Prior Art Introduced During Prosecution Has Important Implications for 101 Challenges

Attorney: Richard D. Kelly
September 19, 2019

Five years after Alice Corp. Pty. v. CLS Bank Int'l, 573 U.S. 208 (2014) and the institution of the Alice test, district courts are still wading through precedent set by the Federal Circuit while it attempts to apply the test. Recently, one New Mexico District Court turned to prior art introduced during the prosecution process that was aimed at the questions of novelty and non-obviousness to determine whether there was an "inventive concept" for the Alice/Mayo test.... Read more

Prosecution History Estoppel And Amendments Tangential To Patentability

Attorney: Richard D. Kelly
September 17, 2019

The doctrine of equivalents is an equitable exception to the basic concept that the patent claims define the limit of claim protection. It is intended to prevent one from making an insubstantial change to a claimed invention to avoid infringement which is defined by the function-way-result test. The doctrine is limited by the prior art, dedication to the public, and prosecution history estoppel.... Read more

Method-of-Treatment Claims, Comprising Excluding Certain Patients from Treatment, Found to Be Patent-Ineligible Under 35 U.S.C. § 101

Attorney: Matthew E. Barnet, Ph.D.
September 13, 2019

On August 27, 2019, in INO Therapeutics LLC v. Praxair Distribution Inc., in a 2-1 decision, the Federal Circuit upheld a district court decision that method-of-treatment claims, comprising excluding certain patients from treatment, were invalid under 35 U.S.C. § 101.... Read more

Specification Must Adequately Disclose the Claimed Invention to Avoid Invalidation for Lack of Written Description

Attorney: Marina I. Miller, Ph.D.
September 9, 2019

Drs. Stephen Quake and Christina Fan ("Quake") appealed a decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board ("the Board") finding the four claims of Quake's U.S. Patent 8,008,018 and Claim 25 of their U.S. Application No. 12/393,833 unpatentable for lack of written description.... Read more

Thinking Outside the (Utility Patent) Box – Don't Overlook Design Patent Protection in the Life Sciences

Attorney: Lisa M. Mandrusiak
August 30, 2019

Design patents are very different from utility patents in that design patents only protect the ornamental features of an invention. In contrast to utility patents, the design is defined in scope by the content of the drawings rather than the words of a set of claims. Further, design patents have a 15 year term, as opposed to 20 years from filing for utility patents.... Read more

Non-Limiting Clauses and Written Description Based on Substantially Equivalent Disclosure

Attorney: Daniel J. Pereira, Ph.D.
August 16, 2019

Nalpropion Pharmaceuticals, Inc. v Actavis Laboratories FL, Inc (Fed. Cir. Aug. 15, 2019) is a precedential opinion written by Judge Lourie with Judge Wallach and a dissent from Judge Prost in a case centered on an ANDA litigation in which Actavis sought approval for their generic version to Nalpropion's patents for the Contrave® product. Footnote 1 in the opinion outlines the rather complex history of the ownership/license interests as they changed over time.... Read more

Argument with Emphasis on "Particular" Combination of Salts Invoked Prosecution History Estoppel

Attorney: Yuki Onoe
August 16, 2019

 「特定の」塩の組み合わせを強調して反論を行ったために包袋禁反言(審査経過に基づくエストッペル)が適用された事例<... Read more

An Approach to Pharma Life Cycle Management

Attorney: Richard D. Kelly
August 12, 2019

Every innovative pharma company faces the same challenge, how to delay the patent cliff. The existence of the "skinny viii" (21 U.S.C. § 355(j)(2)(A)(viii)) makes developing additional FDA approved indications unattractive from an LCM viewpoint. Such additional indications may allow for market expansion during the life of the patents protecting the original indication but offer no protection once those patents have expired. With a skinny viii the generic seeks approval only for indication with the earliest patent expiration. Formulation patents often provide scant protection because of the possibility of design arounds and being more easily challenged for invalidity since often the original patents are available as prior art... Read more

Invalidity of Broad Claims for Lack of Enablement in the Absence of Sufficient Disclosure of the Structure/Function Correlation and Unpredictability in the Art

Attorney: Marina I. Miller, Ph.D.
July 17, 2019

Enzo Life Sciences, Inc. ("Enzo") appealed the decision of the U.S. District Court for the District of Delaware granting summary judgment against Enzo and holding that the asserted claims were invalid for lack of enablement. The Federal Circuit affirmed.... Read more

ATHENA DIAGNOSTICS - THE FEDERAL CIRCUIT AGAIN ABDICATES ITS RESPONSIBILITY

Attorney: Richard D. Kelly
July 15, 2019

In denying the petition for rehearing en banc the majority of the Federal Circuit abdicated its responsibility to define the limits of the Supreme Court's Mayo decision. Judge Dyk on the 25th birthday of the Federal Circuit noted that: Frequently, the Supreme Court in patent cases articulates a general principle and leaves it to our court to both administer the rule and apply it to the individual case.... Read more

Update & Reminder: Patent Term Adjustment Related to IDS Safe Harbor

Attorney: Vincent K. Shier, Ph.D.
July 5, 2019

On November 9, 2018, I wrote about the USPTO's release of interim procedures for patentees to request recalculation of the patent term adjustment with respect to information disclosure statements accompanied by a proper safe harbor statement under 37 CFR. 1.704(d) (https://www.lifesciencesipblog.com/?t=39&format=xml&A=18655&p=15972).... Read more

Four Decisions Designated Informative on 101: Positive Trend for Life Sciences?

Attorney: Lisa M. Mandrusiak
July 2, 2019

In January, 2019, the USPTO issued new guidance about what constitutes an abstract idea that is ineligible for protection under Section 101. Among other things, the guidance emphasized that claims otherwise reciting a judicial exception (i.e., not patentable), would be permitted if they were directed to some type of practical application. See our previous post for more details.... Read more


Category: PTAB 101

"Statutory" Obviousness-Type Double Patenting for Pharma Patents?

