Showing all posts written by Christie Matthaei
Ms. Matthaei represents various clients in all aspects of intellectual property disputes, with a focus on patent litigation. Ms. Matthaei also counsels clients on pre-litigation matters, including analyzing patent infringement and validity.
Ms. Matthaei earned her J.D. from the George Washington University Law School, where she was a member of the American Intellectual Property Law Association Journal. During her time in law school, Ms. Matthaei interned for the White House, working in the Office of Science and Technology Policy. Prior to law school, Ms. Matthaei worked at Pacific Northwest National Laboratory as a chemical engineer on projects related to alternative energy and green chemicals. Ms. Matthaei obtained a B.S. in Chemical Engineering from the University of Washington.
Ms. Matthaei was a summer associate in 2010 and joined the firm as an associate in 2011. Click here to read full bio
The STRONGER (Support Technology & Research for Our Nation’s Growth and Economic Resilience) Patents Act of 2017 was recently introduced in the Senate by a bipartisan group led by Senator Chris Coons (D-Del.) and co-sponsored by Senators Tom Cotton (R-Ark.), Dick Durbin (D-Ill.), and Mazie Hirono (D-Haw.). According to a press release by Senator Coons, “[t]he STRONGER Patents Act seeks to strengthen the U.S. Patent system through implementing measures to make it easier and less costly for patent holders to enforce their patents.” The “Act is based on legislation that Senator Coons introduced last year with the goal of making the post-issuance proceedings before the Patent Trial and Appeal Board (PTAB) more fair and efficient.” The bill asserts that “unintended consequences of the [AIA] are continuing to become evident, including the strategic filing of post-grant review proceedings to depress stock prices and extort settlements, the filing of repetitive petitions for inter partes and post-grant reviews that have the effect of harassing patent owners, and the unnecessary duplication of work by the district courts of the United States and the Patent Trial and Appeal Board.”
The following table illustrates several key changes proposed by the STRONGER Patents Act compared to the current PTAB practice under the AIA.
|Proposed Changes in STRONGER Patents Act||Current Practice Under AIA|
|Claim Construction||Same standard as that used in district court litigation (Phillips)||Broadest reasonable interpretation|
|Burden of Proof||Presumption of validity||No presumption of validity|
|Standing||IPR Petitioner must have been sued for infringement or have standing to bring declaratory judgment action in Federal Court
|IPR Petitioner may be any third party who is not time-barred or estopped|
|Limitation on Reviews||Review initiated only once per claim of a patent||There is no formal limit, but the PTAB has discretion to deny multiple or follow-on petitions under §§ 314(a), 324(a) or 325(d).|
|Interlocutory Appeals from Institution Decisions||A determination by the Director to institute an IPR may be appealed to the United States Court of Appeals for the Federal Circuit. Patent owners may not appeal the PTAB’s determination in the institution decision that a challenged claim is likely unpatentable.||Institution decisions are not appealable.|
|Eliminating Repetitive Proceedings||Petitioners can only challenge a patent once, unless they are later charged with infringement of additional claims. If an IPR is instituted, the petitioner cannot bring challenges of the same type in district court to eliminate duplicative proceedings.||A petitioner who, in a final written decision, is unsuccessful challenging a claim in an IPR or PGR is estopped from raising or maintaining any ground of challenge for that claim that the petitioner raised or reasonably could have raised during the concluded IPR or PGR proceeding.|
|Real-Party-In-Interest||Defines Real-Party-in-Interest as an entity making financial contributions to the challenge.||A Real-Party-in-Interest is typically considered any party who exercises or could exercise control in the proceeding.|
|Priority of Federal Court Validity Determinations||If a district court reviews the validity of a patent before the PTAB, the post-issuance proceeding should not start, or should be paused pending appeal.|
Stents, which are typically inserted into a blood vessel in order to expand the vessel to prevent or alleviate a blockage, have traditionally been made from metal mesh and remained in the body permanently (or until later removed by surgical intervention). Recently, biodegradable stents (also called bioresorbable or bioabsorbable stents) have been developed. These stents serve the same purpose as traditional stents but are manufactured from materials that may dissolve or be absorbed in the body.
The Food and Drug Administration (FDA) announced in mid-2016 that it had approved the first fully absorbable stent to treat coronary artery disease. According to the FDA, the stent (ABSORB GT1 BVS, which is manufactured by Abbott Vascular and pictured below) is gradually absorbed by the body in approximately three years following implantation. Abbott reportedly received European approval for the ABSORB BVS product in 2011.
