Patent Docs

“Non-Practicing Lawmakers” — The Mark-up of H.R. 3309 (Innovation Act)

November 27, 2013

By Andrew Williams —

As we have previously reported, Rep. Goodlatte (R-VA), the Chairman of the House Committee on the Judiciary, introduced the "Innovation Act" (H.R. 3309) to curb abusive patent litigation, and conducted a hearing of his committee to address the merits of his bill. Last week, on November 20, 2013, the Judiciary committee "marked-up" the bill in a marathon session lasting several hours. However, other than a Manager's Amendment provided by Rep. Goodlatte (at right) the day before, and a few amendments introduced mainly by fellow Republicans, no additional changes were made to the bill despite the introduction of several amendments during the session. Most of these defeated amendments were introduced by Democrats on the committee, and they purported to address concerns that have been articulated by stakeholders about the provisions in the bill. The sense of frustration experienced by these members of Congress can be summed up in the opening remarks of Rep. Watt (D-NC), who noted that "the problem we have now is not with non-practicing entities, but with NPLs, what I call non-practicing lawmakers who have crafted legislation without consideration of how the courtroom actually operates." Nevertheless, the bill was approved by the committee in a vote of 33-5, with the "nay" votes coming from Rep. Conyers (D-MI), Rep. Scott (D-VA), Rep. Watt, Rep. Jackson Lee (D-TX), and Rep. Johnson (D-GA). A copy of the marked-up bill can be found here. The House Committee on Rules will meet on Tuesday, December 3, 2013, to take up the matter, and any House member wishing to offer an amendment must do so be 4:00 pm, Monday, December 2. It is thought that the bill will be taken up by the House next week.

For those keeping track of the various iterations of the bill, Rep. Goodlatte provided an explanation of the changes found in his Manager's Amendment. First, he explained that there were clarifications and edits to the provisions dealing with heighted pleading standards. In addition, he included changes to the joinder provision to ensure that this section is triggered when a party is unable to satisfy a fee-award pursuant to the new fee-shifting provisions. The amendments also included changes to the discovery reform section, providing courts with additional discretion to ensure that party cannot "reverse game" the system. Finally, Rep. Goodlatte explained that changes were made to various other sections to increase clarity, provide for greater discretion of the judicial conference, and comport with the recently introduced Leahy bill in the Senate. While these amendments certainly improve the language of the current bill, none of them address the underlying concerns that stakeholders have expressed about how the provisions in the bill will likely result in unintended consequences. Moreover, Rep. Goodlatte failed to highlight that his Manager's Amendment also did away with the proposed changes to the Covered Business Method Patent Reviews section of the America Invents Act ("AIA"). The original draft had sought to repeal the sunset provision and increase the scope of these reviews. Nevertheless, removal of this section appears to have received mixed reviews from the community.

The only other accepted amendment that required a roll-call vote was introduced by Rep. Jeffries (D-NY). This amendment changed the wording of the fee-shifting provision from an awarding of fees "unless the court finds that the position and conduct of the nonprevailing party or parties was substantially justified or that special circumstances make an award unjust," to "unless the court finds that the position and conduct of the nonprevailing party or parties were reasonable justified in law and fact or that special circumstances (such as severe economic hardship to a named inventor) make an award unjust" (emphasis added). This amendment passed with only two Representatives voting against it — Rep. Conyers and Rep. Johnson. This certainly improves the provision, and would presumably give courts more discretion in shifting fees. However, it does not address the concerns of stakeholders that this essentially shifts U.S. patent litigation to a "loser pays" systems, barring a justification finding by the court. In fact, Rep. Watt attempted to introduce an amendment that would do just that, by amending the current § 285 Attorney fees provision to read: "The court in appropriate cases may award reasonable attorney fees to the prevailing party." This, of course, would have removed the "exceptional" language that has been thought to be the main barrier to the awarding of such fees. Unfortunately, the amendment of Rep. Watt failed by a margin of 12-23.

There were a few other amendments that were accepted by the committee that did not require a roll-call vote. First, Rep. Chaffetz (R-UT) offered a bipartisan amendment to include a "Sense of Congress" regarding demand letters. This provision provided that Congress has a "sense" that demand letters are getting out-of-hand. The provided remedy would prevent a patent holder from establishing willful infringement if did not have evidence of pre-suit notification, including particulars of the patents at issue and the accused products or processes. Despite opposition from members such as Rep. Conyers, who pointed out that the amendment appears to "punish plaintiffs . . . when they may not know all of the details of how the defendant infringes the patent," the amendment passed by voice vote. Rep. Marino (R-PA) proposed that the Director of the Patent Office study the issue of demand letters, and Rep. Issa (R-CA) proposed that the GAO study the issue of business method patent quality. Both of these amendments easily passed. The final amendment that passed by voice vote was introduced by Rep. Richmond (D-LA), and it included apparently non-controversial changes to address the protection of small businesses, minorities, and veterans.

The mark-up session took such a long time because amendments were introduced that would have removed or changed most of the provisions found in the "Innovation Act." Part of the problem that most of the Democrats appeared to have with the bill was that there had been insufficient time to obtain the input from stakeholders in the patent community. Rep. Goodlatte defended the bill, explaining that a "discussion draft of this bill was made available to everyone in the world in May of this year." However, the "discussion draft" was significantly different than the current bill, and did not contain many of the controversial provisions. For example, the section addressing attorney fees looked more like the amendment made by Rep. Watt referred to above than it did to the provision that made it into this bill. The Democrats complained that many of these provisions could result in unintended consequences, especially without a full vetting in the community. Ironically, Rep. Goodlatte spoke out in opposition to an amendment introduced by Rep. Marino addressing demand letter abuse by stating that "the nature of this project and patent reform in general has taught us that even small changes can have unintended consequences unless they have been vetted and gone through a careful process." Fortunately, Rep. Richmand (D-LA) and Rep. Watt called him out on this inconsistency. "There are a lot of unintended consequences that I hope the members will try to address, or help us address, if we haven't closed our minds about making this a better bill that we can coalesce behind," Rep. Watt said.

We will continue to monitor and report on the progress of this bill, and the equivalent bill that has been introduced by Sen. Leahy in the Senate.