Attorney: Daniel J. Pereira, Ph.D.
June 20, 2019

As all patent practitioners know, obviousness-type double patenting is a judicially created doctrine to prevent the unjust extension of patent term of follow on patents that are simply obvious variants of earlier patents. The doctrine is applied during prosecution with the USPTO and can be used to challenge the validity of issued patents in contested matters. 35 USC 121 also speaks to this issue in certain circumstances.<... Read more

Commercial Success of Claimed Product over Non-Infringing Competitive Products as Evidence of Non-Obviousness

Attorneys: Richard D. Kelly and Yuki Onoe
June 17, 2019

During litigation or contested proceeding the patentee can point to commercial success of a product as evidence of non-obviousness of the claimed product. Although some work is necessary to show the nexus between the success in the market and the claimed invention, the evidence showing, for example, the product taking sales from competitive products could help the patentee's case.... Read more

SOVEREIGN IMMUNITY AND IPR'S: AND NOW, THE REST OF THE STORY

Attorney: J. Derek Mason, Ph.D., CLP
June 14, 2019

Radio great Paul Harvey would always leave listeners hanging during his broadcast, then return from a commercial with "the rest of the story". Previously, I wrote on the Federal Circuit ruling with respect to Tribal Immunity (https://www.oblon.com/publications/tribal-immunity-in-ipr-is-dealt-a-death-blow-by-the-federal-circuit). At the end of that article I stated: "I note, however, that in the final sentence of their analysis, the Federal Circuit explicitly stated that this decision did NOT address whether there is any reason to treat state sovereign immunity differently with respect to IPR proceedings. That will remain to be seen…"... Read more

Written Description In Provisional Application: Perdue Pharma L.P. v. Andrei Iancu.

Attorney: Marina I. Miller, Ph.D.
May 28, 2019

Amneal Pharmaceuticals, LLC. ("Amneal") filed two petitions for inter partes review of claims 1–13 and 16–19 of U.S. Patent No. 9,034,376 ("the '376 patent") of Purdue Pharma L.P., P.F. Laboratories, Inc. and Purdue Pharmaceuticals L.P. ("Purdue"). In the petitions, Amneal argued that claims 1–13 and 16–19 were unpatentable for obviousness over the combinations of multiple prior art references including US 2002/0187192 A1 ("Joshi").... Read more

Pending Case, Cannabis Companies May Be Able to Prosecute Patent Infringements in Court

Attorney: Daniel J. Pereira, Ph.D.
May 22, 2019

In "United Cannabis v. Pure Hemp Collective," United Cannabis claims that Pure Hemp used a cannabis extract that United Cannabis had a patent on. Lawyers say this case is the first of its kind.... Read more

What You Say Can Hurt You

Attorney: Richard D. Kelly
May 21, 2019

Often in writing applications there is a tendency to denigrate prior art techniques. This is not risk free as the patentee in Nuvo Pharmaceuticals (Ireland) v. Dr. Reddy's Laboratories, Inc. (Fed. Cir. May 15, 2019) discovered.... Read more


Category: Patent Eligibility

PTAB Issues Two New Precedential Opinions On Discretion to Deny Review - Implications for Generics

Attorney: Lisa M. Mandrusiak
May 9, 2019

The PTAB designated two decisions as precedential this week (in addition to several in previous weeks), both relevant to the Board's discretion to deny review. These cases illustrate that the PTO is in the process of designating precedential opinions on a number of issues, in line with revised Standard Operating Procedure 2 for designating precedential and informative decisions. See my previous posts on other recent precedential decisions here and here.... Read more

The Proper Application of the Supreme Court's Alice Standard is an Evolving and Sometimes Hazy Area of Law

Attorney: Daniel J. Pereira, Ph.D.
April 29, 2019

Marijuana, for medical purposes and recreational purposes, is an area of great political, social and legal interest. By some accounts (https://www.forbes.com/sites/thomaspellechia/2018/03/01/double-digit-billions-puts-north-america-in-the-worldwide-cannabis-market-lead/#6d925dd76510), the industry is rapidly growing leaps and bounds. Not surprisingly, patents and disputes centered on patents for this industry are increasing in numbers.... Read more

Follow-On IPR Petitions - Institution Is Not Impossible But Difficult

Attorney: Yuki Onoe
April 16, 2019

同一特許に対するIPR申請 ¾審理開始は不可能ではないが難しい<... Read more

Cleveland Clinic - Another Black Eye for the Federal Circuit and Dissing the USPTO

Attorney: Richard D. Kelly
April 3, 2019

In the April 1 Cleveland Clinic Foundation v. True Health Diagnostics LLC decision, the Federal Circuit has once again given itself a black eye in finding a new diagnostic procedure to be patent ineligible and with the same punch dissed the USPTO.... Read more

Natural Alternatives - Claim Construction Defeats A 101 Challenge On The Pleadings

Attorney: Richard D. Kelly
March 26, 2019

The Federal Circuit on March 19 in Natural Alternatives Intl. v Creative Compounds LLC. reversed a district court's opinion finding Natural's patent claims to be patent ineligible. The district court's decision arose out of a motion for judgment on the pleadings filed by Creative.... Read more


Category: Federal Circuit

Invention by "Another": Duncan Parking Technologies, Inc. v. IPS Group, Inc., Appeal No. 2018-1205, -1360 (Fed. Cir. Jan. 31, 2019)

Attorney: Marina I. Miller, Ph.D.
March 19, 2019

IPS Group Inc. ("IPS") appealed from two decisions of the United States District Court for the Southern District of California granting summary judgment of non-infringement of U.S. Patents 8,595,054 and 7,854,310. Duncan Parking Technologies Inc. ("DPT") appealed from a related decision of the Patent Trial and Appeal Board ("the Board") in an inter partes review holding that claims 1–5 and 7–10 of the '310 patent were not shown to be unpatentable as anticipated under 35 U.S.C. § 102(e).... Read more

Biologic Patent Transparency Act - New Bill Aimed at Biologics

Attorney: Lisa M. Mandrusiak
March 12, 2019

A bipartisan group of senators sponsored a bill this week—the Biologic Patent Transparency Act, S. 659—aimed at making patent information associated with biologics easier to identify and easing the approval process for biosimilar manufacturers encountering patent roadblocks.... Read more

Motions to Amend: Is the PTAB's Lectrosonics Order Just of Western Digital?

