Patent Docs

Patent Offices Issue Warnings Regarding Fraudulent Requests for Fees

April 1, 2015

By Donald Zuhn —

Several patent offices, including the European Patent Office (EPO), United Kingdom Intellectual Property Office (UK IPO), World Intellectual Property Organization (WIPO), and Israel Patent Office (ILPO), have recently issued warnings to applicants and practitioners regarding invitations or requests to pay fees that do not come from those patent offices and that are unrelated to the processing of applications at those patent offices. The fraudulent notices purport to offer registration or publication services that are not connected to those patent offices or to any of the official publications distributed by those offices. In its warning, the EPO notes that the firms distributing such notices use names, abbreviations, and logos that are designed to make it appear that the notice has been issued by an official source, and that frequently, the notices bear a confusing similarity to documents that are actually issued by the EPO or WIPO in order to give the impression that the firms distributing the notices are acting on the behalf of the EPO or WIPO. The EPO warning advises applicants and practitioners that (emphasis in original):

Despite the misleading official look of such invoices, the services offered by these firms are unrelated to the processing of European patent applications and PCT applications by the EPO and WIPO. There is therefore no obligation to pay any invoice issued by these firms for the processing of your patent application by the EPO and WIPO. Moreover, any payment made to these firms will have no legal effect whatsoever in proceedings under the EPC and the PCT.

The EPO warning also provides 26 examples of notices that have been issued by the following firms or organizations requesting payment of "fees":

• E.C.R.-Euro Central Reg.

• EOOD Patent und Markendienst

• EPTR – European Patent and Trademark Register

• Euro IP Register

• European Patent Portal

• European Register of Brands and Patents

• Federated Organization for Intellectual Property (F.O.I.P.)

• F.O.I.P.

• IBIP – International Bureau for Intellectual Property

• International Patent and Trademark Service

• International Trademark and Patent Registration

• IP Data

• IPTG International Patent and Trademark Guide

• IPTR International Patent and Trademark Register

• Novislink Limited

• Patent Trademark Register

• PMS Patent und Markenservice AG

• Registration of International Patent

• RCE – Registre Central Européen

• RPT Servis

• TPS Trademark and Patent Service

• UPTS

• WDTP Worldwide Database of Trademarks and Patents

• WIPP – World Intellectual Property Publisher

• World Patent and Trademark Index

The warning from UKIPO includes an example of a notice from OHIM-Organization for Harmonizing in the Intern. Market.

The warning from WIPO includes a list of 91 notices requesting payment of "fees".

(We have also collected copies of notices requesting "fees" that were sent by Comm Ctr Ind Trade, CPTD – Central Patent & Trademark Database, IP Data, Patent Trademark Register, USTMS – United States Trademark Maintenance Service, UPTS, WDTP, and WIPT.)

The EPO warning concludes by noting that "[o]nly the EPO can publish and register European patent applications and patents with legal effect, and it does so automatically," and "[s]imilarly, the International Bureau of WIPO alone is responsible for the international publication of PCT applications." The EPO advises applicants and practitioners "to read carefully the content of any invitation to make payments in relation to your patent applications and patents."

Hat tip to the Reinhold Cohn Group for alerting the patent community to the warnings issued by the EPO, WIPO, UKIPO, and ILPO.
Senju Pharmaceutical Co., Ltd. v. Lupin Ltd. (Fed. Cir. 2015)

March 31, 2015

By Kevin E. Noonan —

Earlier this month, the Federal Circuit affirmed a District Court judgment of obviousness in ANDA litigation under the Hatch Waxman Act having a long provenance of earlier litigation, in Senju Pharmaceutical Co., Ltd. v. Lupin Ltd. The case involved patentee Senju Pharmaceutical's (joined by Kyorin Pharmaceutical Co. and Allergan, Inc.) suit against Lupin Ltd., Lupin Pharmaceuticals, and Hi-Tech Pharmacal in response to a Paragraph IV certification against Senju's patented ocular antimicrobial agent containing the drug gatifloxacin as claimed in re-examined U.S. Patent No. 6,333,045 and marketed under the brand name Zymar®. The patent claimed an ophthalmic formulation of the drug containing 0.01% (w/v) disodium edetate (EDTA) that improved delivery of the drug across the cornea of the eye.

In earlier litigation against Apotex (before the same U.S. District Court judge on the same patent), the generic formulation was found to infringe but the asserted claims were found invalid for obviousness. Thereafter, the patentee submitted a request for ex parte reexamination containing all of the art cited at trial. This resulted in cancellation of all but one of the claims asserted against Apotex and a reexamination certificate containing additional claims having limitations that overcame the grounds of obviousness found by the District Court.

Senju and co-plaintiffs filed the lawsuit that is the subject of this appeal against Lupin, asserting the re-examined claims against generic formulations comprising 0.5% w/v gatifloxacin and 0/3% w/v gatifloxacin. The District Court, keeping in mind its earlier obviousness determination (according to Senju) again invalidated the re-examined claims as being obvious while finding that if valid Lupin's generic formulation would infringe the re-examined claims.

The Federal Circuit affirmed, in an opinion by Judge Plager joined by Judge Moore, with Judge Newman dissenting. The opinion exhaustively set forth the arguments from both sides, the Court setting forth these arguments but little regarding the District Court's grounds for finding the claims obvious; claims 6 and 12 are as follows:

6. A method for raising corneal permeability of an aqueous pharmaceutical Gatifloxacin eye drop solution comprising Gatifloxacin or its salt, having a pH of from about 5 to about 6 containing from about 0.3 to about 0.8 w/v% Gatifloxacin or its salt, which comprises incorporating about 0.01 w/v% disodium edetate into [eye drops containing Gatifloxacin or its salt] said Gatifloxacin eye drop solution.

12. An aqueous liquid pharmaceutical eye drop solution which comprises from about 0.3 to about 0.8 w/v% Gatifloxacin or its salt, about 0.01 w/v% disodium edetate, and wherein the aqueous liquid pharmaceutical solution has a pH of from about pH 5 to pH 6.

(following the convention that the italicized portions of the claims were added during reexamination and the bracketed portions deleted).

