Posts in Legislation

Unfortunately, Mr. President, after five years I cannot report back that the AIA has yet ”improve[d] patent quality and help[ed] give entrepreneurs the protection and the confidence they need to attract investment, to grow their businesses, and to hire more workers.” The current implementation of PTO post issuance proceedings is undermining confidence in our patent system, chilling innovation at its roots, and, in eyes of some, giving the AIA a bad name.

To investigate whether applicants have been adopting a strategy of filing more provisional applications, we determined a ratio of the number of provisional filings (with a first-named inventor identified as being a resident of the U.S.) relative to the number of utility filings (with a first-named inventor identified as being a resident of the U.S.). As shown in Figure 2, this ratio also exhibited an uptick in fiscal year 2013, but the ratio has since returned to Fiscal-Year-2012 levels. Thus, this data suggests that applicants have generally not changed their filing strategies to file more provisional applications in view of the AIA’s change to define prior art based on applications’ filing dates.

Although what qualifies as art under the AIA can be distilled to disclosures before a patent application, both pre-AIA and AIA created exceptions for intervening disclosures in Section 102(a)(2). Intervening disclosures are defined by an earlier filing date, but a later publication date and are sometimes referred to as secret prior art. Intervening disclosures apply only to US patents, US publications, and PCT applications. Other types of disclosures, such as disclosures at a Beijing conference in Chinese would need to be considered under Section 102(a)(1). Where is this expansion for intervening disclosures going to come from? Mainly from two primary sources: 1) US patents or publications that have foreign priority claims; and 2) PCT applications published in a language other than English, regardless of foreign priority claim… The potential doubling of available intervening disclosures would create significantly more prior art.

Patent investors are no different than investors in any other asset class. They abhor uncertainty and charge a stiff premium for risk. In the wake of the AIA, the cloud of uncertainty hanging over patents is dark indeed. This uncertainty has depressed the value of patents and the returns to research and development, and may have broader ramifications that are yet to be seen… Like so much well-intended regulation, the AIA may have undermined the very system it was aimed at improving. While well capitalized players may be able to ride out the current storm—or even take advantage of it—many others have been irrevocably harmed by these changes.

The America Invents Act (AIA) was the single worst disaster in the 226 year history of the U.S. patent system. The AIA did very real damage – enough to put many inventors out of business and discourage many others. Prior to the AIA, a patent was a highly valuable asset capable of attracting capital to startup new technology companies. The deck was rearranged by the AIA to radically favor infringers to the point that today, a patent is a liability. Both inventors and investors now associate a patent with high cost and high risk of even higher cost.

On Wednesday, August 24th, the Patent Appeal and Trial Board (PTAB) issued decisions in two inter partes review (IPR) filings made against patents owned by private Israeli firm Yeda Research & Development Co. The company is the tech transfer arm of the Weizmann Institute of Science, a public research university located in Rehovot, Israel. The IPRs, which were filed by American pharmaceutical developer Mylan Inc. (NYSE:MYL), resulted in the invalidation of all claims in both Yeda patents. About a week later, on September 1st, PTAB invalidated a third patent owned by Yeda after another IPR challenge was filed by Mylan.

While the PTAB statistics demonstrate the profound effect that the AIA trials have had on issued patents, it seems to have the greatest impact on non-manufacturing patent assertion entities (PAE). With the increased tendency of district courts showing a willingness to grant stays of the concurrent litigation, the AIA trials have become an effective weapon against PAE. However, nevertheless, it is not surprising that with any dynamic system we have seen a settling process where institution rates have been dropping and the information provided by the PTAB in its publication of informational and precedential decisions has served to provide clarity to those practicing before the PTAB in administrative trials.

The enumerated problems with the post grant procedures could be bettered by both the courts and the USPTO. The courts have had an opportunity to change the standard for claim construction in the post grant procedures but have declined. However, the USPTO can ameliorate the problem itself by providing for more liberal leave to amend. The rationale for BRI at the USPTO is that patentee can amend at the Office but not in court. The Office can more easily allow for claims that are further limiting and this would greatly reduce the problem.

