In HGS v. Eli Lilly (2011) UKSC 51, the patent at issue claimed sequences for the Neutrokine-a protein, which had been discovered using bioinformatics.  Bioinformatics, in general, uses computer programs to compare “unknown” sequences with sequences of previously characterized genes, in order to predict the function of the unknown sequence.  Thus, the patent application at issue listed many possible, and sometimes conflicting, activities of the Neutrokine-a protein, but provided no clinical data to support these predictions. 

Similar to the “utility” requirement under US law, the UK “Industrial Application” provision requires that an invention be able to be “made or used in any kind of industry, including agriculture”.  Due to the lack of substantiating data, the lower courts had found that the industrial application provision was not satisfied, and rather the application could only form the basis for a further research program. 

In a stunning reversal, the UK Supreme Court upheld the validity of the patent, holding that disclosure of the existence and structure of Neutrokine-α and its gene sequence, and its membership of the TNF ligand superfamily, taking into account the common general knowledge in the art, was sufficient to satisfy the requirement of industrial applicability.  The court was particularly influenced by two factors in its decision.  First, the BioIndustry Association intervened and submitted evidence that the UK biotech industry would be negatively impacted if the court set the industrial application bar too high, and followed the decision of the Court of Appeal.  Second, the Supreme Court found that the lower courts’ decisions were inconsistent with the EPO Technical Board of Appeal (“Board”), which had previously found the industrial applicability requirement met in a parallel proceeding in the EPO.  Although the court indicated that the reasoning of the Board is not binding, they stressed the importance “UK patent law aligning itself, so far as possible, with the jurisprudence of the EPO”.  Experts predict that the HGS decision will have a positive impact on the EP biotech industry.

More particularly, the court ruled that “any human ovum after fertilisation, and non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo,’” and that “it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of Directive 98/44 [the EP law which bars patents on inventions “where their commercial exploitation would be contrary to ordre public or morality.”].   The court also determined that the use of human embryos for scientific research is covered by the “exclusion from patentability concerning the use of human embryos for industrial or commercial purposes” under Directive 98/44. Uses of human embryos “for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it” are, however, patentable, according to the court. The court further stated, “Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.”  

This ruling extends to embryonic stem lines which were established in the laboratory many years ago and where the invention itself does not involve obtaining new embryonic stem cells. This decision is based on the argument that even established embryonic stem cell lines were originally derived from fertilized eggs.  At present, many European countries allow embryonic stem cells to be obtained from the large numbers of surplus embryos produced during fertility treatment. Several hundred such cell lines are now available to researchers worldwide. The cells, once obtained, can be grown and multiplied in the lab to give ‘cell lines’ that are able to produce an almost infinite number of embryonic stem cells and can be converted into all the different cell types of the body. This gives embryonic stem cells enormous potential for medical research and cell therapies for a range of conditions, including, e.g., Parkinson’s Disease and Alzheimer’s Disease.  

Scientists are concerned that the verdict, which is legally binding for all EU states, will drive development of stem cell therapies outside Europe.  However, there still exist other territories, such as the US, where no such ban exists.  Earlier this year, the US Supreme Court upheld President Obama’s overturning of the Bush administration’s ban on federal funding for stem cell research, making the US market more attractive than it has been previously. 

The underlying case will now return to the referring German court, which will rule on whether the invention counts as the commercial or industrial exploitation of a human embryo. It is considered likely that the patent will be found to do so and will be invalidated.

The US Patent and Trademark Office will only accept 10,000 or less applications for prioritized examination.  As of October 13, 2011, 254 applications for prioritized examination have been filed in FY2012.

The following are the requirements for requesting prioritized examination.  A Request for prioritized examination that is incomplete on the day of submission will be dismissed. 

• the utility patent application must be filed electronically via EFS-Web (plant patent applications must be filed in paper)
• a Certification and Request for Prioritized Examination must be filed – the USPTO provides form PTO/SB/424 for this purpose
• the application must be complete, i.e., an executed Oath/Declaration must be filed at the time of requesting prioritized examination
• the $4,800 prioritized examination fee must be paid
• any fees due at the time of filing the application, i.e., filing, search, examination, excess claim, excess size, processing, and publication fees, must be paid at that time
• no more than 4 independent and 30 total claims, with no multiple independent claims, may be filed with the application 

Prioritized examination will be discontinued on any application in which a Petition for Extension of Time, Notice of Appeal, Request for Suspension of Action, Interference, or Request for Continued Examination is filed or if the claims are amended to have more than 4 independent claims, 30 total claims, or to include multiple dependent language.  Further, the prioritized examination fee will not be refunded.