Attorney: Todd W. Baker
March 11, 2019

Spring gardening season has begun and the USPTO is once again planting its Motion to Amend ("MTA") seeds. In a substantial redux of Western Digital Corporation v. Spex Technologies, IPR2018-00082,-00084, paper 13, the PTAB this past week designated paper 15 of Lectrosonics v. Zaxcom, IPR2018-01129, 01130("Lectrosonics Order") as an informative decision.... Read more

Onyx v. Cipla: Companies Beware - What Your Patent Agent Tells You May Not Be Privileged

Attorney: Jeffrey B. McIntyre
March 4, 2019

In an order last month, the Delaware district court ruled that some communications involving Onyx's patent agent were not privileged and must be produced to Cipla. The court's order highlights potential pitfalls when relying upon advice solely from patent agents.... Read more

The Federal Circuit Stays the Course in Patent Ineligibility for an Abstract Idea

Attorney: Daniel J. Pereira, Ph.D.
February 27, 2019

In a precedential opinion issued on February 26, 2019, the Federal Circuit affirmed the District Court's finding of patent ineligibility for a claim "directed to the abstract idea of "collecting, analyzing, manipulating, and displaying data."" University of Florida Research Foundation Inc. v General Electric Company et al (Fed. Cir. 2019).... Read more

No More IPRs From Generic Drug Makers?

Attorney: Yuki Onoe
February 24, 2019

The USPTO argues that a petitioner who has received a favorable final written decision in an IPR is estopped from reusing the same winning argument in a district court. If the Federal Circuit in BTG International Ltd. v. Amneal Pharmaceuticals LLC, agrees with the PTO, an ANDA sponsor would not take the risk of "winning" at the PTAB and would rather present the best argument in a district court.... Read more

Bioisosterism, by Itself, May Not be Sufficient Motivation to Modify a Lead Compound

Attorney: Stephen G. Baxter, Ph.D.
February 11, 2019

In the recent decision, Mylan Pharmaceuticals Inc. v. Research Corporation Technologies, Inc., the Federal Circuit affirmed the PTAB's finding that Claims 8 to 13 of U.S. Reissue Patent 38,551 ("the '551 patent") owned by Research Corporation Technologies, Inc. ("RCT") are not unpatentable.... Read more

USPTO's Patent Term Adjustment Policies Reigned in Yet Again

Attorney: Vincent K. Shier, Ph.D.
January 28, 2019

Since the Federal Circuit’s decision in Wyeth v. Kappos, 591 F.3d 1364, 93 U.S.P.Q. 2d 1257 (Fed. Cir. 2010), aff’g, Wyeth v. Dudas, 580 F. Supp. 2d 138, 88 U.S.P.Q.2d 1538 (D.D.C. 2008), which held that the USPTO was improperly reducing patent term adjustment (PTA) by improperly calculating “overlapping” days of agency delay under 35 U.S.C. §154, the courts have been asked on numerous occasions to look at how the USPTO is calculating PTA. Not every case has been decided in favor of the challenger, but a fair amount has. In addition, the USPTO has identified several internal errors including not accounting for the IDS safe harbor under 37 C.F.R. §1.704(d). As such, patentees should be very mindful of this evolving and important provision of law.<... Read more

Patents 4 Patients Extended Until June 30, 2020

Attorney: Yuki Onoe
January 2, 2019

The USPTO has recently announced extension of Patents 4 Patients, also called as the Cancer Immunotherapy Pilot Program, until June 30, 2020.  This pilot program was started on June 29, 2016, to provide a fast-track examination for an application related to cancer immunotherapy.  The PTO’s goal is to issue a final decision within a year of the entry of the program. <... Read more

Federal Circuit Reiterates That Nucleotide Sequences Are Not Patent Eligible under 35 U.S.C. § 101

Attorney: Matthew E. Barnet, Ph.D.
December 27, 2018

An article by Matthew Barnet on "Federal Circuit Reiterates That Nucleotide Sequences Are Not Patent Eligible under 35 U.S.C. § 101" is published in the IP Litigator journal. Click to read article.... Read more

The Federal Circuit Still Doesn't Get Diagnostic Claims

Attorney: Richard D. Kelly
December 12, 2018

In Roche Diagnostics the Federal Circuit continued its failure to recognize that diagnostic claims were not patent ineligible because they used a natural law. Roche involved claims detecting the Mycobacterium tuberculosis strains (MTB) quickly and accurately. Prior to the invention delays often occurred in diagnosing tuberculosis because of the time necessary to detect its presence involved a three to eight week cell culture. Roche discovered that the MTB strains could be quickly identified by identifying the presence of specific nucleotide sequence which functioned as a signature for the MTB. The technique used to identify the presence or absence of the signature nucleotide was conventional PCR analysis. The Federal Circuit affirmed a finding the diagnostic claims to be patent ineligible because the PCR technique was conventional and nucleotides naturally occurring.... Read more

After SAS, Will Estoppel Also Apply to Grounds not Included in Petitions for Inter Partes Review and Post-Grant Review?

December 12, 2018

Since the Supreme Court's decision in SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018), there has been significant discussion on SAS's expected effect on estoppel for IPRs. Essentially universal opinion holds that estoppel will apply to all grounds raised in the IPR petition due to the all-or-nothing institution standard applied by the Patent Trial and Appeal Board ("PTAB") in response to SAS. Post-SAS, final written decisions in IPRs will address all grounds raised in the petition if at least one ground meets the standard for institution, thus making estoppel applicable to all petition grounds as grounds "that the petitioner raised … during that inter partes review" under 35 U.S.C. § 315(e).... Read more

WASHINGTON U. v. WARF – An Implied Covenant Wins the Day

Attorney: J. Derek Mason, Ph.D., CLP
December 10, 2018

In a November 26, 2018 order, the U.S. District Court for the District of Delaware ordered the Wisconsin Alumni Research Fund (WARF) to pay The Washington University – St. Louis (Wash. U.) $31.6 million for breach of contract (The Washington University v. Wisconsin Alumni Research Foundation, Civ. No. 13-2091-JFB). The case originated when Wash. U. filed suit against WARF for breach of contract, breach of fiduciary duty, breach of the implied covenant of good faith and fair dealing, and equitable accounting, relating to a 1995 agreement between the parties entitled "Inter-Institutional Agreement for Prevention of Hyperphosphatemia in Kidney Disorder Patients" (the "IIA"), and particularly relating to the drug paracalcitol. The IIA covered certain patent rights for US Patent 5,597,815, jointly owned by Wash. U. and WARF.... Read more

SAS Affects Use of Disclaimer to Obtain Motion to Dismiss

December 6, 2018

In IPR2018-00673, Paper No. 27, the Patent Trial and Appeal Board ("Board") refused to grant patent owner Wi-Lan's motion to dismiss despite its disclaimer of the only claims for which the Board had found petitioner LG as having a reasonable likelihood of success. LG filed an IPR petition seeking to invalidate claims 1-4 and 6-9 of U.S. Patent No. 9,497,743 ("the '743 patent"). The Board's institution decision found that LG had established a reasonable likelihood that LG would prevail in showing the unpatentability of claims 1-4 of the '743 patent, but not for claims 6-9. Pursuant to SAS, however, the Board instituted trial on claims 1-4 as well as claims 6-9.... Read more

Obviousness of a Dosage Regimen: Yeda Research and Development Co., Ltd. v. Mylan Pharmaceuticals Inc. Teva Pharmaceuticals USA, Inc. v. Sandoz Inc.