IPRs offer many improvements compared to inter partes reexamination[12]. However, the statistics reveal that IPRs are no more of a true alternative for litigation than the challenge proceeding which they replaced and supposedly improved upon – at least not yet, but with all of the publicity about the high rate of invalidation it is hard to imagine that patent challengers just need more time to gain confidence in IPRs. These statistics combined with the relationship between IPR behavior and the increasing phenomenon of efficient infringement suggest that the post grant challenge proceedings as currently implemented are not a substitute for litigation and may, unfortunately, instead actually promote litigation.

At exactly 11:42am on September 16, 2011, President Barak Obama signed the America Invents Act into law. As President Obama put his pen down he said: “All right guys, congratulations, the bill is signed.” It was at this precise moment that U.S. patent laws dramatically changed forever. With this in mind, over the next two weeks we will be examining the AIA in great detail in a special AIA 5th Anniversary series. I’ve invited a number of guests to comment, discuss and/or editorialize about the AIA. Below is a sneak peak of some of the contributions already received. As articles are published this preview article will be updated with links to the entire series.

Three of the judicial emergencies, just less than 10 percent of all judicial emergencies in the U.S. federal court system, are in the U.S. District Court for the Eastern District of Texas (E.D. Tex.). With the judicial vacancies in E.D. Tex., the concern is that a growing docket of patent infringement cases could create a bottleneck for the court, greatly increasing the amount of time that it takes the court to issue a decision. Business litigation is typically given a backseat to criminal litigation in district courts as American law upholds a suspected criminal’s right to a speedy trial. The vacancies also naturally result in an increased percentage of U.S. patent infringement cases assigned to Judge Rodney Gilstrap. This January, we reported that Judge Gilstrap could be deciding as much as 20 percent of all patent infringement cases filed in U.S. district courts. The fact that one judge could be deciding as much as one-fifth of the patent infringement docket at the district court level seems a little less than democratic.

Another incursion into research university governance and operations is now underway. And this time all research universities are affected. Led by the DC Based Electronic Frontier Foundation, a leftist anti-patent activist coalition that has initiated a 50-state legislative campaign to shrink research university patent licensing rights at the state level. (See) The measure’s purported objective is to prevent publicly funded university research patents from being licensed to so-called “Patent Assertion Entities” (PAEs, also known by the pejorative term “patent trolls”). The draft legislation is imprecise, making it even more dangerous than first appears.

The focus of the political advocates pushing march-in may be lower drug costs. But the long-term costs of ripping apart IP rights are far higher and more fundamental than advocates acknowledge. The long-term price of exercising these exceptional prerogatives could include creating a crisis in confidence over use of federally funded research discoveries, dried-up private investments where basic research has federally funded fingerprints, hesitation to commercialize university research, and a corresponding drop in start-ups, new products, economic development and technological advancements. March-in could effectively repeal Bayh-Dole.

Two recent Federal Circuit opinions provide some answers to the issues presented by complaints alleging non-compliance with the BPCIA. In Amgen Inc. v. Sandoz Inc., the Federal Circuit concluded that an aBLA filer’s participation in the patent dance is not mandatory under the BPCIA. 794 F.3d 1347 (Fed. Cir. 2015). Where an aBLA filer elects to forego the patent dance by failing to provide the aBLA and the biosimilar manufacturing information to the RPS, the only remedy available to the RPS lies in a declaratory judgment action for patent infringement, as expressly contemplated by § 262(1)(9)(C). In addition, the court concluded that an aBLA filer who did not engage in the patent dance was required to provide a notice of commercial marketing and that such notice could be effectively given only after the FDA had approved the aBLA. The court’s ruling left open the question whether an aBLA filer who participated in the patent dance was required to provide a notice of commercial manufacturing. This decision is on appeal to the Supreme Court, which has yet to decide whether it will hear the issue.

In recent years, the Chinese government has promoted a roadmap towards “indigenous innovation” which would see the country become a technological superpower by the year 2050. This would be fine if China intended to do so while following international rules regarding intellectual property, but it seems pretty intent on flouting whatever regulations get in the country’s way in that regard. News reports in recent years indicate that China continues to press foreign entities to follow joint venture rules in which foreign players are required to transfer IP to Chinese domestic firms despite the fact that this breaks rules put in place by the World Trade Organization, of which China has been a member since 2001.