According to some commentators, biodegradable stents, like the ABSORB BVS, are the way of the future and will eventually replace conventional metallic stents. This hypothesis is consistent with research conducted by Transparency Market Research. Transparency Market Research recently published a report (Biodegradable Stents Market – Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2016 – 2024) which projects the global market for biodegradable stents to grow from $18 Million US dollars in 2015 to $1.7 Billion US dollars by 2024 (a short 9 years). This amounts to a compound annual growth rate (CAGR) of over 30%. According to the report:
[t]he biggest advantage of [biodegradable] stents is that they get entirely absorbed in the vessels over a period of time, reducing the risk of complications or infections. This advantage is the primary reason for the growth of the global biodegradable stents market.
The report goes on to state that:
[a]s compared to predecessors of biodegradable stents, the newer technology has significantly reduced the risk of thrombosis, . . . in-stent restenosis, dual anti-platelet therapy, and second surgery for removal of the stent. These factors have played a pivotal role in shaping the trajectory of the global market in a positive direction over the past few years. The efficiency of biodegradable stents has won the market numerous consumers in the recent past. Thus, several patients and cardiologists have shown a keen interest in the uptake of biodegradable stents in the treatment of coronary and peripheral artery diseases.
Other manufacturers of biodegradable stents reportedly include Elixir Medical, Biotronik, Kyoto Medical Planning, Micell Technologies, and Reva Medical. Based on this industry’s projected growth, it appears that additional companies are likely to enter the biodegradable stent market and the United States Patent Office may see a marked increase in the number of patent application filings that are directed to biodegradable stents and other biodegradable medical devices.
Supreme Court Makes it Easier for Medical Device Companies to Recover Enhanced Damages for Patent Infringement
The Patent Act provides that, in a case of infringement, courts “may increase the damages up to three times the amount found or assessed.” Previously, in order to recover enhanced damages under the Patent Act, a patent owner had to show two things: (1) the infringer acted with objective recklessness and (2) the risk of infringement was either known or should have been known to the accused infringer. Both of these elements had to be shown by the relatively high standard of “clear and convincing” evidence.
The Supreme Court’s recent decision in Halo Electronics, Inc v. Pulse Electronics, Inc. drastically changed the standard for enhanced damages and made it easier for patent owners to obtain an enhanced damages award. The Court eliminated the objective recklessness prong and lowered the standard of proof from “clear and convincing evidence” to “preponderance of the evidence.” The Court also adopted an abuse of discretion standard for appellate courts reviewing a district court’s decision to grant enhanced damages.
Previously, patent owners struggled to obtain enhanced damages even when they could establish that the infringer acted with bad faith. Infringers were able to avoid enhanced damages by making a reasonable defense at trial. Thus, the ability of a patent owner to obtain enhanced damages sometimes depended more on the ingenuity of the defendant’s attorney than the defendant’s culpability at the time of the challenged conduct. By eliminating the objective recklessness prong, the Supreme Court refocused the analysis on the defendant’s knowledge at the time of the infringing conduct.
The Court’s new contemporaneous focus will likely influence the prelitigation conduct of patent owners and accused infringers. Demand letters informing accused infringers of their infringement and relevant patents will likely become more common place. Opinion letters will also likely take on an increased significance for accused infringers. Not all instances will warrant a full-blown infringement and validity analysis but, under the new standard, accusations of patent infringement should be given prompt, thorough, and carefully documented consideration.
The Senate Committee on Small Business and Entrepreneurship held a meeting titled “An Examination of Changes to the U.S. Patent System and Impacts on America’s Small Businesses” on February 25, 2016. The archived webcast of the hearing can be viewed here.
“MDMA thanks Chairman Vitter and the committee Members for examining the unintended consequences that some proposed changes to the patent system would have on small businesses. MDMA continues to support balanced efforts to curb abusive patent practices, but not in a manner that would be overly broad and would harm medical technology innovation and stifle the development of cures for patients who need them the most.
“MDMA remains committed to working with Congress on targeted efforts to improve the patent system, but we must not do so at the expense of innovators and inventors who are revolutionizing patient care and saving lives.”