Attorney: Marina I. Miller, Ph.D.
December 3, 2018

Yeda Research and Development Co., Ltd. ("Yeda") is the assignee of three "Copaxone patents" that describe and claim COPAXONE® 40mg/mL (glatiramer acetate ("GA")), a treatment for relapsing-remitting multiple sclerosis ("RRMS"). For analyzing the obviousness of the Copaxone patents, a key limitation of the claims is the administration of a 40mg GA dose in three subcutaneous injections over seven days. The Patent and Trademark Appeal Board ("the Board") found (and the district court affirmed) that the prior art described all limitations of the claims except for the administration of 40mg GA 3x/week for seven days. However, the Board and the district court concluded that the claimed dosage regiment would have been obvious to a parson of skill in the art (POSITA). Yeda appealed both decisions.... Read more

Hedge Your Bets in TC 1600 PGRs

Attorney: Lisa M. Mandrusiak
November 30, 2018

Post grant reviews (PGRs) have proven to be more popular in the biotechnology space (TC 1600) than any other art unit, with 42—or 28.1%—of the PGRs filed to date classified as TC 1600 patents.[1] By way of comparison, TC 1600 makes up just 10.1% of all IPRs filed to date.  Perhaps not surprisingly, PGRs are appealing for challengers of biotechnology patents because written description, enablement, and indefiniteness can all be raised, and these § 112 hurdles tend to be more challenging in the unpredictable arts of TC 1600. <... Read more

The Internet of Medical Things (IoMT) in the World of Medical Devices

Attorney: James R. Love
November 20, 2018

The Internet of Medical Things (IoMT) is a hot topic in the world of medical devices. This summer, at the MedTech conference in Philadelphia, IoMT was the word on everyone's lips. No wonder, as a recent report by Allied Market Research predicts that IoMT will be a $136.8 billion market by 2021.... Read more

Assignor Estoppel and IPR's: Possible Impact of Arista v. Cisco on Employment Agreements and Assignment Agreements

Attorney: J. Derek Mason, Ph.D., CLP
November 16, 2018

In a November 9, 2018 decision (copy of decision linked below), the U.S. Court of Appeals for the Federal Circuit ruled that the doctrine of assignor estoppel does not apply in the inter partes review (IPR) context (see Arista Networks, Inc. v. Cisco Systems, Inc., (Fed. Cir. 2018)).... Read more

USPTO Releases Interim Procedure for Requesting Recalculation of Patent Term Adjustment Related to the IDS Safe Harbor

Attorney: Vincent K. Shier, Ph.D.
November 9, 2018

On Friday, November 2, 2018, the USPTO released its interim procedure for patentees to request recalculation of the patent term adjustment with respect to information disclosure statements accompanied by a proper safe harbor statement under 37 CFR. 1.704(d) (83 Fed. Reg. 55102 (Nov. 2, 2018); see text at: https://www.gpo.gov/fdsys/pkg/FR-2018-11-02/pdf/2018-24004.pdf).  The interim procedure is effective from the date of the notice until the USPTO can update the patent term adjustment computer program and provide notice to the public that the program is updated.<... Read more

PTAB Confirms It Will Apply Broad Petitioner Estoppel Post-SAS

Attorney: Lisa M. Mandrusiak
November 8, 2018

The IPR estoppel provision was originally intended as a check against patent challengers attacking patents serially in the USPTO or other forums based on grounds that were raised or "reasonably could have been raised" in the original IPR. Although the Federal Circuit has interpreted estoppel narrowly, district courts were split, and estoppel's impact has remained in flux for several years.... Read more

IP Strategies for Medical Device Technologies: Be Your Own Incubator

Attorney: James R. Love
October 26, 2018

James Love co-edited a medical device book titled "IP Strategies for Medical Device Technologies: Be Your Own Incubator".... Read more

WRITTEN DESCRIPTION: Picking and Choosing and Blaze Marks

Attorney: Daniel J. Pereira, Ph.D.
October 25, 2018

In a non-precedential decision issued by the U.S. Court of Appeals for the Federal Circuit (FWP IP APS v. Biogen MA, Inc., October 24, 2018, http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/17-2109.Opinion.10-24-2018.pdf), the Court was tasked with reviewing a PTAB decision of an interference between the named parties.<... Read more

Teva Challenges the FDA Over its First-Applicant Interpretation

Attorney: Tia D. Fenton
October 22, 2018

Teva Pharmaceutical USA, Inc. filed a Complaint and Motion for Preliminary Injunction in the U.S. District Court for the District of Columbia, alleging that the FDA's recent interpretation of the definition of "first applicant" is unlawful.... Read more

Federal Circuit Reiterates That Naturally-Occurring Nucleotide Sequences Are Not Patent Eligible Under 35 U.S.C. § 101

Attorney: Matthew E. Barnet, Ph.D.
October 12, 2018

On October 9, 2018, in Roche Molecular Systems, Inc. v. Cepheid, the Federal Circuit upheld a district court decision that claims reciting nucleotide primers in U.S. Patent No. 5,643,723 (“the ‘723 patent”) were invalid under 35 U.S.C. § 101.<... Read more

Will Rite-Hite Be Next?

