Patent Law Practice Center

Drug patents fare better at PTAB

While the Patent Trial and Appeal Board (PTAB) has not been friendly to patent owners in general, the PTAB has not been inhospitable to pharma patent owners according to a report issued by BiologicsHQ, a searchable database of drugs, patents, and companies involved in PTAB inter partes review (IPR) proceedings developed by attorneys at Fitzpatrick, Cella, Harper & Scinto. The BiologicsHQ report shows a much different story in terms of drug patents facing IPR challenges at the PTAB. The report looks at a combination of data sources, including the Orange Book, Center for Drug Evaluation and Research (CDER) listed biologics and statistics on America Invents Act (AIA) trials published by the PTAB. The BiologicsHQ report draws the conclusion that, despite widespread concerns about the PTAB operating as a patent death squad in IPRs, “such concern is not justified for drug patents.”

According to the March 2017 IPR statistics issued by the PTAB, 53 percent of IPRs resolved as of March 31, 2017 were instituted; the rest were either denied institution or reached some other resolution prior to the institution decision. 35 percent of all resolved IPRs resulted in final written decisions and 23 percent led to findings of all claims unpatentable. Only 7 percent of all resolved IPRs led to final written decisions finding that no claim was unpatentable, and 5 percent led to mixed claim findings.

By contrast, drug patents fare better under PTAB scrutiny in terms of having claims upheld. Of the 4,563 resolved IPRs, BiologicsHQ reports that 222 petitions (5 percent) involved patents covering drugs listed in the Orange Book. Focusing on just the IPRs involving Orange Book patents, 44 percent were instituted and 38 percent reached a final written decision, but only 16 percent led to final written decisions where all claims were found unpatentable. No instituted claim was found unpatentable in 50 percent of final written decisions (19 percent of the total number of resolved Orange Book IPRs).

CDER-listed biologic drug patents also survive PTAB challenges better than patents not directed to pharmaceutical drugs, although the number of resolved challenges is quite small by comparison. By March 31, 2017, BiologicsHQ reports that a total of 29 resolved IPR petitions involved patents covering CDER-listed biologics. 41 percent of those petitions were instituted and 28 percent reached final written decisions. 17 percent of all resolved CDER-listed biologic drug IPRs led to final written decisions of all claims unpatentable, and 10 percent led to final written decisions of no claims unpatentable.

When comparing final written decisions among all IPRs, IPRs relating to Orange Book patents, and IPRs relating to CDER-listed biologic drug patents, Orange Book and CDER-listed biologic drug patents are more likely to escape with all claims intact. For all resolved IPRs, 23 percent led to final written decisions of all claims unpatentable. That’s a higher percentage than the 16 percent of Orange Book IPRs, and 17 percent of CDER-listed biologic drug IPRs that led to final written decisions where all claims are unpatentable. The 7 percent of all IPRs that led to final written decisions of no claims unpatentable is less than the 10 percent of CDER-listed biologic drug IPRs, and the 19 percent of Orange Book IPRs, that met the same fate.

Overall, 58 percent of IPRs involving drug patents resolved by the PTAB resulted in some claims remaining patentable: 60 percent for Orange Book IPRs and 45 percent for CDER-listed biologic IPRs.

House Budget Committee recommends USPTO be independent agency

The House Budget Committee recently 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.

On page 50 of the House budget proposal, under a heading discussing the elimination of overlapping Department of Commerce functions and consolidating necessary Department of Commerce functions into other Departments, the proposal includes the line item: “Establish the U.S. Patent and Trademark Office as an independent agency.” No further information is provided relating how that might be accomplished. The budget proposal does say, however, that the Commerce Department and its various agencies “are rife with waste, abuse, and duplication,” which is why House Republicans are recommending a different approach for the federal government supporting commerce moving forward.

(more…)

Judge finds Allergan patents invalid in Eastern District of Texas and opines on sovereign immunity issue

Recently, in a 135-page opinion, Judge William C. Bryson (left), sitting by designation as a trial judge for the United States Federal District Court for the Eastern District of Texas, found that Allergan’s RESTASIS patents were infringed by Teva Pharmaceuticals USA, but that Teva had demonstrated invalidity of those RESTASIS patents by clear and convincing evidence.

“We are disappointed by the Federal District Court’s decision on the RESTASIS^® patents. We are carefully reviewing the decision and are considering all options,” said Robert D. Bailey, Chief Legal Officer for Allergan. “Allergan remains committed to vigorously defending the intellectual property of our products, which allows us to continue to invest in developing and bringing forward new medicines for millions of patients.”