The majority found Senju's arguments to be unavailing, specifically that the District Court had improperly included her earlier judgment concerning obviousness and thus lowered Lupin's burden for satisfying the clear and convincing evidence standard for invalidating the claims, and further not considering the limiting amendments made during reexamination. The opinion identified two primary arguments on the merits put forth by Senju: (1) the District Court erred by finding that the prior art taught using 0.01 w/v% EDTA in an ophthalmic formulation would work to increase corneal permeability; and (2) the District Court erred by finding appellants' proffer of evidence of unexpected results unavailing. Regarding the first argument, the Court considered the four prior art references asserted by Lupin (which were the same asserted by Apotex in the earlier litigation): "U.S. Patent Nos. 4,551,456 ("the '456 patent"), 4,780,465 ("the '465 patent"), and 4,980,470 ("the '470 patent"), and Grass 1985 [Effects of Calcium Chelating Agents on Corneal Permeability, 26 Investigative Ophthalmology & Visual Science 110 (1985)]." These references taught other examples of topical administration of quinolones (including norfloxacin and lomefloxacin) for treating bacterial infections in the eye, in formulations containing EDTA as a "conventional excipient" at 0.01 w/v% concentrations. One of the references, the '470 patent, taught that gatifloxacin was "an improvement over the prior art quinolones in that it exhibits a broader antibacterial activity, higher selective toxicity and safe oral and parenteral administration." And the Grace reference taught using EDTA to improve corneal permeability, albeit at concentrations much (~50-fold) higher than the 0.01 w/v% specified in the '045 patent's claims. However, the lower concentration (and its efficacy with regard to increased corneal permeability) was disclosed in additional references not earlier considered (including two additional Glass references, which showed concentrations of 0.1, 0.05, and 0.01 w/v% EDTA in quinolone formulations, and the Rojanasakul reference which showed enhanced corneal permeability even at EDTA concentrations of 0.00037 w/v%).

The Federal Circuit, like the District Court, also rejected Senju's argument that two additional references, the Mitra reference and the Kompella reference, supported their non-obviousness argument by teaching away from the combination of other references. The opinion further rejected Senju's argument that, because the references were published "at least eight years" prior to their earliest filing date their claims should not be considered obvious over these references (apparently taking the position that if their invention was obvious at its filing date the references would have motivated the skilled worker to combine them prior to that date). (The Court held that this argument had been waived for not being timely advanced by Senju at trial.) The Court also held that the enhanced corneal permeability limitation was not affirmatively recited in the composition of matter claims (claims 12-16) and thus any evidence of this property was "not relevant" to the asserted non-obviousness of these claims. And absent this limitation inclusion of EDTA was merely one of several "conventional ingredients" the inclusion of which in the claimed formulations was not sufficient to render them non-obvious.

Similarly, the Federal Circuit affirmed the obviousness of claim 6, the sole method claim on the basis that the Mitra and Kompella references did not teach away from the combination of references and this combination (of all the other references of record) supported the District Court's obviousness determination. Curiously the opinion states that "[w]hile both references find success at higher EDTA concentrations, they do not provide any indication that lower EDTA concentrations would not also work," which seems to put the evidentiary shoe on the wrong foot, particularly because Senju argued that the District Court did not properly consider these references. (In her dissent, Judge Newman states in this regard: "[a] reference need not foresee a later-discovered invention and warn against it, to teach away from the discovery," citing Spectralytics, Inc. v. Cordis Corp., 649 F.3d 1336, 1343 (Fed. Cir. 2011).) The opinion also discredits Senju's argument that the art did not show that EDTA was effective at concentrations of 0.01 w/v% based on teachings in the art of concentrations of this component of the claimed formulation that were 30-50-fold higher. The opinion cites with approval disclosure in the cited art that any amount of EDTA increased corneal permeability, even amounts showing no statistically significant increase over control. Finally, the opinion appears to defer to the District Court's crediting of Lupin's witnesses over Senju's (not heretofore mentioned in the opinion) to support its decision affirming the obviousness determination below.

The Federal Circuit approved of the District Court's disregard for evidence of unexpected results put forward by Senju, on the grounds that the results were "a product of routine optimization that would have been obvious to one of skill in the art," again deferring to the credibility determinations of the District Court (and despite the same evidence having been considered sufficient to overcome an obviousness rejection during the re-examination, i.e., under a much lower evidentiary burden). In view of the higher burden at trial, the following statement in the opinion seems somewhat baffling:

We further conclude that the district court properly applied a presumption of validity, considering both the evidence of obviousness and the evidence of unexpected results, to find that appellees set forth clear and convincing evidence of invalidity in this case. See Sciele Pharma Inc., 684 F.3d at 1260. We agree that it was not clear error for the district court to conclude that the unexpected results evidence that Senju relied upon during reexamination, [] did not withstand scrutiny by Lupin's experts and the district court. Ultimately, the district court properly concluded that the theories presented during reexamination proved too weak when challenged in a judicial forum to rise to the level of unexpected results sufficient to rebut a strong case of obviousness. See Proctor & Gamble Co. v. Teva Pharms. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009).

Judge Newman dissented, based on her perception that neither the District Court nor the panel majority showed proper deference to the presumption of validity for the re-examined claims and her belief that both judicial bodies misinterpreted the teachings of the cited art.

She states her understanding of the law of obviousness: "[o]bviousness is a matter of foresight, not hindsight. A determination of obviousness requires some reason or suggestion, in the prior art or in common sense, that the claimed subject matter is likely to be effective for its intended purpose," citing KSR Int'l Corp. v. Teleflex Inc., 550 U.S. 398, 420–22 (2007), and that here the evidence of record was that the art taught away from the method claimed in claim 6 as issued in the reexamination certificate. She also cites Daubert v. Merrell Dow Pharm., Inc., for the proposition that a court must not give unsupported expert testimony greater weight than the experimental data set forth in the cited art. 509 U.S. 579, 589 (1993). She asserts that "[t]he published contemporaneous statements of scientists interpreting their experiments warrant more weight than unsupported opinions appearing for the first time in litigation" and that the District Court improperly dismissed Senju's expert's testimony because he did not use "statistical analysis" to show the significance of the data supporting non-obviousness in the '045 patent specification. This failure was not enough for either the District Court or the panel majority to disregard this expert's opinion, according to Judge Newman, because "[w]ith the exception of Lupin's expert witnesses, those skilled in the art interpreted Senju's experiments as demonstrating unexpected results."