Attorney: Richard D. Kelly
October 12, 2018

In Rite-Hite v. Kelley Co., 56 F.3d 1538 (Fed. Cir. 1995) the Federal Circuit refused to award damages for the goods which were regularly sold as part of a package including patented goods.... Read more

Sufficiency of Invalidity Evidence in IPRs Can Differ for Method and Apparatus Claims

October 5, 2018

Using the same invalidity evidence to address apparatus and corresponding method claims in inter partes review ("IPR") petitions can present difficulties depending on the claim language used in the apparatus claims.... Read more

Two Herceptin® Patents Survive IPR: A Lesson in Separately Arguing Motivation to Combine and Reasonable Expectation of Success

Attorney: Lisa M. Mandrusiak
October 4, 2018

Motivation to combine and reasonable expectation of success are separate requirements that must be independently considered. By capitalizing on shortcomings in the petitions related to separately arguing these issues, Genentech was able to save two of three patents covering its blockbuster drug Herceptin®.... Read more

Trustees of Boston University v. Everlight Electronics Co. (Fed. Cir. July 25, 2018): Specification Must Enable the Full Scope of the Claimed Invention

Attorney: Marina I. Miller, Ph.D.
October 3, 2018

Plaintiff-cross-appellant Trustees of Boston University ("BU") sued defendants-appellants Everlight Electronics Co., Ltd. and others for infringing BU's U.S. Patent No. 5,686,738. A jury found that Defendants infringed the '738 patent and failed to prove the patent's invalidity.... Read more

Helsinn – The Government Sides with Reality

Attorney: Yuki Onoe
October 1, 2018

On September 24, 2018, the Solicitor General filed a motion to participate in oral argument as amicus curiae in Helsinn Healthcare v. Teva Pharmaceuticals. The U.S. government's interest in this case is obvious, as the decision would have a direct impact on how the USPTO examines and determines patentability of invention.... Read more

Travatan Z® Patent Survives IPR: A Lesson in Successfully Arguing Hindsight Bias

Attorney: Lisa M. Mandrusiak
September 27, 2018

Hindsight bias is not simply an old chestnut argued ad infinitum in response to obviousness challenges. In this week's final written decision in IPR2017-01053 upholding all claims of U.S. Patent No. 8,268,299, the PTAB illustrated that—under the right circumstances—this argument can have teeth.... Read more

JTEKT v. GKN: Federal Circuit Finds Competitor Lacks Standing to Appeal PTAB's Final Written Decision

Attorney: Lisa M. Mandrusiak
September 7, 2018

After determining that its competitor GKN's patent raised a potential risk of infringement for a product under development, JTEKT[1] challenged the patentability of claims 1–7 of U.S. Patent No. 8,215,440 via inter partes review (IPR2016-00046). When claims 2 and 3 were confirmed as patentable in the final written decision—and thus the risk of infringement remained—JTEKT appealed, and GKN moved to dismiss the appeal based on lack of standing.... Read more

WHAT DOES AND/OR MEAN? IT DEPENDS

Attorney: Daniel J. Pereira, Ph.D.
September 7, 2018

In an interesting, but non-precedential, decision from the Court of Appeals for the Federal Circuit (Supernus Pharmaceuticals, Inc. v TWI Pharmaceuticals, Inc et al (Fed. Cir., September 6, 2018-http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/17-2513.Opinion.9-6-2018.pdf), the Court affirmed a decision from the U.S. District Court of New Jersey.... Read more

Recent Pharmaceutical House and Senate Bills

Attorney: Tia D. Fenton
August 28, 2018

Over the summer, representatives introduced bills and amendments of interest to the pharmaceutical industry. First, Senator Orrin Hatch, co-author of the Hatch-Waxman Act, filed an amendment in the Senate Judiciary Committee that would require a generic manufacturer wishing to challenge a brand-name drug patent to choose between Hatch-Waxman litigation and IPR, removing the option to use both. According to Senator Hatch, this Hatch-Waxman Integrity Act of 2018 would ensure that Hatch-Waxman continues to operate as originally intended by protecting the ability of generic drug companies to develop lower-cost drugs, while at the same time providing innovators a period of exclusivity to recoup investments. Specifically, Senator Hatch commented that the availability of an alternative path to challenge patents through IPRs has threatened to upend the carefully-crafted Hatch-Waxman balance by enabling companies to put added litigation pressure on drug innovators above and beyond what Hatch-Waxman already provides.... Read more

A Different Lesson from Vanda v. West-Ward

Attorney: Stephen G. Baxter, Ph.D.
August 20, 2018

Last week the Federal Circuit denied West-Ward's petition for rehearing en banc. At the time of the original Federal Circuit decision (Vanda Pharms. Inc. v. West-Ward Pharms. Int'l Ltd., 887 F.3d 1117 (Fed. Cir. 2018), the case generated substantial commentary in regard to its patent eligibility context. West-Ward's petition focused on the question of whether "adjusting a dose of an old drug based on a patient's genetic risk of poorly metabolizing it" is patent eligible subject matter, so the pro-patent crowd will no doubt be pleased. There is another aspect of the case, however, which is worthy of consideration.... Read more

PTAB Removes "Informative" Designation From Ex Parte Jung

Attorney: Matthew E. Barnet, Ph.D.
August 13, 2018

In July, the U.S. Patent & Trademark Office's Patent Trial and Appeal Board designated its ex parte Jung decision as informative (see here and here). In this decision, the Board held that the phrase "at least one of A and B" was presumed to be conjunctive. That is, the phrase was presumed to mean "at least one of A and at least one of B."... Read more

Boston University v. Everlight: Claim Invalid For Lack Of Enablement Because 17% Was "Physically Impossible"

Attorney: Jeffrey B. McIntyre
August 10, 2018

Last week, the Federal Circuit issued its opinion in Boston University (BU) v. Everlight, in which the court found that the only asserted claim (claim 19) was invalid for lack of enablement because 1/6 (17%) of the claimed subject matter was "physically impossible." Claim 19 was the only claim asserted at trial. The claim was directed to a semiconductor device comprising a substrate, a non-single crystalline buffer layer, and a growth layer grown on the buffer layer.... Read more

WesternGeco – Impacts Lost Profits Beyond 35 U.S.C. 271(f) Infringement

Attorney: Richard D. Kelly
August 6, 2018

The Supreme Court found Ion Geophysical Corp. (Ion) responsible for profits WesternGeco LLC. lost as a result of Ion's supplying to foreign buyers the parts necessary to assemble the patented ocean floor surveying equipment. WesternGeco's damages claim included a request for the lost profits of its foreign surveying business caused by Ion's 35 U.S.C. § 271(f) infringement. The Federal Circuit has denied these profits because, in its opinion, it would extend U.S. patent protection to foreign activities. The Supreme Court disagreed not with the concept that U.S. patent laws did not extend to foreign activities but because of the patent damages statute, 35 U.S.C. § 284 which provided:... Read more

