordinary Meaning standards).

One of PTO Director Iancu’s early initiatives has been to unify the standards.  That process began with a notice of proposed rulemaking with finalized rules coming later this fall.

The USPTO has posted comments submitted on the proposed change — with over 350 submissions.  Although the bulk of submissions favor the change, a substantial number also argue that the BRI standard is an important aspect of IPR effectiveness — with the beneficial result of lowering consumer costs and improving access to medicines. It will take some time to review these comments.

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Jazz Pharms., Inc. v. Amneal Pharms., Inc., — F.3d —, 2018 U.S. App. LEXIS 19268 (Fed. Cir. 2018)

The patented invention at issue in Jazz Pharms is not a drug or drug treatment, but rather to a “drug distribution system for tracking prescriptions” for drugs with a risk of abuse[1]  The PTAB found claims from all six patents to be invalid as obvious.

The core issue on appeal was whether a pre-filing disclosure by Jazz counted as a prior art “printed publication.”

Printed Publication: As the language suggests, a “printed publication” must be both “printed” and also a “publication.”  These requirements though have been broadly construed.  “Printed” publications go well beyond physical hard-copies to allow for various media – including video and online forms.  To be a “publication,” the reference needs to be made sufficiently available to the public – publication.  In the leading case of In re Hall,[2] the Federal Circuit explained that accessibility to the relevant public is key – we ask “whether interested members of the relevant public could obtain the information if they wanted to.”  Although the court has developed a number of guide posts, the question of sufficient availability is seen as a factual inquiry handled on a case-by-case basis.

The prior art here was developed as part of an FDA drug safety review for one of Jazz’s drug products that was known as a potential date-rape drug.  In May 2001, the FDA announced in the Federal Register an upcoming public meeting – noting that the focus of the meeting would be on risk management for the drug.  The notice included a hyperlink to the pin-cite that eventually included meeting information, including background material, minutes, transcripts, and slides.

With these facts, Jazz Pharms appears an easy case – the materials were freely available online and relevant members of the public were directed to the material via the official public source.

A few caveats here:

  • The materials were not proven to be searchable or indexed at the time. In response, the court explained that these are not required elements of publication if sufficiently disseminated via other mechanisms.
  • Jazz argued that folks of skill would not have seen the notice in the Federal Register and therefore not have been pointed to the underlying documents. In response, the Federal Circuit explained that a Federal Register notice might not always be sufficient to place the relevant public on notice of a publication, but that it was sufficient in this case since it was indexed and directed toward members of the public interested in systems to protect the public from potentially dangerous drugs.  The court also endorsed the PTAB’s “sensible observation that the purpose of the Federal Register is to provide notice of government action such as the advisory committee meeting here.”

Note here that with publication, the touch stone is “accessibility” rather than “actual access.”  The court has repeatedly explained that “[i]f accessibility is proved, there is no requirement to show that particular members of the public actually received the information.”  Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560 (Fed. Cir. 1988).

= = = =

[1] U.S. Patents 7,668,730, 7,765,106, 7,765,107, 7,895,059, 8,589,182, 8,457,988.

[2] In re Hall, 781 F.2d 897 (Fed. Cir. 1986).

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The USPTO has recently designated five PTAB decisions as “informative.” (I have also included the recent Western Digital decision as well).

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On July 11, I wrote about the recent Federal Circuit decision in Apple v. ContentGuard. My post erroneously stated that the court found that the patent does not qualify as a “covered business method” patent.  The court did not take that bold of a step of a reversal. Rather, the court vacated the PTAB’s finding that was based upon an improper legal standard and remanded for a reconsideration.

 On remand, the Board must determine whether the ’280 patent qualifies as a CBM patent in the first instance without relying on the “incidental to” or “complementary to” standard.

Thanks to Patently-O reader and USPTO Examiner Scott Anderson for pointing me to this missed detail. – DC

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