Patentability of COVID-19 Biotech, Pharma & Personal Protective Equipment Inventions

The innovative workforce has been redirected.  Spurred by the  Coronavirus pandemic, scientific research that once floundered from a lack of funding has been rejuvenated.[i]  The current innovation upsurge is not out of sheer interest for promoting the useful arts, however, but out of necessity.  Around the world, inventors are developing ways to cope with the new world engendered by COVID-19, from treatments for fighting disease to methods of predicting the next outbreak.

Alongside the proliferation of inventions and discoveries is the issue of financial rewards for these innovations.  Should inventions related to fighting COVID-19 be patentable? Many economists and lawmakers are critical of the exclusivity period granted by patents, especially in the case of vaccines and drugs.  Recently, several members of Congress requested “no exclusivity” for any “COVID-19 vaccine, drug, or other therapeutic.”[ii]

This article examines the patentability of developments in the Biotechnology, Pharmaceutical, and Personal Protective Equipment (PPE)  technology sectors related to COVID-19 and looks into the merits of patent criticism.   Part two of this series examines the Patentability of  COVID-19 Software Inventions – Artificial Intelligence (AI), Data Storage & Blockchain.

The Patentability of Inventions Related to COVID-19 – Biotechnology and Pharmaceutical Inventions

No doubt the most vociferous anti-patent sentiment is directed at the idea of patenting vaccines and treatments which enable companies to price their products well above the marginal cost of production.  Remdesivir, which was recently approved by the FDA for emergency COVID treatment, has a projected cost ranging from $390 to $4,460 per treatment course depending on the mortality benefit.[iii]  But an outright prohibition of patent protection for these inventions is an over-correction of these understandable concerns.  Patent protection has already been eroded over the last ten years and further erosion could lead to a decline in US leadership in the healthcare sector over time[iv]

Disclosure of Ideas

One of the basic principles of having patents is that a period of exclusivity is granted in return for inventors disclosing their inventions to the public, thereby probing further downstream studies and research into the disclosed art. Proponents of patent pools and “open science” argue that the free exchange of ideas will occur without the disclosure requirement that accompanies patent application, pointing to systems like the WHO’s Global Influenza Surveillance and Response System (GISRS).  Under GISRS, experts around the world collaborate to develop each year’s flu vaccine.[v]  GISRS is cited as proof that a patent-less system does not prohibit the disclosure of ideas and findings.[vi]

This type of open science system is not realistic for private companies, however.  GISRS is composed of national collaborating centers that collect data from participating public entities such as federal agencies and state public health laboratories.[vii]  The participants of GISRS have very little commercial stake when it comes to the disclosure of research findings.  A similar system cannot be expected to work in the realm of private enterprise especially in the long term.

Incentive to Innovate

Inventions related to the biotechnology and pharmaceutical spheres are already extremely difficult to patent as it is due to Mayo v. Prometheus Laboratories.[viii]  The Supreme Court found that a therapeutic treatment for a gastrointestinal disorder was not patentable whatsoever, believing that the diagnostics involved in the treatment was similar to patenting a “law of nature.”  The aftermath of Mayo was a significant increase in rejections against patent applications related to biotechnology and pharmaceuticals on the grounds of them being non-patentable subject matter.[ix]  The ongoing cost of prosecution in the face of these rejections was especially damaging to small and medium-sized companies that lack the financial means to repeatedly contend with the USPTO.[x]

Importantly, Mayo is a case related to diagnostics.  Therefore, inventions directed to diagnostics are even more difficult to patent.  It is no secret that the US has struggled when it comes to providing widespread and accurate COVID testing.  Judge Michel of the Federal Circuit believes that Mayo contributed to the country’s unpreparedness for the crisis by eliminating “incentives for private companies to develop diagnostic tests”.[xi]  There are many reasons for the failure of the test rollouts, but the US would have been better positioned to fight the pandemic had the proper innovative incentives been in place for the companies that we now rely on.