Ex Parte Jung Puts the Conjunctive in the Phrase "at least one of A and B"

August 3, 2018

Last month, the U.S. Patent & Trademark Office's Patent Trial and Appeal Board ("PTAB") newly designated five decisions as informative. These five decisions included ex parte Jung, a Board decision regarding the construction of the phrase "at least one of A and B." According to the Board in Jung, the proper construction for this phrase is the conjunctive, i.e., at least one of A AND at least one of B. This presumptive construction now applies during patent examination absent certain exceptions.... Read more

Distribution of Certain Materials to Groups of People Without Restriction May Render Such Materials Printed Publications Under § 102(b)

Attorney: Marina I. Miller, Ph.D.
August 1, 2018

The Federal Circuit affirmed in-part and vacated in-part the PTAB's (the Board) decision that the petitioner, Medtronic, Inc., had not proven that the challenged patent claims were unpatentable. The Court affirmed the Board's determination that challenged claims were not obvious over two prior art references, but vacated and remanded the Board's determination that other references, a video "Thoracic Pedicle Screws for Idiopathic Scoliosis" and slides "Free Hand Thoracic Screw Placement and Clinical Use in Scoliosis and Kyphosis Surgery," were not "publicly accessible" under 35 U.S.C. § 102(b) and therefore were not prior art.... Read more

Enforceability of Medical Procedure Patents Under 35 U.S.C. § 287(c)

Attorney: James R. Love
July 30, 2018

Unlike many other countries, medical procedures are not per se unpatentable in the United States. This comes with a major caveat, specifically, 35 U.S.C. § 287(c) bars a medical procedure patent owner from enforcing the patent, by obtaining an injunction, monetary damages, and attorney fees, against a medical practitioner and a related health care entity based on the medical practitioner's performance of "a medical activity" (§ 287(c)(1)).... Read more

Jazz v. Amneal: Public Accessibility of Prior Art v. Reasonable Pertinence of Analogous Art

Attorney: Jeffrey B. McIntyre
July 26, 2018

Earlier this month, the Federal Circuit issued an opinion in Jazz Pharmaceuticals v. Amneal Pharmaceuticals, upholding the PTAB's finding that certain materials related to the FDA regulatory review process for Xyrem® were sufficiently accessible to the public to constitute prior art to seven Jazz patents. These materials (the "ACA materials") were accessible via a link on the FDA website "where background material would be posted before the meeting, and the meeting minutes, transcript, and slides would be posted after the meeting."... Read more

Tribal Immunity in IPR is Dealt a Death Blow by The Federal Circuit

Attorney: J. Derek Mason, Ph.D., CLP
July 26, 2018

The Federal Circuit issued its decision in Saint Regis Mohawk Tribe et al v. Mylan Pharmaceuticals Inc., et al (18-1638) on July 20, 2018. The central question addressed in the Federal Circuit's decision was whether the principal of sovereign immunity can be asserted by a patent owner to avoid their patent being subjected to the Inter Partes Review (IPR) process. The decision hinged on whether the IPR process is more akin to the civil litigation-like proceedings in adjudications before the Federal Maritime Commission in which state sovereign immunity was held to apply (Fed. Maritime Comm'n v. S.C. State Ports Auth., 535 U.S. 743, 754–56 (2002) ("FMC") or whether IPR is a traditional agency action in which it has been previously held that sovereign immunity does not typically apply (see, for example, Pauma v. NLRB, 888 F.3d 1066 (9th Cir. 2018); Karuk Tribe Hous. Auth., 260 F.3d at 1074; and Fed. Power Comm'n v. Tuscarora Indian Nation, 362 U.S. 99, 122 (1960)). It is important to note, however that there is no blanket rule that immunity does not apply in federal agency proceedings.... Read more

The Federal Circuit Lays Out What Does and Does Not Meet the Standard of Inherency, Motivation to Combine and Burden of Proof in Challenging Validity of Issued Claims

Attorney: Daniel J. Pereira, Ph.D.
July 20, 2018

Endo Pharmaceuticals Solutions, Inc et al v. Custopharm, Inc. (Fed. Cir. July 13, 2018), is an appeal of a Delaware District Court rejecting Custopharm's validity challenge to patents covering Endo's Aveed® testosterone undecanoate (TU) intramuscular injection as part of a Paragraph IV ANDA filing.... Read more

Decs, Slides, and Video[tape]: Utilizing non-patent literature in IPR

Attorney: Todd W. Baker
June 18, 2018

In Medtronic, Inc. v. Barry (2017-1169 and 2017-1170), the Federal Circuit (Circuit Judges Taranto, Plager, and Chen, decision authored by Judge Chen, hereinafter "the panel") vacated the PTAB's finding in IPRs2015-00780 and -00783 that Medtronic's slides and videos constitute "printed publications" within the meaning of 35 U.S.C. §102(b). Since only patents and printed publications are eligible as prior art in inter partes review ("IPR"), the question whether non-patent literature ("NPL") such as slides and videos distributed at a conference constitute printed publications is clearly of interest to those in the medical device field.... Read more

Is Real and Positive Change Coming for Patent Owners?

Attorney: Vincent K. Shier, Ph.D.
June 11, 2018

New USPTO Director Andrei Iancu provided the Intellectual Property Track plenary lecture at the 2018 BIO International Convention last week. As has been a common theme since being sworn in to office in February, Director Iancu's focus was on changes to provide greater certainty and quality for applicants and patent owners. Yes, we have heard this before, but the time is ripe for real change that positively impacts applicants and patent owners.... Read more

Federal Circuit Distinguishes Between Enablement and Reasonable Expectation of Success

Attorney: Matthew E. Barnet, Ph.D.
June 11, 2018

In the recent UCB v. Accord opinion, a panel of the Federal Circuit drew a distinction between (i) the enablement of a patentee's claims, and (ii) a reasonable expectation of success in an obviousness analysis. The majority found that the presumption of enablement for a claimed genus of compounds did not preclude a finding that there was not a reasonable expectation of success in creating a species falling within that genus.... Read more