For additional information regarding this and other related topics, please see:

• "The Futility of Petitioning Congress (After the Fix Is In): Stakeholders Tell Judiciary Committee What's Wrong with Goodlatte Bill (H.R. 3309)," November 21, 2013
• "Yet Another 'Patent-Troll' Bill – Senator Leahy Introduces Patent Transparency and Improvements Act," November 20, 2013
• "Trolls Better Watch Out This Halloween — Senator Hatch Introduces Patent Litigation Integrity Act," October 30, 2013
• "House Judiciary Committee Holds Hearing on Innovation Act," October 29, 2013
• "Rep. Goodlatte Introduces "Innovation Act" to Combat Patent Trolls," October 23, 2013
• "Rep. Goodlatte Introduces Second 'Discussion Draft' of Legislation Aimed at Curbing 'Abusive Patent Litigation'," September 24, 2013
• "Coalition Opposes Expansion of AIA § 18," September 23, 2013
• "The War on Patent Trolls — Congress Prepares for Battle," September 18, 2013
• "The GAO Issues a Report on Patent Litigation Trends — It Turns Out that the Sky Is Not Falling," August 29, 2013
• "New Patent Litigation Bill Introduced in House," July 16, 2013
• "Congress Continues Efforts to 'Reform' U.S. Patent Law," June 10, 2013
Myriad Genetics Sues Invitae over BRCA Gene Testing and Invitae Sues Right Back

November 27, 2013

By Kevin E. Noonan —

The latest company targeted by Myriad Genetics for offering a genetic diagnostic test encompassing the human BRCA 1 and BRCA 2 genes is Invitae Corp. located in San Francisco. Myriad sued Invitae on Monday in the District of Utah, Central Divisions (Case No. 2:13-CV-01049-EJF; complaint), and the next day Invitae filed its own lawsuit, seeking a declaratory judgment, in the Northern District of California (Case No. 3-13-cv-05495; complaint). Myriad's complaint is similar to Myriad's complaints against other defendants, and includes infringement allegations relating to its mutY homolog (MUTYH) test for hereditary colon cancer in addition to its BRCA gene patent-based claims. Once again, Myriad is joined by the University of Utah Research Foundation, the Trustees of the University of Pennsylvania, HSC Research and Development Limited Partnership, and Endorecherche Inc.

This Complaint alleges that:

On September 10, 2013, Defendant announced that it would "add BRCA1 and BRCA2 testing in future product releases." At the 2013 Annual Meeting of the Association for Molecular Pathology held in Phoenix, Arizona from November 12-16, 2013, Defendant announced that it would begin offering its BRCA1 and BRCA2 analysis as part of its cancer-testing menu during the week of November 18, 2013. Defendant added BRCA1 and BRCA2 gene testing into the offered panel testing services promoted on its website on November 19, 2013. On information and belief, Defendant offers full gene sequencing and deletion/duplication analyses for the BRCA 1, BRCA 2, and MUTYH genes as part of multiple hereditary cancer panels that test cancer susceptibility using next-generation sequencing technology.

Myriad alleges infringement by Invitae's "making, manufacturing, promoting, marketing, advertising, distributing, offering for sale and selling and/or causing to be offered or sold certain "Hereditary Breast and Ovarian Cancer Syndrome," "High-Risk Hereditary Breast Cancers," "Women's Hereditary Cancers," and "Hereditary Cancer Syndromes" panel products." The specific claims Myriad alleges are infringed include the following: claim 6 of U.S. Patent No. 5,747,282; claims 7, 8, 12, 23, and 26 of U.S. Patent No. 5,753,441; claim 4 of U.S. Patent No. 6,033,857; claims 32 and 33 of U.S. Patent No. 6,051,379; claim 5 of U.S. Patent No. 6,951,721; claims 3, 4, 5, 6, 7, 8, 11, 14, 17, 18, 19 of U.S. Patent No. 7,250,497; claims 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 and 18 of U.S. Patent No. 7,470,510; claims 10, 11, 15, 16, 17 and 19 of U.S. Patent No. 7,622,258; claims 2, 8 and 16 of U.S. Patent No. 7,838,237; claims 2, 3, 5, 9, 10 and 12 of U.S. Patent No. 7,670,776; and claims 2 and 7 of U.S. Patent No. 7,563,571.

This complaint is unlike several of Myriad's earlier complaints, insofar as Myriad is not asserting certain patents or claims that it has asserted in past complaints. These non-asserted patents and claims include:

This claim from U.S. Patent No. 5,709,999:

Claim 6: A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1, wherein a germline alteration is detected by amplifying all or part of a BRCA1 gene in said sample using a set of primers specific for a wild-type BRCA1 gene to produce amplified BRCA1 nucleic acids and sequencing the amplified BRCA1 nucleic acids.

These claims of U.S. Patent No. 5,747,282:

Claim 16: A pair of single-stranded DNA primers for determination of a nucleotide sequence of a BRCA1 gene by a polymerase chin reaction, the sequence of said primers being derived from human chromosome 17q, wherein the use of said primers in a polymerase chain reaction results in the synthesis of DNA having all or part of the sequence of the BRCA1 gene.

Claim 17: The pair of primers of claim 16 wherein said BRCA1 gene has the nucleotide sequence set forth in SEQ ID NO:1.

These claims of U.S. Patent No. 5,837,492:

Claim 29. A pair of single-stranded DNA primers of at least 15 nucleotides in length for determination of the nucleotide sequence of a BRCA2 gene by a polymerase chain reaction, the sequence of said primers being isolated from human chromosome 13, wherein the use of said primers in a polymerase chain reaction results in the synthesis of DNA comprising all or at least 15 contiguous nucleotides of the BRCA2 gene.

Claim 30. The pair of primers of claim 29 wherein said BRCA2 gene has the nucleotide sequence set forth in SEQ ID NO:1.

These claims of U.S. Patent No. 5,654,155:

Claim 2. A method of identifying individuals having a BRCA1 gene with a BRCA1 coding sequence not associated with breast or ovarian cancer comprising:
    a) amplifying a DNA fragment of an individual's BRCA1 coding sequence using an oligonucleotide primer which specifically hybridizes to sequences within the gene;
    b) sequencing said amplified fragment by dideoxy sequencing;
    c) repeating steps (a) and (b) until said individual's BRCA1 coding sequence is completely sequenced;
    d) comparing the sequence of said amplified DNA to the sequence of SEQ. ID. NO: 1;
    e) determining the presence or absence of each of the following polymorphic variations in said individual's BRCA1 coding sequence:
    AGC and ACT at position 2201, TTG and CTG at position 2430, CCG and CTG at position 2731, GAA and GGA at position 3232, AAA and AGA at position 3667, TCT and TCC at position 4427, and ACT and GGT at position 4956;
    f) determining any sequence differences between said individual's BRCA1 coding sequences and SEQ. ID. NO: 1 wherein the presence of any of the said polymorphic variations and the absence of a polymorphism outside of positions 2201, 2430, 2731, 3232, 3667, 4427, and 4956, is correlated with an absence of increased genetic susceptibility to breast or ovarian cancer resulting from a BRCA1 mutation in the BRCA1 coding sequence.