Recouping Cost

Currently, Gilead has not yet set a price for remdesivir but will be donating its initial supply of 1.5 million doses.[xii]  Ultimately, they will set a price that will most likely be above the marginal cost of $10 to produce a 10-day course of treatment per patient.  Remdesivir was in the process of R&D for over ten years.  Originally developed for SARS and MERS, the commercial price of remdesivir will not be commensurate with the cost of manufacturing but rather the overall investment towards developing the drug over time.[xiii]  The company also recently announced in a SEC filing that they could invest up to “$1 billion or more” in remdesivir in 2020.[xiv]  Pricing remdesivir marginally above cost will result in a substantial net loss for Gilead that will hurt the company’s incentive to develop further treatments.  This is an unwelcomed fact but ignoring it would be wrong and dangerous.

The Patentability of Inventions Related to COVID-19 – PPE 

Patents are not to blame for the shortage of PPE – Personal Protective Equipment and respirators.  PPE and respirators are primarily manufactured abroad and due to the current disproportionate balance between supply and demand, they are scarce commodities.  But for some reason, the Governor of Kentucky wants 3M to license its patents on the N95 mask so that “everybody else can manufacture it.”[xv]  Even Nobel laureates suggest that 3M’s patents over the N95 mask “have made it more difficult for new producers to manufacture medical-grade face masks at scale.”[xvi]

3M does not have a monopoly over the N95 mask.  No one does.  Honeywell, Kimberly-Clark Corporation, Moldex-Metric, GlaxoSmithCline are just a few companies among many that are listed by the CDC that make and manufacture NIOSH-approved N95 respirators.[xvii]

The Coalition for Breathing Safety forewarned the shortage of respirators in 2006.  Manufacturers of the N95 mask were forced to move offshore due to the cost of defending product liability suits over the tightly regulated masks.[xviii]  Again, patents are not to blame for the shortage and do not stand in the way of manufacturers other than 3M from making these products.

See the next segment: Artificial Intelligence (AI), Data Storage & Blockchain –  the patentability of COVID19 Software Inventions.

The opinions stated herein are the sole opinions of the author and do not reflect the views or opinions of the National Law Review or any of its affiliates.


[i] Robert Langreth and Susan Berfield, Famed AIDS Researcher Is Racing to Find a Coronavirus Treatment, Bloomberg Businessweek (March 20, 2020), https://www.bloomberg.com/news/features/2020-03-19/this-famous-aids-researcher-wants-to-find-a-coronavirus-cure.

[ii] Congressional Progressive Leaders Announce Principles On COVID-19 Drug Pricing for Next Coronavirus Response Package, (2020), https://schakowsky.house.gov/media/press-releases/congressional-progressive-leaders-announce-principles-COVID-19-drug-pricing (last visited May 10, 2020).

[iii] Melanie D. Whittington, PhD and Jonathan D. Campbell, PhD, Alternative Pricing Models for Remdesivir and Other Potential Treatments for COVID-19, Institute for Clinical and Economic Review (May 1, 2020), https://icer-review.org/wp-content/uploads/2020/05/ICER-COVID_Initial_Abstract_05012020-3.pdf.

[iv] Paul R. Michel, To prepare for the next pandemic, Congress should restore patent protections for diagnostic tests, Roll Call (April 28, 2020), https://www.rollcall.com/2020/04/28/to-prepare-for-the-next-pandemic-congress-should-restore-patent-protections-for-diagnostic-tests/.

[v] Joseph E. Stiglitz, Should patents come before patients? How drug monopolies hamper the fight against coronavirus, Project Syndicate (April 23, 2020), https://www.marketwatch.com/story/should-patents-come-before-patients-how-drug-monopolies-hamper-the-fight-against-coronavirus-2020-04-23?mod=article_inline

[vi] Id.

[vii]  U.S. Influenza Surveillance System: Purpose and Methods, Center for Disease Control, available at https://www.cdc.gov/flu/weekly/overview.htm (last accessed May 10, 2020).

[viii] Mayo v. Prometheus, 566 U.S. 66 (2012), available at https://www.supremecourt.gov/opinions/11pdf/10-1150.pdf.

[ix] Mateo Aboy, Mayo’s impact on patent applications related to biotechnology, diagnostics and personalized medicine, Nature Biotechnology (May 3, 2019), https://www.nature.com/articles/s41587-019-0111-5.