Legislative information may be found at http://www.senate.gov/legislative/LIS/roll_call_lists/vote_menu_112_1.htm

The USPTO’s page directed to implementation is found at http://www.uspto.gov/patents/init_events/aia_implementation.jsp

Legislative information may be found at http://www.senate.gov/legislative/LIS/roll_call_lists/vote_menu_112_1.htm

The USPTO’s page directed to implementation is found at http://www.uspto.gov/patents/init_events/aia_implementation.jsp

.XXX (known as “dot triple-X”) is a sponsored top-level domain (sTLD) intended as a voluntary option for pornographic sites on the Internet. The Board of the International Corporation for Assigned Names and Numbers (ICANN), which governs the domain name system for the Internet, voted to approve the sTLD on March 18, 2011. It went into operation on April 15, 2011.

The launch of this .XXX domain comes with a unique opportunity for brand owners, i.e., a time period termed a Sunrise Period (Sunrise “B”) between September 7, 2011 and October 28, 2011, in which brand owners can file to BLOCK their registered marks from being registered with a .XXX domain name. Although this process comes at a cost ($225 per domain name for a 10-year period), it may be worthwhile to block the association of your mark with the .XXX domain. Following this Sunrise “B” Period, it will be necessary for trademark owners to go through a more cumbersome procedure (i.e., Uniform Domain-Name Dispute-Resolution Policy (often referred to as the “UDRP”)) should a cyber squatter attempt to register another’s marks with the .XXX domain.

As a corollary to the Sunrise “Blocking” Period, there are also phase-in periods for owners of registered marks in the adult industry which wish to register their mark in this new domain (Sunrise “A”); a “Landrush”, for nonbrand-owning businesses to register .XXX domain names; and a General Availability period, for anyone to register .XXX domain names on a first-come, first-served basis.

If you would like any assistance in evaluating the impact of this new domain on your business and marks, please contact our offices.

The following YouTubeTM video by ICM Registry provides an additional summary of these changes: http://www.youtube.com/watch?v=hIDKnDSaWqE&feature=player_embedded.

An ultimate vote on H.R. 1249 is expected shortly thereafter.  Provisions of H.R. 1249 are anticipated to be effective ten to fifteen days following signature by the President.  The USPTO is actively preparing to implement the anticipated legislation, and has posted a page dedicated to this process linked HERE.

With respect to the “isolated” DNA sequences, the court found a distinction between a product of nature and a human-made invention for purposes of § 101.  The court maintained that there is a change in the claimed composition’s identity compared with what exists in nature.  In the opinion authored by Judge Lourie, the Federal Circuit panel referenced the line drawn by the US Supreme Court between compositions that, even if combined or altered in a manner not found in nature, have similar characteristics as in nature, and compositions that human intervention has given “markedly different,” or “distinctive,” characteristics.

Applying this test to the isolated DNAs in this case, the Federal Circuit concludes that the challenged claims are drawn to patentable subject matter because the claims cover molecules that are markedly different—have a distinctive chemical identity and nature—from molecules that exist in nature.  In this case, the Federal Circuit drew a distinction between “isolated” molecules and those which are merely purified.  The Court concluded that “isolated” DNA has to be chemically cleaved from their chemical combination with other genetic materials.  The court stated that when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity. Attention was also drawn to the fact that some forms of isolated DNA require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules.

With respect to the method claims, the court started with the machine-or-transformation test to assess whether the claims include transformative steps.   Claims which recited only “comparing” or “analyzing” two gene sequences were considered to fall outside the scope of § 101 because they claim only abstract mental processes.  However, where the claims included the step of “growing” transformed cells in the presence or absence of a potential cancer therapeutic, the presence of mental steps within the claim did not defeat the patent eligibility of the claims, because the steps involved physical manipulation of the cells and these steps were central to the purpose of the claimed process.

In summary, the Federal Circuit concluded that “isolated” the claimed DNA molecules were patentable subject matter under 35 USC § 101.  In addition, they concluded that a method claim which contains solely mental “comparing” or “analyzing” steps do not contain patentable subject matter.

Previous to the First Action Interview Pilot Program, the granting of interviews for utility patent application prior to the receipt of a First Office Action was at the discretion of the Examiner.  Briefly, the requirements¹ for participating in this program include the following:

1. The application must be a non-reissue, non-provisional utility application filed under 35 USC 111(a), or an international application that has entered the national stage under 35 USC 371(c).
2. No more than three independent claims and twenty total claims are permitted.
3. The subject matter of the claims must be drawn to a single invention.
4. The Request for a first action interview must be filed electronically.
5. The Request must be filed at least one day before a first Office Action on the merits.
6. The Request must include a statement that applicant agrees not to file a request for a refund of the search fee and any excess claim fees.

This program is expected to continue until at least May 16, 2012.

This OG Notice can be found at: http://www.uspto.gov/web/offices/com/sol/og/2011/week23/TOC.htm#ref11

Full opinion located at:  http://www.paed.uscourts.gov/documents/opinions/11D0613P.pdf