Senju Pharmaceutical Co., Ltd. v. Lupin Ltd. (Fed. Cir. 2015)
Panel: Circuit Judges Newman, Plager, and Moore
Opinion by Circuit Judge Plager; dissenting opinion by Circuit Judge Newman
USPTO Director Announces “Quick-Fix” and Anticipated Changes to PTAB Practice

March 30, 2015

By Grantland Drutchas and Andrew Williams —

On Friday, March 27, U.S. Patent and Trademark Office Director Michelle Lee issued a statement on the PTO Blog indicating several "quick-fix" and proposed rule changes. The "quick-fix" rules package will apply to all newly filed petitions before the Board, and will be implemented in pending cases by APJs through scheduling orders effective immediately. The second proposed-rules package will likely be released this summer and the community will be given an opportunity to provide feedback before the rules are finalized. These new rules packages stem from 37 written comments that the Office received when it requested feedback at the end of last year. See "Deputy Directory Lee Announces the Request for Written Comments to Help Improve PTAB Proceedings"; "PTAB Update — A Review of the First Round of Comments (Part 1)"; "PTAB Update — A Review of the First Round of Comments — Part 2". In fact, the authors of this post, along with Alison Baldwin and Lisa Schoedel, submitted one of these comments advocating that the Board adopt the same standard for construing claim terms as used by federal courts as articulated in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). See "PTAB Update — Is "Broadest Reasonable Interpretation" the Appropriate Standard?"

According to Director Lee, immediate changes include nearly doubling the number of pages for a motion to amend to up to 25 pages, along with the addition of a claims appendix. Opposition briefing and reply briefing will get a commensurate amount of additional pages. Judges will begin implementing these changes through scheduling orders effective immediately.

The increase in the number of pages allowed for a motion to amend is up from the current 15 pages, which must include the listing of the claims (unless indicated otherwise in a scheduling order). As a result, we are likely to see an increase in the number of motions being granted. Of course, it is hard to imagine any less (considering only two sets of motions have been granted in the past 2 ½ years). The patent owner was already at a huge disadvantage because of the high hurdle required to establish it was entitled to amend a claim, but the 15-page limit made it practically impossible. It is really no surprise that so few motions have been granted.

The other "quick fix" rule change will also be significant, especially as it relates to a petitioner's reply brief responding to a patent owner response. The current page limit is 15 pages, which puts the petitioner at a disadvantage in responding to the assertions made by the patent owner in response to the petition (which can be up to 60 pages for an IPR petition). Even though the petitioner initially received a commensurate number of pages when it filed its original petition, it is very difficult to anticipate every argument that the Patent Owner will raise. This is especially true with regard to secondary indicia of non-obviousness, for which the patent owner bears the burden of establishing. The page increase will relieve some of the pressure on the petitioner to anticipate every argument in the petition.

The upcoming anticipated rule changes (second rule changes) include:

• Modifying the motion to amend process;

• Adjustments to the evidence a patent owner can provide in a preliminary response; and

• Clarification of the claim construction standard as applied to expired patents in AIA proceedings.

This last noted change is somewhat disheartening, because it suggests that the Patent Office is not entertaining the possibility of changing the claim construction standard for unexpired patents. The final remaining hope of a "plain and ordinary meaning" standard may rest with Congress, which is a distinct possibility, considering such a standard has been proposed in almost every piece of legislation.

The other rule changes under consideration mentioned by Director Lee include:

• Adjustments to the scope of additional discovery;

• How to handle multiple proceedings before the Office involving the same patent;

• Use of live testimony at oral hearings;

• Whether the parties should be required to make a certification with their filings similar to a Rule 11 certification in district court litigation;

• For motions to amend, emphasizing that a motion for a substitutionary amendment will always be allowed to come before the Board for consideration (i.e., be "entered");

• For amendments to result in the issuance ("patenting") of amended claims, a patent owner will not be required to make a prior art representation as to the patentability of the narrowed amended claims beyond the art of record before the Office;

• Changes to the Trial Practice Guide to clarify usage of live testimony and to emphasize the importance of real-party-in-interest discovery; and

• A single-judge pilot program where the single judge would make the decision on whether to institute a trial.

Director Lee's full blog posting is available here.

For those interested in following the events at the PTAB, the authors are proud to announce the launch of the PTAB TRIALS group on LinkedIn, which provides up-to-date information on IPR, PGR and CBM Info. That group will continue to cover the roll-out of the new AIA post-issuance proceeding rule packages. And, of course, we will continue to cover any significant updates here on Patent Docs.
Court Report

March 29, 2015

By Sherri Oslick —

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.

Purdue Pharma L.P. et al. v. Collegium Pharmaceutical, Inc.
1:15-cv-11294; filed March 26, 2015 in the District Court of Massachusetts

• Plaintiffs: Purdue Pharma L.P.; P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies
• Defendant: Collegium Pharmaceutical, Inc.

Purdue Pharma LP et al. v. Collegium Pharmaceutical Inc.
1:15-cv-00260; filed March 24, 2015 in the District Court of Delaware

• Plaintiffs: Purdue Pharma LP; P.F. Laboratories Inc.; Purdue Pharmaceuticals LP; Rhodes Technologies
• Defendant: Collegium Pharmaceutical Inc.

The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 7,674,799 ("Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March 9, 2010), 7,674,800 (same title, issued March 9, 2010), and 7,683,072 (same title, issued March 23, 2010) following a Paragraph IV certification as part of Collegium's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture its Extampza ER product (oxycodone myristate), comparable to Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain). Also, infringement of U.S. Patent No. 8,652,497 ("Pharmaceutical Formulation Containing Irritant," issued February 18, 2014) based on Collegium's filing of its Extampza ER NDA. View the Delaware complaint here.

Helsinn Healthcare S.A. et al. v. Hospira Inc.
1:15-cv-00264; filed March 25, 2015 in the District Court of Delaware

• Plaintiffs: Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendant: Hospira, Inc.