[x] Id.

[xi] Paul R. Michel, To prepare for the next pandemic, Congress should restore patent protections for diagnostic tests, Roll Call (April 28, 2020), https://www.rollcall.com/2020/04/28/to-prepare-for-the-next-pandemic-congress-should-restore-patent-protections-for-diagnostic-tests/.

[xii] Sydney Lupkin, Putting A Price On COVID-19 Treatment Remdesivir, NPR (May 8, 2020), https://www.npr.org/sections/health-shots/2020/05/08/851632704/putting-a-price-on-COVID-19-treatment-remdesivir.

[xiii] John F. CoganRemdesivir Affirms the American Way, Wall Street Journal (May 1, 2020), https://www.wsj.com/articles/remdesivir-affirms-the-american-way-11588368750.

[xiv] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934, Gilead Sciences Inc., available at http://investors.gilead.com/node/36926/html (last visited May 10, 2020).

[xv] The Netherlands Joins COVID-19 IP Pool Initiative; Kentucky Governor Requests 3M Release N95 Patent, Health Policy Watch (April 8, 2020), https://healthpolicy-watch.org/the-netherlands-joins-COVID-19-ip-pool-initiative-kentucky-governor-requests-3m-release-n95-patent/?mod=article_inline.

[xvi] Joseph E. Stiglitz, Should patents come before patients? How drug monopolies hamper the fight against coronavirus, Project Syndicate (April 23, 2020), https://www.marketwatch.com/story/should-patents-come-before-patients-how-drug-monopolies-hamper-the-fight-against-coronavirus-2020-04-23?mod=article_inline.

[xvii] NIOSH-Approved N95 Particulate Filtering Facepiece Respirators, Center for Disease Control, available at https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/N95list1-a.html (last accessed May 10, 2020).

[xviii]  Sandy Smith, Six Respirator Manufacturers Warn President of Shortage of Masks, EHSToday (June 22, 2006), https://www.ehstoday.com/emergency-management/article/21912885/six-respirator-manufacturers-warn-president-of-shortage-of-masks.


Copyright (C) GLOBAL IP Counselors, LLP

For more on COVID-19 protective equipment, see the National Law Review Coronavirus News section.

New Platform to Facilitate Development of COVID-19 Technologies

The United States Patent and Trademark Office (USPTO) has launched a new platform that could expedite the development of COVID-19 related technologies. As explained in the USPTO’s press release, the Patents 4 Partnerships web-based marketplace is designed to “facilitate the voluntary licensing and commercialization of innovations in a variety of key technologies” related to “the prevention, treatment, and diagnosis of COVID-19.”

The Patents 4 Partnerships IP marketplace platform currently lists 175 granted U.S. patents and pending U.S. patent applications, covering such diverse technologies as “Methods of Treating Coronavirus Infection,” “Air-Sampling Device and Method of Use,” “Rapid and Highly Fieldable Viral Diagnostic,” and “Dexterous Humanoid Robotic Wrist.” According to the press release, the initially listed items were “drawn from a variety of public sources, including the USPTO, the Federal Laboratory Consortium for Technology Transfer (FLC Business), the AUTM Innovation Marketplace (AIM), universities, and a number of federal agencies.”

Stakeholders wanting to add their U.S. patents or applications to the Patents 4 Partnerships platform can complete this simple form. As noted on the form, the technology should be “reasonably related to the prevention, treatment, diagnosis, protection from or alleviation of symptoms of coronaviruses in general.”


© 2020 Foley & Lardner LLP

For more in COVID-19 tech-development, see the National Law Review Coronavirus News section.

Patent Practitioners: Inventions and the Ecosystem of Ideas

Womble Carlyle Law firm

There are some striking parallels between inventions and living organisms, and between technology in a consumer marketplace and an ecosystem.  Insights gained through the comparisons may be beneficial to inventors, companies, consumers and the patent community.  What are the connections?  To review, living organisms exist in an ecosystem, and flourish or perish according to the laws of nature, with survival of the fittest.  Variations among the organisms occur from generation to generation, and are positively or negatively selected over the passage of time and generations, as organisms evolve.  This begets new species, which occupy environmental niches in the ecosystem, and also begets extinction in which species die off.  Ideas, invention and technology exist in a sort of man-made ecosystem, with the consumer marketplace performing a selection process, the whole experiencing a type of guided evolution.