According to press releases, the American Association for Respiratory Care (AARC) and Edison Nation Medical have partnered to search for innovations for improving the process, outcomes, and comfort for patients requiring intubation and mechanical ventilation. Respiratory Care Therapists are encouraged to submit product invention ideas to be evaluated for safety and efficacy, intellectual property, and market potential. According to the announcement, “Edison Nation Medical will review each submission through an in-depth review process led by our team of medical, product development and legal experts. Promising ideas submitted throughout the search will be presented to leading medical device companies and healthcare retailers with whom Edison Nation Medical has partnered.” The AARC website announcement also states that winners will receive an advance of $2,500 and 50 percent of licensing royalties or revenues, and also notes that submissions are accepted through October 31, 2015.
According to its website, the AARC is a not-for-profit professional association founded in 1947 with more than 52,000 members worldwide, most of whom are respiratory therapists. Edison National Medical, according to its website, is a healthcare innovation marketplace with expertise in open innovation, product development, and medicine.
The Innovation Act (H.R. 9), a patent reform bill introduced this congressional session, received bipartisan support in a 24-8 positive vote by the House Judiciary Committee on June 11, 2015. The bill is now scheduled to proceed to the full House of Representatives for consideration. A press release announcing the vote stated that a goal of the Innovation Act is to address, for example, the following:
- Targets Abusive Patent Litigation;
- Protects the Patent System;
- Increases Transparency;
- Prevents Extortion;
- Provides Greater Clarity;
- Provides Small Business Education;
- Places Reasonable Limits on Venue in Patent Cases; and
- Reduces Unnecessary, Expensive Discovery.
A related bill, the Protecting American Talent and Entrepreneurship (PATENT) Act (S. 1137), was also recently approved by the Senate Judiciary Committee for consideration by the Senate.
Prior to the vote in the House Judiciary Committee, the Medical Device Manufacturers Association (MDMA) issued a statement opposing the Innovation Act. The statement, made by MDMA President and CEO Mark Leahey, asserts that the Innovation Act “remains overly broad and would harm medical technology innovation and stifle the development of cures for patients who need them most.” Specifically, Leahey’s statement claims the Innovation Act “would severely weaken the ability of small companies and the innovators behind them to attract early stage investment for their inventions and defend them against infringement.”
The MDMA has been critical of the Innovation Act in the past, including sending a letter addressing its concerns in April. The group has also supported another patent reform bill, the Support Technology and Research for Our Nation’s Growth (STRONG) Patents Act of 2015 (S. 632), in the Senate.
The United States Patent and Trademark Office (“USPTO”) is hosting a Medical Tech Fair & Medical Device Partnership Meeting on June 2-3, 2015. According to the USPTO, the event, which is sponsored by Technology Center 3700, brings “industry stakeholders and patent examiners and directors from Technology Center 3700 (TC 3700) together to share ideas, experiences, and insights on best practices in advancing prosecution and provide a forum for discussion on how the agency can improve and expand its relationship with the medical device technology community.” The agenda for the program includes an open forum discussion on topics such as compact prosecution, after final practice, the America Invents Act, and new quality initiatives at the USPTO. There will also be a presentation on 35 U.S.C. § 101 and its effects in the medical technology area. The last event of this kind was held in January 2013.
Participation in the event can be in person or via WebEx. Registration information can be found here.
(March 3, 2015) Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued a statement regarding the Support Technology and Research for Our Nation’s Growth (STRONG) Patents Act of 2015. According to the bill, the STRONG Patents Act aims to “strengthen the position of the United States as the world’s leading innovator by amending title 35, United States Code, to protect property rights of the inventors that grow the country’s economy.” The STRONG Patents Act was introduced by U.S. Senators Chris Coons (D-Del.) and Dick Durbin (D-Ill.), members of the Senate Judiciary Committee, and Mazie Hirono (D-Hawaii), member of the Senate Committee on Small Business and Entrepreneurship. According to a press release by Senator Coons:
The STRONG Patents Act would strengthen and combat abuse by:
- Cracking down on abusive demand letters by empowering the Federal Trade Commission to target firms that abuse startups rather than invent anything;
- Ensuring that pleading standards for patent-infringement cases match the standards used for all other forms of civil actions, creating a significant barrier to frivolous lawsuits before any funds are spent on discovery;
- Eliminating fee diversion from the U.S. Patent and Trademark Office (PTO) so we can ensure that those who examine patents have adequate training and dependable funding;
- Ensuring balance in post-grant proceedings at the PTO, so that this expedited form of patent litigation is both fast and fair; and
- Analyzing the impact that our patent system has on small businesses, both from the perspective of startups reliant on patents and those small businesses facing allegations of infringement.