Claim 3. A method according to claim 2 wherein said oligonucleotide primer is labeled with a radiolabel, a fluorescent label, a bioluminescent label, a chemiluminescent label or an enzyme label.

Claim 4. A method of detecting an increased genetic susceptibility to breast and ovarian cancer in an individual resulting from the presence of a mutation in the BRCA1 coding sequence, comprising:
    a) amplifying a DNA fragment of an individual's BRCA1 coding sequence using an oligonucleotide primer which specifically hybridizes to sequences within the gene;
    b) sequencing said amplified fragment by dideoxy sequencing;
    c) repeating steps (a) and (b) until said individual's BRCA1 coding sequence is completely sequenced;
    d) comparing the sequence of said amplified DNA to the sequence of SEQ. ID. NO: 1;
    e) determining any sequence differences between said individual's BRCA1 coding sequences and SEQ. ID. NO: 1 to determine the presence or absence of polymorphisms in said individual's BRCA coding sequences wherein a polymorphism which is not any of the following:
    AGC or AGT at position 2201, TTG or CTG at position 2430, CCG or CTG at position 2731, GAA or GGA at position 3232, AAA or AGA at position 3667, TCT or TCC at position 4427, and AGT or GGT at position 4956;
    is correlated with the potential of increased genetic susceptibility to breast or ovarian cancer resulting from a BRCA1 mutation in the BRCA1 coding sequence.

These claims of U.S. Patent No. 5,750,400:

Claim 2. A method of identifying individuals having a BRCA1 gene with a BRCA1 coding sequence not associated with ovarian or breast cancer disease, comprising:
    (a) amplifying a DNA fragment of an individual's BRCA1 coding sequence using an oligonucleotide primer which specifically hybridizes to sequences within the gene;
    (b) sequencing said amplified DNA fragment by dideoxy sequencing;
    (c) repeating steps (a) and (b) until said individual's BRCA1 coding sequence is completely sequenced;
    (d) comparing the sequence of said amplified DNA fragment to a BRCA1^(omi) DNA sequence selected from the group consisting of: SEQ ID NO: 1 together with SEQ ID NO: 3, SEQ ID NO: 1 together with SEQ ID NO: 5, SEQ ID NO: 3 together with SEQ ID NO: 5, SEQ ID NO: 1 together with SEQ ID NO: 3 together with SEQ ID NO: 5, SEQ ID NO: 3 and SEQ ID NO: 5;
    (e) determining the presence or absence of each of the following polymorphic variations in said individual's BRCA1 coding sequence:
        (i) C and T at position 2201,
        (ii) T and C at position 2430,
        (iii) C and T at position 2731,
        (iv) A and G at position 3232,
        (v) A and G at position 3667,
        (vi) T and C at position 4427, and
        (vii) A and G at position 4956;
    (f) determining any sequence differences between said individual's BRCA1 coding sequences and a BRCA1^(omi) DNA sequence selected from the group consisting of: SEQ ID NO: 1 together with SEQ ID NO: 3, SEQ ID NO: 1 together with SEQ ID NO: 5, SEQ ID NO: 3 together with SEQ ID NO: 5, SEQ ID NO: 1 together with SEQ ID NO: 3 together with SEQ ID NO: 5, SEQ ID NO: 3 and SEQ ID NO: 5, wherein the presence of said polymorphic variations and the absence of a variation outside of positions 2201, 2430, 2731, 3232, 3667, 4427 and 4956 is correlated with an absence of increased genetic susceptibility to breast or ovarian cancer resulting from a BRCA1 mutation in the BRCA1 coding sequence.

Claim 3. A method of identifying individuals having a BRCA1 gene with a BRCA1 coding sequence not associated with ovarian or breast cancer disease, comprising:
    (a) amplifying a DNA fragment of an individual's BRCA1 coding sequence using an oligonucleotide primer which specifically hybridizes to sequences within the gene;
    (b) sequencing said amplified DNA fragment by dideoxy sequencing;
    (c) repeating steps (a) and (b) until said individual's BRCA1 coding sequence is completely sequenced;
    (d) comparing the sequence of said amplified DNA fragment to a BRCA1^(omi)) DNA sequence selected from the group consisting of: SEQ ID NO: 1 together with SEQ ID NO: 3, SEQ ID NO: 1 together with SEQ ID NO: 5, SEQ ID NO: 3 together with SEQ ID NO: 5, SEQ ID NO: 1 together with SEQ ID NO: 3 together with SEQ ID NO: 5, SEQ ID NO: 3 and SEQ ID NO: 5;
    (e) determining the presence or absence of each of the following polymorphic variations in said individual's BRCA1 coding sequence:
        (i) C and T at position 2201,
        (ii) T and C at position 2430,
        (iii) C an d T at position 2731,
        (iv) A and G at position 3232,
        (v) A and G at position 3667,
        (vi) T and C at position 4427, and
        (vii) A and G at position 4956; and
    (f) determining any sequence differences between said individual's BRCA1 coding sequences and a BRCA1^(omi) DNA sequence selected from the group consisting of: SEQ ID NO: 1 together with SEQ ID NO: 3, SEQ ID NO: 1 together with SEQ ID NO: 5, SEQ ID NO: 3 together with SEQ ID NO: 5, SEQ ID NO: 1 together with SEQ ID NO: 3 together with SEQ ID NO: 5, SEQ ID NO: 3 and SEQ ID NO: 5, wherein the presence of said polymorphic variations and the absence of a variation outside of positions 2201, 2430, 2731, 3232, 3667, 4427 and 4956 is correlated with an absence of increased genetic susceptibility to breast or ovarian cancer resulting from a BRCA1 mutation in the BRCA1 coding sequence;
    wherein codon variations occur at the following frequencies, respectively, in a Caucasian population of individuals with no family history of breast or ovarian cancer:
        (i) at position 2201, C and T occur at frequencies from about 35 to about 45%, and from about 55 to about 65%, respectively;
        (ii) at position 2430, T and C occur at frequencies from about 35 to about 45%, and from about 55 to about 65%, respectively;
        (iii) at position 2731, C and T occur at frequencies from about 25 to about 35%, and from about 65 to about 75%, respectively;
        (iv) at position 3232, A and G occur at frequencies from about 35 to about 45%, and from about 55 to about 65%, respectively;
        (v) at position 3667, A and G occur at frequencies from about 35 to about 45%, and from about 55 to about 65%, respectively;
        (vi) at position 4427, T and C occur at frequencies from about 45 to about 55%, and from about 45 to about 55%, respectively; and
        (vii) at position 4956, A and G occur at frequencies from about 35 to about 45%, and from about 55 to about 65%, respectively.