Ex Parte Jadran Bandic – Patent Eligibility Analysis After Berkheimer

Attorney: Marina I. Miller, Ph.D.
June 4, 2018

In Ex Parte Bandic, the PTAB ("the Board") has given an insight into how the Office intends to examine patent eligibility under the two-step Alice test, considering the Memorandum published by the USPTO on April 19, 2018 explaining "Changes in Examination Procedure Pertaining to Subject Matter Eligibility" in view of Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018).... Read more

The POPR and Expert Declarations

Attorney: Richard D. Kelly
June 4, 2018

The PTAB in the past year has loosened rules governing IPR practice. In most cases the changes have been good for the process. However, some of the changes while introducing a greater degree of fairness into the system have created traps for the unwary. One such trap is allowing patentees to submit declarations with the POPR (Patent Owner's Preliminary Response). Contrary to what many practitioners expect, the submission of a declaration actually increases the probability of the petition being instituted. Indeed, it might even guarantee institution.... Read more

Sequenom v. Ariosa: The Saga Continues…

Attorney: J. Derek Mason, Ph.D., CLP
May 21, 2018

      Three years after a previous legal battle between Sequenom and Ariosa ended in a difficult loss for Sequenom (in what some commentators have characterized as a misapplication of the holding in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012)), Sequenom and its exclusive licensee Illumina have just this week filed a new patent infringement case against Ariosa Diagnostics, its parent Roche Molecular Systems, Inc. and sister company Roche Sequencing Solutions, Inc.,  in the US District Court for the Northern District of California San Francisco Division, for patents covering DNA testing in pregnant women. <... Read more

Anacor Pharmaceuticals, Inc. v. Iancu

Attorney: Tia D. Fenton
May 17, 2018

On May 14, 2018, in Anacor v. Iancu, the Federal Circuit issued its opinion affirming the Board's invalidation of Anacor's tavaborole patent. The patent-in-suit, U.S. Patent No. 7,582,621, entitled "Boron-containing Small Molecules," is directed to the use of tavaborole to treat fungal infections. According to the disclosure, tavaborole can be used to treat a fungal infection known as onychomycosis, which is a nail disease responsible for approximately half of all nail disorders in humans. In an inter parties review, the Patent Trial and Appeal Board found all of the claims of the '621 patent unpatentable for obviousness. Anacor appealed with respect to only one of the claims and the Federal Circuit affirmed.... Read more

"Clearing Out Invalid Patents" Insufficient for Declaratory Judgment Jurisdiction

Attorney: Jacob A. Doughty
May 15, 2018

In the recent AIDS Healthcare Foundation v. Gilead opinion, the Federal Circuit considered whether AHF's desire to "‘clear out the invalid patents' so that it ‘would have the ability then to partner with generic makers'" immediately upon expiration of the five-year NCE exclusivity for the antiviral agent tenofovir alafenamide fumarate (TAF) was sufficient to give rise to declaratory judgment jurisdiction. It was not.... Read more

USPTO Webinar on Subject Matter Eligibility

Attorney: Daniel J. Pereira, Ph.D.
May 3, 2018

The USPTO announced that Deputy Commissioner for Patent Examination Policy Robert Bahr will be presenting a webinar pertaining to Subject Matter Eligibility on May 8, 2018 at noon (Eastern Time). See, https://www.uspto.gov/patent/initiatives/patent-quality-chat. The webinar "will discuss the USPTO's recently-issued memorandum implementing changes to examination procedure in view of the U.S. Court of Appeals for the Federal Circuit decision in Berkheimer v. HP, Inc. This judicial decision provides clarification on the subject matter eligibility analysis." See also: https://www.oblon.com/publications/uspto-issues-memorandum-and-publishes-fed-reg-notice-for-comment-regarding-101-eligibility/... Read more

Biosimilars IPRs: Any Lessons From PTAB Institution Decisions On Coherus Petitions?

Attorney: Jeffrey B. McIntyre
May 2, 2018

In March, the PTAB denied institution of Coherus's IPRs against Hoffman-LaRoche (2017-1916 and 2017-2066). Previously, however, the PTAB instituted Coherus's early IPRs against Abbvie (2016-172, 2016-0188, and 2016-0189). Can any lessons be learned from the different outcomes in these cases?... Read more

Jurisdiction for "Late Listed" Orange Book Patent and Injunction Based on Induced Infringement by Drug Label

Attorney: Yuki Onoe
April 25, 2018

As re ported earlier, the Federal Circuit in Vanda Pharm. Inc. v. West-Ward Pharm. Int'l. Ltd. held that jurisdiction exists under 35 U.S.C. § 271(e)(2) for a "late listed" Orange Book patent. The Court also decided that an injunction is available to prevent inducement of infringement by a label.... Read more

USPTO Issues Memorandum and Publishes Fed Reg Notice for Comment Regarding 101 Eligibility

Attorney: Daniel J. Pereira, Ph.D.
April 23, 2018

On April 20, 2018, the USPTO published (https://www.gpo.gov/fdsys/pkg/FR-2018-04-20/pdf/2018-08428.pdf) in the Federal Register a "Request for Comments on Determining Whether a Claim Element is Well-Understood, Routine, Conventional for Purposes of Subject Matter eligibility" that references a memorandum to the Examiner Corps the day before pertaining to examination procedure regarding Subject Matter Eligibility (https://www.uspto.gov/sites/default/files/documents/memo-berkheimer-20180419.PDF). The public comment period ends on August 20, 2018.... Read more

Federal Circuit Rules in Favor of Patent Eligibility

Attorney: Richard D. Kelly
April 16, 2018

On April 13 the Federal Circuit affirmed the lower court decision in Vanda Pharm. Inc. v. West-Ward Pharm. Int'l. Ltd., appeal Nos. 2016-2707 and 2016-2708. The opinion addresses a number of concerns in ANDA litigation including whether jurisdiction exists under 35 U.S.C. § 271(e)(2) for a "late listed" Orange Book patent (it does), the availability of an injunction to prevent inducement of infringement by a label (it is available), and the patent eligibility of a claim to using a drug based upon the results of a diagnostic technique. It is this latter point which is of significant importance. Claim 1 of the patent (USP 8,586,610 (‘610)):... Read more