(January 13, 2015) The United States Court of Appeals for the Federal Circuit affirmed a lower court’s finding that W.L. Gore & Associates, Inc. (“Gore”) willfully infringed U.S. Patent No. 6,436,135 (“the ’135 patent”) . The ’135 patent, entitled “Prosthetic Vascular Graft,” states that its invention relates to vascular prostheses fabricated from highly expanded polytetrafluoroethylene [ePTFE].” According to the opinion, ePTFE is sold by Gore under the brand name “Gore-Tex®.” Figure 3 from the ‘135 patent is illustrated below:
According to the opinion, the dispute over the ’135 patent began with the filing of the 1974 patent application from which the ’135 patent issued – twenty-eight years later. The opinion states that during the pendency of the patent application, there was a dispute over inventorship between, inter alia, Peter Cooper, a Gore employee who assigned his rights to Gore, and Dr. David Goldfarb, who assigned his rights to C. R. Bard, Inc. (“Bard”). The opinion also notes that the patent office awarded the patent to Dr. Goldfarb and the patent issued in August 2002.
The opinion indicates that in 2003, Bard Peripheral Vascular, Inc. (“BPV”) and Dr. Goldfarb filed a complaint against Gore for infringement of the ’135 patent, and a jury found the ’135 patent valid and that Gore willfully infringed. After a lengthy procedural history, including three prior Federal Circuit decisions, the Federal Circuit affirmed a finding of willful infringement.
Federal Circuit Finds Antares’ Patent Claims Invalid for Failure to Satisfy the “Original Patent” Requirement
(November 17, 2014) The United States Court of Appeals for the Federal Circuit affirmed a lower court’s denial of Antares Pharma, Inc.’s (“Antares”) motion for a preliminary injunction seeking to enjoin Medac Pharma, Inc. and Medac GMBH (collectively, “Medac”) from infringing U.S. Patent No. RE44,846 (a reissue patent of U.S. Patent No. 7,776,015). U.S. Patent No. RE44,846, entitled “Needle assisted jet injector,” states that it is “directed to a device for delivery of a medicament, and in particularly to a jet injector with a short needle to reduce the pressure at which the jet injector must eject the medicament for proper delivery.” Figure 1 from the patent is illustrated below:
The Federal Circuit held the reissue claims were invalid “for failure to comply with the ‘original patent’ requirement of 35 U.S.C. § 251.” According to the Court, to satisfy the “Original Patent” requirement, the original patent’s specification “must clearly and unequivocally disclose the newly claimed invention as a separate invention.” The opinion stated that Antares’ original patent (U.S. Patent No. 7,776,015) claimed jet injection devices and Antares broadened its claims to cover any “injection device” on reissue and that any hints, suggestions, or indications in the specification to other means of injection were not enough to save the reissue claims.
Medical Device Manufacturer’s Association Submits Comments on USPTO’s Proposed Rule to Require Identification of Attributable Ownership
(April 24, 2014) The Medical Device Manufacturer’s Association (MDMA) announced that it submitted comments to the United States Patent and Trademark Office (USPTO) in regard to the USPTO’s Notice of Proposed Rulemaking Proposing Changes to Require Identification of Attributable Ownership. The proposed rule, published in the Federal Register at 79 Fed. Reg. 9677 on February 20, 2014, would require more transparent identification of the patent owner. In particular, the proposed rule would require that the attributable owner, including the ultimate parent entity, be identified during the pendency of a patent application and at specified times during the life of a patent. Specifically, the attributable owner would need to be identified on the filing of an application (or shortly thereafter), when there is a change in the attributable owner during the pendency of an application, at the time of issue fee and maintenance fee payments, and when a patent is involved in supplemental examination, ex parte reexamination, or a trial proceeding before the Patent Trial and Appeal Board (PTAB).
According to the announcement, the comments by the MDMA expressed concern over proposed changes that “would require identification of attributable ownership, which would be extremely costly and burdensome for innovative and entrepreneurial medical technology companies.” The MDMA states that their position on patent reform is “supportive of efforts to curb abusive practices of patent assertion entities (PAEs) or ‘patent trolls’ but not while making it more costly and burdensome for innovators when defending or asserting their intellectual property rights.”
Several other organizations expressed similar concerns to the proposed rule; two public hearings were conducted in March. Final rulemaking is scheduled for later this month.