Claim 4. A method according to claims 2 or 3, wherein said oligonucleotide primer is labeled with a radiolabel, a fluorescent label, a bioluminescent label, a chemiluminescent label, or an enzyme label.

Claim 5. A method of detecting an increased genetic susceptibility to breast and ovarian cancer in an individual resulting from the presence of a mutation in the BRCA1 coding sequence, comprising:
    (a) amplifying a DNA fragment of an individual's BRCA1 coding sequence using an oligonucleotide primer which specifically hybridizes to sequences within the gene;
    (b) sequencing said amplified DNA fragment by dideoxy sequencing;
    (c) repeating steps (a) and (b) until said individual's BRCA1 coding sequence is completely sequenced;
    (d) comparing the sequence of said amplified DNA fragment to a BRCA1^(omi) DNA sequence selected from the group consisting of: SEQ ID NO: 1 together with SEQ ID NO: 3, SEQ ID NO: 1 together with SEQ ID NO: 5, SEQ ID NO: 3 together with SEQ ID NO: 5, SEQ ID NO: 1 together with SEQ ID NO: 3 together with SEQ ID NO: 5, SEQ ID NO: 3 and SEQ ID NO: 5;
    (e) determining any sequence differences between said individual's BRCA1 coding sequences and a BRCA1^(omi) DNA sequence selected from the group consisting of: SEQ. ID. NO.: 1 together with SEQ ID NO: 3, SEQ ID NO: 1 together with SEQ ID NO: 5, SEQ ID NO: 3 together with SEQ ID NO: 5, SEQ ID NO: 1 together with SEQ ID NO: 3 together with SEQ ID NO: 5, SEQ ID NO: 3 and SEQ ID NO: 5 in order to determine the presence or absence of base changes in said individual's BRCA1 coding sequence wherein a base change which is not any one of the following:
        (i) C and T at position 2201,
        (ii) T and C at position 2430,
        (iii) C and T at position 2731,
        (iv) A and G at position 3232,
        (v) A and G at position 3667,
        (vi) T and C at position 4427, and
        (vii) A and G at position 4956, is correlated with the potential of increased genetic susceptibility to breast or ovarian cancer resulting from a BRCA1 mutation in the BRCA1 coding sequence.

Claim 6. A method of detecting an increased genetic susceptibility to breast and ovarian cancer in an individual resulting from the presence of a mutation in the BRCA1 coding sequence, comprising:
    (a) amplifying a DNA fragment of an individual's BRCA1 coding sequence using an oligonucleotide primer which specifically hybridizes to sequences within the gene;
    (b) sequencing said amplified DNA fragment by dideoxy sequencing;
    (c) repeating steps (a) and (b) until said individual's BRCA1 coding sequence is completely sequenced;
    (d) comparing the sequence of said amplified DNA fragment to a BRCA1^(omi) DNA sequence selected from the group consisting of: SEQ ID NO: 1 together with SEQ ID NO: 3, SEQ ID NO: 1 together with SEQ ID NO: 5, SEQ ID NO: 3 together with SEQ ID NO: 5, SEQ ID NO: 1 together with SEQ ID NO: 3 together with SEQ ID NO: 5, SEQ ID NO: 3 and SEQ ID NO: 5;
    (e) determining any sequence differences between said individual's BRCA1 coding sequences and a BRCA1^(omi) DNA sequence selected from the group consisting of: SEQ ID NO: 1 together with SEQ ID NO: 3, SEQ ID NO: 1 together with SEQ ID NO: 5, SEQ ID NO: 3 together with SEQ ID NO: 5, SEQ ID NO: 1 together with SEQ ID NO: 3 together with SEQ ID NO: 5, SEQ ID NO: 3 and SEQ ID NO: 5 in order to determine the presence or absence of base changes in said individual's BRCA1 coding sequence wherein a base change which is not any one of the following:
        (i) C and T at position 2201,
        (ii) T and C at position 2430,
        (iii) C and T at position 2731,
        (iv) A and G at position 3232,
        (v) A and G at position 3667,
        (vi) T and C at position 4427, and
        (vii) A and G at position 4956, is correlated with the potential of increased genetic susceptibility to breast or ovarian cancer resulting from a BRCA1 mutation in the BRCA1 coding sequence, wherein codon variations occur at the following frequencies, respectively, in a Caucasian population of individuals with no family history of breast or ovarian cancer:
        (i) at position 2201, C and T occur at frequencies from about 35 to about 45%, and from about 55 to about 65%, respectively;
        (ii) at position 2430, T and C occur at frequencies from about 35 to about 45%, and from about 55 to about 65%, respectively;
        (iii) at position 2731, C and T occur at frequencies from about 25 to about 35%, and from about 65 to about 75%, respectively;
        (iv) at position 3232, A and G occur at frequencies from about 35 to about 45%, and from about 55 to about 65%, respectively;
        (v) at position 3667, A and G occur at frequencies from about 35 to about 45%, and from about 55 to about 65%, respectively;
        (vi) at position 4427, T and C occur at frequencies from about 45 to about 55%, and from about 45 to about 55%, respectively; and
        (vii) at position 4956, A and G occur at frequencies from about 35 to about 45%, and from about 55 to about 65%, respectively.

Claim 7. A method according to claims 5 or 6, wherein said oligonucleotide primer is labeled with a radiolabel, a fluorescent label, a bioluminescent label, a chemiluminescent label, or an enzyme label.

This claim from U.S. Patent No. 6,083,698:

Claim 73. A chip array having "n" elements for performing allele specific sequence-based techniques comprising:
    a solid phase chip and
    oligonucleotides having "n" different nucleotide sequences,
    wherein "n" is an integer greater than one, p1 wherein said oligonucleotides are bound to said solid phase chip in a manner which permits said oligonucleotides to effectively hybridize to complementary oligonucleotides or polynucleotides,
    wherein oligonucleotides having different nucleotide sequence are bound to said solid phase chip at different locations so that a particular location on said solid phase chip exclusively binds oligonucleotides having a specific nucleotide sequence, and
    wherein at least one oligonucleotide is an oligonucleotide that is an isolated nucleotide that hybridizes to either a normal or a mutant BRCA1 gene selected from the group consisting of:
    a first oligonucleotide for detecting a deletion of a nucleotide in intron 6 at nucleotide number 421-2 of a BRCA1 gene sequence, wherein said first oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 421-2 of the BRCA1 gene,
    a second oligonucleotide for detecting a deletion of two nucleotides at nucleotide number 815 of a BRCA1 gene sequence, wherein said second oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 815 of the BRCA1 gene,
    a third oligonucleotide for detecting an insertion of 10 nucleotides at nucleotide number 926 of a BRCA1 gene sequence, wherein said third oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 926 of the BRCA1 gene,
    a fourth oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 1506 of a BRCA1 gene sequence, wherein said fourth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 1506 of the BRCA1 gene,
    a fifth oligonucleotide for detecting a mutation of one nucleotide at nucleotide number 2034 of a BRCA1 gene sequence, wherein said fifth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 2034 of the BRCA1 gene,
    a sixth oligonucleotide for detecting an amino acid change from serine to a stop codon at codon 770 of a BRCA1 gene sequence, wherein said sixth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 2428 of the BRCA1 gene,
    a seventh oligonucleotide for detecting an amino acid change from tryptophan to a stop codon at codon 1508 of a BRCA1 gene sequence, wherein said seventh oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 4643 of the BRCA1 gene,
    an eighth oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 5053 of a BRCA1 gene sequence, wherein said eighth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5053 of the BRCA1 gene,
    an ninth oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 5210 of a BRCA1 gene sequence, wherein said ninth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5210 of the BRCA1 gene,
    a tenth oligonucleotide for detecting an insertion of 12 nucleotides at nucleotide number 5396+40 in intron 20 of a BRCA1 gene sequence, wherein said tenth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5396+40 of the BRCA1 gene,
    an eleventh oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 5150 of a BRCA1 gene sequence, wherein said eleventh oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5150 of the BRCA1 gene,
    a twelfth oligonucleotide for detecting an amino acid change from serine to a stop codon at codon 1262 of a BRCA1 gene sequence, wherein said twelfth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 3904 of the BRCA1 gene,
    a thirteenth oligonucleotide for detecting an amino acid change from tyrosine to stop at nucleotide number 903 of a BRCA1 gene sequence, wherein said thirteenth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 903 of the BRCA1 gene, and
    a fourteenth oligonucleotide for detecting a detecting an amino acid change from threonine to proline at nucleotide number 4164 of a BRCA1 gene sequence, wherein said fourteenth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 4164 of the BRCA1 gene.

It is unclear from the complaint whether Myriad has not asserted these claims because Invitae's genetic diagnostic methods are substantially different from the other Defendants sued in other lawsuits, or if Myriad is changing its litigation strategies at least with regard to whether it can assert claims to oligonucleotide primers and probes.

Myriad and its co-plaintiffs demand a jury trial, and request judgment of patent infringement, a preliminary and permanent injunction, an accounting and damages, delivery for destruction of all "products" that infringe any of the asserted claims, a finding of willful infringement, and a request for attorneys' fees, enhanced damages, and costs of suit.

Invitae's lawsuit seeks a declaratory judgment that its genetic diagnostic tests do not infringe any of Myriad's asserted patents and (or) that these patents are invalid. In its General Allegations, Invitae asserts that it is a CLIA-certified lab "that offers customizable, clinically-relevant next-generation sequencing-based genetic testing services." Among those services are "state of the art" genetic sequencing and testing methodologies that provide "a single test for numerous genes of interest at less than the cost of most single gene tests" currently available. These tests encompass "over 200 human genes," including the human BRCA 1 and BRCA 2 as well as the MUTYH genes that are the subject of Myriad's patents. Importantly, like Quest in its declaratory judgment action, Invitae alleges that it "performs its sequencing using a very different approach" than the ways claimed in Myriad's asserted patents.

Invitae's complaint acknowledges Myriad's complaint filed in Utah, and the company asserts that it intends to file a motion to dismiss in that action. Invitae asserts that "Myriad's filing of the Utah Action, however, makes it inescapably clear that an actual and justiciable controversy has arisen and presently exists between the parties with respect to the validity and infringement by Invitae of the Myriad Patents," justifying Invitae's attempt to have the California court grant judgment of non-infringement and/or invalidity. Invitae claims that it does not use BRCA gene-specific primers, and thus that it does not infringe any of Myriad's claims reciting primer-based hybridization or sequencing methods. In addition, like other defendants, Invitae invokes the Supreme Court (and Federal Circuit) decisions in AMP v. Myriad and the Supreme Court's Mayo v. Prometheus decision for its invalidity contentions ("A vast portion of the landscape purportedly claimed by the Myriad Patents has been washed away in the wake of the Federal Circuit and Supreme Court’s decisions" in those cases, according to Invitae).

Invitae also demands a jury trial, a declaration of non-infringement and invalidity and a finding that this is an exceptional case entitling Invitae to attorneys' fees and costs.

For those keeping score, there are now five patent infringement lawsuits pending in the District of Utah, against Ambry Genetics, Gene-by-Gene, Quest, GeneDx, and Invitae, and three declaratory judgment actions by Quest, Invitae, and Counsyl, pending in various California district courts.

For additional information regarding this and other related topics, please see:

• "Where Do We Stand?" October 31, 2013
• "Defendants' Oppose Myriad's Motions to Dismiss Antitrust Counterclaims," October 28, 2013
• "Myriad Genetics Files Amended Complaint Relating to Colon Cancer Genetic Diagnostic Testing," October 23, 2013
• "Myriad Genetics Sues Quest for Patent Infringement," October 22, 2013
• "Myriad Sues GeneDx on BRCA and Other Genetic Diagnostic Patents," October 21, 2013
• "Diagnostics Giant Quest Files Declaratory Judgment Action against Myriad Genetics," October 13, 2013
• "Bay Area Genetic Diagnostics Company Files Declaratory Judgment Action against Myriad Genetics," October 10, 2013
• "Preliminary Injunction in Myriad v. Ambry and Gene-by Gene: Myriad Replies," October 9, 2013
• "Defendants' Response to Myriad's Preliminary Injunction Motions," September 19, 2013
• "Myriad Moves to Dismiss Ambry's Antitrust Counterclaims on Noerr-Pennington Doctrine," August 28, 2013
• "Amici Submit Brief in Support of Ambry Genetics and Gene by Gene," August 27, 2013
• "Ambry Responds to Myriad Lawsuit," August 7, 2013
• "Why Does Myriad Think It Can Win BRCA Gene Lawsuits?" July 30, 2013
• "Senator Leahy Urges NIH to Use March-In Rights on Myriad BRCA Test," July 17, 2013
• "Myriad Genetics Files Infringement Suit Against Gene by Gene for Genetic Diagnostic Testing of BRCA Genes," July 10, 2013
• "Myriad Genetics Files Suit Against Ambry Genetics for Genetic Diagnostic Testing of BRCA Genes," July 9, 2013
Patients Push Back on FDA Threats to 23andMe Genetic Testing Products

November 26, 2013

By Kevin E. Noonan —

In a petition published on the "We the People" portion of the White House website, a group of self-titled healthcare consumers call for the Obama Administration to overrule the FDA and permit genetic testing company 23andMe to continue to market the company's Personal Genomic Services (PGS) product. The petition is a response to the FDA sending a Warning Letter to 23andMe, threatening the company with "seizure, injunction, and civil money penalties" unless the company ceases offering its services until it obtained FDA approval under 21 U.S.C. § 321(h) as a "medical device" (see "FDA Threatens Agency Action Against 23andMe Over Personal Genetic Testing").

