Posts Tagged: "Senator Orrin Hatch"

What was the federal government thinking when Hatch-Waxman originally passed. Why would Congress incentivize generic manufacturers to challenge the patents of pharmaceutical companies? It is the same insidious thought process underlying Hatch-Waxman seen underlying the justification for post grant challenges of all patents at the USPTO. How absurd is it that those who question the need for incentive to innovate are so eager to provide incentive to challenge patents?

Late yesterday, Senator Orrin Hatch (R-UT), co-author of the Hatch-Waxman Act, filed an amendment in the Senate Judiciary Committee to address what many characterize as abusive inter partes review (IPR) filings relating to brand name pharmaceuticals. According to Senator Hatch, his amendment is intended to restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development. The Hatch-Waxman Act encourages generic drug manufacturers to challenge patents of brand name drugs by filing Abbreviated New Drug Applications with the Food and Drug Administration, which can and typically does result in patent infringement litigation in federal district court.

Sen. Harris followed up by asking whether algorithms were mathematical representations of laws of nature. “You’re getting right to the heart of the issue,” Iancu said. What Iancu said after that should be a major breath of fresh air to inventors and patent owners frustrated by Section 101 validity issues in the wake of Alice and Mayo: “This is one place where I believe courts have gone off the initial intent. There are human-made algorithms, human-made algorithms that are the result of human ingenuity that are not set from time immemorial and that are not absolutes, they depend on human choices. Those are very different from E=mc2 and they are very different from the Pythagorean theorem, for example.”

Vishal Amin was confirmed to be the IP enforcement coordinator at the White House and Peter Davidson was confirmed to be general counsel at the Commerce Department. Amin had been a lawyer for Congressman Lamar Smith (R-TX) working on the AIA and then for Congressman Bob Goodlatte (R-VA) working on the Innovation Act. Therefore, Amin has been in the middle of IP legislation since President Obama took office in January 2009. Before that he worked in the Bush White House and Commerce Department on patent reform and IP issues.  Amin generally favors the Patent Trial and Appeal Board (PTAB) and going after patent trolls.

At the top of Amin’s prepared remarks delivered to the Senate judiciary committee, he noted the fact that the importance of protecting IP was made explicit by Article I, Section 8, Clause 8 of the U.S. Constitution, often referred to as “the IP clause.” Amin said that his first responsibility as IPEC, if confirmed, would be to work with the White House as well as senior leadership at relevant agencies and departments to ensure well-coordinated efforts as well as the effective and efficient use of resources. “We need to ask ourselves three important questions — What are we doing well? What isn’t working? And what should we be doing?” Amin’s remarks read. Second, Amin would use existing law enforcement tools in order to ensure IP laws are enforced and prevent counterfeit and infringing goods from entering the U.S. market by engaging with stakeholders and trading partners on those issues. Third, he would focus on developing an IP enforcement policy which addresses all sectors of intellectual property including patents, copyright, trademark and trade secrets.

Phyllis Schlafly was a true friend of and advocate for the American inventor. Mrs. Schlafly’s life-long admiration of inventors was deeply felt and well-founded. Her biographer reports Mrs. Schlafly regarded an inventor to be “the most glorious product of the free-enterprise system.” She had firsthand exposure to an inventor: her father, Bruce Stewart.

With respect to the thorny issue of patent litigation, Senator Hatch explained that there is a very real chance that venue reform will happen this year… HATCH: “The Supreme Court is currently examining the issue, so we won’t have a full view of the landscape until after the Court rules. But no matter what the Court does, we’re likely going to need follow-on legislation to prevent future forum-shopping and to ensure that litigants have a meaningful connection to the site of the suit.”

I am particularly concerned about the impact this case law has on the patent application process. Instead of focusing on novelty and clarity, examiners and applicants alike spend time struggling to make sense of Section 101 jurisprudence. That is a serious misallocation of the limited resources of both patent examiners and applicants, leading to longer examination times and less reliable patent grants. Delays in patent review and patent grants can interrupt a startup’s lifecycle, negatively influencing employment growth, sales, and subsequent innovation. This is just one of several factors lengthening patent examination, but it is one that may warrant a congressional response.

Among the names under consideration is Randall Rader, the former Chief Judge of the United States Court of Appeals. But according to patent expert and noted commentator Hal Wegner, who generally does have well placed sources for this kind of information, the short list currently includes Phil Johnson (Johnson & Johson), Michael McKeon (Fish & Richardson), and Steve Pinkos (American Continental Group)… Another scenario being floated is that current USPTO Director Michelle Lee will be asked to stay on, a rumor flamed by remarks by Congressman Darrell Issa (R-CA) made at a CES panel last weekend… There has also been some speculation that Kevin Rhodes, who is Chief IP counsel at 3M, is or was under consideration at one point.

The Senate Judiciary Committee is where any action relating to intellectual property reform will be played out during the 115th Congress, at least on the Senate side of the Capitol. Unlike in previous years, we enter 2017 without much support for a fresh round of patent reform, but at least some patent reform measures are sure to be introduced during the 115th Congress… Look for efforts to grant the Copyright Office greater autonomy and independence during the 115th Congress, even a push to remove the Copyright Office out form under the Library of Congress… Without further ado, meet the Republicans on the Senate Judiciary Committee.

Given the devastating impact of counterfeit medicines on patients and the importance of intellectual property protection in combating pharmaceutical counterfeiting, it is troubling that the UN High Level Panel seems poised to prevent a series of recommendations that will undermine public health under the guise of enhancing access. Without the assurance of quality medicines, access is meaningless. Moreover, while falsely presenting intellectual property rights as the primary obstacle to global health care, the High Level Panel downplays a host of other factors that prevent developing country patients from getting the drugs they need: inadequate medical infrastructure, insufficient political will, a shortage of clinical trials in nations where neglected diseases are endemic, poverty, and insufficient market incentives.

In today’s political climate, any bipartisan legislative action is, well, unusual. Unanimous votes are like unicorns. But one happened yesterday, as the Senate voted 87-0 to approve the Defend Trade Secrets Act, S.1890. The DTSA does not preempt state laws, but provides trade secret owners with another, optional forum when the subject matter of the trade secret relates to interstate commerce. This means that local disputes will for the most part continue to be litigated in state courts, but for cases that can use the special advantages provided by nationwide service of process and a single set of rules across multiple jurisdictions, plaintiffs are likely to use the federal option.

Earlier today the White House released a Statement of Administration Policy, which strongly supports passage of s. 1890, the Defend Trade Secrets Act of 2016 (DTSA). The policy statement explained: ”The Administration strongly supports Senate passage of S. 1890, the Defend Trade Secrets Act of 2016… S. 1890 would establish a Federal civil private cause of action for trade secret theft that would provide businesses with a more uniform, reliable, and predictable way to protect their valuable trade secrets anywhere in the country.”

This extra attention on Wisconsin, coupled with Paul Ryan being the dream candidate for those who favor an open Republican Convention, provides us with a somewhat manufactured, yet novel and non-obvious opportunity to examine Ryan’s views on patents. Oddly, much like those of candidate Kasich, Ryan’s views have been in favor of fee diversion, which have been identified by former heads of the U.S. Patent & Trademark Office as the single biggest problem that has or will face the Office. Indeed, the mentality that leads Donald Trump to exalt the virtues of eminent domain for the greater good isn’t all that different from the thinking that must be required when Paul Ryan (and Kasich too) decide it is appropriate to siphon off user fees from the USPTO.