Posts Tagged: "aia"

At the time, many thought this change in law would significantly assist patentees in avoiding full-blown cancellation of their claims. However, our review suggests a case-by-case analysis without overwhelming success on a motion to amend… Although the industry expected Aqua Products to cause a sea change for motions to amend, there has been little, if any, substantive effect. Since Aqua Products, the Board has considered the opinion’s impact in 92 cases, referring to the memorandum guidance in 38. Of those 92 cases, the Board has rendered decisions in 43 cases, denying 32 motions to amend, granting in whole or in part 7 motions, and denying as moot 4 motions.

New patent legislation would rectify some of the damage done by several court rulings and by Congress.  It would reestablish the fundamental constitutional principle that a U.S. patent secures certain rights in private property. Reps. Thomas Massie (R-KY) and Marcy Kaptur (D-OH) have introduced H.R. 6264, the Restoring America’s Leadership in Innovation Act.

This article reviews recent Federal Circuit and Supreme Court decisions addressing the scope of appellate review of institution of inter partes review (IPR) by the Patent Trial and Appeal Board. The America Invents Act, 35 U.S.C. § 314(d), provides that: “[t]he determination… whether to institute an inter partes review under this section shall be final and nonappealable.” Federal courts initially interpreted Section 314(d) to bar appellate review of institution decisions entirely. However, recent decisions have narrowed Section 314(d) and expanded the scope of appellate review of matters decided by the Board at institution. This article will review decisions interpreting Section 314(d) to date, and explain how recent precedents have created new opportunities for appellate review of the Board’s decisionmaking in IPR proceedings.

On Monday, June 25, 2018, the United States Supreme Court granted cert. in Helsinn Healthcare S.A., v. Teva Pharmaceuticals USA, Inc. The single question presented by Helsinn in the petition accepted by the Supreme Court read: Whether, under the Leahy-Smith America Invents Act, an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.

In 2011, as part of the American Invents Act (“AIA”), Congress significantly restructured the way in which previously issued patents could be challenged.   In some cases, existing post-issuance proceedings, like ex parte reexamination and reissue proceedings, were kept intact as such proceedings existed prior to the AIA.  In other cases, existing post-issuance proceedings, like inter partes reexamination, were replaced with new proceedings, such as the inter partes review proceedings (“IPRs”).    In addition, brand new proceedings were created, such as post-grant review proceedings (“PGRs”), covered business method patent review proceedings (“CBMs”), and supplemental examination proceedings.  In each instance, Congress made policy choices as to who could (or could not) bring and/or participate in such proceedings, and who could (or could not) raise challenges to decisions made by the government in such proceedings. 

In accordance with the above discussion, particularly point (a), the client should be apprised of the necessity of fully fleshing out the inventive aspects of the technical implementation (i.e. the fuzzy logic). The client, however, may not know what the technical implementation is or what technical problems may need to be overcome. At this point, there may be no harm in filing a provisional patent application to capture the earliest priority date for the client. The next step under point (b) is to work with the client to develop a plan for implementation. Actual technical implementation can be expensive, but it is a very effective way to reveal technical problems that have to be solved. Technical implementation always (in our humble experience) reveals unforeseen technical problems. At some point, what is readily available may need to be modified or customized to serve the specific needs of the new business application, particularly as that application is scaled up. This is where patentable innovation occurs.

While there has been much optimism due to the arrival of USPTO Director Andrei Iancu and his recent speeches signaling he understands the U.S. patent system must move along a different path, it is impossible to think that one man will be able to correct the collective mistakes of 535 elected Members of Congress and 9 ivy league educated jurists who seem convinced that forfeiting America’s patent system is somehow what the Constitution demands. His job just became much more difficult, and all the more important.

Earlier today, the US Supreme Court issued it’s highly anticipated 7 to 2 decision in Oil States Energy Services, LLC v. Greene’s Energy Group, LLC which upheld the Constitutionality of inter partes review (IPR) proceedings at the Patent Trial and Appeal Board (PTAB). SCOTUS applied the public rights doctrine to the government’s grant of a patent, finding that patent validity trials need not take place in an Article III court nor did they violate the Seventh Amendment, which ensures a person’s right to a jury trial. The majority opinion was authored by Justice Clarence Thomas. Justice Neil Gorsuch penned a dissent to which Chief Justice John Roberts concurred.

Ever since the introduction of AIA post-grant proceedings, many have questioned whether the procedural deck is stacked against patent owners.  Limits on making claim amendments, having to bear the burden of showing the validity of claims already issued, and being subjected to multiple serial attacks, certainly have made it seem so.  But have recent cases signaled the playing field may now be tipping ever so slightly in a patent owner’s favor?  Or are these decisions just an illusion?

Just as Swift’s solution to the crises of his day was abhorrent, i.e., eating the children of the poor for nourishment, eating the issue of our Founders is also abhorrent, as well as ill-advised. Our Founders recognized the value of patent and copyright systems, and inculcated this philosophy into the Constitution itself – and our nation has benefited thereby. Likewise, trademarks provide considerable benefits to us all. A societal reward for innovation and creativity is a small price to pay to assure our greatness for generations to come.

The legal principles set out above, while seemingly straight-forward enough, leave ample room for case-specific interpretation and application when it comes to the question of whether the use of a claimed invention in connection with carrying out clinical trials will constitute an invalidating public use. Patent applications are typically filed early on in the process of developing and commercializing a pharmaceutical drug product. One reason for this approach is to secure the earliest possible filing date thereby pre-dating as much would-be prior art as possible. Such would-be prior art, however, is not limited to that published or otherwise emanating from others but also includes time bars such as the public use bar. The circumstances under which clinical trials involving administration of a drug product that occur prior to the critical date may constitute an invalidating public use is a murky area of the law and courts’ decisions in this area are highly dependent on the facts of the case before them.

Longtime Texas Representative Lamar Smith (R-TX), chairman of the House Committee on Science, Space, & Technology, will be retiring from his duties on Capitol Hill and will not seek reelection for another term of service. Smith, a former Chairman of the House Judiciary Committee and powerful member of the Republican leadership, will leave a void. His retirement marks the end of a 30-year tenure of public service and will immediately create a leadership void on the House committee responsible for overseeing our nation’s science and space policies.

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.

Patenting and secrecy are the two major methods of protecting technology that supports competitive advantage. Trade secrets protect a wide range of confidential information, ranging from customer lists to strategic plans and business methods.  While this has been true for decades, the legal landscape in which businesses must choose between them has changed dramatically in recent years, mainly as a result of two forces. The first of these was a series of court rulings that collectively have narrowed the scope of patentable subject matter and have made patents more difficult to enforce. The second was the America Invents Act of 2011 (the “AIA”), which effectively eliminated or reduced certain risks of choosing secrecy, while providing new ways to challenge patents in administrative proceedings.  Considered together, these forces require innovators to reconsider their cost/benefit models for evaluating protection mechanisms. This paper discusses risk factors counsel should weigh when advising clients on these issues. I do not advocate one method over the other, but instead suggest that decisions should be guided by clients’ business needs and priorities rather than by patent eligibility alone.

Of the 1,582 patents with a final written decision, 1,343 were found to have defects by the PTAB. That is an 85% defect rate. Only 239 patents were affirmed to be fully compliant with the statutes by the PTAB. Yet the Office of Patent Quality Assurance (OPQA) claims a 6-8% defect rate… 263 patents were found valid in full and fair trials in a court of law and also tried in the shortcut infringer-biased PTAB. Only 63 of them got the same results in both venues. The other 200 the PTAB came to a different conclusion. If the courts are correct then the PTAB is wrong 76% of the time.