Using Expert Testimony in Prosecution

Attorney: Stephen G. Baxter, Ph.D.
April 13, 2018

The recent decision by the Federal Circuit in In re Merck & Cie shows what an uphill battle it can be to overcome a finding of obviousness by the PTAB. Merck argued that the PTAB's interpretation of the prior art, van Etten et al., was simply unreasonable and, thus, the PTAB's decision was not supported by substantial evidence.... Read more

Can Commercial Success save your TC 1600 patent from IPR? Probably not

Attorney: Lisa M. Mandrusiak
April 9, 2018

In an attempt to understand the frequency of commercial success arguments and the likelihood of success of those arguments in TC 1600 IPRs, I used information from Oblon's TC 1600 library to compile statistics. As seen below, commercial success is not often relied upon, even for IPRs challenging patents covering named drugs. And, digging into the details of the cases reveals that—even when argued—commercial success very rarely wins the day.... Read more

MPEP § 706.03(y) – Improper Markush Groups Unpatentable

Attorney: Richard D. Kelly
April 2, 2018

As others have observed, the January 2018 MPEP revision instructs the examiners to reject Markush claims. It asserts that "this is a rejection on the merits and may be appealed to the Patent Trial and Appeal Board." Page 700-110. In form ¶ 8.40 it asserts as authority In re Harnisch, 631 F.2d 716, 721-2(CCPA 1980) and Ex Parte Hozumi, 3 USPQ2d 1050, 160 (Bd. Pat. App. & Int. 1984). No statutory authority exists since it has been held the restriction statute, 35 USC § 121 does not provide a basis for a substantive rejection of a claim. In re Weber, 580 F.2d 455 (CCPA 1978) and In re Haas, 580 F.2d 461 (CCPA 1978).... Read more

In Re Urvashi Bhagat: One More Decision Denying Patent Eligibility of Nature-Based Product Claims

Attorney: Marina I. Miller, Ph.D.
March 29, 2018

Urvashi Bhagat appealed the decision of the PTAB ("the Board") affirming the examiner's anticipation rejections and the rejection under Section 101 of multiple claims in application 12/426,034. The Federal Circuit affirmed the Board's decision in the recent In re Urvashi Bhagat nonprecedential opinion. The claims of this application were directed to lipid-containing formulations comprising omega-6 and omega-3 fatty acids. The '034 application stated that dietary deficiency or imbalance of these fatty acids might lead to a variety of illnesses, and that omega-6 and omega-3 fatty acids are naturally occurring in oils, butters, nuts, and seeds. The '034 application claimed ranges and ratios of the fatty acids and other limitations.... Read more

Medical Device Start-ups: Things to Consider Regarding Intellectual Property

Attorney: James R. Love
March 23, 2018

Oblon recently participated in the Association of University Technology Managers (AUTM) annual meeting in Phoenix, Arizona (https://www.autm.net/2018-annual-meeting/home/). This conference draws over 1700 tech transfer professionals to discuss licensing and IP issues in the context of technology transfer. This year, at the AUTM meeting, a pitch and play venture competition was held where several start-up companies pitched their business opportunity for a chance to be awarded a cash prize.... Read more

A Glimmer of Hope for Diagnostic Patents (or Perhaps Just a Shimmering Mirage)

Attorney: Jacob A. Doughty
March 19, 2018

In the recent, nonprecedential Exergen opinion, a panel of the Federal Circuit considered the subject matter eligibility of a diagnostic method patent claim. The majority found a diagnostic method to be directed to patent-eligible subject matter, notwithstanding the Supreme Court's decision in Mayo and the Federal Circuit's subsequent decision in Ariosa.... Read more

Is Sovereign Immunity Dead with Respect to PTAB Proceedings?

Attorney: J. Derek Mason, Ph.D., CLP
March 13, 2018

There has been a lot of discussion recently regarding claims by the Saint Regis Mohawk Tribe ("Saint Regis") of sovereign immunity as a defense against inter partes review of certain patents owned by Saint Regis. The issue came about as a result of a deal made between Allergan and Saint Regis under which Allergan (the original owner of the six patents involved) paid Saint Regis $13.75 million to take ownerhip of the six patents for Allergan's Restasis drug, and license them back exclusively to Allergan, with the promise of ongoing royalties. When those six patents were challenged in an inter partes review at the Patent Trial and Appeal Board (PTAB), Saint Regis asserted that the patents were shielded from such inter partes review by the theory of tribal sovereign immunity, by extension of a 2017 PTAB ruling that the University of Florida (as a state entity of the state of Florida) was immune to such IPR challenge by Covidien LP. In other decisions, the PTAB has reiterated that state sovereign immunity applies in IPR's.... Read more

The Trials and Tribulations of Patent Eligibility of Natural Products at the PTAB

Attorney: Daniel J. Pereira, Ph.D.
March 8, 2018

As patent prosecution practitioners, we often look for direction from the judges at the PTAB, particularly when agreement cannot be reached at the examining level. This is very evident when there is imprecise guidance as to what constitutes patent eligible subject matter for inventions including natural products following the Supreme Court's decision in Myriad as well as the various iterations of PTO guidance and training materials. Here is a tale of two cases with two different panels (yet each panel interestingly includes one common APJ (New)) and each panel renders very different decisions.... Read more

Apotex v. OSI Pharmaceuticals: Beware What You Say To The SEC

Attorney: Jeffrey B. McIntyre
February 12, 2018

In a recent IPR between Apotex v. OSI Pharmaceuticals, the PTAB relied on an OSI Securities and Exchange Commission (SEC) filing, a 10-K, to find the challenged claims unpatentable. (A 10-K is an SEC filing that provides a summary of a company's financial performance).... Read more

Rasuvo® Patent Survives IPR: Failure to Properly Frame Arguments Proves Fatal

Attorney: Lisa M. Mandrusiak
February 9, 2018

The PTAB recently reminded Petitioners of the importance of properly framing prior art arguments, upholding all claims of U.S. Patent No. 8,664,231 in IPR2016-01370 in a final written decision issued yesterday. The '231 patent—covering Rasuvo®, a rheumatoid arthritis drug containing high doses of methotrexate formulated for subcutaneous injection—was challenged based on two primary references: Grint (a U.S. patent) and Wyeth (a pharmaceutical label for conventional uses of methotrexate). The primary grounds for each reference were based on anticipation, and the PTAB determined that neither reference anticipated claim 1, the only independent claim of the '231 patent.... Read more