The text of the petition reads as follows:

We, the healthcare consumers of America, demand that we maintain access to genomics testing services like 23andMe's, which serve as a 100% privately purchased complement to government-regulated healthcare.

The FDA grossly overstates the risks associated with 23andMe's assessments. Statements such as those suggesting that dangers like false positives may "lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions" are outrageous and patently false.

Risks associated with services like 23andMe's are understood by private consumers, while the benefits of these services (such as early diagnoses for chronic diseases) are significant. The price of over-regulation is lengthy delays in potentially life-saving medical innovations.

The petition has a goal of 100,000 signatures by December 25, 2013 (according to the website) and since it went live yesterday has garnered 1,904 signatures. The website notes that the purpose of the site is to provide a new way for citizens to petition the government by exercsing their First Amendment rights. The site asserts that "[i]f a petition gets enough support, White House staff will review it, ensure it's sent to the appropriate policy experts, and issue an official response." It will be interesting to see what part of the policy apparatus of the Obama Administration responds to the petition (presuming there are enough signatures, where "enough" is undefined): that part of the Administration having a populist cast that might support the company, or the part responsible for the government's antagonism to diagnostic testing.
News from Abroad: UKIPO Decides on Correct Term of an SPC

November 26, 2013

A recent UKIPO decision will extend the term of SPCs by a few days. The decision concerned Genzyme Corporation's product colesevelam hydrochloride, which was the subject of an SPC. Genzyme disputed the term of the SPC on two grounds.

First, Genzyme argued that the term of the SPC should be calculated using the date of notification of the relevant marketing authorisation, rather than the date of the decision itself. The term of an SPC is calculated as the duration between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community, reduced by a period of five years. However, every marketing authorisation has two dates, namely the date of the decision and the date of notification (which can be up to four days later).

The UKIPO decided that it is indeed the date of notification and not the date of the decision that should be used to calculate the term of an SPC, mainly based on the wording in the TFEU that specifies that decisions (including the decision of the authorisation) take effect upon notification. Further, the applicant is not aware of the grant until the date of notification and a copy of the granted marketing authorisation is required to apply for an SPC. The earliest date an applicant can apply for an SPC is therefore the date of notification.

Secondly, Genzyme argued that the "Euratom Regulation" should be applied to the term of an SPC. This regulation determines the rules applicable to periods, dates and time limits and states that, where a period of time is calculated from the occurrence of an event, the day on which the event falls should not be part of the period itself. This would extend the term of an SPC by an additional day. However, it was held that this is not relevant as the period at issue is a period which can only be calculated after a specific event occurs, rather than a period expressed as so many hours, days, weeks, months and/or years after the occurrence of an event. In other words, the period at issue is a period between two specific events and so the regulation does not apply.

The duration of an SPC should therefore be calculated using the date of notification of the marketing authorisation, rather than the date of the decision itself. This can increase the term of the SPC by up to four days, which can be important for commercially valuable products. However, the calculation of the term should remain the same, as the Euratom Regulation does not apply.

This report comes from European Patent Attorneys at WP Thompson & Co., 55 Drury Lane, London UK. Further details and commentary can be obtained from Gill Smaggasgale, a partner at the firm.
ABA Journal Announces 2013 Blawg 100

November 25, 2013

Patent Docs Makes List for Second Year in a Row

The ABA Journal has announced its annual list of the 100 best legal blogs — or blawgs — following a nomination process that began in July. The 100 blogs selected for the 2013 list have been divided into thirteen categories: Criminal Justice, Torts, LPM, Legal Research/Legal Writing, Litigation, Niche, News/Analysis, Labor & Employment, IP, Careers/Law Schools, Courts, Legal Tech, and For Fun. Five honorees of the 2013 Blawg 100 were selected in the IP category, including Patent Docs, which was selected to the Blawg 100 for the second year in a row. The other blogs selected to the IP Law category were Biederman Blog; Hollywood, Esq.; IPWatchdog; and Rebecca Tushnet's 43(B)log.

An alphabetical list of the 2013 Blawg 100 can be found here and a list of the top blawgs sorted by category can be found here. In announcing the 2013 Blawg 100, ABA Journal Editor and Publisher Allen Pusey noted that "[i]n our 7th year selecting the Blawg 100, we recognize that it takes more than luck to make it onto our list. Bloggers with the creativity to attract readers to their blogs and keep them engaged continue to be a pleasure to celebrate each year."

Now that the ABA Journal has selected its Blawg 100 for 2013, it is asking readers to choose their favorites from among the top 100. In order to vote for your favorites, you will first have to register here (registration is free). Readers can then vote for their favorite blogs here. Voting will conclude on December 20, and the winners will be announced in January.

In addition to releasing its 7th annual Blawg 100, the ABA Journal added ten new inductees to the Blawg 100 Hall of Fame, featuring law blogs that have "consistently been outstanding throughout multiple Blawg 100 lists." Last year's inaugural list of ten blawgs included Patently-O, and this year, the ABA Journal inducted IPWatchdog to the Blawg 100 Hall of Fame. A list of the twenty Blawg 100 Hall of Fame inductees can be found here.

We would like to thank our readers for nominating Patent Docs for the Blawg 100, and we would like to thank the ABA Journal for making Patent Docs a 2013 Blawg 100 honoree.
FDA Threatens Agency Action Against 23andMe Over Personal Genetic Testing

November 25, 2013

By Kevin E. Noonan —

As reported in Fierce Medical Devices by Damian Garde, the FDA has issued a Warning Letter to personal genomics company 23andMe, demanding that the company stop selling its Personal Genomic Services (PGS) product without obtaining FDA approval. The letter characterizes the PGS product of being a "medical device" falling within the scope of Section 201(h) of the Food, Drug and Cosmetic Act (21 U.S.C. § 321(h)) and thus requiring FDA approval prior to marketing (something 23andMe has failed to obtain).

