Posts Tagged: "Congress"

The PTAB subjects all patent owners to double jeopardy, but the situation is particularly bad for pharmaceutical companies which already have to face a Congressionally-mandated validity review process under the Drug Price Competition and Patent Term Restoration Act, colloquially known as Hatch-Waxman. This law creates a regime by which a generic drugmaker can file an abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA). The branded pharmaceutical listed in the Orange Book will be covered by patents but the generic drugmaker can include a Paragraph IV certification in the ANDA, a declaration that the patents covering the Orange Book-listed drug are unenforceable and invalid. When a company like Allergan has to face Hatch-Waxman validity trials in federal district court and serial IPRs at the PTAB, it turns Allergan’s Restasis patents into piñatas taking hit after hit at multiple forums before being finally ripped asunder at some point.

On Thursday, October 12th, a pair of letters addressed to the bipartisan leadership of the Senate Judiciary Committee were delivered in an attempt to inform Senators on that committee of various issues in play regarding the recent patent deal between multinational pharmaceutical firm Allergan and the sovereign St. Regis Mohawk Tribe. The two groups sending the letters represent stakeholders in the U.S. patent system coming from very different backgrounds who realize that there are fundamental flaws in the system created by inter partes review (IPR) proceedings which are carried out at the Patent Trial and Appeal Board (PTAB).

There is growing speculation among Capitol Hill watchers that the Judiciary Committee may soon be ready to hold a nomination hearing to vet Iancu’s credentials to serve as USPTO Director, perhaps as soon as this month. Although there’s a strong chance that the hearing would focus on recent developments like the Allergan-St. Regis Mohawk Tribe patent arbitrage deal, the hearing will be the patent world’s first true glimpse into Iancu’s vision for the role of the USPTO in promoting America’s innovation economy… Some additional details have begun to emerge thanks to a public response to a questionnaire submitted by Iancu to the Senate Judiciary Committee. This filing and attached documents help to flesh out many of the details surrounding the patent attorney’s experience as well as his viewpoints on certain trends affecting patent system stakeholders as outlined in articles and speeches given by this individual.

The patent deal with the St. Regis tribe doesn’t shield the patents from validity challenges coming from a Hatch-Waxman trial recently concluded in Texas federal court. “To be clear, if the District Court ruling is adverse to Allergan’s patent position, and there is an FDA approval of a generic version of RESTASIS®, that product could enter the market many years in advance of the listed patent expiry dates,” Allergan’s note reads. The drugmaker further argues that the IPR process in force at the PTAB undermines the 33-year-old Hatch-Waxman statutory regime regarding validity challenges to pharmaceutical patents, is subject to changes to validity proceedings implemented within the executive branch which are not impartial, and creates an unfair burden on innovators by opening patents to challenge proceedings which are often inconsistent before both the PTAB and the Court of Appeals for the Federal Circuit, the court to which PTAB decisions can be appealed.

After a panel of the Federal Circuit affirmed the Board’s decision, in Aqua Products v. Matal, Aqua requested an en banc rehearing. The USPTO Director Joseph Matal joined the appeal on behalf of the USPTO. At issue was whether the Board could place the burden of proof for patentability of amended claims on the patent owner in an IPR, and the Board’s underlying interpretation of the relevant statutes, specifically § 316(d) governing claim amendments and 35 U.S.C. § 316(e) allocating the burden of proof in an IPR… With respect to the burden of proof, the burden of persuasion for patentability of amended claims in an IPR proceeding is placed on the petitioner, not the patent owner. However, considering Judge Reyna’s concurrence, patent owners might still have the burden of production; depending on future cases.

This afternoon the House Budget Committee released a non-binding budget blueprint titled Building a Better America: A Plan for Fiscal Responsibility. As a part of this proposed fiscal year 2018 budget the House Budget Committee is proposing that the United States Patent and Trademark Office (USPTO) be made an independent agency.

The effects of proposed Rule 11 on the patent system will be like putting an additional bullet to a dying man. As far as patent litigation is concerned, the pending rule is intended to deliver what was missed in the AIA: shifting fees from infringers to patent owners.

Congressman Lamar Smith (R-TX), has sponsored a bill to amend Rule 11 — H.R. 720. The changes are made to remove the safe harbor provision and make sanctions mandatory. This bill has passed the House. A companion bill — S. 237 — has been introduced in the Senate with no action yet being taken… The proposed changes to Rule 11, if enacted, will have an impact of keeping unrepresented parties out of courts, and make the U.S. courts even more inefficient. It will have an adverse impact on patent owners in patent cases… Given the nature of patent litigation, experience teaches that it is inevitable that whenever a case is disposed of the winner will almost certainly try to shift litigation fees by any means possible, including by invoking Rule 11 sanctions. The parties with strong financial powers will have better chances to get sanction awards.