Human beings have ideas.  We brainstorm them, communicate them to each other, and come up with more ideas.  Humans invent, bringing some of these ideas to fruition.  In turn, humans bring some of these ideas to actual products, which are then put up for sale and use in the consumer marketplace.  This is a sort of test in the ecosystem, as to which products will survive.  Consumers then make choices, purchasing the products they like, for various reasons.  Products that are not purchased and used influence manufacturers to stop making those products.  Products that are purchased and used influence manufacturers to continue making those products, and to develop next-generation variations of those products.  New features are added to next-generation products, and some of these new features are popular, and some are not.  The process of selection as to popularity, and sales volume, of products, is made by the consumers.

Next-generation variations of products are rather like offspring with mutations, in the comparison to living organisms in an ecosystem.  A brand-new, never before seen product is rather like a new species that has suddenly emerged.  Entire product types that become obsolete are rather like the dinosaurs that went extinct long ago.  Even the term “dinosaur”, in colloquial usage, is synonymous with outdated technology (and is also sometimes applied to people who still prefer to use such outdated technology).

Ideas, invention, products and technology thus emerge, develop, thrive or perish, beget variations, and evolve over time in the consumer marketplace.  The ever-present interest by, and purchasing power of, consumers drives the selection process that guides the evolution of products and technology.  The ever-present ingenuity of inventors, and desire for companies to succeed in the marketplace, drives the production and mutation (variation) processes that guide the evolution of products and technology.  The history of technology thus parallels the history of living organisms. 

We patent practitioners are privileged to be chroniclers of inventions.  A study through the body of published patent applications and issued patents illuminates the more recent history of invention and key aspects of technology.  A study of the United States Patent Classification System, as developed and used by the United States Patent and Trademark Office, is rather like studying the taxonomy of living organisms.

How might we apply these insights?  Consider a new product without a marketplace.  Is such a product likely to survive?  Perhaps a new marketplace will emerge for the new product, which could then dominate.  How will other products compete with this new product?  How will consumers decide whether to select and use, or deselect the new product?  Consider competition against a product that is well-established in a marketplace.  What new feature or new product could compel consumers to favor it?  If some branch of technology is headed for obsolescence, why is this?  If some new branch of technology is emerging, how might it fare, and why?  And, for the patent practitioners in the audience, how might we best capture the innovative aspects and the inventions in our drawings, descriptions and claims on behalf of the inventors?  This is all part of the art of patenting.

 
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Microsoft-Nokia: China’s MOFCOM Quietly Slips Into the Debate about Injunctive Relief for FRAND (Fair, Reasonable and Nondiscriminatory)-Encumbered SEPs (Standard Essential Patents)

Sheppard Mullin 2012

This past November and December, the US Federal Trade Commission (“FTC”) andEuropean Commission (“EC”) cleared Microsoft Corporation’s (“Microsoft”) acquisition of the bulk of the devices and services business of Nokia Corporation of Finland (“Nokia”) without any conditions. In contrast, on April 8, 2014, the Chinese Ministry of Commerce (“MOFCOM”) approved the acquisition subject to conditions that include an intellectual property issue that is still to be resolved in the US, EU and other countries: whether holders of standard essential patents (“SEPs”) who make licensing commitments under fair, reasonable and nondiscriminatory (“FRAND”) terms should be barred from seeking injunctive relief against alleged infringers of their patents.  MOFCOM’s conditional approval is not controversial for this specific transaction, but raises the question of how MOFCOM’s treatment of this issue will be interpreted in future merger reviews and whether this will affect investigations related to anticompetitive conduct.