Helsinn Healthcare S.A. et al. v. Par Pharmaceutical Companies Inc. et al.
1:15-cv-00265; filed March 25, 2015 in the District Court of Delaware

• Plaintiffs: Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendants: Par Pharmaceutical Companies Inc.; Par Pharmaceutical Inc.

Helsinn Healthcare S.A. et al. v. Hospira, Inc.
3:15-cv-02077; filed March 23, 2015 in the District Court of New Jersey

• Plaintiffs: Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendant: Hospira, Inc.

Helsinn Healthcare S.A. et al. v. Par Pharmaceutical Companies, Inc. et al.
3:15-cv-02078; filed March 23, 2015 in the District Court of New Jersey

• Plaintiffs: Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendants: Par Pharmaceutical Companies, Inc.; Par Pharmaceutical, Inc.

The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 7,947,724 ("Liquid Pharmaceutical Formulations of Palonosetron," issued May 24, 2011), 7,947,725 (same title, issued May 24, 2011), 7,960,424 (same title, issued June 14, 2011), 8,598,219 (same title, issued December 3, 2013), and 8,729,094 (same title, issued May 20, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used to prevent chemotherapy induced nausea and vomiting). View the Hospira New Jersey complaint here.

Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC
1:15-cv-00250; filed March 20, 2015 in the District Court of Delaware

Infringement of U.S. Patent No. 6,127,353 ("Mometasone Furoate Monohydrate, Process for Making Same and Pharmaceutical Compositions," issued October 3, 2000) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Merck's Nasonex® (mometasone furoate monohydrate metered nasal spray, used to treat diseases of the upper airways, including allergic and nonallergic rhinitis). View the complaint here.

Noven Pharmaceuticals Inc. v. Actavis Laboratories UT Inc.
1:15-cv-00249; filed March 20, 2015 in the District Court of Delaware

Infringement of U.S. Patent No. 8,231,906 ("Transdermal Estrogen Device and Delivery," issued July 31, 2012) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Noven's Minivelle® (estradiol transdermal system, used for the treatment of moderate to severe vasomotor symptoms due to menopause and for the prevention of postmenopausal osteoporosis). View the complaint here.

Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Breckenridge Pharmaceutical, Inc.
9:15-cv-80377; filed March 20, 2015 in the Southern District of Florida

• Plaintiffs: Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim International GMBH; Boehringer Ingelheim Pharmaceuticals, Inc.
• Defendant: Breckenridge Pharmaceutical, Inc.

Infringement of U.S. Patent No. 6,087,380 ("Disubstituted Bicyclic Heterocycles, the Preparations and the Use Thereof as Pharmaceutical Compositions," issued July 11, 2000) following a Paragraph IV certification as part of Breckenridge's filing of an ANDA to manufacture a generic version of Boehringer's Pradaxa® (dabigatran etexilate mesylate, used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation). View the complaint here.

Horizon Pharma Ireland Ltd. et al. v. Taro Pharmaceuticals USA, Inc. et al.
1:15-cv-02046; filed March 13, 2015 in the District Court of New Jersey

• Plaintiffs: Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
• Defendants: Taro Pharmaceuticals USA, Inc.; Taro Pharmaceutical Industries, Ltd.

Infringement of U.S. Patent Nos. 8,217,078 ("Treatment of Pain with Topical Diclofenac," issued July 10, 2012), 8,252,838 ("Diclofenac Topical Formulation," issued August 28, 2012), 8,546,450 ("Treatment of Pain with Topical Diclofenac," issued October 1, 2013), 8,563,613 ("Diclofenac Topical Formulation," issued October 22, 2013), 8,618,164 ("Treatment of Pain with Topical Diclofenac," issued December 31, 2013), and 8,871,809 ("Diclofenac Topical Formulation," issued October 28, 2014) following a Paragraph IV certification as part of Taro's filing of an ANDA to manufacture a generic version of Horizon's Pennsaid® (diclofenac sodium topical solution, used for the treatment of signs and symptoms of osteoarthritis of the knee(s)). View the complaint here.
Conference & CLE Calendar

March 29, 2015

March 30-31, 2015 – Post-Grant Patent Challenges at the PTAB*** (Momentum) – San Jose, CA

March 31, 2015 – "Overcoming Sect. 101 Rejections Post-Alice Corp. — Leveraging USPTO Guidance and Recent Decisions to Meet Sect. 101 Patent Eligibility Requirements" (Strafford) – 1:00 to 2:30 pm (EDT)

March 31, 2015 – "Trade Secret or Patent Protection? Making the Right Choice for Your University’s Innovations" (Technology Transfer Tactics) – 1:00 to 2:00 pm (Eastern)

April 1, 2015 – "PCT Filing and International Patent Prosecution" (American Intellectual Property Law Association)

April 2, 2015 – "IP5 Global Dossier: A New Era in Global Patent Prosecution?" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

April 7, 2015 – Biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting (U.S. Patent and Trademark Office) – 11:00 am to 5:00 pm (EDT)

April 9, 2015 – "Conducting and Analyzing Patent Searches — Strategies for Validity, Patentability, Infringement, FTO and State-of-the-Art Searches" (Strafford) – 1:00 to 2:30 pm (EDT)

April 15-17, 2015 – 2015 Spring Intellectual Property Counsels Committee (IPCC) Conference (Biotechnology Industry Organization) – St. Louis, MO

April 16, 2015 – "Patent Subject Matter Eligibility: Navigating the New USPTO Guidance — Analyzing Subject Matter and Avoiding Rejection Under the USPTO's Detailed Framework" (Strafford) – 1:00 to 2:30 pm (EDT)

April 21, 2015 – U.S. Biosimilars (American Conference Institute) – Munich, Germany

April 27-29, 2015 – M&A and Strategic Alliances in the Life Sciences Industries*** (American Conference Institute) – New York, NY

***Patent Docs is a media partner of this conference or CLE
U.S. Biosimilars Conference

March 27, 2015

American Conference Institute (ACI) will be holding a conference on U.S. Biosimilars on April 21, 2015 in Munich, Germany. ACI faculty will offer presentations on the following topics:

• Minimizing the Uncertainty Surrounding the Pathway: Insights Into USFDA’s Current Initiatives Regarding the First Wave of Biosimilars Applications
• Evaluating the Risk and Commercial Opportunity in the Emerging U.S. Biosimilars Landscape
• In-House Keynote Address
• Timing is Everything: A Cheat Sheet for Managing the Logistics of the BPCIA Exchange Process
• Biosimilars Litigation Spotlight: Immediate Action Plans for Innovators and Biosimilars to Prepare For the Battles to Come
• Incorporating Inter-Partes Review and New USPTO Procedures Into Branded and Biosimilar Litigation Strategies
• Open Floor Session: Lessons Learned so Far: Comparing and Contrasting the US and EU Biosimilars Experience

A pre-conference boot camp, entitled "Biosimilars 101: Essential Training for EU Pharmaceutical Lawyers on the Relevant US Regulatory and Legal Landscape," will be held on April 20, 2015. The boot camp will offer presentations on the following topics:

• Diving Into the Science of Biologics and Biosimilars: What Counsel Needs to Know to Formulate a Regulatory and Patent Strategy
• Understanding the Structure of the USFDA and Its Role in Approving and Regulating Biosimilars
• Delving into the Mechanics of the USFDA Biosimilars Approval Process and Section 351(k) Applications Under the Pathway
• Mastering the Essentials of New USPTO Post-Grant Proceedings For Effective Use in the Biosimilars Space — to be presented in part by Patent Docs author Kevin Noonan
• Obtaining Adequate Patent Protection in the US: Factoring Key Cases into Your Biosimilars Patent Strategy
• US Federal Trade Commission and State Law Updates: Understanding the Controversy Surrounding Competition, Substitution, and Naming in the Biosimilars Arena

The agenda for the U.S. Biosimilars conference can be found here, and additional information about the pre-conference boot camp can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee for the conference is €1195. Those interested in registering for the conference can do so here.
IPO Webinar on IP5 Global Dossier

March 27, 2015

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "IP5 Global Dossier: A New Era in Global Patent Prosecution?" on April 2, 2015 beginning at 2:00 pm (ET). Don Levin of the U.S. Patent and Trademark Office, Samson Helfgott of Katten Muchin Rosenman LLP, and John Treangen of Dow Chemical will discuss the implications of the IP5 Dossier for corporations and law firms. The IP Dossier is an international cooperative effort of the patent offices of the U.S., Europe, China, Japan, and Korea that allows the patent offices to share work. The panel will also discuss the Common Citation Document (CCD), which consolidates the prior art cited by all participating offices for the family members of a patent application.

The registration fee for the webinar is $130 (government and academic rates are available upon request). Those interested in registering for the webinar can do so here.
Cadence Pharmaceuticals Inc. v. Exela Pharmsci Inc. (Fed. Cir. 2015)

March 26, 2015

By Kevin E. Noonan —

The Federal Circuit has availed itself of another opportunity to demonstrate that the Supreme Court's recent decision in Teva v. Sandoz may be relevant in cases that are the exception rather than the rule. The Federal Circuit's decision in Cadence Pharmaceuticals Inc. v. Exela Pharmsci Inc. affirmed the District Court's findings of literal infringement, infringement under the doctrine of equivalents, and failure of the defendant Exela Pharmsci to show the claims were invalid by clear and convincing evidence.

At issue were two Cadence Pharmaceuticals patents: U.S. Patent No. 6,028,222 ("the '222 patent) and U.S. Patent No. 6,992,218 (the "'218 patent") which are directed to formulations of acetaminophen (also called paracetamol and exemplified by brands like Tylenol®). As it turns out, formulated in aqueous solution acetaminophen can break down to produce toxic decomposition products. The '222 patent claims formulations that inhibit this decomposition using a buffer and a free-radical capture agent:

1. A stable, liquid formulation consisting essentially of acetaminophen dispersed in an aqueous medium containing a buffering agent and at least one member of the group consisting of a free radical scavenger and a radical antagonist. (emphasis added)

The '218 patent claims a method for producing such formulations:

1. A method for preparing an aqueous solution with an active [principle of phenolic] nature susceptible to oxidation, which is paracetamol, while preserving for a prolonged period, comprising de-oxygenation of the solution by bubbling with at least one inert gas and/or placing under vacuum, until the oxygen content is below 2 ppm, and optionally the aforementioned aqueous solution with an active principle is topped with an inert gas atmosphere heavier than air and placed in a closed container in which the prevailing pressure is 65,000 Pa maximum, and the oxygen content of the aqueous solution is below 2 ppm, and optionally the deoxygenation of the solution is completed by addition of an antioxidant.

Cadence's product is provided as an injectable sold under the name Ofirmev® and Cadence has listed both the '222 and '218 patents in the Orange Book (also known as the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations). Litigation ensued under the Hatch-Waxman statutory scheme when Exela sent a Paragraph IV motion to Cadence asserting that the '222 and '218 patents are invalid and not infringed. The District Court found neither patents invalid but found both were infringed by Exela's generic formulations. These decisions were appealed to the Federal Circuit with regard to the infringement judgments (both literal and under the Doctrine of Equivalents) and the Court's invalidity determinations (except that Exela did not appeal the District Court's finding that the asserted claims of the '222 patent were not infringed.

The Federal Circuit affirmed in an opinion by Judge Linn, joined by Judges Reyna and Wallach. With regard to claim construction, the opinion noted that "the district court's claim constructions were based solely on the intrinsic record" and hence "the Supreme Court's recent decision in Teva does not require us to review the district court's claim construction any differently than under the de novo standard we have long applied," citing Fenner Invs., Ltd. v. Cellco P'ship, 2015 WL 570730 (Fed. Cir. Feb. 12, 2015). Accordingly, the Court then turned to the issues on appeal regarding the '222 patent, which "turned" on claim construction according to the opinion. The disputed term, "buffering agent," was construed by the District Court to mean "[a]n agent that helps the formulation resist change in pH." The Court did not adopt Exela's proposed construction that the term should mean "in an effective concentration to resist material changes in pH" based on an absence in the specification of any basis for this construction. Exela argued that the specification and prosecution history did in fact contain support for this construction, but the Federal Circuit was content to rely on the "plain and ordinary meaning" of the term because there was nothing (in its view) "in the intrinsic record [that] warrant[ed] adding requirements of effective concentration or resistance to material change." With this construction the opinion found substantial evidence that "the sodium ascorbate present in Exela's formulation as an antioxidant met the buffering agent limitation, as correctly construed" and affirmed the judgment of literal infringement of the '222 patent claims.