Inasmuch as the new Director can change, or do whatever they want once in the job, and will be subject to political winds, I thought I’d just tell them what I want and why. Simple. Here’s my list. First, believe in your product and the team that produces the product. Stop the labeling of “legitimate patents” as compared to other, presumably, “illegitimate patents”. There is only one type of patent, the one produced by the PTO. End of story. Each receives the examination it can in light of the fees paid. Each examination is done according to the laws and rules set forth in the statute and in accord with the CAFC administration of that statute vis-à-vis the PTO. This is true across all technologies. Examiner’s do the best they can with the tools available. This includes training, searching, and examining. The PTO does not favor one group over another. It calls balls and strikes in light of the relevant statute or rule.

Both the U.S. House of Representatives and the U.S. Senate are currently contemplating versions of the Defending Against Imitations and Replacements of Yogurt, Milk and Cheese to Promote Regular Intake of Dairy Everyday (DAIRY PRIDE) Act; the House version is bill H.R.778 and the Senate’s is S.130. If passed, the bill would amend the Food, Drug, and Cosmetic Act to prohibit the sale of any food using the market name of a dairy product, is not the milk of a hooved animal, is not derived from such milk and doesn’t contain such milk as a primary ingredient. The findings section of the bill notes that the U.S. Food and Drug Administration (FDA) already has regulations finding that milk is “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.” The Senate bill is originally sponsored by Sen. Tammy Baldwin (D-WI) while the House version is sponsored by Rep. Peter Welch (D-VT). The House bill includes five original co-sponsors: Rep. Michael Simpson (R-ID); Rep. Sean Duffy (R-WI); Rep. Joe Courtney (D-CT); Rep. David Valadao (R-CA); and Rep. Suzan DelBene (D-WA).

Those now familiar with IPR proceedings will already have recognized how little resemblance current IPR proceedings have to what most supporters of the AIA envisioned upon its passage. In current practice, the role of the Director as an independent IPR gatekeeper never materialized because the USPTO’s implementing rules bypass the Director altogether, assigning the institution function to the PTAB, which in turn routinely assigns both the institution and final decisions to the same three judge panel. As a result, most of the safeguards against patent owner harassment were lost…. By failing to adopt the implementing rules needed to carry out the intent of the AIA, and by adopting other rules and procedures that are plainly skewed towards petitioners, the PTAB has intentionally tilted its IPR proceedings against patent owners. While this has been good for the PTAB, which has quadrupled in size, it was neither Congress’s intent nor that of most of AIA’s supporters to create an unfair IPR patent “killing field.”

The five year experiment of the Patent Trial and Appeal Board (PTAB) is a colossal mistake. It is a failure to inventors, startups, early stage investors, job creation, economic growth, our national standing, and most importantly, our national security. The extraordinary damage of the PTAB on so many levels cannot be overstated. I’ve always believed that it’s okay to make a mistake. A mistake can be corrected. But the real sin is ignoring that mistake and watching it become a disaster. Congress made a huge mistake in creating the PTAB. If Congress ignores it, it will absolutely become a national disaster. And, we are on the brink of that national disaster right now.

Though aimed at certain pharmaceutical products, Sens. Angus King’s and Bernie Sanders’ potential amendments would throw the key to the Bayh-Dole Act’s success —certainty and exclusivity of the intellectual property associated with technology transfer in order to agree to attempt commercialization in the first place — into disarray beyond a single product or sector, the signatories contend.

There are clearly many thousands of companies both large and small with far greater experience and in a far better position to advise Congress on the issue of patent reform. So why Mapbox? As is so frequently the case whenever business and politics intersect, follow the money! We have done just that and we’ve found that a no-name, no-experience company like Mapbox, without any patent applications and no patent litigation experience became thrust into the public debate over patents because all the money people behind Mapbox are card carrying members of the anti-patent efficient infringer lobby.

Given that Lee testified that Mapbox has been a party to multiple patent lawsuits and only a single lawsuit can be located, coupled with Lee’s testimony that Mapbox has used the patent system as an applicant and no patents or applications can be found, Congress should question whether or not false testimony has been given in this case. Perhaps there is a reasonable explanation, but based on publicly available information serious questions exist regarding the veracity of his testimony.