Microsoft develops, produces, licenses, and sells computer software, such as its computer operating system and PC-based productivity software, and consumer electronics. Microsoft owns both standard essential patents (“SEPs”) and non-SEPs for Android (smartphone operating system).  In general, the SEPs are important in terms of implementing certain telecommunication standards, such as 2G, 3G and 4G, in smartphones. The target, the devices and services business of Nokia, includes a design team and business units for devices such as mobile phones and smart devices, production facilities, related sales and marketing activities and support functions, as well as design rights related to the devices produced by the devices and services business.  Excluded from this acquisition are Nokia’s reserves of SEPs related to telecom and smartphones (the MOFCOM decision does not specify what these SEPs are for).

MOFCOM determined that Microsoft’s acquisition of Nokia’s design and services business had the effect of eliminating or restricting competition in China’s smartphone market both in terms of what Microsoft could do as a result of the acquisition and in terms of what Nokia could do with the assets that were not part of the acquisition.  MOFCOM conditioned its approval of the acquisition on Microsoft’s and Nokia’s compliance with the following conditions  (an unofficial translation of the MOFCOM decision can be found here).

MICROSOFT must:

1. (a) With regard to SEPs, continue to adhere to the existing FRAND terms of the standard setting organizations (SSOs).

(b) Refrain from seeking injunctions for infringement of such SEPs against smartphones produced by Chinese producers.

(c)  Refrain from demanding cross-licenses when licensing such SEPs except for any patents that the licensees have in the same industry.

(d) Only transfer such SEPs to a third party who agrees to comply with the above limitations. Any potential licensee with Microsoft-related SEPs should also be bound by the same principles.

2. (a) With regard to non-SEPs, continue to offer, at consistent or discounted rates, non-exclusive licenses of its non-SEPs to domestic Chinese smartphone producers

(b) For the next five years, not transfer its SEPs listed in attachment 1 or 2 (Attachment 1 lists Microsoft patents that were reviewed by MOFCOM, Attachment 2 lists Microsoft patents related to Android) to other parties. After this five-year period, Microsoft will transfer these SEPs only to those who agree to be bound by conditions imposed on Microsoft.

MOFCOM is entitled to inspect Microsoft’s compliance with the above conditions and Microsoft is obligated to report its compliance 45 days after the end of each calendar year.

NOKIA must:

  1. Make sure its commitments to license its SEPs continue to comply with the existing FRAND terms of the SSOs.
  2. Refrain from seeking injunctive relief against licensees of SEPs that are subject to FRAND except in the case where a licensee has breached the FRAND terms.
  3. Agree to define licensor or licensee “good faith” as a matter of each party’s willingness to resolve FRAND terms-related disputes through arbitration and to be bound by the arbitration decision.
  4. Agree that licensees are not obligated to accept any license not complying with FRAND terms by Nokia.
  5. Transfer SEPs only to those who agree to be bound by the FRAND terms applicable to those SEPs.
  6. Not change its valuation standards for FRAND licenses.

MOFCOM is entitled to inspect Nokia’s compliance with the above conditions and Nokia is obligated to report its compliance 45 days after the end of each calendar year.

Neither the FTC nor the EC speculated on the likely post-merger licensing conduct of the merged entity or the portion of Nokia that was excluded from the acquisition with respect to SEPs and non-SEPs. The EC noted that concerns related to the licensing of Nokia’s patent portfolio that was not part of the acquisition were beyond the scope of its review, but that it will monitor Nokia’s post-merger licensing practices.

MOFCOM, in contrast, without providing any basis for its conclusion other than speculation on the companies’ motives, stated that:

(a) Microsoft “could” exclude and impede competition in China’s smartphone market based on its patents for Android:  “Microsoft has the motive to raise royalty fees”—MOFCOM provides no basis for this conclusion other than the observation that, before the acquisition, Microsoft was not a player in the smartphone market. Now, with the SEPs and non-SEPs related to the Android system, it has the potential for excluding and restricting competition in the smartphone market because the Android smartphone has an 80% share of the China market.

(b) Nokia “could abuse its reserve of patent licenses” (“the acquisition enhances Nokia’s motive to rely on profits from patent licensing”)—MOFCOM provides no basis for this conclusion. MOFCOM states: “As Nokia will basically exit from downstream market of devices and services, Nokia will not have to obtain cross-licenses for its smartphone business after the acquisition, so its motivation to maintain a low level royalty fee in the smartphone industry will go down. Such lack of need will enhance Nokia’s motive to rely on profits from patent licensing.”

