Disincentivizing the Use of IPRs and PGRs Against Pharmaceutical and Biologic Patents

Senator Orrin Hatch has introduced legislation designed to curb the use of IPRs and PGRs against pharmaceutical and biologic patents by essentially the denying the benefits to generic/biosimilar companies of the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act.  Allowing the usage of IPRs against pharmaceutical and biologic patents was a serious oversight in enacting the America Invents Act.  Senator Hatch’s Office has released the following information concerning the new Hatch-Waxman Integrity Act of 2018 (which includes a section by section analysis):

In 2012, Congress enacted the America Invents Act to fix a problem unrelated to drug/biologic innovation and drug/biologic affordability; it created the inter partes review (“IPR”) and post-grant review (“PGR”) processes to combat the growing problem of patent trolls.

Even though Congress did not intend to upset its drug/biologic-specific Hatch-Waxman and BPCIA procedures with the enactment of the IPR and PGR processes, generic drug and biosimilars manufacturers have increasingly used the IPR process to circumvent the Hatch-Waxman Act and BPCIA patent challenge processes while nonetheless taking advantage of their abbreviated processes for drug entry.1  Moreover, hedge funds with no interest in manufacturing or marketing drugs have filed IPR challenges against drug patents with the goal of profiting from stock market declines triggered by the IPR filings—a type of market manipulation.

The Hatch-Waxman Integrity Act of 2018 would close the loophole unintentionally created by the America Invents Act. To restore the careful balance of the Hatch-Waxman Act and the BPCIA, and to prevent the IPR or PGR processes from undercutting them, the FD&C Act and the PHS Act would be amended to prevent using IPR (or PGR) challenges to circumvent the specific patent challenge processes for drugs and biologics painstakingly created by Congress. In addition, the federal securities rules would be clarified to indicate that filing IPR patent challenges and profiting from resulting stock price changes is a form of prohibited market manipulation.

The Press Release is available, here.  The text of the proposed legislation is available, here.  [Hat Tip to Professor Dennis Crouch’s Patently Obvious Blog]

Judges Lourie and Newman of the Federal Circuit Critique Alice/Mayo and Myriad

The U.S. Court of Appeals for the Federal Circuit, in AatrixSoftware, Inc. v. Green Shades Software, Inc., recently denied a rehearing en banc concerning two cases that may make it more difficult to dismiss a claim challenged for lack of patent eligible subject matter under the Alice/Mayo test because of factual issues.  This leaves intact the ability of counsel to raise factual issues which may avoid early resolution of a patent infringement action on patent eligible subject matter grounds.  Notably, Judges Lourie and Newman, both of whom have graduate degrees in technical fields and are very experienced members of the Federal Circuit, requested in a concurring opinion that the U.S. Congress revisit patent eligible subject matter, particularly in light of the Alice/Mayo test and the U.S. Supreme Court “abstract idea gloss.”  Judge Lourie states:

The case before us involves the abstract idea exception to the statute.  Abstract ideas indeed should not be subject to patent.  They are products of the mind, mental steps, not capable of being controlled by others, regardless what a statute or patent claim might say.  Gottschalk v. Benson, 409 U.S. 63, 67 (1972) (“[M]ental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.”).  No one should be inhibited from thinking by a patent.  See Letter from Thomas Jefferson to Isaac McPherson (Aug. 13, 1813) (“[I]f nature has made any one thing less susceptible, than all others, of exclusive property, it is the action of the thinking power called an Idea.”).  Thus, many brilliant and unconventional ideas must be beyond patenting simply because they are “only” ideas, which cannot be monopolized.  Moreover such a patent would be unenforceable.  Who knows what people are thinking?  

But why should there be a step two in an abstract idea analysis at all?  If a method is entirely abstract, is it no less abstract because it contains an inventive step?  And, if a claim recites “something more,” an “inventive” physical or technological step, it is not an abstract idea, and can be examined under established patentability provisions such as §§ 102 and 103.  Step two’s prohibition on identifying the something more from “computer functions [that] are ‘well-understood, routine, conventional activit[ies]’ previously known to the industry,” Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2359 (2014) (alteration in original) (quoting Mayo, 566 U.S. at 73), is essentially a §§ 102 and 103 inquiry.  Section 101 does not need a two-step analysis to determine whether an idea is abstract.   I therefore believe that § 101 requires further authoritative treatment.  Thinking further concerning § 101, but beyond these cases, steps that utilize natural processes, as all mechanical, chemical, and biological steps do, should be patent-eligible, provided they meet the other tests of the statute, including novelty, nonobviousness, and written description.  A claim to a natural process itself should not be patentable, not least because it lacks novelty, but also because natural processes should be available to all.  But claims to using such processes should not be barred at the threshold of a patentability analysis by being considered natural laws, as a method that utilizes a natural law is not itself a natural law.