The patents include United States Patent Nos. 8,629,111; 8,648,048; 8,685,930 and 9,248,191. These patents, along with United States Patent Nos. 8,633,162 and 8,642,556, are listed in the Orange Book for RESTASIS^® and expire on August 27, 2024.

(more…)

ITC institutes investigation against Hisense

The U.S. International Trade Commission (ITC) announced that it has decided to institute a patent infringement investigation against Chinese electronics manufacturer Hisense. The investigation, which follows from a Section 337 complaint filed by Japanese electronics firm Sharp, will seek to determine whether certain Wi-Fi enabled devices and their components, specifically televisions which are capable of wireless Internet connectivity imported into the U.S. by Hisense, infringe upon two patents covering similar technologies held by Sharp.

The ITC’s decision to institute the Section 337 investigation comes after the agency announced on August 30th that it had received the patent infringement complaint from Sharp. In Sharp’s Section 337 complaint, two patents held by Sharp are identified as being infringed by Hisense’s television products:

• U.S. Patent No. 8325838, titled Communication Method and Radio Transmitter. Issued in December 2012, it claims a receiving apparatus operable in a wireless communication system which increases the efficiency of frequency utilization and seamlessly provide services to private isolated cells within a wireless local area network (LAN).
• U.S. Patent No. 8279809, titled Transmission Power Control for Orthogonal Frequency Division Multiplexing (OFDM) Signals, issued in October 2012, covers an apparatus configured for transmitting orthogonal frequency division multiplexing (OFDM) signals for communication in a wireless system in a way that delivers rich content services via OFDM wireless schemes while achieving the use of OFDM recievers in low-cost and smaller terminals.

Sharp’s Section 337 infringement complaint seeks a permanent limited injunction order against Hisense’s Wi-Fi-enabled television sets as well as a permanent cease and desist order prohibiting Hisense from importing and selling the patent infringing products. Sharp argued to the ITC that there are no public welfare concerns and that articles like the infringing Hisense products are available to the public in sufficient capacity to meet demand. Although Sharp notes that the asserted patents cover aspects of wireless communication which are in part described in the IEEE 802.11n wireless standard, they are not subject to fair, reasonable and non-discriminatory (FRAND) licensing obligations as they are not standard essential patents (SEPs). Although Hisense has entered into a trademark licensing agreement with Sharp to sell TVs branded under the Sharp name in the U.S., it does not have a license to either the ‘809 or ‘838 patents.

As Sharp explains in its complaint, the technology covered by the ‘809 patents resolves an issue regarding terminals with different capabilities which coexist in a system. The IEEE 802.11n standard introduced a new high-throughput access point and non-access point stations capable of receiving or transmitting by a broader part of a 20 megahertz (MHz) frequency band than legacy technologies. The technology allows the new high-throughput access points to communicate with legacy stations while also communicating with new high-throughput devices to achieve better performance in signal transmission.

Sharp’s complaint also notes that the technology covered by the ‘838 patent solves a similar issue created by the IEEE 802.11n amended standard so that legacy stations and new stations can coexist, reducing the cost of replacing devices for the new standard. This technology allows some new high-throughput stations to use multiple frequency channels for maximum throughput while allowing other new stations to use fewer subcarriers, minimizing energy use.

Sharp contends that Hisense, or others on the behalf of Hisense, manufacture infringing television products in Mexico, China or other countries outside of the U.S., and import them for sale in this country. For example, four infringing Hisense products were purchased this June through Walmart.com or at a Best Buy in Union City, CA. These products include three 50-inch TVs and one 43-inch TV with markings indicating that they were made in either Mexico or China.

 

CAFC reverses on erroneous application of BRI

The United States Court of Appeals for the Federal Circuit recently issued a decision in In re Smith International, Inc. As described by Judge Alan Lourie, writing for the unanimous panel (consisting of Judges Reyna and Hughes), “[t]his case primarily concerns what the word ‘body’ means in the context of the ‘817 patent.” More specifically, however, the legal point at issue making this case a precedential decision was how far the Patent Office may go when applying the “broadest reasonable interpretation” (“BRI”). The Federal Circuit decided that in applying the broadest reasonable interpretation, the examiner and Patent Trial and Appeal Board (PTAB) arrived at an unreasonable interpretation not supported by the specification.

The examiner interpreted the critical term “body” as being very broad and possible of encompassing other components such as a “mandrel” and a “cam sleeve,” which were taught by the Eddison reference. The Board affirmed this interpretation by the examiner because the specification did not prohibit the examiner’s broad reading of the term “body.”

(more…)