As in the Google-Motorola deal in 2012, this time both the FTC and the EC took a “wait and see” approach:  they will continue to monitor Microsoft’s and Nokia’s post-merger conduct.  MOFCOM took its analysis a step further.  MOFCOM wanted in black and white Microsoft’s and Nokia’s confirmations of what they are obligated to do under the FRAND terms of the standard setting organizations.  MOFCOM also wanted Microsoft to confirm that it would not seek an injunction against Chinese companies; such policy is actually already in Microsoft’s website statement of February 8, 2012, where, in reference to essential patents that are offered under FRAND terms, Microsoft announced that it would not seek an injunction against any firm on the basis of a SEP.

MOFCOM, without any discussion but merely by imposing a condition that the SEP holders, Microsoft and Nokia are barred from seeking injunctive relief against alleged patent infringers, has opened the door for debate in China. The issue of whether a FRAND commitment precludes a patent owner from seeking injunctive relief is still being debated in the US, EU and other jurisdictions. In July, 2013, the FTC lifted the ban against injunctions for FRAND patents in the Google-Motorola Mobility case.  In August, 2013, the US Trade Representative wrote a letter to the US International Trade Commission (“ITC”) stating that it opposed the injunction order of the ITC but included in a footnote when injunctions would be appropriate, including but not limited to when the “putative licensee is unable or refuses to take a FRAND license and is acting outside the scope of the patent holder’s commitment to license on FRAND terms…if a putative licensee is not subject to the jurisdiction of a court that could award damage.”  The bottom line was that public interest considerations must be part of the determination whether or not to grant injunctive relief. The EC’s stance is reflected in the Google/Motorola merger review decision of February, 2012—that competition may be threatened if SEP holders threaten injunctive relief.

MOFCOM’s approach may well have been influenced by Chinese domestic competitors raising concerns about the merger; in the media it has been reported that ZTE and Huawei, among others, raised concerns.  Of course, this is part of the merger review process, so it is not unusual for competitors to influence proceedings, but one must not forget that MOFCOM appears to wear two hats:  supporting China’s industrial policy and antitrust enforcer.  Furthermore, perhaps MOFCOM required these confirmations because it would be more difficult for the enforcement agencies, the National Development and Reform Commission (“NDRC”) and the State Administration of Industry and Commerce (“SAIC”), to monitor the companies’ actions in the future.

The relevance of this decision is the following:

  1. MOFCOM applies the antitrust laws as a regulator:  rather than waiting to see how the parties behave, it micro-manages their conduct (Microsoft and Nokia are already bound by FRAND terms that can include voluntary limitations on seeking injunctive relief).
  2.  How will SAIC use the condition regarding the ban on injunctive relief in abuse of dominance investigations?  Will the condition imposed by MOFCOM be interpreted as the definitive government position even though MOFCOM did not address this issue in its analysis?  If so, then there is the potential that a holder of an SEP may be accused of violating Chinese antitrust law if it seeks injunctive relief against an alleged infringer because it is allegedly abusing its dominant position (assuming that this holder is found to have a dominant position in the relevant market).
  3. Will SAIC include a ban on injunctive relief related to FRAND-encumbered SEPs in its final rules concerning intellectual property rights and the enforcement of Chinese antitrust law?
  4. It may be prudent for holders of SEPs to review their FRAND commitments.
  5. Potential patent infringers might want to check if there are FRAND commitments that would protect them.

This acquisition shows once more that for offshore acquisitions, which have been cleared by other jurisdictions, Chinese antitrust clearance is not to be taken for granted. This time China has quietly stepped into the debate over injunctive relief for FRAND-encumbered SEPs.