Judge Lourie also criticized the U.S. Supreme Court’s decision in Myriad Genetics:

[F]inding, isolating, and purifying such products are genuine acts of inventiveness, which should be incentivized and rewarded by patents.  We are all aware of the need for new antibiotics because bacteria have become resistant to our existing products.  Nature, including soil and plants, is a fertile possible source of new antibiotics, but there will be much scientific work to be done to find or discover, isolate, and purify any such products before they can be useful to us.  Industry should not be deprived of the incentive to develop such products that a patent creates.  But, while they are part of the same patent-eligibility problems we face, these specific issues are not in the cases before us.   Accordingly, I concur in the decision of the court not to rehear this § 101 case en banc.  Even if it was decided wrongly, which I doubt, it would not work us out of the current § 101 dilemma.  In fact, it digs the hole deeper by further complicating the § 101 analysis.  Resolution of patent-eligibility issues requires higher intervention, hopefully with ideas reflective of the best thinking that can be brought to bear on the subject.

There are numerous proposals for changing patent eligible subject matter before the U.S. Congress, for example, see the AIPLA proposal, here. 

Independent judiciary requires reliability and factual credibility in economic analysis

In a major ruling that underscores judicial independence, federal judge Richard J. Leon has just unconditionally approved the merger between AT&T and Time Warner, rebuffing the US government’s effort to stop the $85.4 billion deal.

A Rube Goldberg machine or contraption

Judge Leon made headlines during the trial when he questioned whether a key Justice Department theory, backed by a well-known testifying-expert economist, was a Rube Goldberg contraption: “a machine intentionally designed to perform a simple task in an indirect and over-complicated fashion.” The UK equivalent of this is a Heath Robinson contraption: “any unnecessarily complex and implausible contrivance.” The Dane Robert Strom Peterson was similarly creative with “comic drawings of machines that perform very simple tasks through an unnecessarily complex and usually humorous series of actions.”

The judge was also quite damning in his written Decision:

Page 149: “After hearing Professor Shapiro’s bargaining model described in open Court I wondered on the record whether its complexity made it seem like a Rube Goldberg contraption. Professor Carlton agreed at the trial that that was a fair description. But in fairness to Mr. Goldberg, at least his contraptions would normally move a pea from one side of a room to another. By contrast, the evidence at trial showed that Professor Shapiro’s model lacks both ‘reliability and factual credibility,’ and thus fails to generate probative predictions of future harm associated with the Government’s increased-leverage theory. Accordingly, neither Professor Shapiro’s model, nor his testimony based upon it, provides me with an adequate basis to conclude that the challenged merger will lead to any raised costs on the part of distributors or consumers — much less consumer harms that outweigh the conceded $350 million in annual cost savings to AT&T customers.” (citation omitted, emphasis already included)

Professor Shapiro’s work on alleged patent holdup has similar failings, as I discussed, here (including my full analysis in a 12-page download), in August 2016, and as follows:

I came upon a paper entitled “Patent Holdup: Myth or Reality?” by Carl Shapiro, dated 6^th October 2015, which was circulated as a hard-copy and presented at an IEEE-SIIT conference at the Intel-sponsored key-note address. In this, the author concedes that there are “few documented instances of actual holdups” and that they are “exceedingly difficult for researchers to detect and reliably quantify.” He has backed off from his previous claims of prevalence of “patent holdup” where he stated “patentees regularly settle with companies in the information technology industries for far more money than their inventions are actually worth. These companies are paying holdup money to avoid the threat of infringement.” Shapiro has retreated due to lack of empirical support for these original claims which is because portfolio licensing among many licensees on FRAND terms together with the courts ensure that holdup royalties are rarely demanded and are never paid. However, Shapiro takes another position where there is also no supporting evidence. He now claims that the social costs caused by the alleged “patent holdup” problem are in the actions taken to prevent holdup and in the opportunities forgone under the threat of “patent holdup.” (emphasis added)

It is reassuring that even well-known and widely-cited economists are expected support their opinions with facts when testifying in court. Royalty-stacking theory peddlers should also beware because they are likewise devoid of supporting evidence while there is copious evidence and solid economic analysis to the contrary.

Government agencies pursuing policy objectives must be more diligent in their deliberations. Academics and other experts should also be more principled when publishing academic articles and giving speeches. As I recently wrote in another publication on the question of “Economists: Do They Have a Place?” following a conference panel speech on the topic:

Economists need to take responsibility for what their own economic analysis relies upon. We need economists to publish, and as expert witnesses, but we need to flush out inapplicable theories, biases, and nonsense with more empirical testing, public debate including academic peer review, and rebuttal in litigation according to the applicable rules of evidence.