Regarding the '218 patent, the issue was whether reducing the oxygenation level of the acetaminophen formulation to below 2 ppm before admixture of the drug product was equivalent to reducing the dissolved oxygen levels to below 2 ppm after admixture. Exela also argued that the "vacuum stoppering step" in the claimed method was not optional (and thus the absence of this step in Exela's process avoided application of the doctrine of equivalents). The distinction between deoxygenating before (per Exela's method) or after (per the claimed method) precluded a finding of literal infringement. However, the District Court found no difference in when the formulation was deoxygenated and thus applied the doctrine of equivalents to find infringement. The Federal Circuit found no clear error in this determination, based on expert testimony from Cadence that the timing of the deoxygenation step "would have no impact on the stability of the final product." This conclusion was supported by unchallenged testimony that the final formulation is stable regardless of when the deoxygenation step takes place. The Federal Circuit opinion also agreed with the District Court that finding equivalence in deoxygenating before and after admixture of acetaminophen did not "vitiate" a claim limitation, distinguishing over Exela's citation of the Court's decision in Planet Bingo, LLC v. GameTech International, Inc., 472 F.3d 1338, 1345 (Fed. Cir. 2006). In that case, according to the opinion, the outcome was "substantially different" and that vitiation is equivalent to a determination that "the evidence is such that no reasonable jury could conclude that an element of an accused device is equivalent to an element called for in the claim, or that the theory of equivalence to support the conclusion of infringement otherwise lacks legal sufficiency." More generally, the Federal Circuit set forth its understanding (supported by copious citation) that "vitiation" "is not an exception or threshold determination that forecloses resort to the doctrine of equivalents, but is instead a legal conclusion of a lack of equivalence based on the evidence presented and the theory of equivalence asserted." The Federal Circuit again agreed with the District Court that the phrase on its own terms indicated that the step was optional ("optionally topped with an inert gas . . . and placed in a closed container in which the prevailing pressure is 65,000 Pa maximum"). In addition to the plain meaning, the opinion found support in the specification for the optional nature of this step and rejected Exela's argument that Cadence had disclaimed the optionality of this step during prosecution, saying that the evidence of disavowal was not "clear and unmistakable."

With regard to the '222 patent (and keeping in mind that the District Court decision and briefing before the Federal Circuit occurred before the Supreme Court's Teva decision), it seems likely that Exela would have benefited from independent testing and expert testimony regarding the function of the buffering agent in the formulations disclosed in the '222 patent. In view of the Teva decision it seems equally apparent that accused infringers will avail themselves of this opportunity in future infringement actions. Similarly, with regard to the '218 patent there is no mention in the opinion that the appellate record contained affirmative evidence of a difference in the formulation when deoxygenation was performed before rather than after admixture of acetaminophen in the formulation and thus no basis for either the District Court or the Federal Circuit to rule in Exela's favor.

Finally, the Federal Circuit affirmed the District Court's determination that Exela had not established by clear and convincing evidence that the '218 patent was invalid for obviousness over the '222 patent. This part of the opinion also highlights the importance of the underlying facts supporting an obviousness determination in view of the standards of review (clear error for factual matters and de novo review for the ultimate legal conclusion of obviousness). Exela was also under a heightened burden, according to the Federal Circuit, because the arguments and the art put forward by Exela had been considered by the Examiner during prosecution. Thus, the combination of the statutory presumption of validity, and the additional presumption that "the Patent Office is 'presumed to have properly done its job' when it ultimately allowed the '218 patent" (citing PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1304 (Fed. Cir. 2008), quoting Am. Hoist & Derrick Co. v. Sowa & Sons, Inc., 725 F.2d 1350, 1360 (Fed. Cir. 1984) made finding of clear error the only avenue by which Exela could prevail. The evidence was that the teachings of the cited prior art related to degradation by oxidation rather than hydrolysis, as with acetaminophen and Exela did not proffer sufficient evidence to the contrary to amount to clear error in the district court's conclusion.

While not particularly unconventional, this decision highlights a tendency for legal questions (obviousness, claim construction, enablement) to be much more a matter to the underlying facts than had been the case heretofore. As a consequence, Federal Circuit review of these questions may be less frequently de novo and district courts may be entitled to greater deference based on their factual determinations. Which, of course, merely enhances the value of patent practitioners who can adduce the necessary evidence at trial now that it has become evident that they will need to do so.

Cadence Pharmaceuticals Inc. v. Exela Pharmsci Inc. (Fed. Cir. 2015)
Panel: Circuit Judges Reyna, Linn, and Wallach
Opinion by Circuit Judge Linn
WIPO Releases Data on 2014 International Patent Filings

March 25, 2015

By Donald Zuhn —

Last week, the World Intellectual Property Organization (WIPO) released data on 2014 international application filings under the Patent Cooperation Treaty (PCT). WIPO noted that U.S. and Japanese filings accounted for almost half (48.5%) of all PCT filings last year, with total filings coming in at just under 215,000, a 4.5% increase over the previous year. The rest of the top 10 consisted of China, Germany, South Korea, France, the United Kingdom, the Netherlands, Switzerland, and Sweden. Among the top three countries, filings in which the U.S. was primary country of origin were up 7.1% over the prior year, Japanese filings were down 3%, and Chinese filings were up 18.7%. A complete list of filings by country of origin can be found here.

WIPO also released a list of top PCT applicants, which not surprisingly was dominated by hi-tech companies. While few life sciences companies cracked the WIPO top 50, five companies or institutions that made our most recent list of top "Life Sciences" U.S. patentees (see "IPO Releases List of Top 300 Patent Holders for 2013 — Life Sciences Top 49") — BASF, Procter & Gamble, Dow, Commissariat a L'Energie Atomique et Aux Energies Alternatives, and the University of California — made it onto the WIPO list. The list of the top 50 PCT applicants can be found here.

The University of California led all educational institutions with regard to PCT filings. WIPO noted that nine of the top ten educational institutions were U.S. universities. WIPO's list of top 50 educational institutions can be found here.