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Top Ten Intellectual Property Stories from 2013

Schwegman Lundberg Woessner

 

I admit it, I like lists, even completely subjective ones like this one, that is tilted toward patent law and prep/pros. So in no particular order, except for number one, here we go:

top 10 2013 intellectual property patent

  1.  Myriad [Add your pun title here!]. No story can top a unanimous Supreme Court opinion (Thomas writing even!) holding that a discrete chemical molecule is really a data storage device made for us all by Mother Nature, and so is a “natural product”. More troubling, I fear, are Judge Lourie’s two opinions below, holding that the broadly-claimed diagnostic methods were patent-ineligible as “abstract ideas.” Combine this with Mayo and PerkinElmer v. Intema and you get caught in a perfect storm that can sink almost any claim to a diagnostic method.
  2. CLS Bank v. Alice. A big story indeed, as commentators tried, with little success, to unravel the threads in multiple opinions issued by the Fed. Cir. judges. Now the Supreme Court will try to define an abstract idea. Is C =pi(D) carved into a brick concrete enough for you?
  3. Inequitable Conduct goes into IP hospice. While we still have a duty of candor and good faith in dealing with the PTO, Rule 1.56(b) is gone. A simple failure to submit even “material” information will seldom, if ever, lead to an IC holding. In 1st Media v Electronic Arts, Sony, a defendant in the suit, petitioned for cert., playing the “rigid test” card, but the Supreme Court stood pat and denied the petition. In Network Signatures v. State Farm, Judge Newman suggested that facially false petitions would not amount to “egregious misconduct” unless they involved statutory standards of patentability, as opposed to formal PTO filings. However, the Supreme Court also denied cert.  in Apotex v. Cephalon, in which the Cephalon attorney and scientist obtained a patent on an invention made by their supplier – both the D.C. and the Fed. Cir found IC. And where are the final PTO rules?
  4. The rise of the Written Description Requirement as a patent-killer. I predicted this trend post-Ariad and the Fed. Cir. has ruled accordingly. It is much easier to invalidate a claim by finding that the specification does not demonstrate enough “possession” of the claimed invention that it is to have to sort through all those messy Wands factors for enablement. Even with a lot of structural data, Novozymes’ patent on its improved enzyme sank like a stone. And the Fed. Cir. has pretty much ignored patentee’s attempts to argue that a thin disclosure can be supplemented by information available to the art. See Wyeth v. Abbott Labs. Even “Gentry Gallery” –based decisions seem to be in vogue again (no support in specification for later claim amendment) – see Synthes v. Spinal Kinetics. However, possession did “rule” in Sanofi-Aventis v. Pfizer, so perhaps it is possible to turn this ocean liner around.
  5. Section 112(b) Indefiniteness. Supreme Court may grant cert to resolve the question: “Does the Federal Circuit’s acceptance of ambiguous patent claims with multiple reasonable interpretations—so long as the ambiguity is not ‘insoluble’ by a court—defeat the statutory requirement of particular and distinct patent claiming.” Nautilus v Biosig Instruments. This is one of the few lines of Fed. Cir. decisions that favor patentees.
  6. Who induced infringement, or did they? In Limelight Networks v. Akami Techs., the Supreme Court may well grant cert. to decide the question: “Whether the Fed. Cir. erred in holding that a defendant may be held liable for inducing patent infringement under [271(b)] even though no one has committed direct infringement under [271(a)]?” This somewhat muddled question could be clearer if “no one” was defined more completely, but the Solicitor General has recommended that the Court take this one up, so watch out.
  7. The Rise of Secondary Considerations. In the wake of KSR’s termination of the teaching-suggestion-motivation test, the Fed. Cir. and the Board are increasingly looking for, and giving weight to, the oft neglected bag of secondary considerations. The court has noted that unexpected results are a secondary consideration (I don’t think that John Deere said that), and has put increased emphasis on long-felt need, failure of others, commercial success and the like. This does not mean that applicants or patentees will always “win”, but it significantly increases the number of patentability “chips” they have to play. For example, see Galderma v Tolmar, Appeal No. 2013-1034 ( Fed. Cir., December 11, 2013)in which a split panel of the Fed. Cir. found Galderma’s add-on patent for adapalene obvious, but spent a lot of space evaluating unexpected results and defining “teaching away.”
  8. Has Cybor’s Time Finally Come? The Fed. Cir. en banc will soon decide whether or not Fed. Cir. panels should overrule its practice of reviewing claim construction de novo, as a matter of law. Cybor has been much reviled in recent years, but there are voices that feel Cybor comports with the mission of the Fed. Cir. to bring uniformity to patent law. If the court takes this step, some commentators think that the Supreme Court will be the final arbiter.
  9. Stem Cell Research to Continue. The suit seeking to ban Federal funding for embryonic stem cell research was finally dismissed.
  10. The Battle Against “Patent Trolls” continues. And continues to threaten a system that has worked to advance innovation for over 200 years. The biggest threat posed by attempts to limit suits by NPE’s against – mostly – high tech communications companies is that they tar patent holders as a group, particularly universities and individual inventors and start-ups, by making it more difficult/costly for them to enforce their patent rights against deep pocket infringers. H.R. 3309 is just one of the latest shotgun blasts fired at the patent system. Now the Office may have a new “Director” who believes that the patent system is broken and needs to be fixed. I don’t like legislative and administrative bodies cooperating to fix a problem that almost no one has clearly defined. The last time this happened, there was a bill passed to reduce the backlog by severely limiting application filing and prosecution in general.