ESPN+ and the streaming of sports events--will it complement or cannibalize?

Already in the 19th century, the book industry had begun to experiment with publishing paperback versions. The question early on was whether paperbacks expanded the market, by reaching readers who would not otherwise have purchased the more expensive hardback, or whether it tended to cannibalize sales. The advent of paper books was perhaps the first example of the tension between complementing and cannibalizing a copyright-driven market.

A version of this arose in the recent announcement by Disney of ESPN+, which is meant to be a sports-streaming service that will be available for a (modest?) monthly subscription fee. Still, even die-hard sports fans who cannot get enough of televised sports may have missed the launch of the service on April 12th. Usually, when Disney does a launch, one can expect bells, whistles, and a lot more, the better to draw attention to the new offering. Add to that is the fact that ESPN is the most consistently lucrative part of the Disney empire. Still, all in all, the launch of ESPN+ was a modest affair. It is interesting to consider the reasons this was so, and why Disney is gingerly taking steps as it enters the sports streaming business.

According to The Economist ("ESPN starts a streaming service", April 19th), Disney’s ultimate goal (bad sports pun, this ….) for ESPN+ is to create “a sort of mini [njw-at least for the moment] -Netflix for sports”, namely a commercial streaming service, as opposed to pay-tv packages that offer all the coveted major (at least US) sports. While a cable company may offer hundreds of channels, it is primarily the live sports programming (together with perhaps news) that principally draw subscribers to its services. This is why ESPN is such a valuable channel, with a reported 86 million subscribers, for which ESPN receives $8.14 in fees per subscriber per month, the highest of any network.

Enter the streaming challenge, embodied by Netflix. For a fraction of the cost, viewers can in principle cut the cable cord and still enjoy a wide array [although how "wide" can still be debated] of contents for viewing. So what is Disney to do? ESPN is ever so lucrative as a cable channel, but streaming could disrupt and thereby threaten that industry, if the right business model can be found. For the moment, therefore, the solution is apparently for Disney/ESPN to take baby steps.

This means no streaming of mainline sports events. Instead, ESPN+ will focus on streaming "secondary sports", described by Wikipedia as such events as—

“… combat sports, college sports, cricket, rugby union, soccer (including out-of-market Major League Soccer matches), and tennis”.

The aim in showing such sporting events is to reach what ESPN, according to The Economist, calls the “hard-core sports fanatic” or the “underserved sports fan.” On this basis, ESPN+ would appear to pose no current threat of materially cannibalizing its own cable offerings. As noted by Wikipedia—

“The service is not intended to cannibalize ESPN's core linear networks, so it will not carry ESPN's core professional sports rights or offer access to ESPN's linear programming. ESPN+ will instead serve as a complement to them as part of the ongoing market trend of cord cutting and over-the-top pay television….”

However, it is difficult to believe that ESPN+ will continue to limit itself to streaming only these kinds of live sporting events to the tails of the viewing population. Presumably, at some point, Disney will want to make real money from this. When crunch time comes, Disney will have to answer the question—how will it manage the clash between cable and internet streaming?

Hardback and softback books continue to co-exist (now joined by e-books as a third form of book product) on the basis that they are more complementary than cannibalizing of the book industry, taken as a whole. Whether that model will characterize the relationship between streaming and cable remains an open question. Will ESPN+ will be limited to being a niche form of live sports streaming, "a sort of mini-Netflix for sports". Or will it be something more; if so, how much more? Stay tuned.

Photo on lower left by Roger Cornfoot and is licensed under the Creative Commons Attribution-ShareAlike 2.0 license

By Neil Wilkof

FDA Attempts to Shame Pharmacuetical and Biotechnology Companies

The U.S. Federal Drug Administration (FDA) recently decided to try to “shame” some pharmaceutical and biotechnology companies for failing to provide samples to companies who wish to produce generic versions of their pharmaceuticals.  The FDA states:

In passing the 1984 Hatch-Waxman Amendments to the Federal Food, Drug & Cosmetic Act, Congress created a system that balances encouraging and rewarding medical innovation with facilitating robust and timely market competition. One of the primary ways that FDA facilitates a competitive marketplace is through the efficient approval of generic drugs, which are often lower-cost than brand drugs.

Unfortunately, the process established by Congress may not always function as intended. At times, certain “gaming” tactics have been used to delay generic competition. One example of such gaming is when potential generic applicants are prevented from obtaining samples of certain brand products necessary to support approval of a generic drug. The inability of generic companies to purchase the samples they need slows down, or entirely impedes, the generic drug development process – leading to delays in bringing affordable generic alternatives to patients in need.