The letter was sent on November 22 by Alberto Gutierrez, Director of the Agency's Office of In vitro Diagnostics and Radiological Health and Center for Devices and Radiological Health to 23andMe's CEO Ann Wojcicki. In it, the Agency provides its rationale for determining that the company's PGS product is a device within the meaning of the statute, saying that it "is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body." The letter cites the company's website for touting the product as providing "health reports on 254 diseases and conditions" (today, the site says 260 diseases and conditions), which include "carrier status" (for the genetic predisposition of particular diseases), "health risks" and drug response[s]"(see "how it works"). Also noted in the letter are 23andMe's claims that its PGS product can be used as "[a] first step in prevention" wherein users can "take steps toward mitigating" disease like diabetes, coronary artery disease, and breast cancer (including Myriad's BRCA genes). And the letter evinces the Agency's frustration at the company's apparent recalcitrance in obtaining approval, stating that "[m]ost of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions."

The Agency's letter sets out as particular concerns inclusion of the BRCA genes in the company's tests, as well as testing related to genetically based, individualized reactions to warfarin, clopidogrel, and 5-fluorouracil "because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these." At issue is patients undergoing unnecessary prophylaxis or "self-managing" their drug dosing depending on their personal genetic proclivities, in ways that are best done under a doctor's supervision. The genetic information provided by 23andMe's PGS product could be misinterpreted or provide patients with misunderstood, incorrect, or misleading information, according to the Agency's letter.

The Agency notes that the company submitted an application under Section 510(k) for "several of these indications" but that 23andMe has "failed to address the issues described during previous interactions with the Agency," including specifically requests for additional information sent in September and November, 2012. As a consequence, 23andMe's applications are considered by the Agency to be withdrawn, meaning there are currently pending no applications for the PGS product as required by law.

The Agency attests to its willingness to "work[] with" 23andMe to assist the company in complying with Agency requirements, and cites its efforts since July 2009 in this regard. These include:

FDA has spent significant time evaluating the intended uses of the PGS to determine whether certain uses might be appropriately classified into class II, thus requiring only 510(k) clearance or de novo classification and not PMA approval, and we have proposed modifications to the device's labeling that could mitigate risks and render certain intended uses appropriate for de novo classification. Further, we provided ample detailed feedback to 23andMe regarding the types of data it needs to submit for the intended uses of the PGS. As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies.

Nevertheless, the Agency complains that it has not yet received the necessary assurances that the PSG product has been "analytically or clinically validated" for its intended uses, which have "expanded" since the company's original 510(k) submissions (and even in the past week). Despite a letter from the company in January 2013 attesting that it was "completing the additional analytical and clinical validations for the tests that have been submitted" and is "planning extensive labeling studies that will take several months to complete" that evidence has yet to be submitted. And these promises were made "months after [23andMe] submitted your 510(k)s and more than 5 years after [23andMe] began marketing" the PGS product. The litany of failure continues:

You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May.

Instead, the letter alleges, "we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS's uses and consumer base without obtaining marketing authorization from FDA."

The FDA then issues the following warning: "23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device," which will fall within the scope of the following provisions of FDA law and regulation:

The PGS is in class III under section 513(f) of the FD&C Act, 21 U.S.C. 360c(f). Because there is no approved application for premarket approval in effect pursuant to section 515(a) of the FD&C Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the FD&C Act, 21 U.S.C. 360j(g), the PGS is adulterated under section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. 351(f)(1)(B). Additionally, the PGS is misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because notice or other information respecting the device was not provided to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

The company is given fifteen days to comply, or provide a reason why it cannot comply within this time, and required to provide "the specific actions you have taken to address all issues noted above, [including] documentation of the corrective actions you have taken." If not, the Agency threatens actions which "include, but are not limited to, seizure, injunction, and civil money penalties."

Despite the copy on 23andMe's website extolling the virtues of its testing for disease prevention and mitigation, it also carries the disclaimer that the results are "intended for research and educational purposes only and [are] not intended for diagnostic use" (which in itself might implicate state consumer protection laws). The company has acknowledged the FDA's action and issued a statement, as reported on the Fierce Medical Device site that "we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us, and we are committed to fully engaging with them to address their concerns."

The Agency's actions raise interesting questions on the future of genetic testing, particularly under circumstances where the Supreme Court has raised significant barriers to obtaining patent protection for these types of testing. In such an environment there may be a much lower impetus for disclosing the "natural law" correlations between disease propensity and genetic variability, because once that disclosure is made it cannot be retracted. If patent exclusivity is not possible, there could easily arise a "tragedy of the commons," where no company is motivated to undertake the type of efforts demanded by the Agency of 23andMe just to have those efforts coopted by its competitors. In this situation, the Agency may be required to permit applicants to keep substantial portions of their submissions confidential and be satisfied by a showing that the correlation between a particular genetic variant and a particular disease is sufficiently robust to justify approval. And even that arrangement is problematical, as most confidentiality provisions in applications for government approval can be overcome on notice to the proprietor that a member of the public has filed a Freedom of Information Act request. It is hard to discern instances where there would not be intense political pressure to rescind confidentiality for genetic testing regarding a medical disease or condition, with that propensity increasing with increased reliability of the test and incidence of the disease or condition. Of course, the Agency cannot disclose what it doesn't know, so perhaps (and against the tendencies of governments and particularly science-based government agencies like the FDA) approval could be obtained without disclosing the identities of the genes involved in the testing. The perpetual nature of this state of nondisclosure is such that even if the Agency were willing to permit nondisclosure for a time it is unlikely that it would agree to less than a reasonable term, for example, 20 years from the date the application was submitted for approval. Thus it could be that in such a roundabout way Agency action could achieve what the patent system has always provided, but perhaps in a form less amenable to meddling from the Court.
Court Report

November 24, 2013

By Sherri Oslick —

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

Shire LLC et al. v. Apotex Corp. et al.
1:13-cv-24236; filed November 21, 2013 in the Southern District of Florida

• Plaintiffs: Shire LLC; Shire Development LLC; Supernus Pharmaceuticals, Inc.
• Defendants: Apotex Corp.; Apotex, Inc.

Infringement of U.S. Patent Nos. 6,287,599 ("Sustained Release Pharmaceutical Dosage Forms with Minimized pH Dependent Dissolution Profiles," issued September 11, 2001) and 6,811,794 (same title, issued November 2, 2004) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Shire's Intuniv® (guanfacine, used to treat attention-deficit hyperactivity disorder). View the complaint here.

Teijin Ltd. et al. v. Alembic Pharmaceuticals Ltd.
1:13-cv-01939; filed November 19, 2013 in the District Court of Delaware

• Plaintiffs: Teijin Ltd.; Teijin Pharma Ltd.; Takeda Pharmaceuticals USA Inc.
• Defendant: Alembic Pharmaceuticals Ltd.