Merry holidays (or year-end rushes) to us all and many happy allowances!

Article by:

Warren Woessner

Of:

Schwegman, Lundberg & Woessner, P.A.

Transfer of Ownership Requires a Written Assignment

Recently in The National Law Review was an article by Jeremy T. Elman of McDermott Will & Emery regarding the Transfer of Patent Ownership:

Addressing the issue of patent ownership based on contractual assignments, the United States Court of Appeals for the Federal Circuit affirmed the district court’s decision dismissing patent ownership claims where a consulting agreement contained no express assignment language requiring defendant to assign the patents-in-suit to plaintiffs.Abbott Point of Care, Inc. v. Epocal, Inc., Case No. 11-1024 (Fed. Cir., Jan. 12, 2012) (Rader, C.J.)

Defendant-appellee Epocal was founded by Dr. Imants Lauks (Lauks), who was previously an employee of a predecessor company of plaintiff-appellant Abbott, with whom he signed three contracts (two employment agreements and one consulting agreement).  Both Epocal and Abbott claim to own the patents-in-suit, which cover systems for testing blood samples.Epocal is the assignee of both patents.  Lauks’ 1984 employment agreement contained language assigning all inventions to Abbott’s predecessor company (Integrated Ionics), but his 1999 consulting agreement, although it stated that the 1984 agreement remained in effect for work done while Lauks was an employee, was “silent” as to assignments of any inventions.  Lauks filed applications for these two patents in 2001, after which Abbott sued Epocal and claimed ownership of the patents pursuant to the 1984 agreement.  Epocal claimed ownership pursuant to the 1999 consulting agreement.After the district court granted Epocal’s motion to dismiss, Abbott appealed.

After noting that the Court reviews decisions on standing and contracts without deference, the Federal Circuit noted that Abbott had the burden of showing ownership and concluded that under New Jersey law, where the contract was apparently signed, the 1984 employment agreement ceased upon the execution of 1999 consulting agreement.  The 1999 consulting agreement expressly stated that Lauks resigned from his position and the 1999 consulting agreement then refers to Lauks as a “Senior Consultant,” i.e., no longer an employee.  The Court found that the 1999 consultant agreement did not specify that the entire 1984 employment agreement remained in effect, but only the confidentiality provisions.  The 1999 consulting agreement was silent as to any assignment of inventions, but “recognized and allowed Lauks to pursue other, non-conflicting interests.”  The Court thus found that there was an express recognition that Lauks’ agreement in the 1984 employment agreement to assign his inventions had ceased.   The Court rejected the contention that Lauks had a duty to continue to assign his inventions to Abbott, finding that proposed interpretation to be in conflict with the express language of the 1999 consulting agreement.  The Court thus held that Epocal was the owner of the patents-in-suit and affirmed the district court’s dismissal of Abbott’s infringement claim.

Practice Note: Companies should carefully examine patent assignment obligations of their employees or consultants and, in connection with corporate changes, examine whether prior assignment agreements will impose continuing assignment obligations after the employee or consultant has ceased employment with the company.

© 2012 McDermott Will & Emery