As described in further detail below, these kinds of problems with generic access to necessary samples may occur when brand products are subject to limited distribution – whether the company has voluntarily adopted limitations on distribution, or the limitations have been imposed in connection with a Risk Evaluation and Mitigation Strategy (or REMS), a program that FDA implements for certain drugs to help ensure that their benefits outweigh their risks. In some cases, brand drug sponsors may use these limited distribution arrangements, whether or not they are REMS-related, as a basis for blocking potential generic applicants from accessing the samples they need.

As part of the FDA’s Drug Competition Action Plan (DCAP), FDA is committed – among other things – to addressing and improving transparency about this and other gaming tactics that delay the generic competition Congress intended.

There are around 50 drugs listed, including about 40 different pharmaceutical and biotechnology companies.  Do you think this tactic will work?  Interestingly, a New York Times article describes Celgene’s response, here. 

Gender Diversity in IP and Technology Policy: A New Resource and Way to get Noticed

The most recent WIPO Magazine is devoted to women and IP.  There are a number of fascinating articles concerning women involved in creating in various technology and artistic spaces.  One interesting story involves Sybilla Masters.  She “developed a way to process Indian corn in 1715 and her achievements were recorded in the patent document, the associated right was issued to her husband.  At that time, the prevailing laws stated that women could not own property.”  WIPO also discusses the gender gap in patent filings—only about 4% to 20% of patent applications include a female inventor depending on the country.  The United States is at 10%.  Interestingly, WIPO points to several causes of the gap: 1) fewer women in STEM fields; 2) “Female scientists and engineers are less likely than their male counterparts to think about commercializing their inventions, and are less comfortable marketing themselves and their work to potential business partners.;” and 3) Female scientists and engineers “are less likely to be invited to sit on prestigious scientific boards or advisory panels where they could meet potential innovation partners.” 

The Brookings Institute recently announced the creation of Sourcelist.  Sourcelist is a database of women who are experts in technology policy, and coming soon—a database of other diverse groups who are also experts in technology policy.  Sourcelist states that it was created because:

Recognizing that women and underrepresented genders in technology policy—a field at the intersection of Silicon Valley and the Washington Beltway—face a particular set of institutional barriers, we dedicated the first Sourcelist database to Women+. Issues associated with underrepresentation have not gone unnoticed, and countless organizations have made important progress in raising awareness of the problem and educating stakeholders on the importance of greater gender diversity. Sourcelist seeks to help in the last mile of those efforts; it is a resource for those looking to put good intention into practice.

This looks like a great idea!  If you are female, sign up to get on the list! 

Solutions in Search of a Problem: The Trademark Register Clogged?

Commentators have debated the question of whether there are too many trademarks.  Are we going to end up in a situation where there just are not enough good trademarks left, particularly wordmarks?  Some would argue that there is an inexhaustible supply of potential trademarks, particularly when considered with words and designs in combination.  A recent Wall Street Journal article asserts that U.S. intellectual property officials are concerned about a large number of applications filed in the United States by Chinese companies and citizens.  Apparently, part of the concern is with fraudulent applications. 

One of the curbs on excessive use of trademarks in the United States is the use requirement.  For most filings in the United States, there must be a use--or eventually a use with an intent to use based application.  Interestingly, CompuMark has released a survey which states that China will become the leader in trademark filings domestically and in the world by 2020.  According to CompuMark, China has filed "nearly 120,000 foreign trademark applications in 2017."  And, the number of trademark applications in the U.S. by Chinese companies or individuals has increased by 800% since 2014.  The Chinese trademark registry now has "over 5 million new trademark applications in 2017" and sixty percent of the trademark registrations in the world are in China.  In the U.S., trademark registrations stay in effect for a basic ten year term after the first five years.  

Let's assume there is a problem.  The problem is there aren't enough good trademarks for legitimate businesses and there's a potential for hold-up of legitimate businesses by "weak" marks.  I suppose another related problem is the increase in search costs due to avoiding a massive number of marks.  Some of our solutions could include increasing filing fees and maintenance fees.  Another solution is shortening the time periods for requiring fees.  The U.S. has very long terms.  We could shorten them to two to three years.  We could increase penalties for the filing of fraudulent marks, including increased penalties for the US attorney who files the marks.  We could lower the costs for challenging existing marks.  We could also create a way to dismiss spurious suits for trademark infringement early and penalize over-enforcement through cease and desist letters.  Many of these solutions have been proposed.  Is there a problem?