WIPO also provided a list of PCT filings by field of technology, with the list divided into five categories: electrical engineering, instruments, chemistry, mechanical engineering, and other fields. Computer technology accounted for the largest share of PCT applications in 2014, with 8.4% (17,653 applications, up 19.4% since 2013). Digital communications (7.7%) and electronic machinery (7.3%) rounded out the rest of the top three technology fields. In the chemistry category, PCT filings were up 2.8% to 5,874 for biotechnology and up 4.1% to 8,568 for pharmaceuticals in 2014. However, WIPO noted that relative to the total number of PCT filings, the share of pharmaceutical filings has steadily declined since 2007. Among the top pharmaceutical filers in 2014 Merck Sharp & Dohme Corp. (171 applications), Novartis AG (141), F. Hoffmann-La Roche AG (135), and the University of California (111). WIPO also noted that while universities and public research organizations are responsible for 26% of pharmaceutical PCT filings, these entities are only responsible for 4.6% of computer technology filings and 2.8% of digital communication filings. A complete list of PCT filings by technology field can be found here.

WIPO also released the following infographic, while summarizes some of the data for PCT application filings in 2014.
The ACLU, Working for the Man

March 24, 2015

By Kevin E. Noonan —

The ACLU championed its efforts in the AMP v. Myriad case as being another instance of the group fighting for the rights of the many and the powerless against corporate America and the oligarchical few. In a paradox, it now seems that the fruits of their efforts are to have empowered just those whom it has traditionally opposed, and that the question of whether personalized medicine will become widely available is in the hands of insurance companies and large diagnostic testing providers (who traditionally have not needed to rely on patent protection in view of their economic clout).

To better appreciate the irony it is useful to compare the history of the most successful personalized medicine effort to date, Myriad's BRCA gene tests for breast and ovarian cancer, with an alternative history premised on the Supreme Court's Myriad decision being rendered 10-15 years earlier that it was. Absent the prohibitions produced by the Myriad decision, Myriad had its patent exclusivity to rely upon in building its BRCA gene testing business. This began in 1997, three years before the announcement of the results of the Human Genome Project. At that time, genetic testing was in its infancy, and at best BRCA gene testing was considered "experimental": Myriad did not have anything other than genealogical data showing an association of genetic variants in the descendants of women who had dies of breast cancer, and had identified a few dozen specific variants. The reliability of the testing could also be reasonably brought into question because Myriad detected several "variants of unknown significance" (VUS), where the genetic sequence identified in a particular patient was different from the "typical" genetic sequence, but there was insufficient genealogical information. In addition, women having the BRCA gene mutation who suffer from breast or ovarian cancer are a small subset of the totality of breast or ovarian cancer sufferers, with frequencies in line with other diseases having a heritable genetic propensity.

Into this situation came Myriad, who armed with its patent exclusivity was able to obtain investors who permitted it to grow the business of testing women for the genetic mutations that indicated a high likelihood of developing cancer. (It should also be appreciated that the increased risk of breast or ovarian cancer for women bearing a BRCA gene mutation is much higher than is the case for other cancers, making this an anomaly for genetic diagnostic tests.) The investment was not only in laboratories, lab technicians and supplies; Myriad had to enlist a nationwide network of genetic counselors to provide women with the information they would need should their test indicate a propensity (~90%) for developing breast or ovarian cancer, as well as educating ob/gyn doctors about the test. While the latter can be discounted as marketing, Myriad also had to take on public and private insurers to have them pay for the test, and this needed to be done on a state-by-state basis. Indeed, acceptance of Myriad's BRCA test as being significantly reliable as to deserve coverage varied from state to state over the past 18 years since Myriad's BRCA gene patents were obtained.

None of this was (solely) altruism, of course; Myriad was running a business. But whether society benefited from Myriad's efforts can best be considered by comparison to that alternative history, where Myriad did not have exclusivity over BRCA gene tests.

This history can be predicated on an earlier enunciation of the Supreme Court's decision, or more easily by presuming that Mary Claire King or other researchers cloned the BRCA genes before Myriad and, as they have stated did not protect the genes or diagnostic methods by patenting. Under this scenario the gene sequences would have been freely available to anyone, particularly university and academic medical centers, such as New York University (where Dr. Harry Ostrer, one of the named plaintiffs in the Myriad case, was practicing) or the University of Pennsylvania (where other plaintiffs, Drs. Kazakian and Ganguly were working), as well as commercial entities. However, without patent exclusivity, the only commercial concerns capable of providing the service would have been unlikely to entertain the possibility, due in part to the high hurdles and costs associated with garnering acceptance from payors at that time. (Myriad didn't have a choice because BRCA testing for breast and ovarian cancer was a core business.)

Under these circumstances the role of providing genetic testing would likely have fallen to academic sources. This raises a few problems regarding the goal of making such testing broadly available and affordable. The first is geographic: while residents of cities and other locations that are the sites of major medical centers would likely have had access to BRCA gene testing it is less likely that less geographically accessible areas would have had such access. Women residing in and around Boston, or New Haven, or New York, or Philadelphia, or Washington, or Atlanta, or Dallas, or Houston, or San Diego, or Los Angeles, or San Francisco, or Portland, or Seattle, or Denver, or Rochester (MN), or Madison (WI), or Chicago, or Detroit, or Cleveland, or Buffalo, or Cincinnati, or Pittsburgh or St. Louis would have access. But women in Appalachia, or the Four Corners region of the Southwest, or rural Idaho, or Montana, or Arkansas or the Dakotas, would need the kind of outreach Myriad provided — is it reasonable to expect any of the hospitals in metropolitan areas far from these more remote (and typically impoverished) regions of the country?

Perhaps more fundamentally, is genetic diagnostic testing as performed by Myriad the best use of academic medical facilities? Academic medicine, like most academic pursuits is involved in discovering causes of disease and developing new treatments. It is also not well adapted to the type of rote performance of thousands or millions of tests under circumstances where no errors are tolerated. It is hard to contemplate university or medical center counsel being comfortable with academic or even clinical labs performing such tests; inevitably, any such testing would come in conflict (for resources, personnel, lab space) with the traditional purpose of such labs and testing, being ancillary to providing optimal patient care. And this is as it should be: patients look to these hospitals and the physicians populating them as being primarily concerned with helping them get well (while acknowledging the reality that finances and in some cases profit enter into the equation).