Infringement of U.S. Patent No. 6,225,474 ("Polymorphs of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid and Method of Producing the Same," issued May 1, 2001) following a Paragraph IV certification as part of Alembic's filing of an ANDA to manufacture a generic version of Takeda's Uloric® (febuxostat, used for the chronic management of hyperuricemia in patients with gout). View the complaint here.

Millennium Pharmaceuticals, Inc. v. Apotex Corp. et al.
1:13-cv-08240; filed November 15, 2013 in the Northern District of Illinois

• Plaintiff: Millennium Pharmaceuticals, Inc.
• Defendants: Apotex Corp.; Apotex Inc.

Infringement of U.S. Patent Nos. 6,713,446 ("Formulation of Boronic Acid Compounds," issued March 30, 2004) and 6,958,319 (same title, issued October 25, 2005), licensed exclusively to Millennium, following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Millenium's Velcade® (bortezomib, used to treat multiple myeloma). View the complaint here.

Dow Pharmaceutical Sciences, Inc. et al. v. Perrigo Company et al.
2:13-cv-06922; filed November 15, 2013 in the District Court of New Jersey

• Plaintiffs: Dow Pharmaceutical Sciences, Inc.; Valeant Pharmaceuticals North America LLC
• Defendants: Perrigo Company; Perrigo Israel Pharmaceuticals Ltd.

Infringement of U.S. Patent No. 8,288,434 ("Topical Pharmaceutical Formulations Containing a Low Concentration of Benzoyl Peroxide in Suspension in Water and a Water-Miscible Organic Solvent," issued October 16, 2012) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of Dow's Acanya® (clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5%, used to treat acne). View the complaint here.

Janssen Pharmaceuticals, Inc. et al. v. Roxane Laboratories, Inc.
3:13-cv-00639; filed November 15, 2013 in the District Court of Nevada

• Plaintiffs: Janssen Pharmaceuticals, Inc.; Grunenthal GmbH
• Defendant: Roxane Laboratories, Inc.

Janssen Pharmaceuticals, Inc. et al. v. Sandoz Inc. et al.
2:13-cv-06929; filed November 14, 2013 in the District Court of New Jersey

• Plaintiffs: Janssen Pharmaceuticals, Inc.; Grunenthal GmbH
• Defendants: Sandoz Inc.; Roxane Laboratories, Inc.

The complaintis in these cases are substantially identical. Infringement of U.S. Patent Nos. RE39,593 ("1-Phenyl-3-Dimethylaminopropane Compounds With a Pharmacological Effects," issued April 24, 2007) and 7,994,364 ("Crystalline Forms of (-)-(1R,2R)-3-(3-Dimethylamino-1-Ethyl-2-Methylpropyl)-Phenol Hydrochloride," issued August 9, 2011), licensed to Janssen, following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Janssen's Nucynta® (tapentadol hydrochloride, used for the management of moderate to severe acute pain in adults). View the Sandoz complaint here.
Conference & CLE Calendar

November 24, 2013

December 3, 2013 – "Post-AIA Preissuance Prior Art Submissions at the USPTO — Best Practices for Third-Party Challenges to Patent Applications and for Monitoring Competition" (Strafford) – 1:00 to 2:30 pm (EST)

December 4, 2013 – Congress on Biotech & Pharma Patenting*** (C5 (UK)) – London, UK

December 5, 2013 – Forum on Biosimilars*** (C5 (UK)) – London, UK

December 9-10, 2013 – Patent Infringement Litigation Summit (Legal iQ (IQPC)) – San Francisco, CA

December 10-11, 2013 – Advanced Forum on Patent Litigation*** (American Conference Institute) – New York, NY

December 10-11, 2013 – International Patent Litigation (IBC Legal) – London, UK

December 12, 2013 – "Using Competitive Technical Intelligence Techniques to Assess University Patents" (Technology Transfer Tactics) – 1:00 – 2:00 pm (Eastern)

December 12, 2013 – "Patent Exhaustion and Licensing Strategies — Leveraging Recent Decisions for Structuring Patent Licenses and Resolving Litigation" (Strafford) – 1:00 to 2:30 pm (EST)

December 16, 2013 – "Means-Plus-Function Patent Claims After the AIA — Assessing Benefits and Risks, Surviving AIA's PGRs, IPRs and Reissue" (Strafford) – 1:00 to 2:30 pm (EST)

***Patent Docs is a media partner of this conference or CLE
Webinar on Patent Exhaustion

November 22, 2013

Strafford will be offering a webinar/teleconference entitled "Patent Exhaustion and Licensing Strategies — Leveraging Recent Decisions for Structuring Patent Licenses and Resolving Litigation" on December 12, 2013 from 1:00 to 2:30 pm (EST). Iona Kaiser of McDermott Will & Emery, and Patent Docs co-author Kevin E. Noonan, Ph.D. of McDonnell Boehnen Hulbert & Berghoff will provide guidance to counsel on the patent exhaustion doctrine and its impact on licensing and selling patented products, and offer their experiences and outline best practices for addressing patent exhaustion issues for licensing. The webinar will review the following questions:

• Is a patent exhausted by the use of an unpatented component in a sold or licensed patented product?
• What are the implications of the doctrine of patent exhaustion for patent licenses?
• Under what circumstances could licensees be making royalty payments that aren't necessary?

The registration fee for the webinar is $297 ($362 for registration and CLE processing). Those interested in registering for the webinar, can do so here.
Webinar on Means-Plus-Function Patent Claims After the AIA

November 22, 2013

Strafford will be offering a webinar/teleconference entitled "Means-Plus-Function Patent Claims After the AIA — Assessing Benefits and Risks, Surviving AIA's PGRs, IPRs and Reissue" on December 16, 2013 from 1:00 to 2:30 pm (EST). Thomas L. Irving, John Mulcahy, and Dr. Amanda Murphy of Finnegan Henderson Farabow Garrett & Dunner will provide patent counsel with a review of the benefits and limitations in using means-plus-function claims in pursuing a patent, and offer their experiences and best practices for overcoming the challenges of means-plus-function claims and leveraging Section 112(f) (aka 112, 6). The webinar will review the following questions:

• What are the benefits of using means-plus-function patent claims?
• What are the limitations of means-plus-function claims?
• What practices can counsel employ to leverage 112(f) to increase the likelihood of surviving post-grant review, inter partes review and reissue?

The registration fee for the webinar is $297 ($362 for registration and CLE processing). Those interested in registering for the webinar, can do so here.

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