(March 6, 2014) Medtronic, Inc. announced in a press release that the European Patent Office (EPO) has invalidated European Patent Number EP2055266B1 (“the ’266 Patent”) assigned to Edwards Lifesciences PVT, Inc. The ’266 Patent, entitled “Implantable Prosthetic Valve,” states that the invention “relates to a valve prosthesis for cardiac implantation or for implantation in other body ducts.” Figure 1 of the ’266 patent is illustrated below:
According to the press release, the ’266 Patent was the basis for an August 26, 2013 injunction prohibiting sales of Medtronic’s CoreValve® System in Germany. The EPO stated that the oral proceedings resulted in “[t]he European patent [being] revoked because at least one ground for opposition prejudices the maintenance of the European patent.” The EPO file is available here.
United States Supreme Court Reverses Federal Circuit Decision in Medtronic, Inc. v. Mirowski Family Ventures, LLC
(January 22, 2014) A unanimous Supreme Court reversed the Federal Circuit and held that, when a licensee seeks a declaratory judgment against a patentee to establish that there is no infringement, the burden of proving infringement remains with the patentee.
According to the opinion, Mirowski Family Ventures, LLC (“Mirowski”) owns patents (U.S. Reissue Patents Nos. RE38,119 and RE39,897) relating to implantable heart stimulators. Figure 1 of U.S. Reissue Patent No. RE38,119 is illustrated below:
By way of background, Mirowski entered into a licensing agreement that permitted Medtronic, Inc. (“Medtronic”) to practice certain Mirowski patents in exchange for royalty payments. Mirowski notified Medtronic of its belief that several of Medtronic’s new products infringed the licensed patents, and thus royalty payments relating to those product were owed. Medtronic then brought a declaratory judgment action asserting that their products did not noninfringe the Mirowski patents. The district court concluded that Mirowski, as the party asserting infringement, had the burden of proving infringement and that Mirowski had not met that burden. The Federal Circuit disagreed. It acknowledged that a patentee normally bears the burden of proof, but concluded that where the patentee is a declaratory judgment defendant and, like Mirowski, is foreclosed from asserting an infringement counterclaim by the continued existence of a licensing agreement, the party seeking the declaratory judgment, namely Medtronic, bears the burden of persuasion.
The Supreme Court reversed the decision of the Federal Circuit and held that, “when a licensee seeks a declaratory judgment against a patentee to establish that there is no infringement, the burden of proving infringement remains with the patentee.” The case was remanded for further proceedings.
(Dec. 20, 2013) Cynosure, Inc., which according to its website develops and markets laser- and light-based aesthetic treatment systems for high-volume applications, announced that it will receive $10 million plus future royalty payments under a settlement agreement with Tria Beauty, Inc. The settlement ends the patent infringement litigation between Tria and Palomar Medical Technologies, which Cynosure acquired in June 2013. According to the press release, the settlement includes two non-exclusive patent license agreements between Cynosure and Tria. The first agreement reportedly grants Tria non-exclusive, worldwide licenses to U.S. Patent Nos. 5,735,844, titled “Hair Removal using Optical Pulses,” and 5,595,568, titled “Permanent Hair Removal using Optical Pulses,” and their foreign counterparts. The second agreement reportedly grants Tria non-exclusive, worldwide licenses to U.S. Patent Nos. 8,182,473, 8,328,794, and 8,328,796, for consumer hair removal products. The press release states:
“This agreement resolves the litigation involving certain Palomar patents, eliminating potential future legal expense to enforce those patents,” said Michael R. Davin, Cynosure’s President and CEO. “Equally important, the settlement fully values our intellectual property rights by fairly compensating Cynosure and its shareholders for sales of products based on our proprietary hair-removal technology.”
According to its website, Cynosure is based in Westford, Massachusetts.
Lombard Medical Technologies PLC announced yesterday that the USPTO granted its request to dismiss the Inter Partes Review of U.S. Patent No. 6,306,141 to Jervis (“the ’141 Patent”). The ’141 Patent, entitled “Medical Devices Incorporating SIM Alloy Elements,” issued on October 23, 2001. According to the ’141 Patent, the patent relates to “medical devices incorporating shape memory allows, and to improvements therein.” Figures 3 and 4 from the ’141 Patent are shown below:
Lombard had requested Inter Partes Review of claims 1-10 and 18-22 of the ‘141 Patent. According to Lombard’s announcement, Lombard’s request to withdraw the IPR was a condition of the non-exclusive license granted to Lombard by Medtronic for the ’141 Patent. More information pertaining to the Inter Partes Review Petition can be seen by visiting the Board’s website, searching for the ’141 Patent, and clicking on the Case Number link.