But if the goal is the widest proliferation of diagnostic genetic testing then the question is, what is the best way to accomplish it. The idea that academic research and medicine will be able to do so is a fantasy for at least the reasons set forth above; more importantly, such researchers are best utilized in identifying the genetic causes of disease. Thus, the question comes down to whether small, academic-based start-up biotech and diagnostic companies or larger, more corporate diagnostic testing labs will monopolize the space. As the Myriad example illustrates, start-ups must have reliable patent protection in order to establish the protocols, networks, and reimbursement infrastructure needed to sustain such a business, while the larger diagnostic companies do not. The economic advantages these larger companies have will typically be enough for them to out-compete a startup, even one with better understanding of the science and technology. This is true upon inspection: for the startup one or a few genetic tests may be the only product they have to sell, while larger, more established diagnostic testing labs have a much larger product list (and much longer history with diagnostic customers) to sustain them while they adapt to a disruptive new technology like genomic testing.

Even with this economic clout success is not certain, because part of the impetus for startup companies such as Myriad to aggressively advocate for payors to reimburse patients for the testing stem from the reality that this is usually the only way such companies will survive. Larger companies have far less motivation for new technology (think Xerox/IBM vs. Microsoft/Apple) even if there is perceived profit in it. One example of this situation is reflected in a paper in Genetics in Medicine from the American College of Medical Genetics and Genomics published February 25, 2015. In this paper, the College provides a policy statement, arguing that payors should be willing to reimburse genetic testing costs even when the effects of these tests on clinical outcome in unclear:

Clinical utility for genetic tests was discussed in 1998 by the US Task Force on Genetic Testing. The Task Force specifically stated that "the development of tests to predict future disease often precedes the development of interventions to prevent, ameliorate, or cure that disease in those born with genotypes that increase the risk of disease. Even during this therapeutic gap, benefits might accrue from testing. "http://www.genome.gov/10001733. In the broadest sense, "clinical utility" refers to the likelihood that a given intervention (in this case, genetic information) will lead to an improved health outcome (http://www.phgfoundation.org/tutorials/clinicalUtility/) or to whether a test can provide information about diagnosis, treatment, management, or prevention of a disease that will be helpful to a consumer. http://ghr.nlm.nih.gov/handbook/testing/validtest. Establishing an etiological diagnosis is generally asserted to no longer be sufficient to claim clinical utility. Further, evidence that physicians change their management of a patient based on an etiological diagnosis is said to lack clinical utility unless clinical outcomes research has demonstrated that such changes in an individual's treatment will result in benefit. http://www.palmettogba.com/palmetto/moldx.nsf/MolDX_Manual.pdf. Moreover, coverage decision-making policy is now driven by a narrowed perspective that clinical benefit accrues only to the individual receiving the services. [emphasis added]

The College disagrees with this "narrow view" that only tests directly related to improved clinical outcomes should be recompensed. The article expresses the view that such testing should be considered for its "effects on diagnostic or therapeutic management, implications for prognosis, health and psychological benefits to patients and their relatives, and economic impact on health-care systems." Examples include those familiar to anyone who has taken Myriad's BRCA test: not only the benefit of an individual knowing her genetic status, but how that knowledge impacts the likelihood that her relatives will also have the test and know their risk (something for which Myriad charged much less than the widely reported $3,000-4,000 for the BRCA gene test). "Current models" of these benefits "define utility as either (i) clinical benefit specific to the individual receiving the service or (ii) "personal" benefit because it applies to other family members or because the result may suggest interventions that are less well defined. Grosse & Khoury, 2006, "What is the clinical utility of genetic testing?," Genet Med 8:448–450; Robson et al., 2010, American Society of Clinical Oncology policy statement update: genetic and genomic testing for cancer susceptibility. J Clin Oncol 28:893–901. This paradigm "frames the utility of genetic and genomic information too narrowly and fails to acknowledge that information regarding significant genetic risks can enable highly actionable — indeed, life-saving — interventions for individuals and their family members," according to the College. Further:

As genetic and genomic information increasingly enables disease prevention and reproductive planning, a narrow focus on medical benefit only to the individual originally tested and diagnosed is apparent as a construct of an obsolete system in which care is provided only to those with overt disease and that clinical benefit can be achieved only when a therapeutic option (i.e., a drug) is available.

Contrary to the predictions of the ACLU and many on its side of the debate, the Myriad decision has not led to an idyllic world of genetic diagnostics (an outcome aided by the Court's other decision negatively affecting the competitive position of startup companies, Mayo v. Prometheus). It will be instructive to see how BRCA gene testing progresses in the aftermath of Myriad "giving up the ghost" on its efforts to maintain a modicum of exclusivity with the Federal Circuit's invalidation of many of Myriad's remaining genetic testing claims. Many companies, including some large diagnostic testing labs, have entered these waters, but it is too soon to know how reimbursement, costs and accessibility are affected.

There is one way that a small company can maintain its exclusivity which forms Myriad's only remaining competitive advantage. Taking advantage of being the "first mover" in this space, Myriad has accumulated a large database of undisclosed "variants of unknown significance" (VUS) in the BRCA genes, the significance of which is not unknown to Myriad. Thus, even now an ob/gyn is faced with the quandary of advising a patient to have the "Brand X" test (which may be cheaper although how much cheaper is an unanswered question) or the Myriad test. If the patient has a widely known BRCA gene mutation all is well (for the physician), because she now knows how to advise her patient. If, on the other hand, the patient's genetic report contains one or several VUS's then the only responsible course would be to have the patient's sample retested (or at least reevaluated). Any benefits accruing from having the test available from parties other than Myriad thus evaporates.

Of course the larger companies have the same capacity and perhaps even moreso, which leads to the possibility that such companies will simply avail themselves of this model and keep all diagnostic testing information to themselves. In either case, the final result of the ACLU's overheated efforts will be that large corporate entities will "own" your DNA, and there will be nothing anyone can do about it. Which is something of a paradox, if not amounting to an irony.

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